Herbal Cream Preparation
Herbal Cream Preparation
HEALING
MASTER OF PHARMACY
IN
PHARMACEUTICS
Submitted by
JamshiyaShamsu
Reg NO.261510752
Dr.R.MANAVALAN,M-Pharm,Ph.D,FICS,FIC
Professor & Head
Department of Pharmaceutics
R.V.S College of Pharmaceutical Sciences
Sulur,Coimbatore
(April 2017)
DEPARTMENT OF PHARMACEUTICS
R.V.S COLLEGE OF PHARMACEUTICAL SCIENCES
SULUR, COIMBATORE-641402, TAMIL NADU.
Certificates
Evaluation Certificate
PLACE: Coimbatore
DATE:
Certificate
This is to certify that the dissertation work entitled“FORMULATION
AND ELAVUATION OF SKIN CREAM FOR WOUND HEALING” is a bonafide
work done by JamshiyaShamsu,RVS college of Pharmaceutical
Sciences,Sulur,Coimbatore,for the partial fulfillment of the University rules and
regulations for the award of Master of Pharmacy in Pharmaceutics under my
guidance and supervision during the academic year 2016-17.
Dr.R.MANAVALAN,M-Pharm,Ph.D,FICS,FIC
Professor and Head
Department of Pharmaceutics
R.V.S College of Pharmaceutical Sciences
Sulur, Coimbatore-641 402.
Dr.R.VENKATANARAYANAN,M-Pharm,Ph.D
Principal
R.V.S College of Pharmaceutical Sciences
Sulur, Coimbatore-641 402
Certificate
This is to certify that the dissertation work entitled“FORMULATION
ANDELAVUATION OF SKIN CREAM FOR WOUND HEALING” is a bonafide
work done by JamshiyaShamsuunder my direct guidancefor the partial
fulfillment of the award of degree of Master of Pharmacy in Pharmaceutics,
RVS college ofPharmaceutical Sciences, Sulur, Coimbatore, affiliated to The
Tamil naduDr.M.G.R. Medical University, Chennai.
Dr.R.MANAVALAN,M-Pharm,Ph.D,FICS,FIC
Professor and Head
Department of Pharmaceutics
R.V.S College of Pharmaceutical Sciences
Sulur, Coimbatore-641 402.
Certificate
This is to certify that the dissertation work entitled
“FORMULATIONAND ELAVUATION OF SKIN CREAM FOR
WOUNDHEALING” is a bonafide work done by JamshiyaShamsuunder the
guidance of Dr.R.MANAVALAN,M-Pharm,Ph.D.FICS,FIC in the department of
pharmaceutics, in the partial fulfillment of the award of degree of Master of
Pharmacy in Pharmaceutics, RVS college ofPharmaceutical Sciences, Sulur,
Coimbatore, affiliated to the Tamil naduDr.M.G.R. Medical University, Chennai.
Dr.R.VENKATANARAYANAN,M-Pharm,Ph.D
Principal
R.V.S College of Pharmaceutical Sciences
Sulur, Coimbatore-641 402
PLACE: Coimbatore
DATE:
ACKNOWLEDGEMENT
In the name of God, The Most Gracious, The Most Merciful…
At the very outset, I thank my Lord for His Blessings and support in completing this project
work.
In the first place, I would like to record my sincere and heartfelt gratitude to my Institution
Guide Dr.R.Manavalan, M-pharm, Ph.D, Professor and head, Department of Pharmaceutics,
R.V.SCollage of Pharmaceutical Sciences,Sulur, Coimbatore for his supervision,advise and
inspiring guidance throughout my dissertation work. Above all, he provided me unflinching
encouragement and support.
Let me express my sincere gratitude to Mr.Barish for his meticulous guidance and
encouragement provided to me for the completion of my dissertation work.
Let me express my sincere thanks to Mr.PONNAPPAN P.J, Managing Director and all the
staffs in Southern Union Pharmaceuticals (Kerala)Pvt.Ltd. and special thanks to my industrial
guide Mr. R. Shankar Iyer without whose guidance and support, my work would have been
incomplete.
Let me express my sincere thanks to my classmates and to all my well-wishersfor their keen
support and suggestions.
Above all, I dedicate myself for the constant love and encouragement given to me by my
beloved parents who deserve the credit of success in whatever work I did.
