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0% found this document useful (0 votes)
114 views156 pages

B Pharm

B Pharma

Uploaded by

shivanijangid741
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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BANASTHALI VIDYAPITH

Bachelor of Pharmacy

Curriculum Structure

First Semester Examination, December-2019


Second Semester Examination, April/May-2020
Third Semester Examination, December-2020
Fourth Semester Examination, April/May-2021
Fifth Semester Examination, December-2021
Sixth Semester Examination, April/May-2022
Seventh Semester Examination, December-2022
Eighth Semester Examination, April/May-2023

BANASTHALI VIDYAPITH
P.O. BANASTHALI VIDYAPITH
(Rajasthan)-304022

July, 2019 50
2

No. F. 9-6/81-U.3

Government of India
Ministry of Education and Culture
(Department of Education)

New Delhi, the 25th October, 1983

NOTIFICATION

In exercise of the powers conferred by Section 3 of the University


Grants Commission Act, 1956 (3 of 1956) the Central Government,
on the advice of the Commission, hereby declare that Banasthali
Vidyapith, P. O. Banasthali Vidyapith, (Rajasthan) shall be deemed
to be a University for the purpose of the aforesaid Act.

Sd/-
(M. R. Kolhatkar)
Joint Secretary of the Government of India

NOTICE
Changes in Bye-laws/Syllabi and Books may from time to time be
made by amendment or remaking, and a Candidate shall, except in
so far as the Vidyapith determines otherwise, comply with any
change that applies to years she has not completed at the time of
change.

© BANASTHALI VIDYAPITH
3

Sl. No. Contents Page No.


1 Programme Educational Objectives 4

2 Programme Outcomes 5

3 Curriculum Structure 7

4 Evaluation Scheme and Grading System 14

5 Syllabus 16
4

Programme Educational Objectives


Pharmacy programme deals with various aspects of modern drug design,
drug development, production and quality assurance that are the basis for
expertise in all domains of medicine. Pharmacy professionals being a
member of healthcare team are unique in their detailed and comprehensive
understanding of physical, chemical and biological interactions on the
outcomes of drug therapy. They require an understanding of drug entities
chemistry, delivery characteristics of dosage formulations, physiological
and pharmacological outcomes of drug interactions.Pharmacy curriculum
incorporate components of problem solving, case study and project work in
the areas of specialization.The main objectives of the Pharmacy programme
are:
 To provide exemplary education in a stimulating environment
where delivery of pharmaceutical knowledge is integrated with
nationally and internationally recognized research to conduct and
publish cutting-edge multidisciplinary research in the discovery,
utilization and evaluation of therapeutic agents.
 To prepare competent pharmacists at various levels for India.
 To raise sensitivity to professional ethical codes of conduct and
social values.
 To prepare globally recognized pharmacy professionals.
 To demonstrate standards of digital literacy that would support
professional needs in manufacture, patient care, hospital
administration etc.
 To create awareness in society for rationale usage of medicines.
 To create awareness about environmental hazards in relation to
GMP & GLP.
 To develop gender-neutral attitudes and practices; respect for all
races, nations, religions, cultures, languages and traditions.
 To nurture a temperament that would enable individuals to set and
work towards self-driven performance-goals, entrepreneurial
ventures and overall leadership.
5

Programme Outcomes
PO1: Pharmacy Knowledge: Possess knowledge and comprehension of
the core and basic knowledge associated with the profession of
pharmacy, including biomedical sciences; pharmaceutical science
and technology; behavioral, social, and administrative
pharmaceutical sciences; and manufacturing practices.
PO2: Planning abilities: Demonstrate effective planning abilities
including time management, resource management, delegation
skills and organizational skills. Develop and implement plans and
organize work to meet deadlines.
PO3: Problem analysis: Utilize the principles of scientific enquiry,
thinking analytically, clearly and critically, while solving problems
and making decision during daily practice. Find, analyze, evaluate
and apply information systematically and shall make defensible
decisions.
PO4: Modern tool usage: Learn, select, and apply appropriate methods
and procedures, resources, and modern pharmacy-related
computing tools with an understanding of the limitations.
PO5: Leadership skills: Understand and consider the human reaction to
change, motivation issues, leadership and team building when
planning changes required for fulfillment of practice, professional
and societal responsibilities. Assume participatory roles as
responsible citizen or leadership roles when appropriate to
facilitate improvement in health and well-being.
PO6: Professional Identity: Understand, analyze and communicate the
value of their professional roles in society (e.g. health care
professionals, promoters of health, educators, managers,
employers, employees).
PO7: Pharmaceutical Ethics: Honor personal values and apply ethical
principles in professional and social contexts. Demonstrate
behavior that recognizes cultural and personal variability in values,
communication and lifestyles. Use ethical frameworks; apply
ethical principles while making decisions and take responsibility
for the outcomes associated with the decisions.
6

PO8: Communication: Communicate effectively with the pharmacy


community and with society at large, such as, being able to
comprehend and write effective, make effective presentations and
documentation, and give and receive clear instructions.
PO9: The Pharmacist and society: Apply reasoning informed by the
contextual knowledge to assess societal, health, safety and legal
issues and the consequent responsibilities relevant to the
professional pharmacy practice.
PO10: Environment and sustainability: Understand the impact of the
professional pharmacy solutions in societal and environmental
contexts, and demonstrate the knowledge of, and need for
sustainable development.
PO11: Life- long learning: Recognize the need for, and have the
preparation and ability to engage in independent and life-long
learning in the broadest context of technological change. Self-
access and use feedback effectively from others to identify
learning needs and to satisfy theses needs on an ongoing basis.
7

Curriculum Structure
Bachelor of Pharmacy
First Year
Semester - I
Course Code Course Name L T P C*
BVF 011/ General English /lkekU; fgUnh 2 0 0 2
BVF 014
Core Foundation Course - I 2 0 0 2
PHAR 102 Human Anatomy and Physiology-I 4 0 0 4
PHAR 104 Pharmaceutical Analysis - I 4 0 0 4
PHAR 105 Pharmaceutical Inorganic Chemistry 4 0 0 4
PHAR 107 Pharmaceutics - I 4 0 0 4
PHAR 108/ Remedial Biology@/ Remedial Mathematics 3 0 0 3
MATH 110
PHAR 102L Human Anatomy and Physiology - I Lab 0 0 4 2
PHAR 104L Pharmaceutical Analysis - I Lab 0 0 4 2
PHAR 105L Pharmaceutical Inorganic Chemistry Lab 0 0 4 2
PHAR 107L Pharmaceutics - I Lab 0 0 4 2
Semester Total: 23 0 16 31
@ : Only for students who have been admitted from mathematics
background (10+2)

Semester - II
Course Code Course Name L T P C*
BVF 014/ lkekU; fgUnh/General English 2 0 0 2
BVF 011
Core Foundation Course - II 2 0 0 2
CS 102 Computer Applications in Pharmacy 3 0 0 3
PHAR 101 Biochemistry 4 0 0 4
PHAR 103 Human Anatomy and Physiology - II 4 0 0 4
PHAR 106 Pharmaceutical Organic Chemistry - I 4 0 0 4
PHAR 212 Pathophysiology 4 0 0 4
CS 102L Computer Applications in Pharmacy Lab 0 0 4 2
PHAR 101L Biochemistry Lab 0 0 4 2
PHAR 103L Human Anatomy and Physiology - II Lab 0 0 4 2
PHAR 106L Pharmaceutical Organic Chemistry - I Lab 0 0 4 2
Semester Total: 23 0 16 31
8

Second Year
Semester - III
Course Code Course Name L T P C*
Core Foundation Course - III 2 0 0 2
Elective Foundation Course - I 2 0 0 2
PHAR 204 Pharmaceutical Microbiology 4 0 0 4
PHAR 205 Pharmaceutical Organic Chemistry - II 4 0 0 4
PHAR 213 Pharmaceutical Engineering 4 0 0 4
PHAR 217 Physical Pharmaceutics - I 4 0 0 4
PHAR 219 Pharmaceutical Physical Chemistry 3 0 0 3
PHAR 204L Pharmaceutical Microbiology Lab 0 0 4 2
PHAR 205L Pharmaceutical Organic Chemistry - II Lab 0 0 4 2
PHAR 213L Pharmaceutical Engineering Lab 0 0 4 2
PHAR 217L Physical Pharmaceutics - I Lab 0 0 4 2
Semester Total: 23 0 16 31

Semester - IV
Course Code Course Name L T P C*
Core Foundation Course - IV 2 0 0 2
Elective Foundation Course - II 2 0 0 2
PHAR 211 Medicinal Chemistry - I 4 0 0 4
PHAR 214 Pharmaceutical Organic Chemistry - III 4 0 0 4
PHAR 215 Pharmacognosy and Phytochemistry - I 4 0 0 4
PHAR 216 Pharmacology - I 4 0 0 4
PHAR 220 Physical Pharmaceutics - II 3 0 0 3
PHAR 211L Medicinal Chemistry - I Lab 0 0 4 2
PHAR 215L Pharmacognosy and Phytochemistry - I Lab 0 0 4 2
PHAR 216L Pharmacology - I Lab 0 0 4 2
PHAR 218L Physical Pharmaceutics - II Lab 0 0 4 2
Semester Total: 23 0 16 31
9

Third Year
Semester - V
Course Code Course Name L T P C*
Vocational Course - I 2 0 0 2
Core Foundation Course - V/ 2 0 0 2
Elective Foundation Course - III
PHAR 313 Industrial Pharmacy-I 4 0 0 4
PHAR 403 Medicinal Chemistry-II 4 0 0 4
PHAR 317 Pharmacology-II 4 0 0 4
PHAR 316 Pharmacognosy and 4 0 0 4
phytochemistry-II
PHAR 315 Pharmaceutical Jurisprudence 4 0 0 4
PHAR 313L Industrial Pharmacy-I Lab 0 0 4 2
PHAR 317L Pharmacology-II Lab 0 0 4 2
PHAR 316L Pharmacognosy and 0 0 4 2
Phytochemistry-II Lab
Semester Total: 24 0 12 30

Semester - VI
Course Code Course Name L T P C*
Vocational Course - II 2 0 0 2
Elective Foundation Course - III/ 2 0 0 2
Core Foundation Course - V
PHAR 311 Biopharmaceutics and 4 0 0 4
Pharmacokinetics
PHAR 312 Herbal Drug Technology 3 0 0 3
PHAR 404 Medicinal Chemistry-III 4 0 0 4
PHAR 318 Pharmacology-III 4 0 0 4
PHAR 314 Pharmaceutical Biotechnology 3 0 0 3
PHAR 319 Quality Assurance 3 0 0 3
PHAR 312L Herbal Drug Technology Lab 0 0 4 2
PHAR 404L Medicinal Chemistry-III Lab 0 0 4 2
PHAR 318L Pharmacology-III Lab 0 0 4 2
Semester Total: 25 0 12 31
10

Fourth Year
Semester - VII
Course Code Course Name L T P C*
PHAR 416 Instrumental Methods of Analysis 4 0 0 4
PHAR 415 Industrial Pharmacy-II 4 0 0 4
PHAR 417 Novel Drug Delivery System 4 0 0 4
PHAR 414 Dosage Form Design 4 0 0 4
PHAR 421 Pharmacy Practice 4 0 0 4
PHAR 416L Instrumental Methods of Analysis Lab 0 0 4 2
PHAR 414L Dosage Form Design Lab 0 0 4 2
PHAR 422L Practice School 0 0 8 4
Semester Total: 20 0 16 28
Semester - VIII
Course Code Course Name L T P C*
PHAR 412 Biostatistics and Research Methodology 4 0 0 4
PHAR 425 Social and Preventive Pharmacy 4 0 0 4
PHAR 423P Project Work 0 0 16 8
Discipline Elective - I 4 0 0 4
Discipline Elective - II 4 0 0 4
Open Elective 4 0 0 4
Semester Total: 20 0 16 28

List of Discipline Elective


Course Code Course Name L T P C
PHAR 411 Advanced Instrumentation Techniques 4 0 0 4
PHAR 419 Pharmaceutical Regulatory Science 4 0 0 4
PHAR 424 Quality Control and Standardization of 4 0 0 4
Herbals
PHAR 420 Pharmacovigilance 4 0 0 4
PHAR 413 Cosmetic Science 4 0 0 4
PHAR 418 Pharmaceutical Marketing 4 0 0 4
11

List of Core Foundation Course


Course Code Course Name L T P C
BVF 002 Environment Studies 2 0 0 2
BVF 013 Indian Cultural Heritage 2 0 0 2
BVF 017 Selected Writings of Great Authors - I 2 0 0 2
BVF 015 Parenthood and Family Relation 2 0 0 2
BVF 020 Women in Indian Society 2 0 0 2

List of Elective Foundation Course


Course Code Course Name L T P C*
BVF 010 Design Thinking 2 0 0 2
BVF 012 Human Body and Health 2 0 0 2
BVF 016 Science of Happiness 2 0 0 2
BVF 019 Universal Human Values 2 0 0 2
BVF 018 Selected Writings of Great Authors - II 2 0 0 2
12

List of Vocational Course


Course Code Course Name L T P C
VOC 011L Basic Dress Making 0 0 4 2
VOC 005L Dress Designing 0 0 4 2
VOC 014 Entrepreneurship - I 2 0 0 2
VOC 015 Entrepreneurship - II 2 0 0 2
VOC 020 Radio Production - I 2 0 0 2
VOC 021 Radio Production - II 2 0 0 2
VOC 022 Web Designing and Internet Technology-I 1 0 0 1
VOC 022L Web Designing and Internet Technology-I Lab 0 0 2 1
VOC 023 Web Designing and Internet Technology-II 1 0 0 1
VOC 023L Web Designing and Internet Technology-II 0 0 2 1
Lab
VOC 009 Library Science - I 1 0 0 1
VOC 009L Library Science - I Lab 0 0 2 1
VOC 010 Library Science - II 1 0 0 1
VOC 010L Library Science - II Lab 0 0 2 1
VOC 018 Photography - I 0 0 4 2
VOC 019 Photography - II 0 0 4 2
VOC 016 Introduction to Artificial Intelligence - I 2 0 0 2
VOC 017 Introduction to Artificial Intelligence - II 2 0 0 2
VOC 012 Computer Assisted Learning and Teaching 1 0 0 1
VOC 012L Computer Assisted Learning and Teaching 0 0 2 1
Lab
VOC 013 Emerging Technologies for Learning and 2 0 0 2
Teaching

* L - Lecture hrs/week; T - Tutorial hrs/week;


P-Project/Practical/Lab/All other non-classroom academic activities,
etc. hrs/week; C - Credit Points of the Course

Student can opt open (Generic) elective from any discipline of the
Vidyapith with prior permission of respective heads and time table
permitting.
Every Student shall also opt for:
Five Fold Education: Physical Education I, Physical Education II,
Five Fold Education: Aesthetic Education I, Aesthetic Education II,
Five Fold Education: Practical Education I, Practical Education II
one each semester
13

Five Fold Activities

Fine Arts Physical Education and Sports


BVFF 101 Classical Dance (Bharatnatyam) BVFF 201 Aerobics
BVFF 102 Classical Dance (Kathak) BVFF 202 Archery
BVFF 103 Classical Dance (Manipuri) BVFF 203 Athletics
BVFF 104 Creative Art BVFF 204 Badminton
BVFF 105 Folk Dance BVFF 205 Basketball
BVFF 106 Music-Instrumental (Guitar) BVFF 206 Cricket
BVFF 107 Music-Instrumental (Orchestra) BVFF 207 Equestrian
BVFF 108 Music-Instrumental (Sarod) BVFF 208 Flying - Flight Radio Telephone
Operator's Licence (Restricted)
BVFF 109 Music-Instrumental (Sitar) BVFF 209 Flying - Student Pilot's Licence
BVFF 110 Music-Instrumental (Tabla) BVFF 229 Aeromodelling
BVFF 111 Music-Instrumental (Violin) BVFF 210 Football
BVFF 112 Music-Vocal BVFF 211 Gymnastics
BVFF 113 Theatre BVFF 212 Handball
BVFF 213 Hockey
Social Service and Extension Activities BVFF 214 Judo
BVFF 301 Banasthali Sewa Dal BVFF 215 Kabaddi
BVFF 302 Extension Programs for Women BVFF 216 Karate – Do
Empowerment
BVFF 303 FM Radio BVFF 217 Kho-Kho
BVFF 304 Informal Education BVFF 218 Net Ball
BVFF 305 National Service Scheme BVFF 219 Rope Mallakhamb
BVFF 306 National Cadet Corps BVFF 220 Shooting
BVFF 221 Soft Ball
BVFF 222 Swimming
BVFF 223 Table Tennis
BVFF 224 Tennis
BVFF 225 Throwball
BVFF 226 Volleyball
BVFF 227 Weight Training
BVFF 228 Yoga
14

Evaluation Scheme and Grading System

Continuous Assessment (CA) End-Semester Grand Total


(Max. Marks) Assessment (Max. Marks)
(ESA)
Assignment Periodical Test Total (Max. Marks)
I II I II (CA)
10 10 10 10 40 60 100
In all theory, laboratory and other non classroom activities (project,
dissertation, seminar, etc.), the Continuous and End-semester assessment
will be of 40 and 60 marks respectively. However, for Reading Elective,
only End semester exam of 100 marks will be held. Wherever desired, the
detailed breakup of continuous assessment marks (40), for project,
practical, dissertation, seminar, etc shall be announced by respective
departments in respective student handouts.
Based on the cumulative performance in the continuous and end-semester
assessments, the grade obtained by the student in each course shall be
awarded. The classification of grades is as under:
Letter Grade Grade Point Narration
O 10 Outstanding
A+ 9 Excellent
A 8 Very Good
B+ 7 Good
B 6 Above Average
C+ 5 Average
C 4 Below Average
D 3 Marginal
E 2 Exposed
NC 0 Not Cleared

Based on the obtained grades, the Semester Grade Point Average shall be
computed as under:
15

Where n is the number of courses (with letter grading) registered in the


semester, CCi are the course credits attached to the ith course with letter
grading and GPi is the letter grade point obtained in the ith course. The
courses which are given Non-Letter Grades are not considered in the
calculation of SGPA.
The Cumulative Grade Point Average (CGPA) at the end of each semester
shall be computed as under:

Where n is the number of all the courses (with letter grading) that a student
has taken up to the previous semester.
Student shall be required to maintain a minimum of 4.00 CGPA at the end
of each semester. If a student's CGPA remains below 4.00 in two
consecutive semesters, then the student will be placed under probation and
the case will be referred to Academic Performance Review Committee
(APRC) which will decide the course load of the student for successive
semester till the student comes out of the probationary clause.
To clear a course of a degree program, a student should obtain letter grade
C and above. However, D/E grade in two/one of the courses throughout the
UG/PG degree program respectively shall be deemed to have cleared the
respective course(s). The excess of two/one D/E course(s) in UG/PG degree
program shall become the backlog course(s) and the student will be
required to repeat and clear them in successive semester(s) by obtaining
grade C or above.
After successfully clearing all the courses of the degree program, the
student shall be awarded division as per following table.
Division CGPA
Distinction 7.50 and above
First Division 6.00 to 7.49
Second Division 5.00 to 5.99
Pass 4.00 to 4.99

CGPA to % Conversion Formula: % of Marks Obtained = CGPA * 10


______
16

First Semester
PHAR 102 Human Anatomy and Physiology-I
Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 4 0 0 4
Learning outcomes
Upon completion of the course, the student shall be able to know
• Gross morphology, structure and functions of cell, skeletal,
muscular, lymphatic cardiovascular system of the human body
• Various homeostatic mechanisms and their imbalances
• Different types of bones and joints in human body
• Various tissues of different systems of human body
• Various experimental techniques related to physiology
• Various techniques like blood group determination, blood pressure
measurement, blood cells counting.
• Structure and functions of special senses and PNS
Section-A
Introduction to human body: Definition and scope of anatomy and
physiology, levels of structural organization and body systems, basic life
processes, homeostasis, basic anatomical terminology.
Cellular level of organization: Structure and functions of cell, transport
across cell membrane, cell division, cell junctions. General principles of
cell communication, intracellular signaling pathway activation by
extracellular signal molecule, Forms of intracellular signaling: a) Contact-
dependent b) Paracrine c) Synaptic d) Endocrine
Tissue level of organization: Classification of tissues, structure, location
and functions of epithelial, muscular and nervous and connective tissues.
Section-B
Integumentary system: Structure and functions of skin
Skeletal system: Divisions of skeletal system, types of bone, salient
features and functions of bones of axial and appendicular skeletal system.
Organization of skeletal muscle, physiology of muscle contraction,
neuromuscular junction.
17

Joints: Structural and functional classification, types of joints movements


and its articulation
Body fluids and blood: Body fluids, composition and functions of blood,
hemopoeisis, formation of hemoglobin, anemia, mechanisms of
coagulation, blood grouping, Rh factors, transfusion, its significance and
disorders of blood, Reticulo endothelial system.
Lymphatic system: Lymphatic organs and tissues, lymphatic vessels,
lymph circulation and functions of lymphatic system
Section-C
Peripheral nervous system: Classification of peripheral nervous system,
Structure and functions of sympathetic and parasympathetic nervous
system. Origin and functions of spinal and cranial nerves.
Special senses: Structure and functions of eye, ear, nose and tongue and
their disorders.
Cardiovascular system: Heart – anatomy of heart, blood circulation, blood
vessels, structure and functions of artery, vein and capillaries, elements of
conduction system of heart and heartbeat, its regulation by autonomic
nervous system, cardiac output, cardiac cycle. Regulation of blood pressure,
pulse, electrocardiogram and disorders of heart.
Books recommended:
1. Sembulingam, K., Sembulingam, P. (2012). Essentials of Medical
Physiology, 6th Ed., New Delhi: Jaypee Brothers’ medical publisher.
2. Kathleen, J.W. (1992). Anatomy and Physiology in Health and
Illness, 7th Ed., New York: Churchill Livingstone.
3. Tandon, O.P., Tripathi, Y. (2011). Physiological basis of Medical
Practice- Best and Tailor, Wolters Kluwer India Pvt. Ltd.
4. Hall, J.E. (2010). Guyton and Hall Textbook of Medical Physiology,
11th Ed., Saunders.
5. Tortora, G.J., Grabowski S.R. (2000). Principles of Anatomy and
Physiology, 9th Ed., New York: Wiley.
6. Singh, I. (2011). Textbook of Human Histology, 6thEd., New Delhi:
Jaypee brother’s medical publishers.
7. Ghai, C.L. (2013). Textbook of Practical Physiology, 8thEd., New
Delhi: Jaypee brother’s medical publishers.
18

8. Srinageswari, K., Sharma, R. (2015). Practical workbook of Human


Physiology, New Delhi: Jaypee brother’s medical publishers.
9. Chatterrje, C.C. (2005). Human Physiology, vol 1-2. Kolkatta:
Academic Publishers.
Suggested e-material:
1. www.opentextbc.ca
2. www.study.com
3. www.getbodysmart.com
4. www.kenhub.com

PHAR 104 Pharmaceutical Analysis-I


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 4 0 0 4

Learning outcomes
Upon completion of the course, the student shall be able to know

 Different types of analysis

 Principles, instrumentation and applications of various types of


titration

 Impurities in medicinal agents

Section-A

Pharmaceutical analysis- Definition and scope, Different techniques of


analysis, Methods of expressing concentration, Primary and secondary
standards, Preparation and standardization of various molar and normal
solutions- Oxalic acid, sodium hydroxide, hydrochloric acid, sodium
thiosulphate, sulphuric acid, potassium permanganate and ceric ammonium
sulphate.

Errors: Sources of errors, types of errors, methods of minimizing errors,


accuracy, precision and significant figures.
19

Pharmacopoeia, sources of impurities in medicinal agents, limit tests.

Acid base titration: Theories of acid base indicators, classification of acid


base titrations and theory involved in titrations of strong, weak, and very
weak acids and bases, neutralization curves

Non aqueous titration: Solvents, acidimetry and alkalimetry titration and


estimation of Sodium benzoate and Ephedrine HCl

Section-B

Precipitation titrations: Mohr’s method, Volhard’s, Modified Volhard’s,


Fajans method, estimation of sodium chloride.

Complexometric titration: Classification, metal ion indicators, masking


and demasking reagents, estimation of Magnesium sulphate, and calcium
gluconate.

Gravimetry: Principle and steps involved in gravimetric analysis. Purity of


the precipitate: co-precipitation and post precipitation, Estimation of barium
sulphate.

Basic principles, methods and application of diazotisation titration.

Redox titrations: Concepts of oxidation and reduction, types of redox


titrations (Principles and applications), cerimetry, iodimetry, iodometry,
bromatometry, dichrometry, titration with potassium iodate

Section-C
Conductometry: Introduction, conductivity cell, conductometric titrations,
applications.
Potentiometry: Electrochemical cell, construction and working of
reference (Standard hydrogen, silver chloride electrode and calomel
electrode) and indicator electrodes (metal electrodes and glass electrode),
methods to determine end point of potentiometric titration and applications.
Polarography: Principle, Ilkovic equation, construction and working of
dropping mercury electrode and rotating platinum electrode, applications
20

Books recommended:
1. Beckett, A.H., Stenlake, J.B. (1962). Practical Pharmaceutical
Chemistry, 4thEd., vol 1-2. London: Stahlone Press.
2. Mendham, (2019). Vogel,s AI- Text Book of Quantitative Inorganic
analysis, 6thEd.,Pearson.
3. Rao, P.G. (2006). Inorganic Pharmaceutical Chemistry,
3rdEd.,Pharma Med Press.
4. Atherden, L.M. (2004). Bentley and Driver's Textbook of
Pharmaceutical Chemistry, Oxford University Press.
5. Kennedy, J.K. (1990). Analytical chemistry principles,
3rdEd.,Brooks/ Cole.
6. Indian Pharmacopoeia, (2014). Addendum 2016.