JAMSHIYA SHAMSU
DEDICATED
TO MY BELOVED
HUSBAND
AND
SON
ABSTRACT
Wound care is constantly evolving with the advances in medicine. Search for the ideal
dressing material still continues as wound care professionals are faced with several
challenges. Due to the emergence of multi-resistant organisms and a decrease in newer
antibiotics, wound care professionals have revisited the ancient healing methods by using
traditional and alternative medicine in wound management. People's perception towards
traditional medicine has also changed and is very encouraging . In this study, creams were
formulated based on the wound healing potential of herbal extracts and its evaluation. Herbal
plants such as Azadirachtaindica, Samaderaindica, Curcuma longa.Glycyrrhizagalbraith and
Aloe vera were selected. Selected plant parts are dried and extracted using alcohol . Quality
evaluation of the product was assessed by using different evaluation methods. No change of
the physical properties was observed; the pH was in a proper range (approximately pH 6). The
formulations showed good spread ability, no evidence of phase separation and good
consistency during this study period. It was found that the viscosity of the cream increases
when decreasing the rate of shear so the viscosity of creams is inversely proportional to rate of
shear (rpm). The creams were found to be stable during stability study according to ICH
guidelines (40 ± 2 °C/ 75 ± 5 % RH) for 3 months. From the present study it can be concluded
that it is possible to develop creams containing herbal extracts having wound healing property
and can be used as the provision of a barrier to protect skin.
LIST OF ABBREVIATIONS
mm Millimeter
cm Centimeter
% Percentage
e.g. Example
pH Hydrogen ion concentration
rpm Rotations per minute
ICH International Conference on
Harmonization
o/w Oil in water
w/o Water in oil
WHO World Health Organization
UV Ultra Violet
ml Milliliter
nm Nanometer
DNA Deoxyribonucleic acid
ft Feet
etc. Etcetera
in. Inch
BC Before Christ
AD Anno Domini
min Minute
gm Gram
RH Relative humidity
sec Second
°C Degree Celsius
°F Degree Fahrenheit
µl Micro liter
HPTLC High performance thin layer
chromatography
λmax Wave length of maximum
absorption
hr. Hour
mg Milligram
µg Microgram
S.No. Serial number
Ext. Extract
TABLE OF CONTENTS
S.NO. CONTENTS PAGE
NO.
1 Introduction 1
2 Aim and Objectives of study 21
3 Review of Literature 23
4 Drug and Polymer Profile 26
5 Materials And Methods 42
6 Results And Discussion 48
7 Summary 57
8 Conclusion 58
9 Bibliography 59
LIST OF TABLES
TABLE NO. TITLE PAGE NO.
1 Properties of stearic acid 34
2 Properties of liquid paraffin 35
3 Properties of bees wax 36
4 Properties of stearyl alcohol 37
5 Properties of Tween 80 38
6 Properties of methyl paraben 39
7 Properties of sorbitol 40
8 Properties of potassium hydroxide 41
9 List of chemicals used 42
10 Formula for preparation of cream 45
11 Physical properties of the cream 53
12 Thermal stability of the cream 53
13 pH of the cream 54
14 Viscosity of the cream 54
15 Spreadability of the cream 54
16 Accelerated stability studies of 55
cream- Physical properties (initial)
17 Accelerated stability studies of 55
cream- Physical properties (after 3
months)
18 Accelerated stability studies of 56
cream- pH of the cream
19 Accelerated stability studies of 56
cream- Viscosity of the cream(initial)
20 Accelerated stability studies of 56
cream- Viscosity of cream (after 3
months)
LIST OF FIGURES
Herbal
Creams are the semisolid dosage forms and intended for topical application to the skin,
placed on the surface of eye, or used nasally, vaginally or rectally for therapeutic or protective
action or cosmetic function. These preparations are used for the localized effects produced at
the site of their application by drug penetration in to the underlying layer of skin or mucous
membrane. These products are designed to deliver drug into the skin in treating dermal
disorders, with the skin as the target organ
Creams are semi-solid emulsions of oil and water. They are divided into two types: oil-
in-water (O/W) creams which are composed of small droplets of oil dispersed in a continuous
phase, and water-in-oil (W/O) creams which are composed of small droplets of water
dispersed in a continuous oily phase. Oil-in-water creams are more comfortable and
cosmetically acceptable as they are less greasy and more easily washed off using water.
Water-in-oil creams are more difficult to handle but many drugs which are incorporated into
creams are hydrophobic and will be released more readily from a water-in-oil cream than an
oil-in-water cream. Water-in-oil creams are also more moisturising as they provide an oily
barrier which reduces water loss from the stratum corneum, the outermost layer of the skin.
World Health Organization (WHO) as well our country has been promoting traditional
medicine because they are less expensive, easily available and comprehensive, especially in
developing countries.
It is also true that eight percent of the world’s population relies on medicinal plants for
their primary health care. Whole world including the developed country recognized the
importance of traditional medicine and has treatment strategies, guidelines and standard for
ethno medicine.
The manifestations of skin diseases are many and many at times the treatment is to be
continued for a long time. The need for a safe and effective herbal skin cream is to treat
various skin diseases likewounds, acne vulgaris, cracks, psoriasis and various types of skin
diseases.
Although various types of cream is considered for wound healing but these are still
appears to be limited in rate of tissue regeneration. Hence after a depth review regarding
pathogenesis as well as different traditional and alternative therapy for wound healing.
The basic idea of skin care lies deep in the Rigveda, Yajurveda, Ayurveda, Unani and
Homeopathic system of medicine. In this modern era, the knowledge and experience of usage
of herbs are being blend with advanced cosmetic technology to develop a safe and effective
product, which has wider range of people acceptability.
1.1 Wound healing
Wound is defined simply as the disruption of the cellular and anatomic continuity of a
tissue. Wound may be produced by physical, chemical, thermal, microbial or immunological
insult to the tissue. Wound healing is the process by which skin or other body tissue repairs
itself after trauma. The process of wound healing consists of integrated cellular and
biochemical events leading to reestablishment of structural and functional integrity with regain
of strength of injured tissue.
Various growth factors like platelet derived growth factor, macrophage derived growth
factor, monocyte derived growth factor etc. are necessary for the initiation and promotion of
wound healing. Many substances like tissue extracts , vitamins & minerals and a number of
plant products have been reported by various workers, to possess pro-healing effects. Wound
healing herbals encourage blood clotting, fight infection and accelerate the healing of wounds.
a) Aloe vera
Aloe, a native to Africa, is also known as “lily of the desert” or the plant of immortality. Its
name was derived from the alloeh meaning “bitter” because of the bitter liquid found in its
leaves. Egyptians recorded use of this herbal plant in treating burns, infections and parasites
as early as 1500B.C..It’s clear gel has a dramatic ability to heal wounds, ulcers and burns by
forming a protective coating on the affected areas and speeding up the healing process. The
fresh plant contains 96% of water and rest is essential oil, amino acids, minerals, vitamins,
enzymes and glycoproteins. Various constituents of Aloe vera have been shown to have anti-
inflammatory activity. They also stimulate wound healing. Some clinical reports suggest topical
Aloe vera gel is useful in healing minor burns and that such application of the gel is harmless
as hypersensitive reactions to it are rare. However, in some severe burns, aloe gel may
actually impede healing.
b) Azardirachtaindica
It is commonly called as Neem and the plant has diverse medicinal properties. Neem oil
contains margosic acid, glycerides of fatty acids, butyric acid and trace of valeric acid. Various
active principles are nimbidin, nimbidal, azardirachtin, nimbin, azadirine, gedunin, salanin.
They have diverse medicinal activities.
Neem oil is especially beneficial for curing skin ailments. Oil is used for dressing for foot
ulcers, eczema and skin diseases like ringworm, scabies and mange in dogs. It is a powerful
insect repellant, anti-bacterial, anti-fungal, anti-viral, anti-inflammatory and also strengthens
the body’s overall immune responses. Neem oil contains fatty acids which build collagen,
promote wound healing and maintain the skin’s elasticity. The active ingredients of neem oil
help in the process of wound healing and the skin is able to retain its suppleness as the
wounds heal. Neem oil has a high content of essential fatty acids. They keep the site moist
and give a soft texture to the skin during the healing process. Alcoholic extract of neem is
useful in eczema, ringworm and scabies. Neem leaf extracts and oil from seeds has proven
anti-microbial effect. This keeps any wound or lesion free from secondary infections by
microorganisms. Clinical studies have also revealed that neem inhibits inflammation as
effectively as cortisone acetate, this effect further accelerates wound healing.
c) Lantana camara
Lantana camara Linn, a shrub native of tropical America has completely been naturalized
in many parts of India as an ornamental plant. The plant has abortificient, antimalarial, anti-
inflammatory and wound healing properties. The hydro-alcoholic extract and fresh juice of
leaves have favoured wound contraction. The plant is potentially toxic and its toxicities include
nephrotoxicity, hepatotoxicity, photosensitization, dermatitis, intestinal haemorrhage, therefore,
the use of this plant in whole or any part thereof needs to be carefully regulated until the
alarming toxic principles of the plant are properly identified and removed.
Plants or chemical entities derived from plants need to be identified and formulated for
treatment and management of wounds.
An ornamental annual herb, with erect, rough and hairy stem is common in Indian Gardens
in swampy areas. In traditional medicine the plant is used by tribals for inflammation of eyes,
sores, dysuria, colic, tiger bites and bone fractures. In a study the alcoholic extract of whole
plant of H. annus applied in the form of an ointment on the excised wound of rat led to a
significant reduction in total healing period. This has been confirmed by histology where earlier
appearances of fibroblasts were seen. Early appearance and higher accumulation of muco-
polysaccharides has been stated as indicators of hastened repair.
e) Jasminumauriculatum
A small herb found in south India and the western peninsula. The alcohol free defatted
extract of J. auriculatum leaves has been reported to contain lupeol and jasminol . Juice of
leaves of J. auriculatum has been shown to be beneficial in wound healing. The juice when
applied in the form of jelly, locally on linear uniform excised wound in rats is found to promote
wound healing. This has been assessed by histological, biochemical and contraction rate
studies . Fresh juice of the leaves showed an increase and early gain of the tensile strength in
the linear wounds in rats. The study indicated that collagenation contributed to improved
tensile strength in the early phase of healing. Ghee medicated with J. auriculatum, on topical
application accelerated the healing time of second degree burn wounds in rats up to six days.