Suggested e-material:
1. https://onlinelibrary.wiley.com/doi/abs/10.1002/9781118695425.ch
10
2. https://www.researchgate.net/publication/280224434_Handbook_of_
Inorganic_Impurities_in_Pharmaceuticals
3. http://www.rroij.com/open-access/a-review-on-impurity-profile-in-
pharmaceutical-substances.php?aid=34989
4. https://www.scribd.com/doc/101354608/Chapter-5-Gastro intestinal-
Agents- Reviewer
5. https://www.who.int/medicines/publications/pharmacopoeia/Radgen
mono
21

PHAR 105 Pharmaceutical Inorganic Chemistry


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 4 0 0 4
Learning outcomes
Upon completion of the course, the student shall be able to know
• Principles of limit tests
• Preparation, assay, properties and medicinal uses different inorganic
compounds
• Identification of different anions, cations and different inorganic
pharmaceuticals.
• Sources of impurities and methods to determine the impurities in
pharmaceuticals

Section-A
Impurities in pharmaceutical substances: History of Pharmacopoeia,
Sources and types of impurities, principle involved in the limit test for
Chloride, Sulphate, Iron, Arsenic, Lead and Heavy metals, modified limit
test for Chloride and Sulphate.
General methods of preparation, assay for the compounds superscripted
with asterisk (*), properties and medicinal uses of inorganic compounds
belonging to the following classes.
Acids, Bases and Buffers: Buffer equations and buffer capacity in general,
buffers in pharmaceutical systems, preparation, stability, buffered isotonic
solutions, measurements of tonicity, calculations and methods of adjusting
isotonicity.
Major extra and intracellular electrolytes: Functions of major
physiological ions, Electrolytes used in the replacement therapy: Sodium
chloride*, Potassium chloride, Calcium gluconate* and Oral Rehydration
Salt (ORS), Physiological acid base balance.
22

Section-B

Dental products: Dentifrices, role of fluoride in the treatment of dental


caries, Desensitizing agents, Calcium carbonate, Sodium fluoride, and Zinc
eugenol cement.

Acidifiers: Ammonium chloride* and Dil. HCl

Antacid: Ideal properties of antacids, combinations of antacids,


SodiumBicarbonate*, Aluminum hydroxide gel, Magnesium hydroxide
mixture Cathartics: Magnesium sulphate, Sodium orthophosphate, Kaolin
and Bentonite

Antimicrobials: Mechanism, classification, Potassium permanganate,


Boric acid, Hydrogen peroxide*, Chlorinated lime*, Iodine and its
preparations

Section-C

Expectorants: Potassium iodide, Ammonium chloride*.

Emetics: Copper sulphate*, Sodium potassium tartarate

Haematinics: Ferrous sulphate*, Ferrous gluconate

Poison and Antidote: Sodium thiosulphate*, Activated charcoal, Sodium


nitrite

Astringents: Zinc Sulphate, Potash Alum

Radiopharmaceuticals: Radio activity, Measurement of radioactivity,


Properties of α, β, γ radiations, Half-life, radio isotopes and study of radio
isotopes - Sodium iodide I131, Storage conditions, precautions &
pharmaceutical application of radioactive substances.
23

Books recommended:

1. Beckett, A.H., Stenlake, J.B. (1962). Practical Pharmaceutical


Chemistry,4thEd., vol 1-2. London: Stahlone Press.

2. Mendham, (2019). Vogel’s AI- Text Book of Quantitative Inorganic


Analysis, 6thEd., Pearson.

3. Rao, P.G. (2006). Inorganic Pharmaceutical Chemistry, 3rdEd.,


Pharma med press.

4. Schroff, M.L. (1968). Inorganic Pharmaceutical Chemistry,


Calcutta: National book centre.

5. Atherden, L.M. (2004). Bentley and Driver's Textbook of


Pharmaceutical Chemistry,Oxford University Press.

6. Chatwal, G.R. (2010). Pharmaceutical Chemistry Inorganic,


Himalaya Publishing House.

7. Indian Pharmacopoeia, (2014). Addendum 2016.

Suggested e-material:

1. http://www.sciencedirect.com/science/book/9780123851109

2. https://onlinelibrary.wiley.com/doi/abs/10.1002/9781118695425.ch
10

3. https://www.researchgate.net/publication/280224434_Handbook_of_
Inorganic_Impurities_in_Pharmaceuticals

4. http://www.rroij.com/open-access/a-review-on-impurity-profile-in-
pharmaceutical-substances.php?aid=34989

5. https://www.scribd.com/doc/101354608/Chapter-5-Gastro intestinal-
Agents-Reviewer

6. https://www.who.int/medicines/publications/pharmacopoeia/Radgen
mono
24

PHAR 107 Pharmaceutics - I


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 4 0 0 4
Learning outcomes
Upon completion of the course, the student shall be able to know
• Importance of IP, BP, USP and Extra Pharmacopoeia
• Definition, preparation, classification, advantages and disadvantages
of different dosage forms
• Pharmaceutical incompatibilities and calculations
• Professional handling of prescription

Section-A
Historical background and development of profession of pharmacy:
Historyof profession of Pharmacy in India in relation to pharmacy
education, industryand organization, Pharmacy as a career,
Pharmacopoeias: Introduction to IP, BP, USP and Extra Pharmacopoeia.
Dosage forms: Introduction to dosage forms, classification and definitions
Prescription: Definition, Parts of prescription, handling of Prescription and
Errors in prescription.
Posology: Definition, Factors affecting posology. Pediatric dose
calculationsbased on age, body weight and body surface area.
Pharmaceutical calculations: Weights and measures – Imperial & Metric
system, Calculations involving percentage solutions, alligation, proof spirit
and isotonic solutions based on freezing point and molecular weight.

Section-B
Powders: Definition, classification, advantages and disadvantages, Simple
& compound powders – official preparations, dusting powders,
effervescent, efflorescent and hygroscopic powders, eutectic mixtures.
Geometric dilutions.
25

Liquid dosage forms: Advantages and disadvantages of liquid dosage


forms. Excipients used in formulation of liquid dosage forms. Solubility
enhancementtechniques
Monophasic liquids: Definitions and preparations of Gargles,
Mouthwashes, Throat Paint, Eardrops, Nasal drops, Enemas, Syrups,
Elixirs, Liniments and Lotions.
Suspensions: Definition, advantages and disadvantages, classifications,
Preparation of suspensions; Flocculated and Deflocculated suspension &
stability problems and methods to overcome.

Section-C
Emulsions: Definition, classification, emulsifying agent, test for the
identification of type of Emulsion, Methods of preparation & stability
problems and methods to overcome.
Suppositories: Definition, types, advantages and disadvantages, types of
bases, methods of preparations. Displacement value & its calculations,
evaluation of suppositories.
Pharmaceutical incompatibilities: Definition, classification, physical,
chemicaland therapeutic incompatibilities with examples.
Semisolid dosage forms: Definitions, classification, mechanisms and
factors influencing dermal penetration of drugs. Preparation of ointments,
pastes, creams and gels. Excipients used in semi solid dosage forms.
Evaluation of semi solid dosages forms

Books recommended:
1. Allen, I.V., Popovich, J.N.G. Ansel, H.C. (2005). Ansel's
Pharmaceutical Dosage Form and Drug Delivery System, 8thEd.,
New Delhi: Lippincott Williams and Walkins.
2. Carter, S.J. (2008). Cooper and Gunn’s-Dispensing for
Pharmaceutical Students, 12thEd., New Delhi: CBS publishers.
3. Aulton, M.E. (2002). Pharmaceutics, The Science & Dosage Form
Design, 2ndEd., Edinbrg: Churchill Livingstone.
26

4. Indian Pharmacopoeia (2014). Addendum 2016.


5. British pharmacopoeia (2019).
6. Lachmann, L., Lieberman, H.A., Kaing, J.L. (2009). Theory and
Practice of Industrial Pharmacy, Lea and Febiger Publisher.
7. Remington, J.P.,Gennaro, A.R.,Remington, A.R.G. (2005). The
Science and Practice of Pharmacy, 21stEd., New Delhi: Lippincott
Williams and willikins.
8. Carter, S.J. (2005). Cooper and Gunn’s-Dispensing for
Pharmaceutical Students, 12thEd., New Delhi: CBS publishers.
9. Rawlins. (2010). Bentley’s Text Book of Pharmaceutics, Elsevier.
10. Bodmier, R. (1989). Pharmaceutical Pelletization Technology, New
York: Marcel Dekker.
11. Pareekh, D.M. (2005). Handbook of Pharmaceutical Granulation
Technology, 2ndEd., New York: Marcel Dekker.
12. Nieloud, F., Mestres, G.M. (2000) Pharmaceutical Emulsions and
Suspensions, New York: Marcel Dekker, INC.

Suggested e-material:
1. https://health.sbmu.ac.ir/uploads/Remington_Essentials_of_Pharmac
eutics_-_Felton,_Linda.pdf
2. http://gmpua.com/Process/EncyclopediaPT.pdf
3. http://pharmacentral.in/wp-
content/uploads/2018/05/INDIAN%20PHARMACOPOEIA%20200
7.pdf
4. https://www.pdfdrive.com/pharmacy-calculations-for-pharmacy-
technicians-d58957811.html
5. http://file.akfarmahadhika.ac.id/E-BOOK/12-1213-akfarmahad-6-1-
fasttrac-g.pdf
27

PHAR 108 Remedial Biology


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 3 0 0 3
Learning outcomes
Upon completion of the course, the student shall be able to know
• Evolutionary biology and behavior.
• Anatomy, physiology and regulation of various body system
• Plant physiology
Section-A
Living world:
Definition and characters of living organisms, Diversity in the living world,
Binomial nomenclature, Five kingdoms of life and basis of classification.
Salient features of Monera, Potista, Fungi, Animalia and Plantae, Virus.
Morphology of Flowering plants:
Morphology of different parts of flowering plants – Root, stem,
inflorescence, flower, leaf, fruit and seed.
General Anatomy of root, stem, leaf of monocotyledons & Dicotylidones.
Body fluids and circulation:
Composition of blood, blood groups, coagulation of blood, Composition
and functions of lymph, Human circulatory system, Structure of human
heart and blood vessels, Cardiac cycle, cardiac output and ECG.
Digestion and Absorption:
Human alimentary canal and digestive glands, Role of digestive enzymes,
Digestion, absorption and assimilation of digested food
Section-B
Breathing and respiration:
Human respiratory system, Mechanism of breathing and its regulation,
Exchange of gases, transport of gases and regulation of respiration,
Respiratory volumes.
28

Excretory products and their elimination:

Modes of excretion, Human excretory system- structure and function, Urine


formation, Rennin angiotensin system.

Neural control and coordination:

Definition and classification of nervous system, Structure of a neuron,

Generation and conduction of nerve impulse, Structure of brain and spinal


cord, Functions of cerebrum, cerebellum, hypothalamus and medulla
oblongata.

Chemical coordination and regulation:

Endocrine glands and their secretions, Functions of hormones secreted by


endocrine glands.

Section-C

Human reproduction:

Parts of female reproductive system, Parts of male reproductive system,


Spermatogenesis and Oogenesis, Menstrual cycle.

Plants and mineral nutrition:

Essential mineral, macro and micronutrients, Nitrogen metabolism,


Nitrogen cycle, biological nitrogen fixation

Photosynthesis:

Autotrophic nutrition, photosynthesis, Photosynthetic pigments, Factors


affecting photosynthesis.

Plant respiration:

Respiration, glycolysis, fermentation (anaerobic). Plant growth and


development, Phases and rate of plant growth, Condition of
growth,Introduction to plant growth regulators

Cell - The unit of life:

Structure and functions of cell and cell organelles. Cell division


29

Tissues:

Definition, types of tissues, location and functions.

Books recommended:

1. Gokhale, S.B., Kokate, C.K., Bidarkar, D.S. (2007). Pharmaceutical


Biology, 5th Ed., Pune: Nirali Prakashan.

2. Thulajappa, Y., Seetaram, P.I. (2005). New Expert Biology, vol 2,


Expert educational publisher.

Suggested e-material:

1. www.opentextbc.ca

2. www.study.com

3. www.getbodysmart.com

4. www.kenhub.com

5. www.apchute.com

6. www.openstax.cnx.org

MATH 110 Remedial Mathematics


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 3 0 0 3
Learning outcomes

Upon completion of the course, the student shall be able to know

• Mathematical concepts and principles to perform various


calculations in Pharmacy

• mathematical expressions and mathematical relationships

• Abstract mathematical reasoning


30

Section-A

Partial fraction: Introduction, Polynomial, Rational fractions, Proper and


Improper fractions, Partial fraction, Resolving into Partial fraction,
Application of Partial Fraction in Chemical Kinetics and Pharmacokinetics

Logarithms: Introduction, Definition, Theorems/Properties of logarithms,


Common logarithms, Characteristic and Mantissa, worked examples,
application of logarithm to solve pharmaceutical problems.

Function: Real Valued function, Classification of real valued functions.

Limits and continuity: Introduction, Limit of a function, Definition of


limit of a function (definition), lim xa xn- an/x-a = nan-1, lim =1

Section-B

Matrices and Determinant: Introduction matrices, Types of matrices,


Operation on matrices, Transpose of a matrix, Matrix Multiplication,
Determinants, Properties of determinants , Product of determinants, Minors
and co-Factors, Adjoint or adjugate of a square matrix , Singular and non-
singular matrices, Inverse of a matrix, Solution of system of linear of
equations using matrix method, Cramer’s rule, Characteristic equation and
roots of a square matrix, Cayley–Hamilton theorem, Application of
Matrices in solving Pharmacokinetic equations

Differentiation: Introductions, Derivative of a function, Derivative of a


constant, Derivative of a product of a constant and a function , Derivative of
the sum or difference of two functions, Derivative of the product of two
functions (product formula), Derivative of the quotient of two functions
(Quotient formula) – Without Proof, Derivative of xn w.r.tx,where n is any
rational number, Derivative of ex,, Derivative of loge x , Derivative of ax
,Derivative of trigonometric functions from first principles (without Proof),
Successive Differentiation, Conditions for a function to be a maximum or a
minimum at a point.
31

Section-C
Analytical Geometry
Introduction: Signs of the Coordinates, Distance formula, Straight Line :
Slope or gradient of a straight line, Conditions for parallelism and
perpendicularity of two lines, Slope of a line joining two points, Slope –
intercept form of a straight line
Integration: Introduction, Definition, Standard formulae, Rules of
integration, Method of substitution, Method of Partial fractions, Integration
by parts, definite integrals, application
Differential Equations: Some basic definitions, Order and degree,
Equations in separable form, Homogeneous equations, Linear Differential
equations, Exact equations, Application in solving
Pharmacokinetic equations
Laplace Transform: Introduction, Definition, Properties of Laplace
transform, Laplace Transforms of elementary functions, Inverse Laplace
transforms, Laplace transform of derivatives, Application to solve Linear
differential equations, Application in solving Chemical kinetics and
Pharmacokinetics equations
Books Recommended:
1. Narayan, S., Mittal, P.K. (2005). Differential Calculus, S Chand
Publisher.
2. Panchaksharappa, G.D.H. (2014). Pharmaceutical Mathematics with
application to Pharmacy, New Delhi: CBS Publishers and
Distributors.
3. Narayan, S. (2005). Integral Calculus, S ChandPublisher.
4. Grewal, B.S. (2001). Higher Engineering Mathematics, 36th Ed.,
Khanna Publisher.
Suggested e-material:
1. www.openculture.com/free-math-textbooks
2. E-Books | mathematics.library.cornell.edu
32

PHAR 102L Human Anatomy and Physiology - I Lab


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 0 0 4 2
Practical physiology is complimentary to the theoretical discussions in
physiology. Practical’s allow the verification of physiological processes
discussed in theory classes through experiments on living tissue, intact
animals or normal human beings. This is helpful for developing an insight
on the subject.

1. Study of compound microscope.

2. Microscopic study of epithelial and connective tissue

3. Microscopic study of muscular and nervous tissue

4. Identification of axial bones

5. Identification of appendicular bones

6. Introduction to hemocytometry.

7. Enumeration of white blood cell (WBC) count

8. Enumeration of total red blood corpuscles (RBC) count

9. Determination of bleeding time

10. Determination of clotting time

11. Estimation of hemoglobin content

12. Determination of blood group.

13. Determination of erythrocyte sedimentation rate (ESR).

14. Determination of heart rate and pulse rate.

15. Recording of blood pressure.


33

PHAR 104L Pharmaceutical Analysis - I Lab


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 0 0 4 2
I Limit Test of the following
(1) Chloride
(2) Sulphate
(3) Iron
(4) Arsenic
II Preparation and standardization of
(1) Sodium hydroxide
(2) Sulphuric acid
(3) Sodium thiosulfate
(4) Potassium permanganate
(5) Ceric ammonium sulphate
III Assay of the following compounds along with Standardization of
Titrant
(1) Ammonium chloride by acid base titration
(2) Ferrous sulphate by Cerimetry
(3) Copper sulphate by Iodometry
(4) Calcium gluconate by complexometry
(5) Hydrogen peroxide by Permanganometry
(6) Sodium benzoate by non-aqueous titration
(7) Sodium Chloride by precipitation titration
IV Determination of Normality by electro-analytical methods
(1) Conductometric titration of strong acid against strong base
(2) Conductometric titration of strong acid and weak acid against strong
base
(3) Potentiometric titration of strong acid against strong base
34

PHAR 105L Pharmaceutical Inorganic Chemistry Lab


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 0 0 4 2
I Limit tests for following ions
Limit test for Chlorides and Sulphates
Modified limit test for Chlorides and Sulphates
Limit test for Iron
Limit test for Heavymetals
Limit test for Lead
Limit test for Arsenic

II Identification test
Magnesium hydroxide
Ferrous sulphate
Sodium bicarbonate
Calcium gluconate
Copper sulphate

III Test for purity


Swelling power of Bentonite
Neutralizing capacity of aluminum hydroxide gel
Determination of potassium iodate and iodine in potassium Iodide

IV Preparation of inorganic pharmaceuticals


Boric acid
Potash alum
Ferrous sulphate
35

PHAR 107L Pharmaceutics - I Lab


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 0 0 4 2
1. Syrups
a) Syrup IP’66
b) Compound syrup of Ferrous Phosphate BPC’68

2. Elixirs
a) Piperazine citrate elixir
b) Paracetamol pediatric elixir

3. Linctus
a) Terpin Hydrate Linctus IP’66
b) Iodine Throat Paint (Mandles Paint)

4. Solutions
a) Strong solution of ammonium acetate
b) Cresol with soap solution
c) Lugol’s solution

5. Suspensions
a) Calamine lotion
b) Magnesium Hydroxide mixture
c) Aluminimum Hydroxide gel

6. Emulsions
a) Turpentine Liniment
b) Liquid paraffin emulsion

7. Powders and Granules


a) ORS powder (WHO)
36

b) Effervescent granules
c) Dusting powder
d) Divided powders

8. Suppositories
a) Glycero gelatin suppository
b) Coca butter suppository
c) Zinc Oxide suppository

9. Semisolids
a) Sulphur ointment
b) Non staining-iodine ointment with methyl salicylate
c) Carbopol gel

10. Gargles and Mouthwashes


a) Iodine gargle
b) Chlorhexidine mouthwash
37

Second Semester
CS 102 Computer Applications in Pharmacy
Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 3 0 0 3
Learning outcomes

Upon completion of the course, the student shall be able to know

• Mathematics and computing fundamentals used in pharmaceutical


applications

• Analyzing pharmaceutical problems using computers

• Integration and application of contemporary IT tools in


Pharmaceutical related activities

• Ethics, social, cultural and regulations with regard to Pharmacy

Section-A

Number system: Binary number system, Decimal number system, Octal


number system, Hexadecimal number systems, conversion decimal to
binary, binary to decimal, octal to binary etc, binary addition, binary
subtraction – One’s complement, Two’s complement method, binary
multiplication, binary division

Concept of Information Systems and Software: Information gathering,


requirement and feasibility analysis, data flow diagrams, process
specifications, input/output design, process life cycle, planning and
managing the project

Section-B

Web technologies: Introduction to HTML, XML,CSS and Programming


languages, introduction to web servers and Server Products Introduction to
databases, MYSQL, MS ACCESS, Pharmacy Drug database
38

Application of computers in Pharmacy – Drug information storage and


retrieval, Pharmacokinetics, Mathematical model in Drug design, Hospital
and Clinical Pharmacy, Electronic Prescribing and discharge (EP) systems,
barcode medicine identification and automated dispensing of drugs, mobile
technology and adherence monitoring. Diagnostic System, Lab-diagnostic
System, Patient Monitoring System, Pharma Information System.

Section-C

Bioinformatics: Introduction, Objective of Bioinformatics, Bioinformatics


Databases, Concept of Bioinformatics, Impact of Bioinformatics in Vaccine
Discovery

Computers as data analysis in Preclinical development:


Chromatographic dada analysis (CDS), Laboratory Information
management System (LIMS) and Text Information Management System
(TIMS)

Books Recommended:

1. Fassett, W.E., Christensen, D.B. (2015). Computer Application in


Pharmacy. Lea & Febiger

2. Ekins, S. (2006). Computer Application in Pharmaceutical Research


and Development, Wiley-Interscience.

3. Rastogi, S.C. (2006). Bioinformatics (Concept, Skills and


Applications), New Delhi: CBS Publishers and Distributors.

4. Prague, C.N., Irwin, M.R., Reardon, J. (2003). Microsoft office


Access - 2003, Application Development Using VBA, SQL Server,
DAP and Infopath, New Delhi: Wiley India (P) Ltd.

Suggested e-material:

1. https://www.ebooks.com/subjects/computers

2. https://bookboon.com/en/it-programming-ebooks
39

PHAR 101 Biochemistry


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 4 0 0 4
Learning outcomes
Upon completion of the course, the student shall be able to know
• Fundamentals roles of biomolecules
• Various metabolic pathways and regulations of biological/
biochemical processes
• Introduction, properties, nomenclature, classification, therapeutic
and diagnostic applications of enzymes

Section-A
Biomolecules: Introduction, classification, chemical nature and biological
role of carbohydrate, lipids, nucleic acids, amino acids and proteins.
Bioenergetics: Concept of free energy, endergonic and exergonic reaction,
Relationship between free energy, enthalpy and entropy; Redox potential.
Energy rich compounds; classification; biological significances of ATP and
cyclic AMP
Carbohydrate metabolism: Glycolysis – Pathway, energetics and
significance Citric acid cycle- Pathway, energetics and significance HMP
shunt and its significance; Glucose-6-Phosphate dehydrogenase (G6PD)
deficiency Glycogen metabolism Pathways and glycogen storage diseases
(GSD) Gluconeogenesis- Pathway and its significance. Hormonal
regulation of blood glucose level and Diabetes mellitus

Section-B
Biological oxidation: Electron transport chain (ETC) and its mechanism.
Oxidative phosphorylation & its mechanism and substrate phosphorylation.
Inhibitors ETC and oxidative phosphorylation/Uncouplers
Lipid metabolism: â-Oxidation of saturated fatty acid (Palmitic acid).
Formation and utilization of ketone bodies; ketoacidosis.De novo synthesis
of fatty acids (Palmitic acid). Biological significance of cholesterol and
40

conversion of cholesterol into bile acids, steroid hormone and vitamin D.


Disorders of lipid metabolism: Hypercholesterolemia, atherosclerosis, fatty
liver and obesity.
Amino acid metabolism: General reactions of amino acid metabolism:
Transamination, deamination & decarboxylation, urea cycle and its
disorders. Catabolism of phenylalanine and tyrosine and their metabolic
disorders (Phenyketonuria, Albinism, alkeptonuria, tyrosinemia).Synthesis
and significance of biological substances; 5-HT, melatonin, dopamine,
noradrenaline, adrenaline. Catabolism of heme; hyperbilirubinemia and
jaundice

Section-C
Nucleic acid metabolism and genetic information transfer: Biosynthesis
of purine and pyrimidine nucleotides. Catabolism of purine nucleotides and
Hyperuricemia and Gout disease.Organization of mammalian
genome.Structure of DNA and RNA and their functions.DNA replication
(semi conservative model).Transcription or RNA synthesis.Genetic code,
Translation or Protein synthesis and inhibitors.
Enzymes: Introduction, properties, nomenclature and IUB classification of
enzymes. Enzyme kinetics (Michaelis plot, Line Weaver Burke
plot).Enzyme inhibitors with examples. Regulation of enzymes: enzyme
induction and repression, allosteric enzymes regulation. Therapeutic and
diagnostic applications of enzymes and isoenzymes. Coenzymes –Structure
and biochemical functions.

Books Recommended:
1. Nelson, D.L., Cox, M.M. (2012). Lehninger-Principles of
Biochemistry, 6th Ed., W. H. Freeman & Co.
2. Murry, R.K., Bender, D.K., Bothom, K.A., Kennely, P.J., Well, P.A.,
Rodwell, V.W. (2009). Harper’s Biochemistry, 28th Ed., New York:
McGraw-Hill.
3. Chakrapani, U., Satyanarayan, U. (2012). Biochemistry, Books and
Allied PVT.
41

4. Rao, A.V.S.S.R. (2008). Textbook of Biochemistry, UBS Publishers


Distributors Pvt. Ltd.
5. Conn, E.E.,Stumpf, P.K.,Bruening, G., Doi R.Y. (2009). Outlines of
Biochemistry, 5th Ed., New York: John Wiley & Sons.
6. Gupta, R.C., Bhargavan, S.(2019). Practical Biochemistry, 5th Ed.,
New Delhi: Jaypee brother's medical publishers

7. Plummer, D.T. (1987). An Introduction of Practical Biochemistry,


3rd Ed., McGraw‐Hill.

Suggested e-material:
1. http://lib.myilibrary.com/?id=276871
2. http://lib.myilibrary.com/?id=527025
3. http://onlinelibrary.wiley.com/book/10.1002/9783527622023
(Enzyme Kinetics: Principles and Methods, Second Edition Hans
Bisswanger Wiley publisher)
4. http://www.sciencedirect.com/science/book/9780123851109

PHAR 103 Human Anatomy and Physiology-II


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 4 0 0 4
Learning outcomes
Upon completion of the course, the student shall be able to know
• Anatomy and physiology of various body systems
• Principles of body energetics
• Concept of genetic material
Section-A
Nervous system: Organization of nervous system, neuron, neuroglia,
classification and properties of nerve fiber, electrophysiology, action
potential, nerve impulse, receptors, synapse, neurotransmitters.
42

Central nervous system: Meninges, ventricles of brain and cerebrospinal


fluid. Structure and functions of brain (cerebrum, brain stem, cerebellum),
spinal cord (gross structure, functions of afferent and efferent nerve
tracts,reflex activity)

Digestive system: Anatomy of GI Tract with special reference to anatomy


and functions of stomach, (Acid production in the stomach, regulation of
acid production through parasympathetic nervous system, pepsin role in
protein digestion) small intestineand large intestine, anatomy and functions
of salivary glands, pancreas and liver, movements of GIT, digestion and
absorption of nutrients and disorders of GIT.

Energetics: Formation and role of ATP, Creatinine Phosphate and BMR.

Section-B

Respiratory system: Anatomy of respiratory system with special reference


to anatomy of lungs, mechanism of respiration, regulation of respiration
Lung Volumes and capacities transport of respiratory gases, artificial
respiration, and resuscitation methods.

Urinary system: Anatomy of urinary tract with special reference to


anatomy of kidney and nephrons, functions of kidney and urinary tract,
physiology of urine formation, micturition reflex and role of kidneys in acid
base balance, role of RAS in kidney and disorders of kidney.

Section-C

Endocrine system: Classification of hormones, mechanism of hormone


action, structure and functions of pituitary gland, thyroid gland, parathyroid
gland, adrenal gland, pancreas, pineal gland, thymus and their disorders.