The mucopolysaccharide accumulation was significantly higher in group treated with
medicated ghee.
Commonly known as turmeric and haldi in Hindi. C. longa has been reported to possess
anti-bacterial, anti-fungal and anti-inflammatory activities . The part used are rhizomes and it
contains curumin (diferuloyl methane), turmeric oil or turmerol and 1,7-bis, 6-hepta-diene-3, 5-
dione. Curcumin has potent anti-inflammatory and analgesic activities .
Volatile oil isolated from C. longa also exhibits antibacterial and potent anti-inflammatory
activity. Curcuma longa also contains protein, fats, vitamins (A, B, C etc) all of which have an
important role in would healing and regeneration. Turmeric has been used for treating the
wounds in the rats . The anti-inflammatory property and the presence of vitamin A & proteins in
turmeric result in the early synthesis of collagen fibers by mimicking fibroblastic activity . Juice
of the fresh rhizome is commonly applied to recent wounds, bruises & leech bites. A paste of
turmeric & leaves of Justicaadhatoda with cow urine is rubbed on skin affected with prurigo&
eczema. It can also be mixed with ginger oil to prevent skin eruptions.
g) Cedrusdeodara
Its oil has been reported to possess anti-inflammatory and anti-microbial activities.
Cedrusdeodarahas also shown wound healing properties and is particularly useful in infective
wounds.
h)Tridaxprocumbens
The plant is a native of tropical America and naturalized in tropical Africa, Australia and
Asia including India. Leaf of Tridaxprocumbens mainly contains crude protein (26%), crude
fiber (17%), soluble carbohydrate (39%) and calcium oxide (5%). The juice of the leaves of
this plant is used by villagers to arrest bleeding from cuts and bruises in animals. This juice
accelerates two phases of healing namely epithelization and collagenization; however it
retards scar formation and granulation.
1.2 Human skin
The skin is the outer covering of the body. It is the largest organ of the integumentary
system. The skin has multiple layers of ectodermal tissue and guards the underlying muscles,
bones, ligaments and internal organs. Human skin is similar to that of most other mammals,
except that it is not protected by a pelt. Though nearly all human skin is covered with hair
follicles, it appears hairless. There are two general types of skin, hairy and globous skin. The
adjective cutaneous literally means "of the skin". Skin plays a key role in protecting (the body)
against pathogens and excessive water loss. Its other functions are insulation, temperature
regulation, sensation, synthesis of vitamin D, and the protection of vitamin B folates. Severely
damaged skin will try to heal by forming scar tissue.
a) Protection: an anatomical barrier from pathogens and damage between the internal and
external environment in bodily defence, Langerhans cells in the skin are part of the adaptive
immune system.
b) Sensation: contains a variety of nerve endings that react to heat and cold, touch, pressure,
vibration, and tissue injury, see somatosensory system and haptics.
c) Heat regulation: the skin contains a blood supply far greater than its requirements which
allows precise control of energy loss by radiation, convection and conduction. Dilated blood
vessels increase perfusion and heat loss, while constricted vessels greatly reduce cutaneous
blood flow and conserve heat.
d) Control of evaporation: the skin provides a relatively dry and semi-impermeable barrier to
fluid loss. Loss of this function contributes to the massive fluid loss in burns.
e) Aesthetics and communication: others see our skin and can assess our mood, physical
state and attractiveness.
f) Storage and synthesis: acts as a storage centre for lipids and water, as well as a means of
synthesis of vitamin D by action of UV on certain parts of the skin.
g) Water resistance: The skin acts as a water resistant barrier so essential nutrients aren't
washed out of the body.
Epidermis is divided into several layers where cells are formed through mitosis at the
innermost layers. They move up the strata changing shape and composition as they
differentiate and become filled with keratin. They eventually reach the top layer called stratum
corneum. This process is called keratinisation and takes place within weeks. The outermost
layer of the epidermis consists of 25 to 30 layers of dead cells.
Sub layers
• Stratum corneum
• Stratum lucidum
• Stratum granulosum
• Stratum spinosum
• Stratum germinativum
1.4 Diseases of skin
a)Vitiligo
Vitiligo is a condition in which areas of skin lose their normal pigment and so become
white. It is common, and affects about 1% of the world’s population. The pigment that gives
your skin its normal colour is melanin, which is made by cells known as melanocytes.
b) Scabies
Scabies is a common and very itchy skin condition caused by human scabies mites. It
can affect people of any age but is most common in the young and the elderly. The mites that
cause scabies are tiny parasites, smaller than a pinhead. The rash of scabies is a mixture of
scratch marks and red scaly areas; later it can become infected and develop small pus spots.
c) Rosacea
Rosacea is a common rash, found on the central part of the face, usually of a middle-
aged person. A tendency to flush easily is followed by persistent redness on the cheeks, chin,
forehead and nose. The cause of rosacea is not fully understood, but many think that the
defect lies in the blood vessels in the skin of the face, which dilate too easily.
d) Psoriasis
e) Melanoma
Atopic eczema is an inflammatory condition of the skin. Atopic is the term used to
describe conditions such as eczema, asthma, seasonal rhinitis and hay fever, which often
have a genetic basis. Eczema is the term used to describe changes in the upper layer of the
skin that include redness, blistering, oozing, crusting, scaling, thickening and sometimes
pigmentation.
1.5 CLASSIFICATION OF HERBAL DRUG ON THE BASIS OF THEIR
ACTION
Our skin is our body’s first line of defence against microbial invaders. Using herbs for skin
is one of the best ways we can take care of our skin. The skin contains one third of the body’s
blood supply.
A healthy person has a smooth, supple, glowing complexion. A skin patient’s skin may be
pull of blemishes or rough patches, their complexion may be grey, translucent, and waxy.
The top supplement for our skin is water. Using herbs for skin help your skin and keep it in
good condition.
* Lavender
* Rosemary
* Rose
* Calendula
* Chamomile
* Aloe
* Allantion
* Lavender oil
* Apricot
* Oatmeal
* Horsetail
* Lavender
* Lemon balm
* Mint
* Calendula, rose
* Chamomile
* Aloe
* Dandelion leaves
g) Moisturizers
* Calendula
* Rosemary
* Chamomile
* Lavender
* Marigold
h) Relive Inflammation
* Lavender
* Rose water
* Lady mantle
i) Blemishes
* Basil , Tea
* Comfrey
j) Burns
* Aloe
* Calendula
* Acne
* Artemisia
* Basil
* Pea
* Pumpkin
* Onion
* Ginseng
l) Anti-inflammatory Treatment
* Chamomile
* Fenugreek
* Jojoba
* Liquorice root
* Red clover
m) Skin protection
* Aloe Vera
Family-Liliaceae
Uses-Leaf juice is applied on skin for smoothness, healing, controlling skin burns & sun burns.
Family-Poaceae
Uses- It is used to treat acne, cuts, eczema, dry skin, wounds, and aging skin. Powdered root
paste is used to cure irritated skin and allergies.
Family-Eriaceae
Uses-Skin whitener, melanin inhibitor, it is used for treat skin pigmentation, sunburns, freckles.
Family-Meliaceae
Uses- It cures wounds, leprosy, skin diseases like acne, ulcers, hair problems.
Botanical Name-Buteafrondosa
Family-Fabaceae
Chemical Constituents- Flavonoids, glucosides – butin, butrin, isobutrin&palastrin, coreopsin,
mono spermoside , and sulphurein&chalcones.
Uses- Leaves extract is useful in pimples and seed extract forfungal infection and bruises,
flower extract for hair and skin conditioning.
Family-Asteraceae
Uses Flower extract is used for smoothening hair. It is used to cure acne, inflammation, and
aging.
Family-Theaceae
Family-Caricaceae
Uses- fruit pulp makes skin soft and removes blemishes. It can be used for treating wrinkles,
sunspots, age spots, acne problems.
Whole plant extract is used for growth and maintenance of hair. It fights oxidation thereby
improves skin firmness and elasticity
Family-Iridaceae
Uses- It is used to treat skin diseases and dresses bruises. It moisturizes, soothes and
promotes fairness of skin. It treats dandruff and nourishes hair.
Family-Zingiberaceae
Family-Ginkgoaceae
Family-leguminosae
Family-Labiatae/lamiaceae
Chemical Constituents- Essential oil- linalool, linalyl acetate, borneol, camphor, lavandulyl
,caryophyllene, limonene. Aerial parts-ursolic acid, lactone, betulin, betuliinic acid, 3 β
formylursolic acid.
Uses- It is cytophylactic and antiaging, refresher; it improves hair growth and texture. It cures
many hair problems like dandruff.
Family-Compositae/Asteraceae
Uses- Flowers are used as Hair tonic. Leaves extract is used for skin problems.
Family-Labiatae
Uses- Acts against pigmentation and skin diseases and has as moisturizing, cooling,
antiperspirant, anti-aging properties.