Reproductive system: Anatomy of male and female reproductive system,


Functions of male and female reproductive system, sex hormones,
physiology of menstruation, fertilization, spermatogenesis, oogenesis,
pregnancy and parturition

Introduction to genetics: Chromosomes, genes and DNA, protein


synthesis, genetic pattern of inheritance.
43

Books Recommended:
1. Sembulingam, K., Sembulingam, P. (2012). Essentials of Medical
Physiology, 6th Ed., New Delhi: Jaypee Brothers’ medical publisher.
2. Kathleen, J.W. (1992). Anatomy and Physiology in Health and
Illness, 7th Ed., New York: Churchill Livingstone.
3. Tandon, O.P., Tripathi, Y. (2011). Physiological basis of Medical
Practice- Best and Tailor, Wolters Kluwer India Pvt. Ltd.
4. Hall, J.E. (2010). Guyton and Hall Textbook of Medical Physiology,
11th Ed., Saunders.
5. Tortora, G.J., Grabowski S.R. (2000). Principles of Anatomy and
Physiology, 9th Ed., New York: Wiley.
6. Singh, I. (2011). Textbook of Human Histology, 6thEd., New Delhi:
Jaypee brother’s medical publishers.
7. Ghai, C.L. (2013). Textbook of Practical Physiology, 8thEd., New
Delhi: Jaypee brother’s medical publishers.
8. Srinageswari, K., Sharma, R. (2015). Practical workbook of Human
Physiology, New Delhi: Jaypee brother’s medical publishers.
9. Chatterrje, C.C. (2005). Human Physiology, vol 1-2. Kolkatta:
Academic Publishers.
Suggested e-material:
1. www.apchute.com
2. www.openstax.cnx.org
3. www.wesnorman.com

PHAR 106 Pharmaceutical Organic Chemistry – I


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 4 0 0 4
Learning outcomes
Upon completion of the course, the student shall be able to know
44

• Types, classification, principles/mechanisms, applications of


isomerism in organic compounds
• General methods of preparation and reactions types, principles/
mechanisms, applications of alkanes, alkenes, conjugated dienes,
alkyl halides, alcohols, carbonyl compounds (aldehydes and
ketones), carboxylic acids & aliphatic amines
General methods of preparation and reactions of compounds superscripted
with asterisk (*) to be explained. To emphasize on definition, types,
classification, principles/mechanisms, applications, examples and
differences
Section-A
Classification, nomenclature and isomerism: Classification of Organic
Compounds. Common and IUPAC systems of nomenclature of organic
compounds (up to 10 Carbons open chain and carbocyclic compounds).
Structural isomerisms in organic compounds

Alkanes*, Alkenes* and Conjugated dienes*: SP3 hybridization in


alkanes, Halogenation of alkanes, uses of paraffins. Stabilities of alkenes,
SP2 hybridization in alkenes.E1 and E2 reactions – kinetics, order of
reactivity of alkyl halides, rearrangement of carbocations, Saytzeffs
orientation and evidences. E1 verses E2 reactions, Factors affecting E1 and
E2 reactions. Ozonolysis, electrophilic addition reactions of alkenes,
Markownikoff’s orientation, free radical addition reactions of alkenes, Anti
Markownikoff’s orientation. Stability of conjugated dienes, Diel-Alder,
electrophilic addition, free radical addition reactions of conjugated dienes,
allylic rearrangement
Section-B
Alkyl halides*: SN1 and SN2 reactions - kinetics, order of reactivity of
alkyl halides, stereochemistry and rearrangement of carbocations. SN 1
versus SN2 reactions, Factors affecting SN1 and SN2 reactions.Structure
and uses of ethylchloride, Chloroform, trichloroethylene,
tetrachloroethylene, dichloromethane, tetrachloromethane and iodoform.
Alcohols*: Qualitative tests, Structure and uses of Ethyl alcohol, Methyl
alcohol, chlorobutanol, Cetosteryl alcohol, Benzyl alcohol, Glycerol,
Propylene glycol
45

Carbonyl compounds* (Aldehydes and ketones): Nucleophilic addition,


Electromeric effect, aldol condensation, Crossed Aldol condensation,
Cannizzaro reaction, Crossed Cannizzaro reaction, Benzoin condensation,
Perkin condensation, qualitative tests, Structure and uses of Formaldehyde,
Paraldehyde, Acetone, Chloral hydrate, Hexamine, Benzaldehyde, Vanilin,
Cinnamaldehyde.

Section-C
Carboxylic acids*: Acidity of carboxylic acids, effect of substituents on
acidity, inductive effect and qualitative tests for carboxylic acids , amide
and ester. Structure and Uses of Acetic acid, Lactic acid, Tartaric acid,
Citric acid, Succinic acid. Oxalic acid, Salicylic acid, Benzoic acid, Benzyl
benzoate, Dimethyl phthalate, Methyl salicylate and Acetyl salicylic acid.
Aliphatic amines*: Basicity, effect of substituent on Basicity. Qualitative
test, Structure and uses of Ethanolamine, Ethylenediamine, Amphetamine.

Books Recommended:
1. Boyd, M. (2010). Organic Chemistry, 7thEd., Pearson.
2. Finar, I.L. (2002). Organic Chemistry, Vol. 1, 6thEd.,Pearson
Education Ltd.

Suggested e-material:
1. http://lib.myilibrary.com?id=527161
2. http://lib.myilibrary.com?id=527192
3. http://lib.myilibrary.com?id=527020

PHAR 212 Pathophysiology


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 4 0 0 4
Learning outcomes
Upon completion of the course, the student shall be able to know
• Basic principles of cell injury and adaptation
46

• Etiology and pathogenesis of the various disease


• Signs, symptoms and complications of various diseases

Section-A
Basic principles of cell injury and adaptation:Introduction, definitions,
homeostasis, components and types of feedback systems, causes of cellular
injury, pathogenesis (cell membrane damage, mitochondrial damage,
ribosome damage, nuclear damage), morphology of cell injury - Adaptive
changes (atrophy, hypertrophy, hyperplasia, metaplasia, dysplasia), cell
swelling, intra cellular accumulation, calcification, enzyme leakage and cell
death acidosis & alkalosis, electrolyte imbalance.

Basic mechanism involved in the process of inflammation and


repair:Introduction, clinical signs of inflammation, different types of
inflammation, mechanism of inflammation - Alteration in vascular
permeability and blood flow, migration of WBC's, mediators of
inflammation, basic principles of wound healing in the skin.
Cardiovascular System: Hypertension, congestive heart failure, ischemic
heart disease (angina, myocardial infarction, atherosclerosis and
arteriosclerosis) Respiratory system: Asthma, chronic obstructive airways
diseases.
Renal System: Acute and chronic renal failure.

Section-B
Haematological Diseases: Iron deficiency, megaloblastic anemia (Vit B12
and folic acid), sickle cell anemia, thalasemia, hereditary acquired anemia,
hemophilia
Endocrine System: Diabetes, thyroid diseases, disorders of sex hormones.
Nervous system: Epilepsy, Parkinson's disease, stroke, psychiatric
disorders: depression, schizophrenia and Alzheimer's disease.

Section-C
Gastrointestinal System: Peptic ulcer, inflammatory bowel diseases,
jaundice, hepatitis (A, B,C,D,E,F) alcoholic liver disease.
47

Disease of bones and joints: Rheumatoid arthritis, osteoporosis and gout.


Principles of Cancer: Classification, etiology and pathogenesis of cancer.
Infectious Diseases: Meningitis, typhoid, leprosy, tuberculosis, urinary
tract infections. Sexually transmitted diseases: AIDS, syphilis, gonorrhea.

Recommended Books:
1. Kumar, V., Abas, A.K. Aster, J.C. (2014). Robbins &Cotran
Pathologic Basis of Disease, South Asia edition, Elsevier.
2. Mohan, H. (2010). Text book of Pathology, 6th Ed., Jaypee
Publications.
3. Laurence, B., Bruce, C., Bjorn, K. (2011). Goodman Gilman’s the
Pharmacological Basis of Therapeutics, 12th Ed., New York:
McGraw-Hill.
4. Herbert, C., Taylor, Burke, N. (2011). Best and Taylor’s
Physiological basis of medical practice, 13th Ed., Wolters Kluwer
India Pvt. Ltd.
5. Colledge, N.R., Walker, B.R., Stuart, H.R. (2010). Davidson’s
Principles and Practice of Medicine, 21st Ed., London:
ELBS/Churchill Livingstone.
6. Guyton, A.J., Hall, E. (2010). Textbook of Medical Physiology, 12th
Ed., WB Saunders Company.
7. Piro, J.D., Talbert, R.L., Yee, G., Wells, B., Michael, L., Posey,
(2014). Pharmacotherapy: A Pathophysiological Approach, 9th Ed.,
London: McGraw-Hill Medical.
8. Kumar, V., Cotran, R.S., Robbins, S.L. (1997). Basic Pathology,
Philadelphia, WB Saunders Company.
9. Walker, R., Edwards, C. (2003). Clinical Pharmacy and
Therapeutics, 3rd Ed., London: Churchill Livingstone publication.

Suggested e-material:
1. www.wesnorman.com
48

2. www.pharmacologyeducation.org
3. www.pharmacology2000.com
4. www.healthline.com
5. www.mayoclinic.org

CS 102L Computer Applications in Pharmacy Lab


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 0 0 4 2
1. Design a questionnaire using a word processing package to gather
information about a particular disease.
2. Create a HTML web page to show personal information.
3 Retrieve the information of a drug and its adverse effects using
online tools
4 Creating mailing labels Using Label Wizard, generating label in MS
WORD
5 Create a database in MS Access to store the patient information with
the required fields using access
6. Design a form in MS Access to view, add, delete and modify the
patient record inthe database
7. Generating report and printing the report from patient database
8. Creating invoice table using – MS Access
9. Drug information storage and retrieval using MS Access
10. Creating and working with queries in MS Access
11. Exporting Tables, Queries, Forms and Reports to web pages
12. Exporting Tables, Queries, Forms and Reports to XML pages
49

PHAR 101L Biochemistry Lab


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 0 0 4 2
1. Qualitative analysis of carbohydrates (Glucose, Fructose, Lactose,
Maltose, Sucrose and starch)
2. Identification tests for Proteins (albumin and Casein)
3. Quantitative analysis of reducing sugars (DNSA method) and
Proteins (Biuret method)
4. Qualitative analysis of urine for abnormal constituents
5. Determination of blood creatinine
6. Determination of blood sugar
7. Determination of serum total cholesterol
8. Preparation of buffer solution and measurement of pH
9. Study of enzymatic hydrolysis of starch
10. Determination of Salivary amylase activity
11. Study the effect of Temperature on Salivary amylase activity.
12. Study the effect of substrate concentration on salivary amylase
activity.

PHAR 103L Human Anatomy and Physiology - II Lab


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 0 0 4 2
Practical physiology is complimentary to the theoretical discussions in
physiology. Practicals allow the verification of physiological processes
discussedin theory classes through experiments on living tissue, intact
animals or normalhuman beings. This is helpful for developing an insight
on the subject.
50

1. To study the integumentary and special senses using specimen,


models etc.
2. To study the nervous system using specimen, models, etc.
3. To study the endocrine system using specimen, models, etc
4. To demonstrate the general neurological examination
5. To demonstrate the function of olfactory nerve
6. To examine the different types of taste.
7. To demonstrate the visual acuity
8. To demonstrate the reflex activity
9. Recording of body temperature
10. To demonstrate positive and negative feedback mechanism.
11. Determination of tidal volume and vital capacity.
12. Study of digestive, respiratory, cardiovascular systems, urinary and
reproductive systems with the help of models, charts and specimens.
13. Recording of basal mass index.
14. Study of family planning devices and pregnancy diagnosis test.
15. Demonstration of total blood count by cell analyser
16. Permanent slides of vital organs and gonads.

PHAR 106L Pharmaceutical Organic Chemistry - I Lab


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 0 0 4 2
1. Systematic qualitative analysis of unknown organic compounds
like
i. Preliminary test: Color, odour, aliphatic/aromatic compounds,
saturation and unsaturation, etc.
51

ii. Detection of elements like Nitrogen, Sulphur and Halogen by


Lassaigne’s test
iii. Solubility test
iv. Functional group test like Phenols, Amides/ Urea,
Carbohydrates, Amines, Carboxylic acids, Aldehydes and
Ketones, Alcohols, Esters, Aromatic and Halogenated
Hydrocarbons, Nitro compounds and Anilides.
v. Melting point/Boiling point of organic compounds
vi. Identification of the unknown compound from the literature
using melting point/ boiling point.
vii. Preparation of the derivatives and confirmation of the
unknown compound by melting point/ boiling point.
viii. Minimum 5 unknown organic compounds to be analysed
systematically.

2. Preparation of suitable solid derivatives from organic


compounds
3. Construction of molecular models
52

Third Semester
PHAR 204 Pharmaceutical Microbiology
Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 4 0 0 4
Learning outcomes
Upon completion of the course, the student shall be able to know
• Methods of identification, cultivation and preservation of various
microorganisms
• The importance and implementation of sterilization in
pharmaceutical processing and industry
• Sterility testing of pharmaceutical products
• Microbial standardization of pharmaceuticals
• Cell culture technology and its applications in pharmaceutical
industries

Section-A
Introduction, history of microbiology, its branches, scope and its
importance.Introduction to Prokaryotes and Eukaryotes. Study of ultra-
structure and morphological classification of bacteria, nutritional
requirements, raw materials used for culture media and physical parameters
for growth, growth curve, isolation and preservation methods for pure
cultures, cultivation of anaerobes, quantitative measurement of bacterial
growth (total & viable count). Study of different types of phase contrast
microscopy, dark field microscopy and electron microscopy.

Section-B
Identification of bacteria using staining techniques (simple, Gram's &Acid
fast staining) and biochemical tests (IMViC). Study of principle, procedure,
merits, demerits and applications of physical, chemical gaseous,radiation
and mechanical method of sterilization. Evaluation of the efficiency of
sterilization methods. Equipments employed in large scale sterilization.
53

Sterility indicators.Study of morphology, classification, reproduction/


replication and cultivation of Fungi and Viruses.
Classification and mode of action of disinfectants.Factors influencing
disinfection, antiseptics and their evaluation. Evaluation of bactericidal &
Bacteriostatic.Sterility testing of products (solids, liquids, ophthalmic and
other sterile products) according to IP, BP and USP.

Section-C
Designing of aseptic area, laminar flow equipments; study of different
sources of contamination in an aseptic area and methods of prevention,
clean area classification.
Principles and methods of different microbiological assay.
Methods for standardization of antibiotics, vitamins and amino
acids.Assessment of a new antibiotic.
Types of spoilage, factors affecting the microbial spoilage of
pharmaceutical products, sources and types of microbial contaminants,
assessment of microbial contamination and spoilage.
Preservation of pharmaceutical products using antimicrobial agents,
evaluation of microbial stability of formulations.
Growth of animal cells in culture, general procedure for cell culture,
Primary, established and transformed cell cultures. Application of cell
cultures in pharmaceutical industry and research.

Books Recommended:
1. Hugo, W.B., Russel A.D. (2004). Pharmaceutical Microbiology, 7th
Ed., London: Blackwell Scientific publications.
2. Reed, G (2004). Prescott and Dunn Industrial Microbiology. 4th Ed.,
Delhi: CBS Publishers & Distributors.
3. Pelczar, M.J., Chan, E.C.S, Kreig, N.R. (2002). Microbiology. 5th
Ed., New Delhi: Tata McGraw Hill.
4. Harris, M., Tindall, B. (2000). Pharmaceutical Microbiology.
London.
54

5. Rose, A.H. (1961). Industrial Microbiology. London: Butterworths.


6. Frobisher, M., Hinsdill, R., Crabtree, K.T., Goodheart, C.R. (1968).
Fundamentals of Microbiology. 9th Ed., WB Saunders Co.
7. Carter, S.J. (2005). Cooper and Gunn’s: Tutorial Pharmacy. 12th
Ed., New Delhi: CBS Publisher and Distributors.
8. Peppler, H.J., Perlman, D. (1979). Microbial Technology. 2nd Ed.,
Wisconsin: Elsevier.
9. I.P., B.P., U.S.P. - latest editions.
10. Ananthnarayan, R. (1990). A Text Book of Microbiology. 4th Ed.,
Hyderabad: Orient Longman Limited.
11. Edward, A.I. (1983). Fundamentals of Microbiology. 4th Ed.,
Addison Wesley Publishing Company.
12. Jain, N.K. (2005). Pharmaceutical Microbiology. 2nd Ed., Delhi:
Vallabh Prakashan.
13. Bergey, D.H., Holt, J.G. (1994.) Bergeys manual of systematic
bacteriology. 2nd Ed., Baltimore: Williams and Wilkins.

Suggested e-material:
1. https://www.elsevier.com/books/pharmaceutical-microbiology/
2. moscmm.org/pdf/Ananthanarayan%20microbio.pdf

PHAR 205 Pharmaceutical Organic Chemistry - II


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 4 0 0 4
Learning outcomes
Upon completion of the course, the student shall be able to know
• General methods of preparation and reactions of various organic
compounds
55

• Classification, reaction principles/mechanisms, properties and


applications of various organic compounds
General methods of preparation and reactions of compounds superscripted
with asterisk (*) to be explained. To emphasize on definition, types,
classification, principles/mechanisms, applications, examples and
differences.

Section-A
Benzene and its derivatives
I. Analytical, synthetic and other evidences in the derivation of
structure of benzene, orbital picture, resonance in benzene,
aromatic characters, Huckel's rule.
II. Reactions of benzene - nitration, sulphonation, halogenation,
Friedel crafts alkylation- limitations and Friedel crafts acylation.
III. Type of substituents, effect of substituents on reactivity and
orientation of mono substituted benzene compounds towards
electrophilic substitution reaction.
IV. Structure and uses of DDT (Dichloro diphenyl trichloroethane),
Saccharin, BHC (Benzene hexachloride) and Chloramine.

Section-B
Phenols* - Acidity of phenols, effect of substituents on acidity, qualitative
tests, structure and uses of phenol, cresols, resorcinol, naphthols
Aromatic Amines* - Basicity of amines, effect of substituents on basicity
and synthetic uses of aryl diazonium salts.
Aromatic Acids* - Acidity, effect of substituents on acidity and important
reactions of benzoic acid.

Fats and Oils-


I. Fatty acids reactions- Hydrolysis, Hydrogenation, Saponification
and Rancidity of oils, Drying oils.
56

II. Analytical constants - Acid value, Saponification value, Ester


value, Iodine value, Acetyl value, Reichert Meissl (RM) value -
significance and principle involved in their determination.

Section-C

Polynuclear hydrocarbons: Synthesis, reactions, structure and medicinal


uses of Naphthalene, Phenanthrene, Anthracene, Diphenylmethane,
Triphenylmethane & their derivatives (1-naphthol, 1-hydroxyphenanthrene,
1-hydroxyanthracene, diphenylmethanol, triphenylmethanol)

Cyclo alkanes*: Stabilities - Baeyer's strain theory, limitation of Baeyer's


strain theory, Coulson and Moffitt's modification, Sachse Mohr's theory
(Theory of strainless rings), reactions of cyclopropane and cyclobutane
only.

Books Recommended:

1. Morrison, R.T., Boyd, R.T. (1992). Organic Chemistry. 6th Ed., New
York:‎Prentice Hall.

2. Finar, I.L. (1963). Organic Chemistry. 4th Ed., London: Longsman.

3. Bahl, A., Bahl, B.S. (2014). Textbook of Organic Chemistry. 5th Ed.,
New Delhi: S Chand and Company Ltd.

4. Soni, P.L., Chawla, H.M. (2012). Textbook of Organic Chemistry.


29th Ed., New Delhi: S Chand & Sons.

5. Mann, F.G., Saunders, B.C. (2009). Practical Organic Chemistry. 4th


Ed., London: Pearson. 2009.

6. Vogel, A.I., Tatchell, A.R., Furnis, B. S., Hannaford, A.J., Smith,


P.W.G. (1989). Vogel’s text book of Practical Organic Chemistry. 5th
Ed., London: Pearson.

7. Vishnoi, N.K. (2009). Advanced Practical organic chemistry. 3rd Ed.,


New Delhi: Vikas Publishing House.

8. Pavia, D.L., Lampman, G.M., Kriz, G.S. (1998). Introduction to


Organic Laboratory techniques. 3rd Ed..
57

Suggested e-material:
1. http://lib.myilibrary.com?id=527383
2. http://lib.myilibrary.com?id=527192
3. http://lib.myilibrary.com?id=527184

PHAR 213 Pharmaceutical Engineering


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 4 0 0 4
Learning outcomes
Upon completion of the course, the student shall be able to know
• Various type of flow and flow meter
• Various objectives, applications and functions of various processes
used in pharmaceutical industries.
• Various preventive methods used for corrosion control in
pharmaceutical industries.
• Different types of conveyors
• Various material used in plant construction

Section-A
Flow of fluids: Types of manometers, reynolds number and its
significance, bernoulli's theorem and its applications, energy losses, orifice
meter, venturimeter, pitot tube and rotometer.
Mixing: Objectives, applications & factors affecting mixing, Difference
between solid and liquid mixing, mechanism of solid mixing, liquids
mixing and semisolids mixing. Principles, construction, working, uses,
merits and demerits of double cone blender, twin shell blender, ribbon
blender, sigma blade mixer, planetary mixers, propellers, turbines, paddles
& silverson emulsifier.
58

Heat Transfer: Objectives, applications & heat transfer mechanisms.


Fourier's law, Heat transfer by conduction, convection & radiation. Heat
interchangers & heat exchangers.

Section-B
Evaporation: Objectives, applications and factors influencing evaporation,
differences between evaporation and other heat process. principles,
construction, working, uses, merits and demerits of Steam jacketed kettle,
horizontal tube evaporator, climbing film evaporator, forced circulation
evaporator, multiple effect evaporator& Economy of multiple effect
evaporator.
Distillation: Basic Principles and methodology of simple distillation, flash
distillation, fractional distillation, distillation under reduced pressure, steam
distillation & molecular distillation.
Drying: Objectives, applications & mechanism of drying process,
measurements & applications of Equilibrium Moisture content, rate of
drying curve. principles, construction, working, uses, merits and demerits of
Tray dryer, drum dryer spray dryer, fluidized bed dryer, vacuum dryer,
freeze dryer.

Section-C
Filtration: Objectives, applications, Theories & Factors influencing
filtration, filter aids, filter medias. Principle, Construction, Working, Uses,
Merits and demerits of plate & frame filter, filter leaf, rotary drum filter,
Meta filter & Cartridge filter, membrane filters and Seidtz filter.
Centrifugation: Objectives, principle & applications of Centrifugation,
principles, construction, working, uses, merits and demerits of Perforated
basket centrifuge, Non-perforated basket centrifuge, semi continuous
centrifuge & supercentrifuge.
Materials of pharmaceutical plant construction, corrosion and its
prevention: Factors affecting during materials selected for Pharmaceutical
plant construction, Theories of corrosion, types of corrosion and there
prevention. Ferrous and nonferrous metals, inorganic and organic non-
metals, basic of material handling systems.
59

Books Recommended:
1. Badger, W.L., Banchero, J.T. (1955). Introduction to chemical
engineering. New York: McGraw- Hill.
2. Simpson, N.J.K. (2000). Solid phase extraction, Principles,
techniques and applications. 1st Ed., California: CRC Press.
3. McCabe, W., Smith, J., Harriott, P. (2017). Unit operation of
chemical engineering. 7th Ed., New York: McGraw- Hill.
4. Subrahmanyam, C.V.S., Setty, J.T., Sarasija, S., Kussum, D.V.
(2009). Pharmaceutical engineering principles and practices. New
Delhi: Vallabh Publication.
5. Martin, E.W., Cook, E.F. (2005). Remington practice of pharmacy.
21st edition. Philadelphia: Lippincott Williams and Wilkins.
6. Lachman, L., Lieberman, H.A., Kanig, J.L. (1990). Theory and
practice of industrial pharmacy. 3th Ed., New Delhi: Varghese
Publishing House.
7. Carter, S.J. (2005). Cooper and Gunn’s Tutorial pharmacy. 6th Ed.,
New Delhi: CBS Publication.

Suggested e-material:
1. gmpua.com/Process/ProcessEngineering

PHAR 217 Physical Pharmaceutics - I


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 4 0 0 4
Learning outcomes
Upon completion of the course, the student shall be able to know
• Various physicochemical properties of drug molecules
• Various aspects in pre formulation studies
• Surface and interfacial phenomenon on formulation
60

• Various aspects of size reduction and size separation pertaining to


dosage preparation

Section-A
Solubility of drugs: Solubility expressions, mechanisms of solute solvent
interactions, ideal solubility parameters, solvation & association,
quantitative approach to the factors influencing solubility of drugs,
diffusion principles in biological systems. Solubility of gas in liquids,
solubility of liquids in liquids (Binary solutions, ideal solutions).Raoult's
law, real solutions.Partially miscible liquids, critical solution temperature
and applications.Distribution law, its limitations and applications.
States of matter and properties of matter: State of matter, changes in the
state of matter, latent heats, vapour pressure, sublimation critical point,
eutectic mixtures, gases, aerosols - inhalers, relative humidity, liquid
complexes, liquid crystals, glassy states, solid crystalline, amorphous &
polymorphism.

Section-B
Physicochemical properties of drug molecules: Refractive index, optical
rotation, dielectric constant, dipole moment, dissociation constant,
determinations and applications.
Surface and interfacial phenomenon: Liquid interface, surface &
interfacial tensions, surface free energy, measurement of surface &
interfacial tensions, spreading coefficient, adsorption at liquid interfaces,
surface active agents, HLB scale, solubilisation, detergency, adsorption at
solid interface.
Complexation and protein binding: Introduction, classification of
complexation, applications, methods of analysis, protein binding,
complexation and drug action, crystalline structures of complexes and
thermodynamic treatment of stability constants.

Section-C
pH, buffers and isotonic solutions: Sorensen's pH scale, pH determination
(electrometric and calorimetric), applications of buffers, buffer equation,
61

buffer capacity, buffers in pharmaceutical and biological systems, buffered


isotonic solutions.
Size reduction: Objectives, mechanisms & laws governing size reduction,
factors affecting size reduction, principles, construction, working, uses,
merits and demerits of hammer mill, ball mill, fluid energy mill, edge
runner mill & end runner mill.
Size separation: Objectives, applications & mechanism of size separation,
official standards of powders, sieves, size separation. Principles,
construction, working, uses, merits and demerits of sieve shaker, cyclone
separator, air separator, bag filter & elutriation tank.