Common Name- Mango
Family-Anacardiaceae
Uses- It soothes, moisturizes, andregenerates skin cells. It is used to treat skin diseases.
Family-labiatae/ lamiaceae
Uses-Leaf extract is useful to control skin infection and rejuvenation. Used as skin and hair
conditioners.
Family-Rosaceae
Chemical Constituents- Amandin, globulin, Oleum Amygdalae, oleic, palmitin, linoleic acids
Uses- It is used for moisturizing and nourishing skin. It nourishes hair and promotes growth.
Kernel extract is used in sun creams.
Family-Rosaceae
Uses- Essential oil from flowers is used for protection from sun burns and skin smoothening.
Common Name- White sandal wood
Family-Santalaceae
Uses- Paste of hardwood is used in face packs. Essential oil for protection from sunburns. It is
an anti-oxidant.
Family-Pedaliaceae
Uses- Seed extract is used for skin protection and rejuvenation. Seed oil is used as base for
hair oils.
Family-Sterculiaceae
Uses- Skin softener and conditioner, moisturizes, anti-wrinkle effect, restores flexibility.
Family-Solanaceae
Uses- Whole plant extract is used for skin cleansing and antioxidant.
Common Name- Watermelon
Family-Cucurbitaceae
Uses- Additives in sun creams,seed oil works as restorative and nourishing for skin, Itcures
acne, sebum secretion.
Everybody gets a cut or a skin abrasion now and then. Having a soothing cream or
ointment on hand is usually enough to treat minor skin wounds. There are numerous products
available, all made with different ingredients. And all are also great for healing more sizable
cuts that don't require stitches.
a)Zinc Ointment
Zinc ointment is an old-time favourite for cuts, abrasions, skin irritations and diaper
rash, according to Drugs.com. Zinc ointment is available in tubes--as a plain, unscented
ointment--or mixed in diaper rash creams and other First-Aid creams.
b) Antibiotic Ointments
An antibiotic cream or ointment is used for treating cuts and abrasions. Try Neosporin,
Polysporin or Ultra Mide, all available in grocery and drug stores. These ointments are said to
protect against bacteria invading a wound. They also help to reduce scarring.
c) Vitamin E Oil
Vitamin E oil applied directly on a cut aids healing and helps to prevent scarring, says
EarthClinic.org. Just prick the tip of the tube with a pin and squeeze to apply.
d)A&D Ointment
Another favourite treatment that soothes and heals minor skin irritations and cuts is
A&D ointment. A&D ointment contains vitamins.
e)Cortisone Ointment
Cortisone ointments help reduce inflammation, protect against infection and heal most
skin abrasions, cuts and irritations. Cortisone ointment comes in different strengths. A
prescription is required for higher potencies.
The present study is to formulate and evaluate ofa herbal skin cream which will be
effective and has better rate of tissue regeneration. The herbal cream that is planned to be
formulated for wound healing will be oil/water (O/W)emulsion type which will be less oily, less
greasy and less sticky in nature so that patient compliance is more and will be beneficial for all
kind of people in our society. After thorough review of ayurvedic system of medicine selected
the following herbs to formulate the cream.
Natural products from plants are rich sources used for treating a number of
diseases. Most of the herbal drugs are a mixture of a number of plant ingredients. Their
synergistic effect increases the efficacy of the drug in curing the diseases. In this
modern era, the knowledge and experience of usage of herbs are being blend with
advanced formulation technology to develop a safe and elegant herbal product, which
has wider range of people acceptability. Formulation of medicinal plant in the form of a
cream will be made by mixing of plant extracts in different proportions and tested for
wound healing activity. Methanolic extracts of plants such as Azadiractaindica
(leaf),Samaderaindica (leaf),Curcuma longa (rhizome),Glycyrrhizagalbraith (root), Aloe
vera (whole plant) are used for formulation of herbal skin cream for wound healing
.Then the formulated skin cream is evaluated for parameters like physical properties,
pH , viscosity, spreadability and stability of the formulated cream.
Humectants
Solvents
Emollient agents
Spreading agents
Gelling agents (Thickening agents)
Nourishing agent
Preservatives
Film formers
Healing agents
Antioxidants
Physical properties
Rheology test
Determination of pH
Spreadability Test
Peroxide Stability test
Test for stability
Skin Irritation test
3. REVIEW OF LITERATURE
Since the beginning of human civilization, medicinal plants have been used by mankind
for its therapeutic value. Nature has been a source of medicinal agents for thousands of years
and an impressive number of modern drugs have been isolated from natural sources. Many of
theseisolations were based on the uses of the agents in traditional medicine.
India has several traditional medical systems, such as Ayurveda and Unani, which has
survived through more than 3000 years, mainly using plant-based drugs. The materiamedicaof
these systems contains a rich heritage of indigenous herbal practices that have helped to
sustain the health of most rural people of India. The ancient texts like Rig Veda (4500-1600
BC) and Atharva Veda mention the use of several plants as medicine.
According to the World Health Organization (WHO, 1977) “a medicinal plant” is any
plant, which in one or more of its organ contains substances that can be used for the
therapeutic purposes or which, areprecursors for the synthesis of useful drugs. This definition
distinguishesthose plants whose therapeutic properties and constituents have beenestablished
scientifically and plants that are regarded as medicinal but which have not yet been subjected
to thorough investigation. The term “herbal drug” determines the part/parts of a plant (leaves,
flowers, seeds, roots, barks, stems, etc.) used for preparing medicines (Anonymous, 2007a).
Furthermore, WHO (2001) defines medicinal plant as herbal preparations produced by
subjecting plant materials to extraction, fractionation, purification, concentration or other
physical or biological processes which may be produced for immediate consumption or as a
basis for herbal products.
Medicinal plants are plants containing inherent active ingredients usedto cure disease
or relieve pain (Okigboet al., 2008).
The use of traditional medicines and medicinal plants in most developing countries as
therapeutic agents for the maintenance of good health has been widely observed (UNESCO,
1996). Modern pharmacopoeia still contains at least 25% drugs derived from plants and many
others, which are synthetic analogues, built on prototype compounds isolated from plants.
Interest in medicinal plants as a re-emerging health aid has been fuelled by the rising
costs of prescription drugs in the maintenance of personal health and well being and the bio
prospecting of new plant-derived drugs (Lucy and Edgar, 1999).
According to World Health Organization, medicinal plants would be the best source to
obtain a variety of drugs. Therefore, such plants should be investigated to better understand
their properties, safety and efficacy (Nascimentoet al., 2000).
The instant rising demand of plant-based drugs is unfortunately creating heavy pressure on
some selected high-value medicinal plant populations in the wild due to over-harvesting.
Several of these medicinal plant species have slow growth rates, low population densities, and
narrow geographic ranges (Nautiyalet al., 2002), therefore they are more prone to extinction
(Jablonski, 2004). Conversely, because information on the use of plant species for therapeutic
purpose has been passed from one generation to the next through oral tradition, this
knowledge of therapeutic plants has started to decline and become obsolete through the lack
of recognition by younger generations as a result of a shift in attitude and ongoing
socioeconomic changes (Kala, 2000). Furthermore, the indigenous knowledge on the use of
lesser-known medicinal plants is also rapidly declining.
Continuous erosion in the traditional knowledge of many valuable plants for medicine in
the past and the renewal interest currently, the need existed to review the valuable knowledge
with the expectation of developing the medicinal plants sector (Kala et al., 2006).
In India, the ayurvedic system has described a large number of suchmedicines based
on plants or plant product and the determination of their morphological and pharmacological or
pharmacognostical characters can provide a better understanding of their active principles and
mode of action. However a large number of tropical plants have not been studied in detail for
their chemical constituents, pharmacological properties of the extracts, and their
pharmacognostical characterization including DNA sequencing etc. In the present review
focused on the development and evaluation of herbal skin cream.
4. DRUG AND POLYMER PROFILE
4.1 Azadirachtaindica
Figure 3: Azadirachtaindica
Botanical Name(s):Azadirachtaindica
Common Name:
Marathi-KaduLimba
Hindi-Neem
Tamil-Vepu
Kingdom: Plantae
Division:Magnoliophyta
Order:Sapindales
Family:Meliaceae
Genus:Azadirachta
Species: A. indica
Popular Name(s): Indian Lilac, Margosa Tree
Parts Used: Leaves, Flower, Oil, Seed
Habitat: Grows throughout India.
Neem is a fast-growing tree that can reach a height of 15–20 metres (49–66 ft), and
rarely 35–40 metres (115–131 ft). It is evergreen, but in severe drought it may shed most or
nearly all of its leaves. The branches are wide and spreading. The fairly dense crown is
roundish and may reach a diameter of 15–20 metres (49–66 ft) in old, free-standing
specimens. The neem tree is very similar in appearance to its relative, the Chinaberry
(Meliaazedarach).
The opposite, pinnate leaves are 20–40 centimetres (7.9–15.7 in) long, with 20 to 31
medium to dark green leaflets about 3–8 centimetres (1.2–3.1 in) long. The terminal leaflet
often is missing. The petioles are short.
The (white and fragrant) flowers are arranged in more-or-less drooping axillarypanicles
which are up to 25 centimetres (9.8 in) long. The inflorescences, which branch up to the third
degree, bear from 150 to 250 flowers. An individual flower is 5–6 millimetres (0.20–0.24 in)
long and 8–11 millimetres (0.31–0.43 in) wide. Protandrous, bisexual flowers and male flowers
exist on the same individual tree.