Books Recommended:
1. Martin, A., Swarbrick, J. (1993). Physical Pharmacy. 3rd Ed.,
Marryland: Lippincott Williams and Wilkins.
2. Parott, L.E., Saski, W. (1977). Experimental Pharmaceutics. 4th Ed.,
Minneapolis: Burgess Publishers.
3. Cater, S.J. (2005). Tutorial Pharmacy. 6th Ed., New Delhi: CBS
publishers.
4. Stocklosam, M.J., Ansel, H.C. (1986). Pharmaceutical Calculations.
8th Ed., Philadelphia: Lippincott Williams and Wilkins.
5. Liberman, H.A., Lachman, C., Schwartz, J.B. (1990).
Pharmaceutical Dosage forms, Tablets, 2nd Ed., New York: Marcel
Dekkar Inc.
6. Liberman, H.A., Lachman, C. (1990). Pharmaceutical Dosage
forms. Disperse systems, 2nd Ed., New York: Marcel Dekkar Inc.
7. Ramasamy, C., Manavalan, R. (2015). Physical Pharmaceutics. 2nd
Ed., Chenniai: Vignesh Publisher.
8. Subramanyam, C.V.S., Settee, T.J. (2014). Laboratory Manual of
Physical Pharmaceutics. 2nd Ed., New Delhi: Vallabh Publication.
9. Subramanyam, C.V.S. (2000). Text book of Physical Pharmaceutics.
2nd Ed., New Delhi: Vallabh publication.
62

10. Jain, G., Khar, R.K., Ahmad, F.J. (2012). Theory and practice of
Physical Pharmacy. 1st Ed., New Delhi: Elsevier India.

Suggested e-material:
1. https://pharmaclub.in/free-pharmacy-ebooks-pharmaceutics/
2. https://www.pdfdrive.com/pharmaceutical-books.html
3. https://pharmaclub.in/free-pharmacy-ebooks-pharmaceutics/
4. http://202.74.245.22:8080/xmlui/handle/123456789/39
5. www.elsevier.com/books/
6. https://accesspharmacy.mhmedical.com/book.aspx?bookid=513

PHAR 219 Pharmaceutical Physical Chemistry


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 3 0 0 3
Learning outcomes
Upon completion of the course, the student shall be able to know
• Different states of matter and their properties
• Principle of thermodynamics and their pharmaceutical applications
• Various aspects of chemical kinetics and quantum mechanics.

Section-A
Behavior of gases: Kinetic theory of gases, deviation from behaviors and
explanation.
Liquid state: Physical properties (vapour pressure, surface tension,
viscosity, refractive index, optical rotation, dipole moment) and their role in
chemical constitution determination.
Solutions: Ideal and real solutions, solutions of gases in liquids, colligative
properties, partition coefficient, conductance and its measurement, Debye
Huckel theory.
63

Section-B
Thermodynamics: Definition of thermodynamic terms: system,
surroundings etc, types of system, intensive and extensive properties, state
and path functions, thermodynamic equilibrium, heat and work.
First law: Postulates, limitations, brief account of heat capacity and
enthalpy.
Second law: Postulates, need of law, reversible and irreversible processes,
Carnot cycle, Carnot theorem, thermodynamic temperature scale, brief
account of entropy.
Third law: Criteria for spontaneity, residual entropy.
Adsorption: Freudlich and Gibbs adsorption, isotherms, Langmuir theory
of adsorption.
Photochemistry: Consequences of light absorption, Jablonski diagram,
Lambert-Beer Law, Quantum efficiency.

Section-C
Chemical kinetics: General consideration and concepts, Zero, first and
second order reactions, complex reactions, theories of reaction kinetics,
half-life determination, influence of temperature, light, solvent, catalytic
species and other factors, characteristics of homogeneous and
heterogeneous catalysis, acid base and enzyme catalysis.
Quantum mechanics: Postulates of quantum mechanics, operators in
quantum mechanics, the Schrodinger wave equation.

BooksRecommended:
1. Bahl, B.S., Tuli, G.D., Bahl, A. (2009). Essential of Physical
Chemistry. 1st Ed., New Delhi: S. Chand & Company Pvt Ltd.
2. Negi, A.S., Anand, S.C. (1985). Textbook of Physical Chemistry, 5th
Ed., New Delhi: Wiley Eastern Ltd.
3. Glasstone, S., Lewis, D. (1993). Elements of Physical Chemistry, 2nd
Ed., London: Macmillan Education.
64

4. Shoemaker, M., David, P., Garland, D.P., Carl, W. (1975).


Experiments of Physical Chemistry. 3rd Ed., New York: McGraw
Hill.

Suggested e-material:
1. https://ocw.mit.edu/courses/chemistry/5-61-physical-chemistry
2. https://www.acs.org/content/acs/en

PHAR 204L Pharmaceutical Microbiology Lab


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 0 0 4 2
1. Introduction and study of different equipments and processing, e.g.,
B.O.D. incubator, laminar flow, aseptic hood, autoclave, hot air
sterilizer, deep freezer, refrigerator, microscopes used in experimental
microbiology.
2. Sterilization of glassware, preparation and sterilization of media.
3. Sub culturing of bacteria and fungus. Nutrient stabs and slants
preparations.
4. Staining methods- Simple, Grams staining and acid fast staining
(Demonstration with practical).
5. Isolation of pure culture of micro-organisms by multiple streak plate
technique and other techniques.
6. Microbiological assay of antibiotics by cup plate method and other
methods
7. Motility determination by Hanging drop method.
8. Sterility testing of pharmaceuticals.
9. Bacteriological analysis of water
10. Biochemical test.
65

PHAR 205L Pharmaceutical Organic Chemistry - II Lab


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 0 0 4 2
I Experiments involving laboratory techniques
 Recrystallization
 Steam distillation
II Determination of following oil values (including standardization of
reagents)
 Acid value
 Saponification value
 Iodine value
III Preparation of compounds
 Benzanilide/Phenyl benzoate/Acetanilide from Aniline/
Phenol/Aniline by acylation reaction.
 2,4,6-Tribromo aniline/Para bromo acetanilide from
Aniline/Acetanilide by halogenation (Bromination) reaction.
 5-Nitro salicylic acid/Meta di nitro benzene from Salicylic
acid/Nitro benzene by nitration reaction.
 Benzoic acid from Benzyl chloride by oxidation reaction.
 Benzoic acid/ Salicylic acid from alkyl benzoate/ alkyl salicylate
by hydrolysis reaction.
 1-Phenyl azo-2-napthol from Aniline by diazotization and
coupling reactions.
 Benzil from Benzoin by oxidation reaction.
 Dibenzal acetone from Benzaldehyde by Claisen Schmidt reaction
 Cinnammic acid from Benzaldehyde by Perkin reaction
 P-Iodo benzoic acid from P-amino benzoic acid
66

PHAR 213L Pharmaceutical Engineering Lab


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 0 0 4 2
1. Determination of radiation constant of brass, iron, unpainted and
painted glass.
2. Steam distillation - To calculate the efficiency of steam distillation.
3. To determine the overall heat transfer coefficient by heat exchanger.
4. Construction of drying curves (for calcium carbonate and starch).
5. Determination of moisture content and loss on drying.
6. Determination of humidity of air - i) From wet and dry bulb
temperatures -use of Dew point method.
7. Description of Construction working and application of Pharmaceutical
Machinery such as rotary tablet machine, fluidized bed coater, fluid
energy mill,de humidifier.
8. Size analysis by sieving - To evaluate size distribution of tablet
granulations-Construction of various size frequency curves including
arithmetic and logarithmic probability plots.
9. Size reduction: To verify the laws of size reduction using ball mill and
determining Kicks, Rittinger's, Bond's coefficients, power requirement
and critical speed of Ball Mill.
10. Demonstration of colloid mill, planetary mixer, fluidized bed dryer,
freeze dryerand such other major equipment.
11. Factors affecting Rate of Filtration and Evaporation (Surface area,
concentration and Thickness/ viscosity
12. To study the effect of time on the rate of crystallization.
13. To calculate the uniformity Index for given sample by using double
cone blender.
67

PHAR 217L Physical Pharmaceutics - I Lab


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 0 0 4 2
1. Determination the solubility of drug at room temperature

2. Determination of pKa value by half neutralization/ Henderson


Hasselbalch equation.

3. Determination of Partition co-efficient of benzoic acid in benzene and


water

4. Determination of Partition co- efficient of Iodine in CCl4 and water

5. Determination of % composition of NaCl in a solution using phenol-


water system by CST method

6. Determination of surface tension of given liquids by drop count and


drop weight method

7. Determination of HLB number of a surfactant by saponification


method

8. Determination of Freundlich and Langmuir constants using activated


charcoal

9. Determination of critical micellar concentration of surfactants

10. Determination of stability constant and donor acceptor ratio of PABA-


Caffeine complex by solubility method

11. Determination of stability constant and donor acceptor ratio of Cupric-


Glycine complex by pH titration method
68

Fourth Semester
PHAR 211 Medicinal Chemistry - I
Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 4 0 0 4
Learning outcomes

Upon completion of the course, the student shall be able to know

 Various aspects of medicinal chemistry

 Classification, synthesis, SAR, mechanism of action and uses of


various drugs

Study of the development of the following classes of drugs,


classification, mechanism of action, uses of drugs mentioned in the
course, structure activity relationship of selective class of drugs as
specified in the course and synthesis of drugs superscripted (*)

Section-A

Introduction to medicinal chemistry: History and development of


medicinal chemistry. Physicochemical properties in relation to biological
action (Ionization, Solubility, Partition Coefficient, Hydrogen bonding,
Protein binding, Chelation).Effect of bioisosterism, optical and geometrical
isomerism on biological activity.

Drugs acting on autonomic nervous system:

Sympathomimetic Agents: SAR of Sympathomimetic agents.

Direct acting: Nor-epinephrine, epinephrine, phenylephrine*, dopamine,


methyldopa, clonidine, dobutamine, isoproterenol, terbutaline, salbutamol*,
bitolterol, naphazoline, oxymetazoline and xylometazoline.

Indirect acting agents: Hydroxyamphetamine, pseudoephedrine,


propylhexedrine.

Agents with mixed mechanism: Ephedrine, Metaraminol.


69

Adrenergic Antagonists:
Alpha adrenergic blockers: Tolazoline*, phentolamine,
phenoxybenzamine, prazosin, dihydroergotamine, methysergide.
Beta adrenergic blockers: SAR of beta blockers, propranolol*,
metibranolol, atenolol, betazolol, bisoprolol, esmolol, metoprolol, labetolol,
carvedilol.
Parasympathomimetic agents: SAR of Parasympathomimetic agents.
Direct acting agents: Acetylcholine, carbachol*, bethanechol,
methacholine, pilocarpine.
Indirect acting/ Cholinesterase inhibitors (Reversible & Irreversible):
Physostigmine, neostigmine*, pyridostigmine, edrophonium chloride,
tacrine hydrochloride, ambenonium chloride, isofluorphate, echothiophate
iodide, parathione, malathion.
Cholinesterase reactivator: Pralidoxime chloride.
Cholinergic blocking agents: SAR of cholinolytic agents
Solanaceous alkaloids and analogues: Atropine sulphate, Hyoscyamine
sulphate, Scopolamine hydrobromide, Homatropine hydrobromide,
Ipratropium bromide*.
Synthetic cholinergic blocking agents: Tropicamide, cyclopentolate
hydrochloride, clidinium bromide, dicyclomine hydrochloride*,
glycopyrrolate, methantheline bromide, propantheline bromide, benztropine
mesylate, orphenadrine citrate, biperidine hydrochloride, procyclidine
hydrochloride*, tridihexethyl chloride, isopropamide iodide, ethopropazine
hydrochloride.

Section-B
Drugs acting on central nervous system

General anesthetics:
Inhalation anesthetics: Halothane*, Methoxyflurane, enflurane, sevoflurane,
isoflurane, desflurane.
70

Ultra-short acting barbitutrates: Methohexital sodium*, thiamylal sodium,


thiopental sodium.
Dissociative anesthetics: Ketamine hydrochloride.*
Narcotic and Non-Narcotic Analgesics:
Morphine and related drugs: SAR of morphine analogues, morphine
sulphate, codeine, meperidine hydrochloride, anilerdine hydrochloride,
diphenoxylate hydrochloride, loperamide hydrochloride, fentanyl citrate*,
methadone hydrochloride*, propoxyphene hydrochloride, pentazocine,
levorphanol tartarate.
Narcotic antagonists: Nalorphine hydrochloride, levallorphan tartarate,
naloxone hydrochloride.
Anti-inflammatory agents: Sodium salicylate, aspirin, mefenamic acid*,
meclofenamate, indomethacin, sulindac, tolmetin, zomepriac, diclofenac,
ketorolac, ibuprofen*, naproxen, piroxicam, phenacetin, acetaminophen,
antipyrine, phenylbutazone.
Section-C
Drugs acting on central nervous system:
Sedatives and Hypnotics:
Benzodiazepines: SAR of benzodiazepines, chlordiazepoxide, diazepam*,
oxazepam, chlorazepate, lorazepam, alprazolam, zolpidem
Barbiturtes: SAR of barbiturates, barbital*, phenobarbital, mephobarbital,
amobarbital, butabarbital, pentobarbital, secobarbital
Miscelleneous:
Amides & imides: Glutethmide.
Alcohol & their carbamate derivatives: Meprobomate, ethchlorvynol.
Aldehyde & their derivatives: Triclofos sodium, paraldehyde.
Antipsy chotics
Phenothiazeines: SAR of Phenothiazeines - Promazine hydrochloride,
chlorpromazine hydrochloride*, triflupromazine, thioridazine
hydrochloride, piperacetazine hydrochloride, prochlorperazine maleate,
trifluoperazine hydrochloride.
71

Ring analogues of phenothiazeines: Chlorprothixene, thiothixene,


loxapine succinate, clozapine.

Flurobuterophenones: Haloperidol, droperidol, risperidone.

Beta amino ketones: Molindone hydrochloride.

Benzamides: Sulpieride.

Anticonvulsants: SAR of anticonvulsants, mechanism of anticonvulsant


action.

Barbiturates: Phenobarbitone, methabarbital.

Hydantoins: Phenytoin*, Mephenytoin, ethotoin

Oxazolidinediones: Trimethadione, paramethadione

Succinimides: Phensuximide, methsuximide, ethosuximide*

Urea and monoacylureas: Phenacemide, carbamazepine*

Benzodiazepines: Clonazepam

Miscellaneous: Primidone, valproic acid, gabapentin, felbamate.

Drug metabolism: Drug metabolism principles- Phase I and Phase II.


Factors affecting drug metabolism including stereo chemical aspects

Books Recommended:

1. Beale, J.M., Block, J., Wilson, G. (2010). Organic medicinal and


Pharmaceutical Chemistry, 12th Ed., Philadelphia: Lippincott
Williams and Wilkins.

2. Lemke, T.L., Williams, D.A., Rocho, V.F., Zito, S.W. (2012).


Foye’s Principles of Medicinal Chemistry, 7th Ed., Philadelphia:
Lippincott Williams and Wilkins.

3. Abraham, D.J., Rotella, R.J. (2010). Burger’s Medicinal Chemistry,


Drug Discovery and Development, 7th Ed., New York: John Wiley
and Sons.
72

4. Smith, J.H., Williams, H. (2010). Introduction to principles of drug


design, 3rd Ed., Harwood academic publishers.
5. Remington, P.J., Beringer, P. (2006). Remington’s Pharmaceutical
Sciences, 21st Ed., Philadelphia: Lippincott Williams and Wilkins.
6. Finar, I.L. (2002). Organic Chemistry: Volume 2. Stereochemistry
and the Chemistry Natural Products. 5th Ed., London: Pearson.
7. Lednicer, D. (1997). The Organic Chemistry of Drug Synthesis, 5th
Ed., New York: John Wiley and Sons Ltd.
8. Indian Pharmacopoeia, (2014). Addendum 2016.
9. Furniss, B.S., Hannaford, A.J., Smith, P.W.G. (2009). Vogel’s
Tatchell: Text book of practical organic chemistry, 5th Ed., London:
Pearson.

Suggested e-material:
1. https://books.google.co.in/books/about/Foye_s_Principles_of_Medic
inal_Chemistry.html?id=R0W1ErpsQpkC
2. https://www.wiley.com/en-us/Burger%27s+Medicinal+
Chemistry%2C+Drug+Discovery%2C+and+Development%2C+7th
+Edition-p-9780470278154

PHAR 214 Pharmaceutical Organic Chemistry - III


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 4 0 0 4
Learning outcomes
Upon completion of the course, the student shall be able to know
• Nomenclature and classification. Synthesis, reactions and medicinal
uses of heterocyclic compounds
• Stereo chemical aspects of organic compounds and stereo chemical
reactions
73

Section-A
Stereo isomerism:

Optical isomerism - Optical activity, enantiomerism, diastereo-isomerism,


meso- compounds, elements of symmetry, chiral and achiral molecules. DL
system of nomenclature of optical isomers, sequence rules, RS system of
nomenclature of optical isomers. Racemic modification and resolution of
racemic mixture.Asymmetric synthesis (partial and absolute) & reactions of
chiral molecules.

Geometrical isomerism: Nomenclature of geometrical isomers (Cis-Trans,


E-Z, Syn-Anti systems), methods of determination of configuration of
geometrical isomers. Conformational isomerism in ethane, n-butane and
cyclohexane. Stereo isomerism in biphenyl compounds (Atropisomerism)
and conditions for optical activity. Stereospecific and stereoselective
reactions.

Section-B

Heterocyclic compounds: Nomenclature and classification. Synthesis,


reactions and medicinal uses of following compounds - Pyrrole, Furan,
Thiophene Pyrazole, Imidazole, Oxazole, Thiazole, Pyridine, Quinoline,
Isoquinoline, Acridine, Indole and their derivatives (pyrrolidine, furfural,
2,2'- bithiophene, N-phenyl pyrazole, imidazoline, 2-alkyloxazole, 4-
hydroxy-1,3-thiazole, 2-methyl pyridine, 8-hydroxylquinoline, 1,2,3,4-
tetrahydroisoquinoline, proflavin, indole-3-acetic acid).

Section-C

Synthesis and medicinal uses of Pyrimidine, Purine, azepines and their


derivatives (6-amino purine, pyrimidine-2,4 (1H, 3H)- dione, benzazepine).

Reactions of synthetic importance: Metal hydride reduction (NaBH4 and

LiAlH4), Clemmensen reduction, Birch reduction, Wolff Kishner reduction.

Oppenauer-oxidation and Dakin reaction.Beckmanns rearrangement and


Schmidt rearrangement. Claisen-Schmidt condensation.
74

Books Recommended:

1. Finar, I.L. (2002). Organic chemistry, 6th Ed., Pearson Education.

2. Bahl, B.S., Bahl, A. (2014). A text book of organic chemistry, 5th Ed.,
S. Chand and Company Ltd.

3. Bansal, R.K. (2017). Heterocyclic Chemistry, 5th Ed., New Age


International Private Ltd.

4. Morrison, R.T., Boyd, R.M., Bhattacharjee, S.K. (2011) Organic


Chemistry, 7th Ed., Pearson Publishers.

5. Gilchrist, T.L. (1997). Heterocyclic Chemistry, 3rd Ed., Prentice Hall.

Suggested e-material:

1. http://lib.myilibrary.com?id=527192

2. http://lib.myilibrary.com?id=527161

3. http://www.sciencedirect.com/science/book/978012801699

PHAR 215 Pharmacognosy and Phytochemistry - I


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 4 0 0 4
Learning outcomes

Upon completion of the course, the student shall be able to know

 History, scope and development of Pharmacognosy

 Quality control of natural products

 Role of the plant tissue culture in enhancing the production of


secondary metabolites

 Standardization of crude drug on the basis of different standardization


parameters
75

Section-A
Introduction to Pharmacognosy:
(a) Definition, history, scope and development of Pharmacognosy
(b) Sources of Drugs - Plants, Animals, Marine & Tissue culture
(c) Organized drugs, unorganized drugs (dried latex, dried juices, dried
extracts, gums and mucilages, oleoresins and oleo- gum -resins).
Classification of drugs: Alphabetical, morphological, taxonomical,
chemical, pharmacological, chemo and sero taxonomical classification of
drugs
Quality control of Drugs of Natural Origin: Adulteration of drugs of
natural origin. Evaluation by organoleptic, microscopic, physical, chemical
and biological methods and properties.Quantitative microscopy of crude
drugs including lycopodium spore method, leafconstants, camera lucida and
diagrams of microscopic objects to scale with camera lucida.

Section-B
Cultivation, Collection, Processing and storage of drugs of natural
origin:
Cultivation and Collection of drugs of natural origin.Factors influencing
cultivation of medicinal plants.Plant hormones and their
applications.Polyploidy, mutation and hybridization with reference to
medicinal plants. Conservation of medicinal plants
Plant tissue culture: Historical development of plant tissue culture, types of
cultures, Nutritional requirements, growth and their maintenance.
Applications of plant tissue culture in pharmacognosy.Edible vaccines.

Section-C
Pharmacognosy in various systems of medicine: Role of Pharmacognosy
in allopathy and traditional systems of medicine namely, Ayurveda, Unani,
Siddha, Homeopathy and Chinese systems of medicine.
Introduction to secondary metabolites: Definition, classification,
properties and test for identification of Alkaloids, Glycosides, Flavonoids,
76

Tannins, Volatile oil and Resins Study of biological source, chemical nature
and uses of drugs of natural origin containing following drugs
Plant Products: Fibers - Cotton, Jute, Hemp, Hallucinogens, Teratogens,
Natural allergens.
Primary metabolites: General introduction, detailed study with respect to
chemistry, sources, preparation, evaluation, preservation, storage,
therapeutic uses and commercial utility as Pharmaceutical Aids and/or
Medicines for the following primary metabolites:
Carbohydrates: Acacia, Agar, Tragacanth, Honey
Proteins and Enzymes: Gelatin, casein, proteolytic enzymes (Papain,
romelain,
serratiopeptidase, urokinase, streptokinase, pepsin).
Lipids (Waxes, fats, fixed oils): Castor oil, Chaulmoogra oil, Wool Fat,
Bees Wax
Marine Drugs: Novel medicinal agents from marine sources.

Books Recommended:
1. Evans, W.C. (2009). Trease and Evans. Pharmacognosy, 16th Ed.,
London: W.B. Sounders & Co.
2. Tyler, V.E., Brady, L.R., Robbers, J.E. (1988). Pharmacognosy, 9th
Ed., Philadelphia: Lea and Febiger.
3. Wallis, T.E., Churchill, A. (2005). Text Book of Pharmacognosy, 5th
Ed., New Delhi: CBS Publishers.
4. Mohammad, A. (2012). Pharmacognosy and Phytochemistry, 2nd
Ed., New Delhi: CBS Publishers and Distribution.
5. Purohit, A.P., Kokate, C.K., Gokhale, S.B. (2007). Text book of
Pharmacognosy, 37th Ed., Pune: Nirali Prakashan.
6. Choudhary, R.D. (1996). Herbal drug industry, 1st Ed., New Delhi:
Eastern Publisher.
77

7. Ansari, S.H. (2007). Essentials of Pharmacognosy, 2nd Ed. New


Delhi: Birla publications.
8. Gokhale, S.B., Kokate, C.K. (2017). Practical Pharmacognosy, 18th
Ed. Pune: Nirali Prakashan.
9. Lyengar, M.A., Nayak, S.G.K. (2017). Anatomy of Crude Drugs,
12th Ed., PharmaMed Press.

Suggested e-material:
1. http://nsdl.niscair.res.in
2. http://www.herbs4youth.eu/files/workbook_processingtransf.pdf
3. https://biot202.files.wordpress.com
4. http://www.naturaldatabase.com.
http://www.nlm.nih.gov/medlineplus/druginfo/herb_All.html
5. http://dietarysupplements.nlm.nih.gov/dietary/ingred.jsp
6. http://ods.od.nih.gov/
7. http://nccam.nih.gov/
8. http://apps.who.int/medicinedocs/en/d/Js2200e/
9. www.fda.gov/medwatch
10. http://apps.who.int/medicinedocs/documents/h1791e/h1791e.pdf
11. http://ayush.gov.in/sites/default/files/File779%20%20%204.pdf
12. www.ayurveda.hu/api/API-Vol-1.

PHAR 216 Pharmacology - I


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 4 0 0 4
Learning outcomes
Upon completion of the course, the student shall be able to know
78

• Various principles of pharmacology


• Classification and mode of actions of different categories of drugs
• Effect of drug action at organ system/sub cellular/ macromolecular
level
• Transduction mechanism of various receptors
• Structure, organization and pharmacology of drugs acting on ANS,
PNS and CNS
• Applications of basic pharmacological knowledge in the prevention
and treatment of various diseases

Section-A
General Pharmacology
a. Introduction to Pharmacology- Definition, historical landmarks
and scope of pharmacology, nature and source of drugs, essential
drugs concept and routes of drug administration, Agonists,
antagonists( competitive and non-competitive), spare receptors,
addiction, tolerance, dependence, tachyphylaxis, idiosyncrasy,
allergy.
b. Pharmacokinetics- Membrane transport, absorption, distribution,
metabolism and excretion of drugs .Enzyme induction, enzyme
inhibition, kinetics of elimination

Section-B
General Pharmacology
a. Pharmacodynamics- Principles and mechanisms of drug action.
Receptor theories and classification of receptors, regulation of
receptors. drug receptors interactions signal transduction
mechanisms, G-protein-coupled receptors, ion channel receptor,
transmembrane enzyme linked receptors, transmembrane JAK-
STAT binding receptor and receptors that regulate transcription
factors, dose response relationship, therapeutic index, combined
effects of drugs and factors modifying drug action.
79

b. Adverse drug reactions.


c. Drug interactions (pharmacokinetic and pharmacodynamic)
d. Drug discovery and clinical evaluation of new drugs -Drug
discovery phase, preclinical evaluation phase, clinical trial phase,
phases of clinical trials and pharmacovigilance.

Pharmacology of drugs acting on peripheral nervous system


a. Organization and function of ANS.
b. Neurohumoral transmission,co-transmission and classification of
neurotransmitters.
c. Parasympathomimetics, parasympatholytics, sympathomimetics,
sympatholytics.
d. Neuromuscular blocking agents and skeletal muscle relaxants
(peripheral).
e. Local anesthetic agents.
f. Drugs used in myasthenia gravis and glaucoma.

Section-C
Pharmacology of drugs acting on central nervous system
a. Neurohumoral transmission in the C.N.S.special emphasis on
importance of various neurotransmitters like with GABA,
Glutamate, Glycine, serotonin, dopamine.
b. General anesthetics and pre-anesthetics.
c. Sedatives, hypnotics and centrally acting muscle relaxants.
d. Anti-epileptics
e. Alcohols and disulfiram
f. Psychopharmacological agents: Antipsychotics, antidepressants,
anti-anxiety agents, anti-manics and hallucinogens.
g. Drugs used in Parkinson's disease and Alzheimer's disease.
80

h. CNS stimulants and nootropics.


i. Opioid analgesics and antagonists
j. Drug addiction, drug abuse, tolerance and dependence.

Books Recommended:
1. Rang, H., MacEwan, D., Ritter, J., Flower, R., Henderson, G., Loke,
Y.K. (2019). Rang and Dale’s Pharmacology, 9th Ed., London:
Churchil Livingstone Elsevier.
2. Katzung, B.G., Masters, S.B., Trevor, A.J. (2010). Basic and clinical
pharmacology, 11th Ed., New York: Mc Graw-Hill.
3. Brunton, L.L., Knollmann, B., Dandan, R.H. (2017). Goodman and
Gilman’s, The Pharmacological Basis of Therapeutics, 13th Ed.,
New York: McGraw-Hill Education.
4. Marry, A.K.K., Lloyd, Y.Y., Brian, K. A., Robbin, L.C., Joseph,
G.B., Wayne, A.K., Bradley, R.W. (2008). Applied Therapeutics,
The Clinical use of Drugs, 9th Ed., Philadelphia: Lippincott Williams
&Wilkins.
5. Tripathi, K.D. (2018). Essentials of Medical Pharmacology, 8th Ed.,
New Delhi: Jaypee Brothers Medical Publishers Ltd.
6. Sharma, H. L., Sharma, K.K. (2012). Principles of Pharmacology,
2nd Ed., Ahmedabad: Paras Medical Publisher.
7. Craig, C.R., Sitzel, R.E. (2003). Modern Pharmacology with clinical
Applications, 6th Ed., Philadelphia: Lippincott Williams &Wilkins.
8. Ghosh, M.N. (2012). Fundamentals of Experimental Pharmacology,
6th Ed., Kolkata: Hilton & Company.
9. Kulkarni, S.K. (2005). Handbook of experimental pharmacology. 3rd
Ed., New Delhi: Vallabh Prakshan.

Suggested e-material:
1. www.cvpharmacology.com
2. www.treatment4addiction.com
81

3. www.medicalnewtoday.com
4. www.edvivas.com
5. www.pharmafactz.com
6. www.ausmed.com

7. www.medicinenet.com

PHAR 220 Physical Pharmaceutics - II


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 3 0 0 3
Learning outcomes

Upon completion of the course, the student shall be able to know

• Principles of chemical kinetics & to use them in assigning expiry


date for formulation

• Rheology principles and their applications on formulations

• Various aspects of drug stability

Section-A

Colloidal dispersions: Classification of dispersed systems & their general


characteristics, size & shapes of colloidal particles, classification of colloids
& comparative account of their general properties. Optical, kinetic &
electrical properties.Effect of electrolytes, coacervation, peptization &
protective action.

Rheology: Newtonian systems, law of flow, kinematic viscosity, effect of


temperature, non-Newtonian systems, pseudoplastic, dilatant, plastic,
thixotropy, thixotropy in formulation, determination of viscosity, capillary,
falling Sphere, rotational viscometers.

Deformation of solids: Plastic and elastic deformation, Heckel equation,


stress, strain, elastic modulus.
82

Section-B
Coarse dispersion: Suspension, interfacial properties of suspended
particles, settling in suspensions, formulation of flocculated and
deflocculated suspensions. Emulsions and theories of emulsification,
microemulsion and multiple emulsions; Stability of emulsions, preservation
of emulsions, rheological properties of emulsions and emulsion formulation
by HLB method.
Micromeretics: Particle size and distribution, mean particle size, number
and weight distribution, particle number, methods for determining particle
size by different methods, counting and separation method, particle shape,
specific surface, methods for determining surface area, permeability,
adsorption, derived properties of powders, porosity, packing arrangement,
densities, bulkiness & flow properties.

Section-C
Drug stability: Reaction kinetics: zero, pseudo-zero, first & second order,
units of basic rate constants, determination of reaction order. Physical and
chemical factors influencing the chemical degradation of pharmaceutical
product: temperature, solvent, ionic strength, dielectric constant, specific &
general acid base catalysis, Simple numerical problems. Stabilization of
medicinal agents against common reactions like hydrolysis &
oxidation.Accelerated stability testing in expiration dating of
pharmaceutical dosage forms.Photolytic degradation and its prevention.

Books Recommended:
1. Martin, A., Swarbrick, J. (1993). Physical Pharmacy, 3rd Ed.,
Marryland: Lippincott Williams and Wilkins.
2. Parott, L.E., Saski, W. (1977). Experimental Pharmaceutics, 4th Ed.,
Minneapolis: Burgess Publishers.
3. Cater, S.J. (2005). Tutorial Pharmacy, 6th Ed., India: CBS publishers.
4. Stocklosam, M.J., Ansel, H.C. (1986). Pharmaceutical Calculations,
8th Ed., Philadelphia: Lippincott Williams and Wilkins.
83

5. Liberman, H.A., Lachman, C., Schwartz, J.B. (1990).


Pharmaceutical Dosage forms, Tablets, 2nd Ed., New York: Marcel
Dekkar Inc.
6. Liberman, H.A., Lachman, C. (1990). Pharmaceutical Dosage
forms. Disperse systems. 2nd Ed., New York: Marcel Dekkar Inc.
7. Ramasamy, C., Manavalan, R. (2015). Physical Pharmaceutics. 2nd
Ed., Chennai: Vignesh Publisher.

Suggested e-material:
1. https://accesspharmacy.mhmedical.com/book.aspx?bookid=513
2. http://www.pharmtech.com/
3. https://www.ncbi.nlm.nih.gov/pmc/
4. https://pharmaclub.in/free-pharmacy-ebooks-pharmaceutics/
5. https://www.pdfdrive.com/pharmaceutical-books.html
6. https://pharmaclub.in/free-pharmacy-ebooks-pharmaceutics/
7. http://202.74.245.22:8080/xmlui/handle/123456789/39/browse?type
=subject
8. www.elsevier.com/books/

PHAR 211L Medicinal Chemistry - I Lab


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 0 0 4 2
I Preparation of drugs/ intermediates
• 1,3-pyrazole
• 1,3-oxazole
• Benzimidazole
• Benztriazole
• 2,3- diphenyl quinoxaline
84

• Benzocaine
• Phenytoin
• Phenothiazine
• Barbiturate

II Assay of drugs
• Chlorpromazine
• Phenobarbitone
• Atropine
• Ibuprofen
• Aspirin
• Furosemide

III Determination of Partition coefficient for any two drugs

PHAR 215L Pharmacognosy and Phytochemistry - I Lab


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 0 0 4 2
1. Analysis of crude drugs by chemical tests: (i)Tragaccanth (ii)
Acacia (iii)Agar (iv) Gelatin (v) starch (vi) Honey (vii) Castor oil
2. Determination of stomatal number and index
3. Determination of vein islet number, vein islet termination and
paliside ratio.
4. Determination of size of starch grains, calcium oxalate crystals by
eye piece micrometer
5. Determination of Fiber length and width
6. Determination of number of starch grains by Lycopodium spore
method
85

7. Determination of Ash value


8. Determination of Extractive values of crude drugs
9. Determination of moisture content of crude drugs
10. Determination of swelling index and foaming

PHAR 216L Pharmacology - I Lab


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 0 0 4 2
1. Introduction to experimental pharmacology.

2. Commonly used instruments in experimental pharmacology.

3. Study of common laboratory animals.

4. Maintenance of laboratory animals as per CPCSEA guidelines.

5. Common laboratory techniques. Blood withdrawal, serum and


plasma separation, anesthetics and euthanasia used for animal
studies.

6. Study of different routes of drugs administration in mice/rats.

7. Study of effect of hepatic microsomal enzyme inducers on the


phenobarbitone sleeping time in mice.

8. Effect of drugs on ciliary motility of frog oesophagus

9. Effect of drugs on rabbit eye.

10. Effects of skeletal muscle relaxants using rota-rod apparatus.

11. Effect of drugs on locomotor activity using actophotometer.

12. Anticonvulsant effect of drugs byMES and PTZ method.

13. Study of stereotype and anti-catatonic activity of drugs on


rats/mice.
86

14. Study of anxiolytic activity of drugs using rats/mice.

15. Study of local anesthetics by different methods


Note: All laboratory techniques and animal experiments are
demonstrated by simulated experiments by softwares and videos

PHAR 218L Physical Pharmaceutics - II Lab


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 0 0 4 2
1. Determination of particle size, particle size distribution using
sieving method
2. Determination of particle size, particle size distribution using
Microscopic method
3. Determination of bulk density, true density and porosity
4. Determine the angle of repose and influence of lubricant on angle
of repose
5. Determination of viscosity of liquid using Ostwald's viscometer
6. Determination sedimentation volume with effect of different
suspending agent
7. Determination sedimentation volume with effect of different
concentration of single suspending agent
8. Determination of viscosity of semisolid by using Brookfield
viscometer
9. Determination of reaction rate constant first order.
10. Determination of reaction rate constant second order
11. Accelerated stability studies
87

Fifth Semester
PHAR 313 Industrial Pharmacy-I
Max. Marks : 60  L T P C
(CA: 20 + ESA: 40) 4 0 0 4
Learning outcomes
Upon completion of this course student will have an understanding of:

 Various pharmaceutical dosage forms and their manufacturing


techniques.

 Various considerations in development of pharmaceutical dosage


forms.

 Evaluation quality of solid, liquid and semisolid dosage forms.

Section-A
Tablets: Introduction, ideal characteristics of tablets, classification of
tablets. Excipients, Formulation of tablets, granulation methods,
compression and processing problems.Equipments and tablet tooling.
Tablet coating: Types of coating, coating materials, formulation of coating
composition, methods of coating, equipment employed and defects in
coating.
Quality control tests: In process and finished product tests
Liquid orals: Formulation and manufacturing consideration of syrups and
elixirs suspensions and emulsions; Filling and packaging; evaluation of
liquid orals official in pharmacopoeia

Section-B
Capsules:
Hard gelatin capsules: Introduction, Production of hard gelatin capsule
shells. size of capsules, Filling, finishing and special techniques of
formulation of hard gelatin capsules, manufacturing defects. In process and
final product quality control tests for capsules.
88

Soft gelatin capsules: Nature of shell and capsule content, size of


capsules,importance of base adsorption and minim/gram factors,
production, in process and final product quality control tests. Packing,
storage and stability testing of soft gelatin capsules and their applications.
Parenteral Products: Definition, types, advantages and limitations.
Preformulation factors and essential requirements, vehicles,
additives.Production procedure, production facilities and controls, aseptic
processing.Formulation of injections, sterile powders, large volume
parenterals and lyophilized products. Filling and sealing of ampoules, vials
and infusion fluids. Quality control tests of parenteral products.

Section-C
Pellets: Introduction, formulation requirements, pelletization process,
equipments for manufacture of pellets.
Ophthalmic Preparations: Introduction, formulation considerations;
formulation of eye drops, eye ointments and eye lotions; methods of
preparation; labeling, containers; evaluation of ophthalmic preparations
Pharmaceutical Aerosols: Definition, propellants, containers, valves,
types of aerosol systems; formulation and manufacture of aerosols;
Evaluation of aerosols; Quality control and stabilitystudies.
Packaging materials Science: Materials used for packaging of
pharmaceutical products, factors influencing choice of containers, legal and
official requirements for containers, stability aspects of packaging
materials, quality control tests.

Books recommended:
1. Troy, D.B. (2006). Remington: The Science and Practice of
Pharmacy, 21st Ed., vol 1-2, Easton Pennsylvania: Mack Publishing
Co.
2. Cooper, J.W. Gunn, G. (1986). Tutorial Pharmacy, London: Petman
Books Ltd.
3. Lachman, L. (1986). Theory and Practice of Industrial Pharmacy,
Philadelphia: Lea & Febiger
89

4. Ansel, HC. Allen, L.V. (2014). Introduction to Pharmaceutical


Dosage Forms, Philadelphia: Wolters Kluwer.
5. Juliano, R.L. (1981) Drug Delivery Systems, Oxford: Oxford
University Press.
6. Harrys. (2000). Cosmetology,Art and Science of Formulating
Cosmetic Products, 9th edition, Palm Springs: Chemical Publishing
Company.
7. Balsam, M.S., Sagarin, E., (2008) Cosmetics: Science and
Technology, 2nd Ed.,Krieger Publishing Company.

Suggested e-material:
1. https://accesspharmacy.mhmedical.com/book.aspx?bookid=513
2. http://www.pharmtech.com/
3. https://www.ncbi.nlm.nih.gov/pmc/
4. https://pharmaclub.in/free-pharmacy-ebooks-pharmaceutics/
5. https://www.pdfdrive.com/pharmaceutical-books.html
6. https://pharmaclub.in/free-pharmacy-ebooks-pharmaceutics/
http://202.74.245.22:8080/xmlui/handle/123456789/39/browse?pe
=subject www.elsevier.com/books/

PHAR 403 Medicinal Chemistry-II


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 4 0 0 4
Learning outcomes
Upon completion of this course student will have an understanding of:

 Chemistry of drugs with respect to their pharmacological activity

 The drug metabolic pathways, adverse effect and therapeutic value of


drugs.
90

 Structural Activity Relationship of different class of drugs.

 Chemical synthesis of selected drugs


Study of the development of the following classes of drugs, Classification,
mechanism of action, uses of drugs mentioned in the course, Structure
activity relationship of selective class of drugs as specified in the course
and synthesis of drugs superscripted (*)

Section-A
Antihistaminic agents: Histamine, receptors and their distribution in the
human body.
H1-antagonists: Diphenhydramine hydrochloride*, Dimenhydrinate,
Doxylamines cuccinate, Clemastine fumarate, Diphenylphyraline
hydrochloride,
Tripelenamine hydrochloride, Chlorcyclizine hydrochloride, Meclizine
hydrochloride, Buclizine hydrochloride, Chlorpheniramine maleate,
Triprolidine hydrochloride*, Phenidamine tartarate, Promethazine
hydrochloride*, Trimeprazine tartrate, Cyproheptadine hydrochloride,
Azatidine maleate, Astemizole, Loratadine, Cetirizine, Levocetrazine,
Cromolyn sodium.
H2-antagonists: Cimetidine*, Famotidine, Ranitidine.
Gastric Proton pump inhibitors: Omeprazole, Lansoprazole,
Rabeprazole, Pantoprazole

Anti-neoplastic agents:
Alkylating agents: Meclorethamine*, Cyclophosphamide, Melphalan,
Chlorambucil, Busulfan, Thiotepa
Antimetabolites: Mercaptopurine*, Thioguanine, Fluorouracil,
Floxuridine, Cytarabine, Methotrexate*, Azathioprine
Antibiotics: Dactinomycin, Daunorubicin, Doxorubicin, Bleomycin
Plant products: Etoposide, Vinblastine sulphate, Vincristine sulphate
Miscellaneous: Cisplatin, Mitotane.
91

Section-B

Antianginal:

Vasodilators: Amyl nitrite, Nitroglycerine*, Pentaerythritol tetranitrate,


Isosorbide dinitrite*, Dipyridamole.

Calcium channel blockers: Verapamil, Bepridil hydrochloride, Diltiazem


hydrochloride, Nifedipine, Amlodipine, Felodipine, Nicardipine,
Nimodipine.

Diuretics:

Carbonic anhydrase inhibitors: Acetazolamide*, Methazolamide,


Dichlorphenamide.

Thiazides: Chlorthiazide*, Hydrochlorothiazide, Hydroflumethiazide,


Cyclothiazide, Loop diuretics: Furosemide*, Bumetanide, Ethacrynic acid.
Potassium sparing Diuretics: Spironolactone, Triamterene, Amiloride.

Osmotic Diuretics: Mannitol

Anti-hypertensive Agents: Timolol, Captopril, Lisinopril, Enalapril,


Benazepril hydrochloride, Quinapril hydrochloride, Methyldopate
hydrochloride,* Clonidine hydrochloride, Guanethidine monosulphate,
Guanabenz acetate, Sodium nitroprusside, Diazoxide, Minoxidil, Reserpine,
Hydralazine hydrochloride.

Anti-arrhythmic Drugs: Quinidine sulphate, Procainamide hydrochloride,


Disopyramide phosphate*, Phenytoin sodium, Lidocaine hydrochloride,
Tocainide hydrochloride, Mexiletine hydrochloride, Lorcainide
hydrochloride, Amiodarone, Sotalol.

Anti-hyperlipidemic agents: Clofibrate, Lovastatin, Cholesteramine and


Cholestipol

Coagulant & Anticoagulants: Menadione, Acetomenadione, Warfarin*,


Anisindione, clopidogrel

Drugs used in Congestive Heart Failure: Digoxin, Digitoxin, Nesiritide,


Bosentan, Tezosentan.
92

Section-C

Drugs acting on Endocrine system: Nomenclature, Stereochemistry and


metabolism of steroids

Sex hormones: Testosterone, Nandralone, Progestrones, Oestriol,


Oestradiol,

Oestrione, Diethyl stilbestrol.

Drugs for erectile dysfunction: Sildenafil, Tadalafil.

Oral contraceptives: Mifepristone, Norgestril, Levonorgestrol

Corticosteroids: Cortisone, Hydrocortisone, Prednisolone, Betamethasone,


Dexamethasone

Thyroid and antithyroid drugs: L-Thyroxine, L-Thyronine,


Propylthiouracil, Methimazole.

Antidiabetic agents:

Insulin and its preparations Sulfonyl ureas: Tolbutamide*, Chlorpropamide,


Glipizide, Glimepiride. Biguanides: Metformin. Thiazolidinediones:
Pioglitazone, Rosiglitazone. Meglitinides: Repaglinide, Nateglinide.
Glucosidase inhibitors: Acrabose, Voglibose.

Local Anesthetics: SAR of Local anesthetics

Benzoic Acid derivatives; Cocaine, Hexylcaine, Meprylcaine,


Cyclomethycaine,

Piperocaine.

Amino Benzoic acid derivatives: Benzocaine*, Butamben, Procaine*,


Butacaine,Propoxycaine, Tetracaine, Benoxinate.

Lidocaine/Anilide derivatives: Lignocaine, Mepivacaine, Prilocaine,


Etidocaine.

Miscellaneous: Phenacaine, Diperodon, Dibucaine.*


93

Books recommended:
1. Beale, J.M., Block, J., Wilson, G. (2010). Organic medicinal and
Pharmaceutical Chemistry, 12th Ed., Philadelphia: Lippincott
Williams and Wilkins.
2. Lemke, T.L., Williams, D.A., Rocho, V.F., Zito, S.W. (2012).
Foye’s Principles of Medicinal Chemistry, 7th Ed., Philadelphia:
Lippincott Williams and Wilkins.
3. Abraham, D.J., Rotella, R.J. (2010). Burger’s Medicinal Chemistry,
Drug Discovery and Development, 7th Ed., New York: John Wiley
and Sons.
4. Smith, J.H., Williams, H. (2010). Introduction to principles of drug
design, 3rd Ed., Australia: Harwood academic publishers.
5. Remington, P.J., Beringer, P. (2006). Remington’s Pharmaceutical
Sciences, 21st Ed., Philadelphia: Lippincott Williams and Wilkins.
6. Buckley, G. (1988). Martindale’s extra pharmacopoeia, 29th Ed.,
British journal of general practice.
7. Finar, I.L. (2002). Organic Chemistry: Stereochemistry and the
Chemistry Natural Products, vol 2, 5th Ed., London: Pearson.
8. Lednicer, D. (1997). The Organic Chemistry of Drug Synthesis, 5th
Ed., New York: John Wiley and Sons Ltd.
9. Indian Pharmacopoeia, (2014). Addendum 2016.
10. Furniss, B.S., Hannaford, A.J., Smith, P.W.G. (2009). Vogel’s
Tatchell: Text book of practical organic chemistry, 5th Ed., London:
Pearson.

Suggested e-material:
1. https://books.google.co.in/books/about/Foye_s_Principles_of_Med
icinal_Chemistry.html?id=R0W1ErpsQpkC
2. https://www.wiley.com/en-us/
Burger%27s+Medicinal+Chemistry%2C+Drug+Discovery%2C+a
nd+Development%2C+7th+Edition-p-9780470278154
94

PHAR 317 Pharmacology-II


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 4 0 0 4
Learning outcomes
Upon completion of this course student will have an understanding of:

 Pharmacological actions of different categories of drugs

 Details about mechanism of drug action at organ system/sub


cellular/ macromolecular levels

 Applications of basic pharmacological knowledge in the


prevention and treatment of various diseases

 Correlation of pharmacology with other bio medical sciences.

 Signal transduction mechanism of various receptors.

 structure, organization and pharmacology of drugs acting on ANS,


PNS and CNS

Section-A
Pharmacology of drugs acting on cardio vascular system: Introduction
to hemodynamic and electrophysiology of heart. Drugs used in congestive
heart failure, anti-hypertensive drugs, anti-anginal drugs, anti-arrhythmic
drugs and anti-hyperlipidemic drugs.
Pharmacology of drugs acting on cardio vascular system: Drug used in
the therapy of shock, hematinics, coagulants, anticoagulants, fibrinolytics,
anti-platelet drugs and plasma volume expanders
Pharmacology of drugs acting on urinary system: Diuretics and anti-
diuretics.

Section-B
Autocoids and related drugs: Introduction to autacoids and classification,
histamine, 5-HT and their antagonists. Prostaglandins, thromboxanes and
leukotrienes, angiotensin, bradykinin and substance P. Non-steroidal anti-
inflammatory agents, anti-gout drugs and anti-rheumatic drugs
95

Pharmacology of drugs acting on endocrine system: Basic concepts in


endocrine pharmacology. Anterior pituitary hormones- analogues and their
inhibitors.Thyroid hormones- analogues and their inhibitors.Hormones
regulating plasma calcium level- parathormone, calcitonin and vitamin-
D.Insulin, oral hypoglycemic agents and glucagon.ACTH and
corticosteroids.

Section-C
Pharmacology of drugs acting on endocrine system: Androgens and
anabolic steroids. Estrogens, progesterone and oral contraceptives.Drugs
acting on the uterus.
Bioassay: Principles and applications of bioassay, types of bioassay,
bioassay of insulin, oxytocin, vasopressin, ACTH, d-tubocurarine, digitalis,
histamine and 5-HT.

Books recommended:
1. Ghosh, M.N., (2007). Fundamentals of Experimental Pharmacology,
Calcutta: Scientific Book Agency.
2. Grover, J.K., (1990). Experiments in Pharmacy & Pharmacology,
New Delhi: CBS Publishers.
3. Kulkarni, S.K., (2005). Hand Book of Experimental
PharmacologyDelhi: Vallabh Prakashan.
4. Barar, F.S.K., (2013). Text Book of Pharmacology, New Delhi: S
Chand.
5. Hardman, J.D., Limbird, L.E., Molinos, B.P., Ruddon, R.W., Gil,
A.G., (1996). Goodman & GilmanThe Pharmacological basis of
Therapeutics, Pergamon press.
6. Katzung, B.G. (2010). Basic & Clinic Pharmacology, Prentice Hall,
International.
7. Laurence, D.R., Bennet, P.N. (1998). Clinical Pharmacology,
Churchill: Livingstone.
96

8. Rang, M.P., Dale, M.M., Riter, J.M., (2015). Pharmacology,


Churchill: Livingstone.

9. Tripathi, K.D., (2013). Essentials of Medical Pharmacology, New


Delhi: Jaypee Publishers.

10. Satoskar, R.S., Nirmala, N.R., Bhandarkar, S.D., (2013).


Pharmacology & Pharmacotheropeutics, Bombay: Popular
Prakashan Pvt. Ltd.

Suggested e-material:

1. www.cvpharmacology.com

2. www.treatment4addiction.com

3. www.medicalnewtoday.com

4. www.edvivas.com

5. www.pharmafactz.com

6. www.ausmed.com

PHAR 316 Pharmacognosy and Phytochemistry-II


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 4 0 0 4
Learning outcomes
Upon completion of this course student will have an understanding of:

 Glycosides as secondary metabolite, their classification, chemical


structure and properties

 Use of different categories of glycosides in different diseases

 How ayurvedic formulations are prepared and stored?

 Use of the traditional medicine in curing different ailments


97

Section-A
Metabolic pathways in higher plants and their determination: Brief
study of basic metabolic pathways and formation of different secondary
metabolites through these pathways- Shikimic acid pathway, Acetate
pathways and Amino acid pathway. Study of utilization of radioactive
isotopes in the investigation of Biogenetic studies.
Basics of Phytochemistry: Modern methods of extraction, application of
latest techniques like Spectroscopy, chromatography and electrophoresis in
the isolation, purification and identification of crude drugs.

Section-B
General introduction, composition, chemistry & chemical classes,
biosources, therapeutic uses and commercial applications of following
secondary metabolites:
Alkaloids: Vinca, rauwolfia, belladonna, opium, phenylpropanoids
Flavonoids: Lignans, tea, ruta steroids, cardiac glycosides
Triterpenoids: Liquorice, dioscorea, digitalis
Volatile oils: Mentha, clove, cinnamon, fennel, coriander
Tannins: Catechu, pterocarpus
Resins: Benzoin, guggul, ginger, asafoetida, myrrh, colophony
Glycosides: Senna, aloes, bitter almond iridoids, other terpenoids
Naphthaquinones: Gentian, artemisia, taxus, carotenoids.

Section-C
Isolation, Identification and Analysis of Phytoconstituents
a) Terpenoids: Menthol, Citral, Artemisin
b) Glycosides: Glycyrhetinic acid & Rutin
c) Alkaloids: Atropine, Quinine, Reserpine, Caffeine
d) Resins: Podophyllotoxin, Curcumin
98

Industrial production, estimation and utilization of the following


phytoconstituents: Forskolin, sennoside, artemisinin, diosgenin, digoxin,
atropine, podophyllotoxin, caffeine, taxol, vincristine and vinblastine.

Books recommended:
1. Evans, W.C. (2009). Trease and Evans. Pharmacognosy, 16th Ed.,
London: W.B. Sounders & Co.
2. Tyler, V.E., Brady, L.R., Robbers, J.E. (1988). Pharmacognosy, 9th
Ed., Philadelphia: Lea and Febiger.
3. Wallis, T.E., Churchill, A. (2005). Text Book of Pharmacognosy, 5th
Ed., New Delhi: CBS Publishers.
4. Mohammad, A. (2012). Pharmacognosy and Phytochemistry, 2nd
Ed., New Delhi: CBS Publishers and Distribution.
5. Purohit, A.P., Kokate, C.K., Gokhale, S.B. (2007). Text book of
Pharmacognosy, 37th Ed., Pune: Nirali Prakashan.
6. Choudhary, R.D. (1996). Herbal drug industry, 1st Ed., New Delhi:
Eastern Publisher.
7. Ansari, S.H. (2007). Essentials of Pharmacognosy, 2nd Ed. New
Delhi: Birla publications.
8. Gokhale, S.B., Kokate, C.K. (2017). Practical Pharmacognosy, 18th
Ed. Pune: Nirali Prakashan.

Suggested e-material:
1. http://nsdl.niscair.res.in
2. http://www.herbs4youth.eu/files/workbook_processingtransf.pdf
3. https://biot202.files.wordpress.com
4. http://www.naturaldatabase.com
5. http://www.nlm.nih.gov/medlineplus/druginfo/herb_All.html
6. http://dietarysupplements.nlm.nih.gov/dietary/ingred.jsp
7. http://ods.od.nih.gov/
99

8. http://nccam.nih.gov/
9. www.fda.gov/medwatch
10. http://apps.who.int/medicinedocs/documents/h1791e/h1791e.pdf
11. http://ayush.gov.in/sites/default/files/File779%20%20%204.pdf
12. www.ayurveda.hu/api/API-Vol-1

PHAR 315 Pharmaceutical Jurisprudence


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 4 0 0 4
Learning outcomes
Upon completion of this course student will have an understanding of:

 Pharmaceutical legislations and their implications in the


development and marketing of pharmaceuticals.

 Various Indian pharmaceutical Acts and Laws

 Regulatory authorities and agencies governing the manufacture


and sale of pharmaceuticals

 Code of ethics during the pharmaceutical practice

Section-A
Drugs and Cosmetics Act, 1940 and its rules 1945: Objectives,
Definitions, Legal definitions of schedules to the Act and Rules Import of
drugs – Classes of drugs and cosmetics prohibited from import, Import
under license or permit. Offences and penalties. Manufacture of drugs –
Prohibition of manufacture and sale of certain drugs, Conditions for grant
of license and conditions of license for manufacture of drugs, Manufacture
of drugs for test, examination and analysis, manufacture of new drug, loan
license and repacking license.
Drugs and Cosmetics Act, 1940 and its rules 1945: Detailed study of
Schedule G, H, M, N, P, T, U, V, X, Y, Part XII B, Sch F & DMR (OA).
100

Sale of Drugs – Wholesale, Retail sale and restricted license. Offences and
penalties Labeling & Packing of drugs- General labeling requirements and
specimen labels for drugs and cosmetics, List of permitted colors. Offences
and penalties. Administration of the Act and Rules – Drugs Technical
Advisory Board, Central drugs Laboratory, Drugs Consultative Committee,
Government drug analysts, licensing authorities, controlling authorities,
Drugs Inspectors.
Section-B
Pharmacy Act 1948: Objectives, definitions, pharmacy council of India, its
constitution and functions, education regulations, state and joint state
pharmacy councils, constitution and functions, registration of pharmacists,
offence and penalties.
Medicinal and toilet preparation act 1955: Objectives, definitions,
licensing, manufacture in bond and outside bond, export of alcoholic
preparations, manufacture of ayurvedic, homeopathic, patent & proprietary
preparations. Office and penalties.
Narcotic drugs and psychotropic substances act 1985 and rules:
Objectives, definitions, authorities and officers, constitution and functions
of narcotic and psychotropic consultative committee, national fund for
controlling the drug abuse, prohibition, control and regulation, opium
poppy cultivation and production of poppy straw, manufacture, sale and
export of opium, offences and penalties.
Section-C
Study of salient features of drugs and magic remedies act and its rules:
Objectives, definitions, prohibition of certain advertisements, classes of
exempted advertisements, offences and penalties.
Prevention of cruelty to animals act 1960: Objectives, definitions,
Institutional animal ethics committee, CPCSEA guidelines for breeding and
stocking of animals, performance of experiments, transfer and acquisition
of animals for experiment, records, power to suspend or revoke registration,
offences and penalties.
National pharmaceutical pricing authority: Drugs price control order
(DPCO) 2013. Definitions, sale prices of bulk drugs, retail price of
formulations, retail price and ceiling price of scheduled formulations,
national list of essential medicines.
101

Pharmaceutical legislations: A brief review, introduction, study of drugs


enquiry committee, health survey and development committee, Hathi
committee and Mudaliar committee.
Code of pharmaceutical ethics: Definition, pharmacist in relation to his
job, trade, medical profession and his profession, Pharmacist’s oath.
Medical termination of pregnancy act.
Right to information act.
Introduction to Intellectual Property Rights (IPR).
Books recommended:
1. Mittal, B.M., (1899). Textbook of Forensic Pharmacy, Calcutta:
National Book Centre.
2. Relevant Acts & Rules, (2006). Delhi: Publishing by the Govt. of
India.
3. Jain, N.K., (2018). A Textbook of Forensic Pharmacy, Delhi:
Vallabh Prakashan.
Suggested e-material:
1. www.imedpub.com/.../pharmaceutical-jurisprudence-journals-
articles-ppts-list.php
2. https://cdsco.gov.in

PHAR 313L Industrial Pharmacy - I Lab


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 0 0 4 2

1. Preparation and evaluation of Paracetamol tablets


2. Preparation and evaluation of Aspirin tablets
3. Coating of tablets- film coating of tables/granules
4. Preparation and evaluation of Tetracycline capsules
102

5. Preparation of Calcium Gluconate injection


6. Preparation of Ascorbic Acid injection
7. Quality control test of (as per IP) marketed tablets and capsules
8. Preparation of Eye drops/ and Eye ointments
9. Preparation of Creams (cold / vanishing cream)
10. Evaluation of Glass containers (as per IP)

PHAR 317L Pharmacology-II Lab


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 0 0 4 2
1. Introduction to in-vitro pharmacology and physiological salt
solutions.

2. Effect of drugs on isolated frog heart.

3. Effect of drugs on blood pressure and heart rate of dog.

4. Studyof diuretic activity of drugs using rats/mice.

5. DRC of acetylcholine using frog rectus abdominis muscle.

6. Effect of physostigmine and atropine on DRC of acetylcholine using


frog rectus abdominis muscle and rat ileum respectively.

7. Bioassay of histamine using guinea pig ileum by matching method.

8. Bioassay of oxytocin using rat uterine horn by interpolation method.

9. Bioassay of serotonin using rat fundus strip by three point bioassay.

10. Bioassay of acetylcholine using rat ileum/colon by four point


bioassay.

11. Determination of PA2 value of prazosin using rat anococcygeus


muscle (by Schilds plot method).
103

12. Determination of PD2 value using guinea pig ileum.

13. Effect of spasmogens and spasmolytics using rabbit jejunum.

14. Anti-inflammatory activity of drugs using carrageenan induced paw-


edema model.

15. Analgesic activity of drug using central and peripheral methods

Note: All laboratory techniques and animal experiments are demonstrated


by simulated experiments by softwares and videos

PHAR 316L Pharmacognosy and Phytochemistry-II Lab


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 0 0 4 2
1. Morphology, histology and powder characteristics & extraction &
detection of: Cinchona, Cinnamon, Senna, Clove, Ephedra, Fennel
and Coriander
2. Exercise involving isolation & detection of active principles a.
Caffeine - from tea dust. b. Diosgenin from Dioscoreac. Atropine
from Belladonna d. Sennosides from Senna
3. Separation of sugars by Paper chromatography
4. TLC of herbal extract
5. Distillation of volatile oils and detection of phytoconstitutents by
TLC
6. Analysis of crude drugs by chemical tests: (i) Asafoetida (ii) Benzoin
(iii) Colophony (iv) Aloes (v) Myrrh
104

Sixth Semester
PHAR 311 Biopharmaceutics and Pharmacokinetics
Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 4 0 0 4
Learning outcomes
Upon completion of this course student will have an understanding of:

 Biopharmaceutics and pharmacokinetics, their role in formulation,


development and clinical testing.

 Compartment modelling and plasma concentration measurement.

 Dosage adjustment in clinical & pathological conditions and


pharmacokinetic drug interaction.

 Bioavailability – bioequivalence (BA-BE) study.

Section-A
Introduction to Biopharmaceutics: Absorption; Mechanisms of drug
absorption through GIT, factors influencing drug absorption though GIT,
absorption of drug from Non per oral extra-vascular routes,
Distribution: Tissue permeability of drugs, binding of drugs, apparent,
volume of drug distribution.
Plasma and tissue protein binding of drugs: factors affecting protein-
drug binding. Kinetics of protein binding, Clinical significance of protein
binding of drugs.

Section-B
Elimination: Drug metabolism and basic understanding metabolic
pathways renal excretion of drugs, factors affecting renal excretion of
drugs, renal clearance, Non renal routes of drug excretion of drugs
Bioavailability and Bioequivalence: Definition and Objectives of
bioavailability, absolute and relative bioavailability, measurement of
bioavailability, in-vitro drug dissolution models, in-vitro-in-vivo
105

correlations, bioequivalence studies, methods to enhance the dissolution


rates and bioavailability of poorly soluble drugs.

Section-C
Pharmacokinetics: Definition and introduction to Pharmacokinetics,
Compartment models, Non compartment models, physiological models,
One compartment open model. Intravenous Injection (Bolus), Intravenous
infusion and Extravascular administrations. Pharmacokinetics parameters -
K, t1/2, Vd, AUC, Ka, ClT and CLRE - definitions methods of eliminations,
understanding of their significance and application.
Multi-compartment models: Two compartment open model, IV bolus.
Multiple dosage regimen: Kinetics of multiple dosing, steady state drug
levels, calculation of loading and maintenance doses and their significance
in clinical settings.
Nonlinear Pharmacokinetics: Introduction, Factors causing Non-linearity,
Michaelis-menton method of estimating parameters, Explanation with
example of drugs.

Books Recommended:
1. Notari, R.E. (1987). Biopharmaceutics and Clinical
Pharmacokinetics, An Introduction, 4th edition, revised and
expanded, New York: Marcel Dekker.
2. Rowland, M. Tozer, T.N. (1995). Clinical Pharmacokinetics,
Concepts and Application, 3rd edition, Philadelphia: Lippincott
Williams and Wilkins.
3. Wagner, J.G. Pemarowski, M. (1971). Biopharmaceutics and
Relevant Pharmacokinetics, 1st edition, Illinois: Drug Intelligence
Publications.
4. Shargel, L., Yu, A., Pong, S.W. (2012). Applied Biopharmaceutics
and Pharmacokinetics. 6th Ed. New York: Mcgraw Hill Publication.
5. Jambhekar, S.S. Breen, P.J. (2009). Basic Pharmacokinetics, 1st
edition: Pharmaceutical press, RPS Publishing.
106

Suggested e-material:
1. http://202.74.245.22:8080/xmlui/handle/123456789/39/browse?type
=subject
2. https://pharmaclub.in/free-pharmacy-ebooks-pharmaceutics
3. https://www.pdfdrive.com/pharmaceutical-books.html

PHAR 312 Herbal Drug Technology


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 3 0 0 3
Learning outcomes
Upon completion of this course student will have an understanding of:

 alkaloidal drugs ,their classification, chemical tests and uses

 various enzymes and functions

 worldwide trade affecting the national economy

 role of the plant tissue culture in enhancing the accumulation of


secondary metabolites

 chromatography helps in identification and quantification of


mixture of chemical constituents present in the drugs

Section-A
Herbs as raw materials: Definition of herb, herbal medicine, herbal
medicinal product, herbal drug preparation, source of herbs selection,
identification and authentication of herbal materials, processing of herbal
raw material. Biodynamic agriculture good agricultural practices in
cultivation of medicinal plants including organic farming.
Pest and Pest management in medicinal plants: Biopesticides/
Bioinsecticides.
107

Indian Systems of Medicine: Preparation and standardization of


Ayurvedic formulations viz Aristas and Asawas, Ghutika,Churna, Lehya
and Bhasma

Section-B
Nutraceuticals: General aspects, market, growth, scope and types of
products available in the market. Health benefits and role of nutraceuticals
in ailments like Diabetes, CVS diseases, Cancer, Irritable bowel syndrome
and various Gastro intestinal diseases.
Study of following herbs as health food: Alfa-alfa, Chicory, Ginger,
Fenugreek, Garlic, Honey, Amla, Ginseng, Ashwagandha, Spirulina
Herbal-Drug and Herb-Food Interactions: General introduction to
interaction and classification. Study of following drugs and their possible
side effects and interactions- Hypercium, kava-kava, Ginkobiloba, Ginseng,
Garlic, Pepper & Ephedra.
Herbal Cosmetics: Herbal Sources and description of raw materials of
herbal origin used via, fixed oils, waxes, gums colours, perfumes, protective
agents, bleaching agents, antioxidants in products such as skin care, hair
care and oral hygiene products.
Herbal excipients: Significance of substances of natural origin as
excipients – colorants, sweeteners, binders, diluents, viscosity builders,
disintegrants, flavors & perfumes.
Herbal formulations: Conventional herbal formulations like syrups,
mixtures and tablets and Novel dosage forms like phytosomes

Section-C
Evaluation of Drugs: WHO & ICH guidelines for the assessment of herbal
drugs Stability testing of herbal drugs.
Patenting and Regulatory requirements of natural products: Definition
of the terms- Patent, IPR, Farmers right, Breeder’s right, Bioprospecting
and Biopiracy.
Patenting aspects of Traditional Knowledge and Natural Products.Case
study of Curcuma & Neem.
108

Regulatory Issues - Regulations in India (ASU DTAB, ASU DCC),


Regulation of manufacture of ASU drugs - Schedule Z of Drugs &
Cosmetics Act for ASU drugs.
General Introduction to Herbal Industry: Herbal drugs industry, Present
scope and future prospects. A brief account of plant based industries and
institutions involved in work on medicinal and aromatic plants in India.
Schedule T: Good Manufacturing Practice of Indian systems of
medicineComponents of GMP (Schedule-T) and its
objectives.Infrastructural requirements, working space, storage area,
machinery and equipments, standard operating procedures, health and
hygiene, documentation and records.

Books Recommended:
1. Evans, W.C. (2009). Trease and Evans. Pharmacognosy, 16th Ed.,
London: W.B. Sounders & Co.
2. Tyler, V.E., Brady, L.R., Robbers, J.E. (1988). Pharmacognosy, 9th
Ed., Philadelphia: Lea and Febiger.
3. Wallis, T.E., Churchill, A. (2005). Text Book of Pharmacognosy, 5th
Ed., India: CBS Publishers.
4. Mohammad, A. (2012). Pharmacognosy and Phytochemistry, 2nd
Ed., New Delhi: CBS Publishers and Distribution.
5. Purohit, A.P., Kokate, C.K., Gokhale, S.B. (2007). Text book of
Pharmacognosy, 37th Ed., New Delhi: Nirali Prakashan.
6. Choudhary, R.D. (1996). Herbal drug industry, 1st Ed., New Delhi:
Eastern Publisher.
7. Ansari, S.H. (2007). Essentials of Pharmacognosy, 2nd Ed. New
Delhi: Birla publications.
8. Gokhale, S.B., Kokate, C.K. (2017). Practical Pharmacognosy, 18th
Ed. New Delhi: Nirali Prakashan.
9. Lyengar, M.A., Nayak, S.G.K. (2017). Anatomy of Crude Drugs, 12th
Ed., PharmaMed Press.
109

Suggested e-material:
1. http://nsdl.niscair.res.in
2. http://www.herbs4youth.eu/files/workbook_processingtransf.pdf
3. https://biot202.files.wordpress.com
4. http://www.naturaldatabase.com
5. http://www.nlm.nih.gov/medlineplus/druginfo/herb_All.html
6. http://dietarysupplements.nlm.nih.gov/dietary/ingred.jsp
7. http://ods.od.nih.gov/
8. http://nccam.nih.gov/
9. http://apps.who.int/medicinedocs/en/d/Js2200e/
10. www.fda.gov/medwatch
11. http://apps.who.int/medicinedocs/documents/h1791e/h1791e.pdf
12. http://ayush.gov.in/sites/default/files/File779%20%20%204.pdf
13. www.ayurveda.hu/api/API-Vol-1

PHAR 404 Medicinal Chemistry-III


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 4 0 0 4
Learning outcomes
Upon completion of this course student will have an understanding of:

 Correlation between pharmacology of a disease and its mitigation or


cure.

 Drug metabolic pathways, adverse effect and therapeutic value of


drugs

 Structural activity relationship of different class of drugs.


110

 Synthesis of some important class of drugs.

 chemistry of drugs with respect to their pharmacological activity

Study of the development of the following classes of drugs,


Classification, mechanism of action, uses of drugs mentioned in the
course, Structure activity relationship of selective class of drugs as
specified in the course and synthesis of drugs superscripted by (*)
Section-A
Antibiotics: Historical background, Nomenclature, Stereochemistry,
Structure activity relationship, Chemical degradation classification and
important products of the following classes.
β-Lactam antibiotics: Penicillin, Cepholosporins, β-Lactamase inhibitors,
Monobactams
Aminoglycosides: Streptomycin, Neomycin, Kanamycin
Tetracyclines: Tetracycline, Oxytetracycline, Chlortetracycline,
Minocycline, Doxycycline.
Macrolide: Erythromycin Clarithromycin, Azithromycin.
Miscellaneous: Chloramphenicol*, Clindamycin.
Prodrugs: Basic concepts and application of prodrugs design.
Antimalarials: Etiology of malaria.
Quinolines: SAR, Quinine sulphate, Chloroquine*, Amodiaquine,
Primaquine phosphate, Pamaquine*, Quinacrine hydrochloride,
Mefloquine.
Biguanides and dihydro triazines: Cycloguanil pamoate, Proguanil.
Miscellaneous: Pyrimethamine, Artesunete, Artemether, Atovoquon

Section-B
Anti-tubercular Agents
Synthetic anti tubercular agents: Isoniozid*, Ethionamide, Ethambutol,
Pyrazinamide, Para amino salicylic acid.*
111

Anti-tubercular antibiotics: Rifampicin, Rifabutin, Cycloserine


Streptomycine, Capreomycin sulphate.
Urinary tract anti-infective agents Quinolones: SAR of quinolones,
Nalidixic Acid,Norfloxacin, Enoxacin, Ciprofloxacin*, Ofloxacin,
Lomefloxacin, Sparfloxacin, Gatifloxacin, Moxifloxacin
Miscellaneous: Furazolidine, Nitrofurantoin*, Methanamine.
Antiviral agents: Amantadine hydrochloride, Rimantadine hydrochloride,
Idoxuridine trifluoride, Acyclovir*, Gancyclovir, Zidovudine, Didanosine,
Zalcitabine, Lamivudine, Loviride, Delavirding, Ribavirin, Saquinavir,
Indinavir, Ritonavir.

Antifungal agents:
Antifungal antibiotics: Amphotericin-B, Nystatin, Natamycin,
Griseofulvin.
Synthetic Antifungal agents: Clotrimazole, Econazole, Butoconazole,
Oxiconazole Tioconozole, Miconazole*, Ketoconazole, Terconazole,
Itraconazole, Fluconazole, Naftifine hydrochloride, Tolnaftate*.

Section-C
Anti-protozoal Agents: Metronidazole*, Tinidazole, Ornidazole,
Diloxanide, Iodoquinol, Pentamidine Isethionate, Atovaquone, Eflornithine.
Anthelmintics: Diethylcarbamazine citrate*, Thiabendazole,
Mebendazole*, Albendazole, Niclosamide, Oxamniquine, Praziquantal,
Ivermectin.
Sulphonamides and Sulfones: Historical development, chemistry,
classification and SAR of Sulfonamides: Sulphamethizole, Sulfisoxazole,
Sulphamethizine, Sulfacetamide*, Sulphapyridine, Sulfamethoxaole*,
Sulphadiazine, Mefenide acetate, Sulfasalazine.
Folate reductase inhibitors: Trimethoprim*, Cotrimoxazole.
Sulfones: Dapsone*.
Introduction to Drug Design Various approaches used in drug design.
Physicochemical parameters used in quantitative structure activity
112

relationship (QSAR) such as partition coefficient, Hammet’s electronic


parameter, Tafts steric parameter and Hansch analysis. Pharmacophore
modeling and docking techniques.
Combinatorial Chemistry: Concept and applications of combinatorial
chemistry: solid phase and solution phase synthesis.

Books Recommended:
1. Beale, J.M., Block, J., Wilson, G. (2010). Organic medicinal and
Pharmaceutical Chemistry, 12th Ed., Philadelphia: Lippincott
Williams and Wilkins.
2. Lemke, T.L., Williams, D.A., Rocho, V.F., Zito, S.W. (2012). Foye’s
Principles of Medicinal Chemistry, 7th Ed., Philadelphia: Lippincott
Williams and Wilkins.
3. Abraham, D.J., Rotella, R.J. (2010). Burger’s Medicinal Chemistry,
Drug Discovery and Development, 7th Ed., New York: John Wiley
and Sons.
4. Smith, J.H., Williams, H. (2010). Introduction to principles of drug
design, 3rd Ed., Harwood Academic Publishers.
5. Remington, P.J., Beringer, P. (2006). Remington’s Pharmaceutical
Sciences, 21st Ed., Philadelphia: Lippincott Williams and Wilkins.
6. Buckley, G. (1988). Martindale’s extra pharmacopoeia, 29th Ed.,
British journal of general practice.
7. Finar, I.L. (2002). Organic Chemistry: Stereochemistry and the
Chemistry Natural Products, vol 2, 5th Ed., London: Pearson.
8. Lednicer, D. (1997). The Organic Chemistry of Drug Synthesis, 5th
Ed., New York: John Wiley and Sons Ltd.
9. Indian Pharmacopoeia, (2014). Addendum 2016.
10. Furniss, B.S., Hannaford, A.J., Smith, P.W.G. (2009). Vogel’s
Tatchell: Text book of practical organic chemistry, 5th Ed., London:
Pearson.
113

Suggested e-material:
1. https://books.google.co.in/books/about/Foye_s_Principles_of_Medic
inal_Chemistry.html?id=R0W1ErpsQpkC
2. https://www.wiley.com/en-us/ Burger %27s+
Medicinal+Chemistry%2C+Drug+Discovery%2C+and+Developmen
t%2C+7th+Edition-p-9780470278154

PHAR 318 Pharmacology-III


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 4 0 0 4
Learning outcomes
Upon completion of this course student will have an understanding of:

 Mechanism of drug action and its relevance in the treatment of


different diseases

 Various receptor actions using isolated tissue preparation.

 Cell communication mechanism

 Newer targets of several disease conditions for treatment

 Structure, organization and pharmacology of drugs acting on cvs,


git, hemopoeitic system, respiratory system, endocrine system,
diuretics and autacoids

Section-A
Pharmacology of drugs acting on Respiratory system: Anti -asthmatic
drugs, Drugs used in the management of COPD, Expectorants and
antitussives, Nasal decongestants, Respiratory stimulants.
Pharmacology of drugs acting on the Gastrointestinal Tract: Antiulcer
agents, Drugs for constipation and diarrhea, Appetite stimulants and
suppressants. Digestants and carminatives.Emetics and anti-emetics.
114

Chemotherapy: General principles of chemotherapy. Sulfonamides and


cotrimoxazole. Antibiotics- Penicillins, cephalosporins, chloramphenicol,
macrolides, quinolones and fluoroquinolins, tetracycline and
aminoglycosides.

Section-B
Chemotherapy: Antitubercular agents, Antileprotic agents, Antifungal
agents, Antiviral drugs, Anthelmintics, Antimalarial drugs, Antiamoebic
agents.
Chemotherapy: Urinary tract infections and sexually transmitted diseases.
Chemotherapy of malignancy.
Immunopharmacology: Immunostimulants, Immunosuppressant, Protein
drugs, monoclonal antibodies, target drugs to antigen, biosimilars.

Section-C
Principles of toxicology: Definition and basic knowledge of acute,
subacute and chronic toxicity. Definition and basic knowledge of
genotoxicity, carcinogenicity, teratogenicity and mutagenicity. General
principles of treatment of poisoning, Clinical symptoms and management of
barbiturates, morphine, organophosphosphorus compound and lead,
mercury and arsenic poisoning.
Chronopharmacology: Definition of rhythm and cycles. Biological clock
and their significance leading to chronotherapy.

Recommended books:
1. Kulkarni, S.K. (2013). Handbook of Experimental Pharmacology,
Vallabh Prakashan.
2. Ghosh, M.N. (2008). Fundamentals of Experimental Pharmacology,
5thEd., Kolkata: Hilton & Company Publishers.
3. Handbook on GLP, Quality Practices for Regulated Non-Clinical
Research and Development, World Health Organization, 2nd Ed.,
2008.
115

4. Schedule Y, Guideline: Drugs and cosmetics (second amendment)


Rules, CDSCO, 1945.
5. Annual Report to the People on Health, Ministry of Health and
Family Welfare, New Delhi, 2005
6. Rick, N.G. (2015). Drugs from Discovery to Approval, 3rdEd., New
York: Wiley-Blackwell Publishers.
7. Gad, C.S. (2015). Animal Models in Toxicology, 3rdEd., New York:
CRC Press.
8. OECD (452) guidelines for the Testing of Chemicals, 2018
9. Stine, E.R., Brown, M.T. (2015). Principles of toxicology, 3rdEd.,
New York: CRC Press.

Suggested e-material:
1. www.cvpharmacology.com
2. www.treatment4addiction.com
3. www.medicalnewtoday.com
4. www.edvivas.com
5. www.pharmafactz.com
6. www.ausmed.com

PHAR 314 Pharmaceutical Biotechnology


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 3 0 0 3
Learning outcomes
Upon completion of this course student will have an understanding of:

 Importance of genetic engineering & enzyme immobilization in


pharmaceutical industries
116

 Production and application of monoclonal antibodies in health


care.

 Use of fermentation technology in pharmaceutical field.

Section-A
Brief introduction to Biotechnology with reference to Pharmaceutical
Sciences.
Enzyme Biotechnology: Methods of enzyme immobilization and
applications.
Biosensors: Working and applications of biosensors in Pharmaceutical
Industries.
Brief introduction to Protein Engineering.
Use of microbes in industry.Production of Enzymes- General consideration
-Amylase, Catalase, Peroxidase, Lipase, Protease, Penicillinase.

Basic principles of genetic engineering.


Study of cloning vectors, restriction endonucleases and DNA ligase.
Recombinant DNA technology: Application of genetic engineering in
medicine. Application of r DNA technology and genetic engineering in the
production of: Interferon; Vaccines- hepatitis- B; Hormones-Insulin. Brief
introduction to PCR

Section-B
Immunity: Types of immunity- humoral immunity, cellular immunity.
Structure of Immunoglobulins.Structure and Function of
MHC.Hypersensitivity reactions, Immune stimulation and Immune
suppressions.General method of the preparation of bacterial vaccines,
toxoids, viral vaccine, antitoxins, serum-immune blood derivatives and
other products relative to immunity.Storage conditions and stability of
official vaccines.
Hybridoma technology: Production, Purification and Applications.
Immuno blotting techniques: ELISA, Western blotting, Southern blotting.
117

Section-C
Genetic organization of Eukaryotes and Prokaryotes.Microbial genetics
including transformation, transduction, conjugation, plasmids and
transposons.
Microbial biotransformation: Introduction and its applications.
Mutation: Types of mutation/mutants.
Fermentation: methods and general requirements, study of media,
equipments, sterilization methods, aeration process, stirring. Large scale
production fermenter design and its various controls.Study of the
production of - penicillins, citric acid, Vitamin B12, Glutamic acid,
Griseofulvin.

Recommended books (Latest editions):


1. Vyas, S.P., Dixit, V.K. (2010). Pharmaceutical Biotechnology, New
Delhi: CBS Publication.
2. Prescott, Dunn’s, (2004). Industrial Microbiology, Delhi: CBS
Publishers and Distributors.
3. Stanbury, P.F., Ahhitar, A., (2008). Principles of Fermentation
Technology, Elsevier.
4. Kieslich, K. (1984). Biotechnology, vol. 69, Verleg Chernie.
5. Standury, P.F., Whitaker, A., Hall, S.J. (1990). Principles of
Fermentation, New Delhi: Aditya Book Private Limited.
6. Crueger, W., Crueger, A., (2000). Biotechnology-A Textbook of
Industrial Microbiology, Delhi: Panima Publishing Corporation.

Suggested e-material:
1. http://site.iugaza.edu.ps/tbashiti/files/2013/02/2.Pharmaceutical_Bi
otechnology_ConceptsApplications-Gary_Walsh.pdf
2. http://web.xidian.edu.cn/yqxia/files/20140227_103205.pdf
3. https://drive.google.com/file/d/0BxB7ZrIzz8L7STd4WEhneHlKc
Xc/view?usp=drivesdk
118

PHAR 319 Quality Assurance


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 3 0 0 3
Learning outcomes
Upon completion of this course student will have an understanding of:

 The importance of quality in pharmaceutical products.

 Importance of Good practices such as GMP, GLP etc.

 Factors affecting the quality of pharmaceutical are explored.

 Regulatory aspects of pharmaceutical taught to the student.

 Process involved in manufacturing of pharmaceuticals different


section/department and activity is learnt.

Section-A
Organization and personnel: Personnel responsibilities, training, hygiene
and personal records.
Premises: Design, construction and plant layout, maintenance, sanitation,
environmental control, utilities and maintenance of sterile areas, control of
contamination.
Equipments and raw materials: Equipment selection, purchase
specifications, maintenance, purchase specifications and maintenance of
stores for raw materials.

Section-B
Quality Control: Quality control test for containers, rubber closures and
secondary packing materials.
Good Laboratory Practices: General Provisions, Organization and
Personnel, Facilities, Equipment, Testing Facilities Operation, Test and
Control Articles, Protocol for Conduct of a Nonclinical Laboratory Study,
Records and Reports, Disqualification of Testing Facilities
119

Complaints: Complaints and evaluation of complaints, Handling of return


good, recalling and waste disposal.

Section-C
Document maintenance in pharmaceutical industry: Batch Formula
Record, Master Formula Record, SOP, Quality audit, Quality Review and
Quality documentation, Reports anddocuments, distribution records.
Calibration and Validation: Introduction, definition and general
principles of calibration, qualification and validation, importance and scope
of validation, types of validation, validation master plan. Calibration of pH
meter, Qualification of UV-Visible spectrophotometer, General principles
of Analytical method Validation.
Warehousing: Good warehousing practice, materials management

Books Recommended:
1. Quality Assurance Guide (1996) by Organization of Pharmaceutical
Procedures of India, 3rd revised Ed., Volume I & II.
2. Weinberg, S. (1995). Good Laboratory Practice Regulations. 2nd
Ed., Vol. 69, New York: Marcel Dekker, Inc.
3. Quality Assurance of Pharmaceuticals- A compendium of Guide
lines and Related materials Vol I & II, 2nd edition, WHO
Publications, 1999.
4. Sharma, P. P. (1991). How to Practice GMP’s. Agra:Vandana
Publications.
5. The International Pharmacopoeia (2005)– Vol I, II, III, IV & V -
General Methods of Analysis and Quality specification for
Pharmaceutical Substances, Excipients and Dosage forms, 3rd Ed.,
WHO, Geneva.
6. Hirsch, A. F. (1989). Good Laboratory Practice Regulations. Vol 38,
New York: Marcel Dekker Inc.
7. Deshpande, S. W., Gandhi, N. The Drugs and Cosmetics Act 1940
and Rules 1945. 8th Ed., Mumbai:Susmit Publishers.
120

8. Shah, D. H. (2000). QA Manual. 1st Ed., Business Horizons,


Elsevier.
9. Willig, S. H., Stoker J. (1991). Good Manufacturing Practices for
Pharmaceuticals A Plan For Total Quality Control. Vol. 52, 3rd Ed.,
New York: Marcel Dekker Inc.

Suggested e-material:
1. www.ich.org
2. https://www.who.int

PHAR 312L Herbal Drug Technology Lab


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 0 0 4 2
1. To perform preliminary phytochemical screening of crude drugs.
2. Determination of the alcohol content of Asava and Arista.
3. Evaluation of excipients of natural origin.
4. Incorporation of prepared and standardized extract in cosmetic
formulations like creams, lotions and shampoos and their evaluation.
5. Incorporation of prepared and standardized extract in formulations
like syrups, mixtures and tablets and their evaluation as per
Pharmacopoeial requirements.
6. Monograph analysis of herbal drugs from recent Pharmacopoeias.
7. Determination of Aldehyde content
8. Determination of Phenol content
9. Determination of total alkaloids
121

PHAR 404L Medicinal Chemistry-III Lab


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 0 0 4 2
I Preparation of drugs and intermediates

1. Sulphanilamide

2. 7-Hydroxy, 4-methyl coumarin

3. Chlorobutanol

4. Triphenyl imidazole

5. Tolbutamide

6. Hexamine

II Assay of drugs

1. Isonicotinic acid hydrazide

2. Chloroquine

3. Metronidazole

4. Dapsone

5. Chlorpheniramine maleate

6. Benzyl penicillin

III Preparation of medicinally important compounds or intermediates by


Microwave irradiation technique

IV Drawing structures and reactions using chem draw®

V Determination of physicochemical properties such as logP, clogP,


MR, Molecular weight, Hydrogen bond donors and acceptors for
class of drugs course content using drug design software Drug
likeliness screening (Lipinskies RO5)
122

PHAR 318L Pharmacology - III Lab


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 0 0 4 2
1. Dose calculation in pharmacological experiments
2. Antiallergic activity by mast cell stabilization assay
3. Studyof anti-ulcer activityof a drug using pylorus ligand (SHAY) rat
model and NSAIDS induced ulcer model.
4. Study of effect of drugs on gastrointestinal motility
5. Effect of agonist and antagonists on guinea pig ileum
6. Estimation of serum biochemical parameters by using semi-
autoanalyser
7. Effect of saline purgative on frog intestine
8. Insulin hypoglycemic effect in rabbit
9. Test for pyrogens ( rabbit method)
10. Determination of acute oral toxicity (LD50) of a drug from a given
data
11. Determination of acute skin irritation / corrosion of a test substance
12. Determination of acute eye irritation / corrosion of a test substance
13. Calculation of pharmacokinetic parameters from a given data
14. Biostatistics methods in experimental pharmacology ( student’s t
test, ANOVA)
15. Biostatistics methods in experimental pharmacology (Chi square test,
Wilcoxon Signed Rank test)
*Experiments are demonstrated by simulated experiments/videos
123

Seventh Semester
PHAR 416 Instrumental Methods of Analysis
Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 4 0 0 4
Learning outcomes
Upon completion of this course student will have an understanding of:

 Instrumentation techniques available.

 Aspects of separation for multi components of drugs and


excipients using various instrumentation techniques.

 Accurate analysis and report the results in defined formats


ofdocumentation and express the observations with clarity.

 professional and safety responsibilities for working in the analysis


laboratory

Section-A
Ultraviolet-visible (UV-vis) spectroscopy:Electronic transitions,
chromophores, auxochromes, spectral shifts, solvent effect on absorption
spectra, Beer and Lambert’s law, Derivation and deviations.
Instrumentation - Sources of radiation, wavelength selectors, sample cells,
detectors (Photo tube, Photomultiplier tube, Photo voltaic cell, Silicon
Photodiode) & calibration as per ICH and USFDA guidelines.
Applications - Spectrophotometric titrations, single component and multi
component analysis.
Infra-red (IR) spectroscopy: Introduction, fundamental modes of
vibrations in poly atomic molecules, sample handling, factors affecting
vibrations. Instrumentation - Sources of radiation, wavelength selectors,
detectors (Golay cell, bolometer, thermocouple, thermister, pyroelectric
detector) & calibration as per ICH and USFDA guidelines.
Applications (Interpretation of data/ IR spectra of some simple
compounds).
124

Section-B
Fluorimetry: Theory, concepts of singlet, doublet and triplet electronic
states, internal and external conversions, factors affecting fluorescence,
quenching, instrumentation, applications & calibration as per ICH and
USFDA guidelines.
Flame photometry (AAS & AES): Principle, interferences,
instrumentation, applications & calibration as per ICH and USFDA
guidelines.
Nephelo-turbidometry: Principle, instrumentation and applications

Section-C

Nuclear magnetic resonance spectroscopy: Principle of proton-


NMR, shielding & de-shielding of magnetic nuclei, chemical shift and its
measurements, factors affecting chemical shift, spin-spin interaction
(relaxation & coupling), coupling constant ‘J’, factors influencing coupling
constant. Instrumentation and applications (Interpretation of data/ NMR
spectra of some simple compounds).
Mass spectrometry: Introduction to mass spectra, principle, fragmentation,
different types of peak (molecular ion, isotopic ion peak, fragmentation
peak) and their importance. Instrumentation.ionization techniques (Electron
impact, chemical, ionization, MALDI, FAB), analyzers (Time of flight and
Quadrupole). Applications (Interpretation of data/mass spectra of some
simple compounds).

Books Recommended:
1. Chatten, L.G. (1966). A text book of PharmaceuticalChemistry. vol.
1-2, New York: Marcel. Dekkar.
2. Backeet, A.H., Stenlake, J.B. (1962). Practical Pharmaceutical
Chemistry, vol. 1-2, London: The Atholone Press of the University
of London.
3. Willard, H.H., Merrit, L., Dean, J.A. (1966) Instrumental methods of
analysis. New York: Van Nostrand Renhold.
125

4. Obonson, J.W.R. (1970). Undergraduate Instrumental Analysis.


New York: Marcel Dekkar Inc.
5. Parikh, V.H. (1974). Absorption Spectroscopy of Organic Molecules.
London: Addison-Wesley Publishing Co.
6. Indian Pharmacopoeia (2018), Ministry of Health, Govt. of India.
7. Backeet, A.H. Stenlake, J.B. (1988). Practical Pharmaceutical
Chemistry, vol. 1-2. London: The Atholone Press.

Suggested e-material:
1. https://nptel.ac.in/downloads/103108100/
2. https://catalog.williams.edu

PHAR 415 Industrial Pharmacy-II


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 4 0 0 4
Learning outcomes
Upon completion of this course student will have an understanding of:

 Process of pilot plant and scale up of pharmaceutical dosage forms.

 Process of technology transfer from lab scale to commercial batch.

 Different Laws and Acts that regulate pharmaceutical industry


Understand the approval process and regulatory requirements for
drug products

Section-A
Pilot plant scale up techniques: General considerations - including
significance of personnel requirements, space requirements, raw materials,
Pilot plant scale up considerations for solids, liquid orals, semi solids and
relevant documentation, SUPAC guidelines, Introduction to platform
technology.
126

Technology development and transfer: WHO guidelines for Technology


Transfer(TT): Terminology, Technology transfer protocol, Quality risk
management, Transfer from R & D to production (Process, packaging and
cleaning), Granularity of TT Process (API, excipients, finished products,
packaging materials) Documentation, Premises and equipments,
qualification and validation, quality control, analytical method transfer,
Approved regulatory bodies and agencies, Commercialization - practical
aspects and problems (case studies), TT agencies in India - APCTD,
NRDC, TIFAC, BCIL, TBSE /SIDBI; TT related documentation -
confidentiality agreement, licensing, MoUs, legal issues

Section-B

Regulatory affairs: Introduction, Historical overview of Regulatory


Affairs, Regulatory authorities, Role of Regulatory affairs department,
Responsibility of Regulatory Affairs Professionals

Regulatory requirements for drug approval: Drug Development


Teams, Non-Clinical Drug Development, Pharmacology, Drug
Metabolism and Toxicology, General considerations of Investigational
New Drug (IND) Application, Investigator’s Brochure (IB) and New Drug
Application (NDA), Clinical research / BE studies, Clinical Research
Protocols, Biostatistics in Pharmaceutical Product Development, Data
Presentation for FDA Submissions, Management of Clinical Studies.

Section-C

Indian Regulatory Requirements: Central Drug Standard Control


Organization (CDSCO) and State Licensing Authority: Organization,
Responsibilities, Certificate of Pharmaceutical Product (COPP),
Regulatory requirements and approval procedures for new Drugs.

Registration of Indian drug product in overseas market

Procedure for export of pharmaceutical products, Technical


documentation, Drug Master Files (DMF), Common Technical Document
(CTD), electronic Common Technical Document (eCTD), ASEAN
Common Technical Document (ACTD) research.
127

Books Recommended:
1. Troy, D.B. (2006). Remington: The Science and Practice of
Pharmacy. 21st Ed., vol.1-2, Easton Pennysylvannia: Mack
Publishing Co.
2. Cooper, J.W. Gunn, G. (1986). Tutorial Pharmacy, London: Petman
Books Ltd.
3. Lachman L. (1986). Theory and Practice of Industrial Pharmacy.
Philadelphia: Lea & Febiger.
4. Ansel, HC. Allen, L.V. (2014). Introduction to Pharmaceutical
Dosage Forms. Philadelphia: Wolters Kluwer.
5. Willing, Tuckerman and Hitching. GMP for Pharmaceuticals.
6. ISO reports.
7. Indian Patent act.
8. Castensen, J. T. (1990). Drug Stability: Principles and Practices.
New York: Marcel Dekker.
Suggested e-material:
1. www.ich.org
2. www.cdsco.in
3. www.who.int

PHAR 417 Novel Drug Delivery System


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 4 0 0 4
Learning outcomes
Upon completion of this course student will have an understanding of:

 Various approaches for development of novel drug delivery


systems.

 Criteria for selection of drugs and polymers for the development of


Novel drug delivery systems, their formulation and evaluation
128

Section-A
Controlled drug delivery systems: Introduction, terminology/definitions
and rationale, advantages, disadvantages, selection of drug
candidates.Approaches to design controlled release formulations based on
diffusion, dissolution and ion exchange principles. Physicochemical and
biological properties of drugs relevant to controlled release formulations
Polymers: Introduction, classification, properties, advantages and
application of polymers in formulation of controlled release drug delivery
systems.
Microencapsulation: Definition, advantages and disadvantages,
microspheres /microcapsules, microparticles, methods of
microencapsulation, applications
Mucosal Drug Delivery system: Introduction, Principles of bioadhesion
/mucoadhesion, concepts, advantages and disadvantages, transmucosal
permeability andformulation considerations of buccal delivery systems
Section-B
Implantable Drug Delivery Systems: Introduction, advantages and
disadvantages, concept of implants and osmotic pump.
Transdermal Drug Delivery Systems: Introduction, Permeation through
skin, factors affecting permeation, permeation enhancers, basic components
of TDDS, formulation approaches
Gastro-retentive drug delivery systems: Introduction, advantages,
disadvantages, approaches for GRDDS – Floating, high density systems,
inflatable and gastro-adhesive systems and their applications
Section-C
Nasopulmonary drug delivery system: Introduction to Nasal and
Pulmonary routes of drug delivery, Formulation of Inhalers (dry powder
and metered dose), nasal sprays, nebulizers
Targeted drug Delivery: Concepts and approaches advantages and
disadvantages, introduction to liposomes, niosomes, nanoparticles,
monoclonal antibodies and their applications
129

Ocular Drug Delivery Systems: Introduction, intra ocular barriers and


methods to overcome -preliminary study, ocular formulations and ocuserts
Intrauterine Drug Delivery Systems: Introduction, advantages and
disadvantages, development of intra uterine devices (IUDs) and
applications.

Books recommended:
1. Chien, Y.W. (1992). Novel Drug Delivery Systems. New York:
Marcel Dekker, Inc.
2. Robinson, J.R., Lee, V.H.L. (1992). Controlled Drug Delivery
Systems. New York: Marcel Dekker, Inc.
3. Mathiowitz, E. (2002). Encyclopedia of Controlled Delivery. New
York: Wiley Interscience Publication.
4. Jain, N.K. (1997). Controlled and Novel Drug Delivery, New Delhi:
CBS Publishers & Distributors.
5. Vyas, S.P., Khar, R.K. (2002). Controlled Drug Delivery-concepts
and advances, New Delhi: Vallabh Prakashan.

Suggested e-material:
1. Indian Journal of Pharmaceutical Sciences (IPA)
2. Indian Drugs (IDMA)
3. Journal of Controlled Release (Elsevier Sciences)
4. Drug Development and Industrial Pharmacy(Marcel & Decker)
5. International Journal of Pharmaceutics (Elsevier Sciences)

PHAR 414 Dosage Form Design


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 4 0 0 4
Learning outcomes
Upon completion of this course student will have an understanding of:
130

 Concept of pre-formulation; prodrug and their influence on formulation


and stability of products.
 BCS Classification and solubilization in context to dosage form
development.
 in vitro dissolution study of solids and interpretation of dissolution
data.
 Bioavailability studies and in vivo methods of evaluation and their
statistical treatment.
Section-A
Pre-formulation Studies: Introduction to pre-formulation, goals and
objectives, study of physicochemical characteristics of drug substances.
Physical properties: Physical form (crystal & amorphous), particle size,
shape, flow properties, solubility profile (pKa, pH, partition coefficient),
polymorphism.
Chemical Properties: Hydrolysis, oxidation, reduction, racemisation,
polymerization. Application of pre-formulation parameters in the
development and stability of dosage forms.
BCS classification: Introduction, classification and its applications.
Section-B
Prodrugs: Introduction, types, application of prodrug in solving problems
related to stability, bioavailability and elegancy of formulation.
Solubility and solubilization: Techniques of solubilization of drugs
including surfactant systems, co-solvents, solid state manipulations,
complexation and chemical modifications.
Section-C
Performance evaluation, in vitro: Dissolution: Introduction, dissolution
studies for solid dosage forms, methods of interpretation of dissolution data:
model dependent and model independent methods, dissolution profile
comparison.
Performance evaluation, in vivo: bioavailability studies: Introduction,
bioavailability testing protocol and procedures, methods of evaluation and
statistical treatment.
131

Books recommended:
1. Wells, J.I. (1990). Pharmaceutical Prefomulation: The
Physicochemical Properties of Drug Substances. London: Ellis
Horwood, Chiechester.
2. Yalkowsky, S.H. (1981). Techniques of Solubilization of Drugs. New
York: Marcel Dekker.
3. Lewis, G.A. (2007). Optimization Methods. In Encyclopedia of
Pharmaceutical Technology. New York: Informa Healthcare.
4. Banker, G.S. Rhode, C.T. (1979). Modern Pharmaceutics. New
York: Marcel DekkarInc.
5. Bean, H.S. Beckett, A.H., Careless, A.H. (1982). Advances in
pharmaceutical sciences, vol.1-4, London: Academic Press.
6. Gibaldi, M. Perrier, D. (1982). Pharmacokinetics. New York: Marcel
Dekkar Inc.
7. Troy, D.B. (2006). Remington: The Science and Practice of
Pharmacy. 21st Ed., vol.1-2,Easton Pennsylvania: Mack Publishing
Co.
8. Khar, R.K., Vyas, S.P., Ahmad, F.J., Jain, G.K. (2013).
Lachman/Liebermans: The Theory and Practice of Industrial
Pharmacy. New Delhi: CBS Publisher.
9. Gibaldi, M. (1991). Biopharmaceutics and clinical
Pharmacokinetics.

Suggested e-material:
1. https://pharmaclub.in/free-pharmacy-ebooks-pharmaceutics/
2. https://www.pdfdrive.com/pharmaceutical-books.html
3. http://202.74.245.22:8080/xmlui/handle/123456789/39/browse?type
=subject
4. http://swepub.kb.se/
132

PHAR 421 Pharmacy Practice


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 4 0 0 4
Learning outcomes

Upon completion of this course student will have an understanding of:

 The role of pharmacist in different areas of hospital and hospital


pharmacy

 Production and handling of radiopharmaceuticals.

 Drug information services and data retrieval in healthcare

Section-A

Hospital and it’s organization: Definition, Classification of hospital-


Primary, Secondary and Tertiary hospitals, Classification based on clinical
and non- clinical basis, Organization Structure of a Hospital, and Medical
staffs involved in the hospital and their functions.

Hospital pharmacy and its organization: Definition, functions of


hospital pharmacy, Organization structure, Location, Layout and staff
requirements, and Responsibilities and functions of hospital pharmacists.

Adverse drug reaction: Classifications - Excessive pharmacological


effects, secondary pharmacologicaleffects, idiosyncrasy, allergic drug
reactions, genetically determined toxicity, toxicity following sudden
withdrawal of drugs, Drug interaction- beneficial interactions, adverse
interactions, and pharmacokinetic drug interactions, Methods for detecting
drug interactions, spontaneous case reports and record linkage studies, and
adverse drug reaction reporting and management.

Community Pharmacy: Organization and structure of retail and


wholesale drug store, types and design, Legal requirements for
establishment and maintenance of a drug store, Dispensing of proprietary
products, maintenance of records of retail and wholesale drug store.
133

Drug distribution system in a hospital: Dispensing of drugs to


inpatients, types of drug distribution systems, charging policy and
labelling, Dispensing of drugs to ambulatory patients, and Dispensing of
controlled drugs.
Section-B
Hospital formulary: Definition, contents of hospital formulary,
Differentiation of hospital formulary and Drug list, preparation and
revision, and addition and deletion of drug from hospital formulary.
Therapeutic drug monitoring: Need for Therapeutic Drug Monitoring,
Factors to be considered during the Therapeutic Drug Monitoring, and
Indian scenario for Therapeutic Drug Monitoring.
Medication adherence: Causes of medication non-adherence, pharmacist
role in the medication adherence, and monitoring of patient medication
adherence.
Patient medication history interview: Need for the patient medication
historyinterview, medication interview forms.
Community pharmacy management: Financial, materials, staff, and
infrastructure requirements.
Pharmacy and therapeutic committee: Organization, functions, Policies
of the pharmacy and therapeutic committee in including drugs into
formulary, inpatient and outpatient prescription, automatic stop order, and
emergency drug list preparation.
Drug information services: Drug and Poison information centre, Sources
of drug information, Computerised services, and storage and retrieval of
information.
Patient counseling: Definition of patient counseling; steps involved in
patient counseling, and Special cases that require the pharmacist
Section-C
Education and training program in the hospital: Role of pharmacist in
the education and training program, Internal and external training
program, Services to the nursing homes/clinics, Code of ethics for
134

community pharmacy, and Role of pharmacist in the interdepartmental


communication and community health education.
Prescribed medication order and communication skills: Prescribed
medication order- interpretation and legal requirements, and
Communication skills- communication with prescribers and patients.
Budget preparation and implementation: Budget preparation and
implementation
Clinical Pharmacy: Introduction to Clinical Pharmacy, Concept of
clinical pharmacy, functions and responsibilities of clinical pharmacist,
Drug therapy monitoring - medication chart review, clinical review,
pharmacist intervention, Ward round participation, Medication history and
Pharmaceutical care. Dosing pattern and drug therapy based on
Pharmacokinetic & disease pattern.
Over the counter (OTC) sales: Introduction and sale of over the counter,
and Rational use of common over the counter medications.
Drug store management and inventory control: Organisation of drug
store, types of materials stocked and storage conditions, Purchase and
inventory control: principles, purchase procedure, purchase order,
procurement and stocking, Economic order quantity, Reorder quantity
level, and Methods used for the analysis of the drug expenditure
Investigational use of drugs: Description, principles involved,
classification, control, identification, role of hospital pharmacist, advisory
committee.
Interpretation of Clinical Laboratory Tests: Blood chemistry,
hematology, and urinalysis

Books Recommended:
1. Merchant, S.H., Quadry, J.S. (2001). A textbook of hospital
pharmacy. Ahmadabad: B.S. Shah Prakakshan.
2. Parthasarathi, G., Nyfort-Hansen, K., Nahata, M.C. (2004). A
textbook of Clinical Pharmacy Practice- essential concepts and
skills. Chennai: Orient Longman Private Limited.
135

3. Hassan, W.E. (1986). Hospital pharmacy. Philadelphia: Lea &


Febiger.
4. Bajaj, A. Tipins, H.P. (2008). Hospital Pharmacy. Nashik: Career
Publications.
5. Lee, M. (2013). Basic skills in interpreting laboratory data,
Bethesda: American Society of Health System Pharmacists Inc.
6. Parmar, N.S. (2008). Health Education and Community Pharmacy,
New Delhi: CBS Publishers & Distributers.

Suggested e-material:
1. Therapeutic drug monitoring. ISSN: 0163-4356
2. Journal of pharmacy practice. ISSN : 0974-8326
3. American journal of health system pharmacy. ISSN: 1535-2900
(online)
4. http://202.74.245.22:8080/xmlui/bitstream/handle/123456789/
418/Martin%20Stephens%20Hospital%20Pharmacy%20%202011.p
df?sequence=1

PHAR 416L Instrumental Methods of Analysis Lab


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 4 0 0 4
Learning outcomes
Upon completion of this course student will know:

 Handling of Various instrumentation technique of analysis.


1. Determination of absorption maxima and effect of solvents on
absorption maxima of organic compounds
2. Estimation of dextrose by colorimetry
3. Estimation of sulfanilamide by colorimetry
136

4. Simultaneous estimation of ibuprofen and paracetamol by UV


spectroscopy
5. Assay of paracetamol by UV- Spectrophotometry
6. Estimation of quinine sulfate by fluorimetry
7. Study of quenching of fluorescence
8. Determination of sodium by flame photometry
9. Determination of potassium by flame photometry
10. Determination of chlorides and sulphates by nephelo turbidometry
11. Separation of amino acids by paper chromatography
12. Separation of sugars by thin layer chromatography
13. Separation of plant pigments by column chromatography
14. Demonstration experiment on HPLC
15. Demonstration experiment on Gas Chromatography

PHAR 414L Dosage Form Design Lab


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 0 0 4 2
Learning outcomes
Upon completion of this course student will know:

 Preformulation study of API for dosage form development

 Evaluation as performance indicator


1. Preformulation studies including determination of solubility,
partition coefficient, flow property, melting point, particle size and
size distribution of paracetamol/aspirin/or any other drug.
2. Preformulation studies including drug excipient compatibility
studies, effect of stabilizers, preservatives etc. in dosage form
design
137

3. Experiments demonstrating improvement in bioavailability


through prodrug concept.
4. Stability evaluation of various dosage forms and their expiration
dating
5. Dissolution testing and data evaluation for oral solid dosage forms
6. Evaluation of Pharmaceutical equivalence of some marketed
products

PHAR 422L Practice School


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 0 0 8 4
Learning outcomes
Upon completion of this course student will have an understanding of:

 Patient based assessment skills.

 Therapeutic decision making skills.

 Interpretation of the laboratory results to aid in clinical diagnosis.

 Rationale pharmacotherapeutic alternatives.

 Individualization of therapeutic regimen.

The students will undertake hospital training during this course.


138

Eighth Semester
PHAR 412 Biostatistics and Research Methodology
Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 4 0 0 4
Learning outcomes
Upon completion of this course student will have an understanding of:

 Operation of M.S. Excel, SPSS, R and MINITAB, DoE (Design of


Experiment)

 Various statistical techniques to solve statistical problems


Section-A
Introduction: Statistics, Biostatistics, Frequency distribution
Measures of central tendency: Mean, Median, Mode- Pharmaceutical
examples
Measures of dispersion: Dispersion, Range, standard deviation,
Pharmaceutical problems
Correlation: Definition, Karl Pearson’s coefficient of correlation, Multiple
correlation Pharmaceuticals examples
Regression: Curve fitting by the method of least squares, fitting the lines
y= a + bx and x
= a + by, Multiple regression, standard error of regression–
Pharmaceutical Examples
Probability: Definition of probability, Binomial distribution, Normal
distribution, Poisson’s distribution, properties - problems Sample,
Population, large sample, small sample, Null hypothesis, alternative
hypothesis, sampling, essence of sampling, types of sampling, Error-I type,
Error-II type, Standard error of mean (SEM) - Pharmaceutical examples
Parametric test: t-test (Sample, Pooled or Unpaired and Paired), ANOVA,
(One way and Two way), Least Significance difference
139

Section-B
Non Parametric tests: Wilcoxon Rank Sum Test, Mann-Whitney U test,
Kruskal-Wallis test, Friedman Test
Introduction to Research: Need for research, Need for design of
Experiments, Experiential Design Technique, plagiarism
Graphs: Histogram, Pie Chart, Cubic Graph, response surface plot,
Counter Plot graph
Designing the methodology: Sample size determination and Power of a
study, Report writing and presentation of data, Protocol, Cohorts studies,
Observational studies, Experimental studies, Designing clinical trial,
various phases.
Blocking and confounding system for Two-level factorials
Regression modeling: Hypothesis testing in Simple and Multiple
regressionmodels
Section-C

Introduction to practical components of industrial and clinical trials


problems: Statistical Analysis Using Excel, SPSS, MINITAB, design of
experiments, R Online Statistical Software’s to Industrial and Clinical trial
approach

Design and Analysis of experiments:


Factorial Design: Definition, 22, 23 design. Advantage of factorial design
Response Surface methodology: Central composite design, Historical
design, Optimization Techniques.

BooksRecommended:
1. Bolton, S. Bon, C. (2010). Pharmaceutical statistics- Practical and
clinical applications. New York: Informa Health Care.
2. Gupta, S.C. (2018). Fundamental of Statistics. Mumbai: Himalaya
Publishing House.
140

3. Pannerselvam, R. (2012). Design and Analysis of Experiments.


Delhi:PHI Learning Private Limited,
4. Montgomery, D.C. (1997). Design and Analysis of Experiments. New
York: Wiley.

Suggested e-material:
1. https://www.elsevier.com/.../research-methodology-and-biostatistics
2. https://www.eolss.net/sample-chapters/C02/E4-31-04-00.pdf

PHAR 425 Social and Preventive Pharmacy


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 4 0 0 4
Learning outcomes

Upon completion of this course student will have an understanding of:

 High consciousness of current issues related to health and


pharmaceutical problems within the country and worldwide.

 Critical way of thinking based on current healthcare development.

 Evaluate alternative ways of solving problems related to health and


pharmaceutical issues.

Section-A

Concept of health and disease: Definition, concepts and evaluation of


public health. Understanding the concept of prevention and control of
disease, social cases of diseases and social problems of the sick.

Social and health education: Food in relation to nutrition and health,


balanced diet, nutritional deficiencies, vitamin deficiencies, malnutrition
and its prevention.

Sociology and health: socio cultural factors related to health and disease.
Imapct of urbanization on health and disease.Poverty and health.
141

Section-B
Preventive medicine: General principles of prevention and control of
diseases such as cholera, SARS, Ebola virus, influenza, acute respiratory
infections, malaria, chicken guinea, dengue, lymphatic filariasis,
pneumonia, hypertension, diabetes mellitus, cancer, drug-addiction-drug
substance abuse.
National health programs, its objectives, functioning and outcome of the
following: HIV and AIDS control programme, TB, integrated disease
surveillance program (IDSP), National leprosy control programme, national
mental health program, nationalprogramme for prevention and control of
deafness, Universal immunization programme, National programme for
control of blindness, Pulse polio programme.
Section-C
National health intervention programme for mother and child, National
family welfare programme, National tobacco control programme, National
Malaria Prevention Program, National programme for the health care for
the elderly, Social health programme; role of WHO in Indian national
program.
Community services in rural, urban and school health: Functions of
PHC, Improvement in rural sanitation, national urban health mission,
Health promotion and education in school.

Books Recommended:
1. Prabhakara, G.N. (2010). Short Textbook of Preventive and Social
Medicine, New Delhi: Jaypee Brothers Medical Publishers (P) Ltd.
2. Roy, R.N., Saha, I. (2013). Mahajan and Gupta-Textbook of
Preventive and Social Medicine. New Delhi: Jaypee Brothers
Medical Publishers (P) Ltd.
3. Jain, V. (2014). Review of Preventive and Social Medicine
(Including Biostatistics. New Delhi: Jaypee Brothers Medical
Publishers (P) Ltd.
142

4. Hiremath, L.D., Hiremath, D.A. (2012). Essentials of Community


Medicine—A Practical Approach. New Delhi: Jaypee Brothers
Medical Publishers (P) Ltd.
5. Park, K. (2011). Textbook of Preventive and Social Medicine,
Jabalpur: Banarsidas Bhanot Publishers.
6. Adepu, R. (2015). Community Pharmacy Practice, Hyderabad: BSP
publishers.

Suggested e-material:
1. Research in Social and Administrative Pharmacy, Elsevier, Ireland

PHAR 423P Project Work


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 0 0 16 8

Learning outcomes
Upon completion of this course student will have an understanding of:
 Experiments, the research tools like literature review, presentation
of data etc.
This course will govern the process of literature review and presentation,
which is prescribed for any type of research work. The project work will be
divided in four equal components
Advanced Instrumentation Techniques Project Lab
1. To perform experiment based on solid phase extraction and liquid-
liquid extraction
2. To perform experiment based on various chromatography:
a) Adsorption and partition column chromatography
b) Thin layer chromatograph
c) Paper chromatography
d) Gel chromatography
143

e) Affinity chromatography
f) Gas chromatography /High performance liquid
chromatography

3. To perform experiment based on electrophoresis.

4. To perform experiment based on thermal techniques.

5. To perform experiment based on XRD.

6. To perform experiment based on radioimmunoassay technique.

Cosmetic Science Project Lab

1. To prepare and evaluate cold cream.

2. To prepare and evaluate Vanishing cream.

3. Formulation & evaluation Suppositories.

4. To prepare and evaluate Shaving creams.

5. Development and evaluation of Shampoo.

6. Development and evaluation of Toothpaste.

7. Development and evaluation of Antidandruff Shampoo.

8. Formulation & evaluation of Clear gel.

9. To prepare and evaluate herbal creams.

Quality Control and Standardization of Herbals Project Lab

1. Determination of lycopodium spores in per mg lycopodium powder.

2. Determination of starch grains in per mg ginger powder by


lycopodium spore method.

3. Determination of acid insoluble and water soluble ash value of given


crude drug.

4. Determination of sugar content in Ayurvedic formulation.

5. Determination of total phenolic content of given extract.


144

6. Determination of total flavonoid content of given extract.

7. Determination of antioxidant activity of given alcoholic extract by


DPPH method.

8. Quantification of flavonoids /steroids By HPTLC.

9. Quantification of flavonoids /steroids By HPLC.

10. Extraction of volatile oil and their chromatographic profile.

11. Standardization of marketed herbal formulation.

Social and Preventive Pharmacy Lab

1. Experiments based on different aspects of social and preventive


pharmacy.

2. Experiments related to prescription analysis.

Evaluation of therapeutic dosage regimen.


145

Discipline Electives
PHAR 411 Advanced Instrumentation Techniques
Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 4 0 0 4
Learning outcomes
Upon completion of this course student will have an understanding of:
 Advanced instruments used and its applications in drug analysis.
 Chromatographic separation and analysis of drugs
 Calibration of various analytical instruments
 Analysis of drugs using various analytical instruments.
Section-A
Extraction techniques: General principle and procedure involved in the
solid phase extraction and liquid-liquid extraction
Chromatography: Introduction to chromatography
Adsorption and partition column chromatography-Methodology,
advantages, disadvantages and applications.
Thin layer chromatography- Introduction, Principle, Methodology, Rf
values, advantages, disadvantages and applications.
Paper chromatography-Introduction, methodology, development
techniques, advantages, disadvantages and applications
Gel chromatography-Introduction, theory, instrumentation and applications
Affinity chromatography-Introduction, theory, instrumentation and
applications.
Section-B
Chromatography:
Gas chromatography - Introduction, theory, instrumentation, derivatization,
temperature programming, advantages, & disadvantages, applications and
calibration of GC as per ICH &US FDA guidelines.
146

High performance liquid chromatography (HPLC)-Introduction, theory,


instrumentation, advantages, applications and calibration of HPLC as per
ICH &US FDA guidelines.
Ion exchange chromatography- Introduction, classification, ion exchange
resins, properties, mechanism of ion exchange process, factors affecting ion
exchange, methodology and applications
Hyphenated techniques: LC-MS/MS, GC-MS/MS, HPTLC-MS.
Electrophoresis: Introduction, factors affecting electrophoretic mobility,
Techniques of paper, gel, capillary electrophoresis, applications.
Section-C
Thermal methods of analysis: Principle, instrumentation and applications
of thermo-gravimeteric analysis (TGA), Differential thermal analysis
(DTA), and differential scanning calorimetry (DSC).
X-ray diffraction methods: Origin of x-rays, basic aspects of crystals, x-
ray crystallography, rotating crystal technique, single crystal diffraction,
powder diffraction, structural elucidation and applications.
Radioimmunoassay: Importance, various components, principle, different
methods, limitation and applications of radioimmunoassay
Books Recommended:
1. Chatten, L.G. (1966). A text book of PharmaceuticalChemistry,vol.
1-2, New York: Marcel. Dekkar.
2. Backeet, A.H., Stenlake, J.B. (1962). Practical Pharmaceutical
Chemistry, vol. 1-2, London: Atholone Press of the University of
London.
3. Willard, H.H., Merrit, L., Dean, J.A. (1966) Instrumental methods of
analysis. New York: Van Nostrand Renhold.
4. Obonson, J.W.R. (1970). Undergraduate Instrumental Analysis.
New York: Marcel Dekkar Inc.
5. Parikh, V.H. (1974). Absorption Spectroscopy of Organic Molecules.
London: Addison-Wesley Publishing Co.
6. Indian Pharmacopoeia (2018), Ministry of Health, Govt. of India.
147

7. Backeet, A.H. Stenlake, J.B. (1988). Practical Pharmaceutical


Chemistry Vol. I and II. London: The Atholone Press.
Suggested e-material:
1. fist.ump.edu.my/index.php/en/
2. https://www.acs.org/content/dam/acsorg

PHAR 419 Pharmaceutical Regulatory Science


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 4 0 0 4
Learning outcomes
Upon completion of this course student will have an understanding of:
 Process of drug discovery and development
 Regulatory authorities and agencies governing the manufacture
and sale of pharmaceuticals
 Regulatory approval process and their registration in Indian and
international markets
Section-A
New Drug Discovery and development Stages of drug discovery-Drug
development process, pre-clinical studies, non-clinical activities, clinical
studies, Innovator and generics, Concept of generics, Generic drug product
development.
Regulatory Approval Process- Approval processes and timelines involved
in Investigational New Drug (IND), New Drug Application (NDA),
Abbreviated New Drug Application (ANDA) in US. Changes to an
approved NDA / ANDA.
Section-B
Regulatory authorities and agencies- Overview of regulatory authorities
of United States, European Union, Australia, Japan, Canada (Organization
structure and types of applications)
148

Registration of Indian drug product in overseas market-Procedure for


export of pharmaceutical products, Technical documentation, Drug Master
Files (DMF), Common Technical Document (CTD), electronic Common
Technical 164 Document (eCTD), ASEAN Common Technical Document
(ACTD) research.
Section-C
Clinical trials- Developing clinical trial protocols, Institutional Review
Board / Independent Ethics committee - formation and working procedures,
Informed consent process and procedures, GCP obligations of Investigators,
sponsors & Monitors, Managing and Monitoring clinical trials,
Pharmacovigilance - safety monitoring in clinical trials
Regulatory Concepts Basic terminologies, guidance, guidelines,
regulations, laws and acts, Orange book, Federal Register, Code of Federal
Regulatory, Purple book.
Books Recommended:
1. Itkar, S. Vyawahare, N.S. Drug Regulatory Affairs, Pune: Nirali
Prakashan.
2. Berry, I.R., Martin, R.P. (2008). The Pharmaceutical Regulatory
Process, Ed. Drugs and the Pharmaceutical Sciences, CRC press.
3. Richard, A. Guarino, M.D. (2004). New Drug Approval Process:
Accelerating Global Registrations. CRC Press.
4. Weinberg, S. (2008). Guidebook for drug regulatory submissions.
New York: John Wiley & Sons. Inc.
5. Pisano, D.J. Mantus, D. (2008). FDA Regulatory Affairs: a guide for
prescription drugs, medical devices, and biologics. CRC Press.
Suggested e-material:
1. www.fda.gov
2. https://www.ich.org/products/guidelines.html
149

PHAR 424 Quality Control and Standardization


of Herbals
Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 4 0 0 4
Learning outcomes
Upon completion of this course student will have an understanding of:
 Detection of different type of adulteration present in the crude
drug
 Evaluation of the quality and purity of the drugs by morphological,
microscopical, chemical, physical and biological evaluation
 Stereochemistry of natural products
 Biogenetic pathways ongoing in the plants for the production of
secondary metabolites
Section-A
Basic tests for drugs – Pharmaceutical substances, Medicinal plants
materials and dosage forms. WHO guidelines for quality control of herbal
drugs. Evaluation of commercial crude drugs intended for use
Quality assurance in herbal drug industry-cGMP, GAP, GMP and GLP
in traditional system of medicine.WHO Guidelines on current good
manufacturing Practices (cGMP) for Herbal Medicines.WHO Guidelines on
GACP for Medicinal Plants.
Section-B
EU and ICH guidelines for quality control of herbal drugs- Research
Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines.
Stability testing of herbal medicines- Application of various
chromatographic techniques in standardization of herbal
products.Preparation of documents for new drug application and export
registration GMP requirements and Drugs & Cosmetics Act provisions.
150

Section-C
Regulatory requirements for herbal medicines-WHO guidelines on
safety monitoring of herbal medicines in pharmacovigilance systems
Comparison of various Herbal Pharmacopoeias.Role of chemical and
biological markers in standardization of herbal products.
Books Recommended:
1. Evans, W. (2009). Trease and Evans' Pharmacognosy. Saunders Ltd.
2. Kokate, C.K., Purohit, A.P., Gokhale, G.B. (2008). Pharmacognosy.
New Delhi: Nirali Prakashan.
3. Rangari, V.D. (2006). Text book of Pharmacognosy and
Phytochemistry. Nashik: Carrier Pub.
4. Aggrawal, S.S. (2002). Herbal Drug Technology. Universities Press.
5. EMEA. Guidelines on Qualityof Herbal Medicinal
Products/Traditional Medicinal Products.
6. Mukherjee, P.W. (2002). Quality Control of Herbal Drugs: An
Approach to Evaluation of Botanicals. New Delhi: Business
Horizons Publishers.
7. Shinde, M.V., Dhalwal, K., Potdar, K., Mahadik, K. (2009).
Application of quality control principles to herbal drugs.
International Journal of Phytomedicine. 1p, 4-8.
8. WHO. Quality Control Methods for Medicinal Plant Materials,
World Health Organization, Geneva, 1998.
9. WHO. Guidelines for the Appropriate Use of Herbal Medicines.
WHO Regional Publications, Western Pacific Series No 3, WHO
Regional office for the Western Pacific, Manila, 1998.
10. WHO. The International Pharmacopeia, Vol. 2:
QualitySpecifications, 3rd edn. World Health Organization, Geneva,
1981.
11. WHO. Quality Control Methods for Medicinal Plant Materials.
World Health Organization, Geneva, 1999.
12. WHO. WHO Global Atlas of Traditional, Complementary and
Alternative Medicine. 2 vol. set. Vol. 1 contains text and Vol. 2,
maps. World Health Organization, Geneva, 2005.
151

13. WHO. Guidelines on Good Agricultural and Collection Practices


(GACP) for Medicinal Plants. World Health Organization, Geneva,
2004.
Suggested e-material:
1. https://www.elsevier.com/books/quality-control-and...of-herbal.../
2. https://onlinelibrary.wiley.com.

PHAR 420 Pharmacovigilance


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 4 0 0 4
Learning outcomes
Upon completion of this course student will have an understanding of:
 history and development of pharmacovigilance
 national and international scenario of pharmacovigilance
 detection of new adverse drug reactions and their assessment
 international standards for classification of diseases and drugs
 adverse drug reaction reporting systems and communication in
pharmacovigilance
 ICH guidelines for ICSR, PSUR, expedited reporting,
pharmacovigilance planning
 CIOMS requirements for ADR reporting
Section-A
Introduction to Pharmacovigilance - History and development of
Pharmacovigilance.Importance of safety monitoring of Medicine.WHO
international drug monitoring programme. Pharmacovigilance Program of
India(PvPI).
Introduction to adverse drug reactions - Definitions and classification of
ADRs .Detection and reporting.Methods in Causality assessment .Severity
and seriousness assessment.Predictability and preventability
assessment.Management of adverse drug reactions.
Basic terminologies used in pharmacovigilanceTerminologies of adverse
medication related events. Regulatory terminologies.
152

Drug and disease classification- Anatomical, therapeutic and chemical


classification of drugs. International classification of diseases .Daily
defined doses . International Nonproprietary Names for drugs.
Section-B
Drug dictionaries and coding in pharmacovigilance - WHO adverse
reaction terminologies . MedDRA and Standardised MedDRA queries .
WHO drug dictionary . Eudravigilance medicinal product dictionary
Information resources in pharmacovigilance - Basic drug information
resources .Specialised resources for ADRs.
Establishing pharmacovigilance programme- Establishing in a hospital
.Establishment & operation of drug safety department in industry .Contract
Research Organisations (CROs).Establishing a national programme.
Vaccine safety surveillance - Vaccine Pharmacovigilance . Vaccination
failure .Adverse events following immunization.
Pharmacovigilance methods - Passive surveillance.Spontaneous reports
and case series. Stimulated reporting . Active surveillance – Sentinel sites,
drug event monitoring and registries . Comparative observational studies –
Cross sectional study, case control study and cohort study .Targeted clinical
investigations.
Communication in pharmacovigilance - Effective communication in
Pharmacovigilance . Communication in Drug Safety Crisis management
.Communicating with Regulatory Agencies, Business Partners, Healthcare
facilities & Media.
Section-C
Statistical methods for evaluating medication safety data - Safety data
generation .Pre-clinicalphase .Clinical phase. Post approval phase.
ICH Guidelines for Pharmacovigilance -Organization and objectives of
ICH . Expedited reporting . Individual case safety reports . Periodic safety
update reports. Post approval expedited reporting . Pharmacovigilance
planning . Good clinical practice in pharmacovigilance studies.
Pharmacogenomics of adverse drug reactions
Drug safety evaluation in special population - Paediatrics .Pregnancy and
lactation .Geriatrics ,CIOMS. CIOMS Working Groups . CIOMS Form
CDSCO (India) and Pharmacovigilance - D&C Act and Schedule
Y.Differences in Indian and global pharmacovigilance requirements.
153

Books Recommended:
1. Gupta, SK. (2011). Textbook of Pharmacovigilance. New Delhi:
Jaypee Brothers, Medical Publishers.
2. Cobert, B. Biron, P. (2009). Practical Drug Safety from A to Z. Jones
and Bartlett Publishers.
3. Andrews, E.B. Moore, N. (2014). Mann's Pharmacovigilance: New
York: Wiley Publishers.
4. Talbot, J. Walle, P. (2003). Stephens' Detection of New Adverse
Drug Reactions. New York: Wiley Publishers.
5. Waller P. Harrison-Woolrych, M. (2017). An Introduction to
Pharmacovigilance. New York: Wiley Publishers.
Suggested e- learning:
1. http://www.whoumc.org/DynPage.aspx?id=105825&mn1=7347&mn
2=7259&mn3=7297
2. http://www.ich.org/
3. http://www.cioms.ch/
4. http://cdsco.nic.in/
5. http://www.who.int/vaccine_safety/en/
6. http://www.ipc.gov.in/PvPI/pv_home.html

PHAR 413 Cosmetic Science


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 4 0 0 4
Learning outcomes
Upon completion of this course student will have an understanding of:
 Various key ingredients and basic science to develop cosmetics
and cosmeceuticals
 Scientific knowledge to develop cosmetics and cosmeceuticals
with desired safety, stability and efficacy with compliance to
Indian Regulatory Authority.
154

Section-A
Classification of cosmetic and cosmeceutical products: Definition of
cosmetics as per Indian and EU regulations, Evolution of Cosmeceuticals
from cosmetics, cosmetics as quasi and OTC drugs Cosmetic excipients:
Surfactants, rheology modifiers, humectants, emollients, preservatives.
Classification and application Skin: Basic structure and function of skin.
Hair: Basic structure of hair. Hair growth cycle.
Oral Cavity: Common problem associated with teeth and gums.
Principles of formulation and building blocks of skin care
products:Face wash, Moisturizing cream, Cold Cream, Vanishing cream
and their advantages and disadvantages. Application of these products in
formulation of cosmecuticals.Antiperspants & deodorants- Actives &
mechanism of action.
Section-B
Principles of formulation and building blocks of Hair care products:
Conditioning shampoo, Hair conditioner, anti-dandruff shampoo. Hair oils.
Chemistry and formulation of Para-phylene diamine based hair dye.
Principles of formulation and building blocks of oral care products:
Toothpaste for bleeding gums, sensitive teeth. Teeth whitening,
Mouthwash.Sun protection, Classification of Sunscreens and SPF.
Role of herbs in cosmetics:
Skin Care: Aloe and turmeric Hair care: Henna and amla.
Oral care: Neem and clove
Analytical cosmetics: BIS specification and analytical methods for
shampoo, skin-cream and toothpaste.
Section-C
Principles of Cosmetic Evaluation: Principles of sebumeter, corneometer.
Measurement of TEWL, Skin Color, Hair tensile strength, Hair combing
properties. Soaps, and syndet bars. Evolution and skin benfits. Oily and dry
skin, causes leading to dry skin, skin moisturisation. Basic understanding of
the terms Comedogenic, dermatitis.
Cosmetic problems associated with Hair and scalp: Dandruff, Hair fall
causes
Cosmetic problems associated with skin: blemishes, wrinkles, acne,
prickly heat and body odor.
155

Books Recommended:
1. Wilkinson, J.B. Moore, R.J. (1982). Harry’s Cosmeticology.
Chemical Publication.
2. Sharma, P.P. (2014). Cosmetics – Formulations, Manufacturing and
Quality Control, Delhi: Vandana Publications Pvt. Ltd.
3. Nanda, S. Khar, R.K. (2010).Cosmetic Technology. Delhi: Birla
Publications Pvt Ltd.
Suggested e-material
1. http://202.74.245.22:8080/xmlui/handle/123456789/39/browse?type
=subject
2. https://pharmaclub.in/free-pharmacy-ebooks-pharmaceutics/
3. https://www.pdfdrive.com/pharmaceutical-books.html

PHAR 418 Pharmaceutical Marketing


Max. Marks : 100  L T P C
(CA: 40 + ESA: 60) 4 0 0 4
Learning outcomes
Upon completion of this course student will have an understanding of:
 Marketing concepts andtechniques used in marketing
 Application of the marketing in the pharmaceutical industry.
Section-A
Marketing: Definition, general concepts, and scope of marketing;
Distinction between marketing & selling; Marketing environment; Industry
and competitive analysis; Analyzing consumer buying behavior; industrial
buying behavior.
Pharmaceutical market: Quantitative and qualitative aspects; size and
composition of the market; demographic descriptions and socio-
psychological characteristics of the consumer; market segmentation&
targeting.Consumer profile; Motivation and prescribing habits of the
physician; patients' choice of physician and retail pharmacist.Analyzing the
Market;Role of market research.
156

Section-B
Product decision: Meaning, Classification, product line and product mix
decisions, product life cycle, product portfolio analysis; product
positioning; New product decisions; Product branding, packagingand
labeling decisions, Product management in pharmaceutical industry.
Promotion: Meaning and methods, determinants of promotional mix,
promotional budget; An overview of personal selling, advertising, direct
mail, journals, sampling, retailing, medical exhibition, public relations,
online promotional techniques for OTC Products.
Pharmaceutical marketing channels: Designing channel, channel
members, selecting the appropriatechannel, conflict in channels, physical
distribution management: Strategic importance, tasks in physicaldistribution
management.
Section-C
Professional sales representative (PSR): Duties of PSR, purpose of
detailing, selection and training, supervising, norms for customer calls,
motivating, evaluating, compensation and future prospects of the PSR.
Pricing: Meaning, importance, objectives, determinants of price; pricing
methods and strategies, issuesin price management in pharmaceutical
industry.An overview of DPCO (Drug Price Control Order) and NPPA
(National Pharmaceutical Pricing Authority).
Emerging concepts in marketing: Vertical & Horizontal Marketing;
RuralMarketing; Consumerism; Industrial Marketing; Global Marketing.
Books Recommended:
1. Kotler, P. Keller, K.L. (2011). Marketing Management, New Delhi:
Prentice Hall of India.
2. Walker, O.C., Boyd, H.W. and Larreche, J.C. (2006). Marketing
Strategy- Planning and Implementation, New Delhi: Tata MC
GrawHill.
3. Grewal, D. Levy, M. Marketing. (2012). 6th Ed., New Delhi: Tata
MC Graw Hill.
4. Kumar, A. Menakshi, N. (2011). Marketing Management, New
Delhi: Vikas Publishing.
5. Saxena, R. (2009). Marketing Management. New Delhi: Tata MC
Graw Hill.

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