The fruit is a smooth (glabrous), olive-like drupe which varies in shape from elongate
oval to nearly roundish, and when ripe is 1.4–2.8 centimetres (0.55–1.10 in) by 1.0–1.5
centimetres (0.39–0.59 in). The fruit skin (exocarp) is thin and the bitter-sweet pulp (mesocarp)
is yellowish-white and very fibrous. The mesocarp is 0.3–0.5 centimetres (0.12–0.20 in) thick.
The white, hard inner shell (endocarp) of the fruit encloses one, rarely two, or three, elongated
seeds (kernels) having a brown seed coat.
Products made from neem trees have been used in India for over two millennia for their
medicinal properties. Neem products are believed by Siddha and Ayurvedic practitioners to be
anthelmintic, antifungal, antidiabetic, antibacterial, antiviral, contraceptive, and sedative. It is
considered a major component in siddha medicine and Ayurvedic and Unani medicine and is
particularly prescribed for skin diseases. Neem oil is also used for healthy hair, to improve liver
function, detoxify the blood, and balance blood sugar levels. Neem leaves have also been
used to treat skin diseases like eczema, psoriasis, etc.
Insufficient research has been done to assess the purported benefits of neem, however.
In adults, short-term use of neem is safe, while long-term use may harm the kidneys or liver; in
small children, neem oil is toxic and can lead to death. Neem may also cause miscarriages,
infertility, and low blood sugar.
4.2 Samderaindica
Figure 4: Samaderaindica
Botanical name:Samaderaindica
Common name:
Kingdom- Plantae
Subkingdom- Tracheobionta
Division- Magnoliophyta
Class- Magnoliopsida
Subclass- Rosidae
Order- Sapindales
Family- Simaroubaceae
Genus – SamaderaGaertn
Species- SamaderaindicaGaertn
The tree is 60 feet or more in height, with many long, crooked branches covered with
smooth, greyish bark, leaves 9 to 12 inches long, and flowers growing in small clusters, with
rather thick, dull-white petals. The bark is usually found in pieces several feet long, the roots
being long, horizontal, and creeping. Very often the outer bark has been removed, when it
shows a pale yellowish or pinkish-brown surface. It is odourless, difficult to powder, and
intensely bitter. It is usually imported from Jamaica, in bales.
Common name:
Malayalam:Manjal
Kingdom: Plantae
(unranked): Angiosperms
(unranked): Monocots
(unranked): Commelinids
Order: Zingiberales
Family: Zingiberaceae
Genus: Curcuma
Species: C. Longa
In Ayurvedic practices, turmeric has been used as an attempted treatment for a variety of
internal disorders, such as indigestion, throat infections, common colds, or liver ailments, as
well as topically to cleanse wounds or treat skin sores.
4.4 Glycyrrhizagalbraith
Figure 6: Glycyrrhizagalbraith
Botanical name:Glycyrrhizagalbraith
Common name:Iratimadhuram
Kingdom: Plantae
(unranked): Angiosperms
(unranked): Eudicots
(unranked): Rosids
Order: Fabales
Family: Fabaceae
Subfamily: Faboideae
Genus: Glycyrrhiza
Species: G. glabra
It is aherbaceousperennial, growing to 1 m in height, with pinnateleaves about 7–15 cm
(2.8–5.9 in) long, with 9–17 leaflets. The flowers are 0.8–1.2 cm (1⁄3–1⁄2 in) long, purple to pale
whitish blue, produced in a loose inflorescence. The fruit is an oblong pod, 2–3 cm (3⁄4–1 1⁄6 in)
long, containing several seeds. The roots are stoloniferous.
Aloe vera is a plantspecies of the genusAloe. It grows wild in tropical climates around
the world and is cultivated for agricultural and medicinal uses. Aloe is also used for decorative
purposes and grows successfully indoors as a potted plant.
It is found in many consumer products including beverages, skin lotion, or ointments for
minor burns and sunburns.
Aloe vera is a stemless or very short-stemmed plant growing to 60–100 cm (24–39 in)
tall, spreading by offsets. The leaves are thick and fleshy, green to grey-green, with some
varieties showing white flecks on their upper and lower stem surfaces. The margin of the leaf
is serrated and has small white teeth. The flowers are produced in summer on a spike up to
90 cm (35 in) tall, each flower being pendulous, with a yellow tubular corolla 2–3 cm (0.8–
1.2 in) long. Like other Aloe species, Aloe vera forms arbuscularmycorrhiza, a symbiosis that
allows the plant better access to mineral nutrients in soil.
Aloe Vera is a major medicinal plant when it comes to treating and protecting the skin.
Used externally, it is very effective on burns and sunburn, as well as a variety of skin diseases
(eczema, pruritus, psoriasis, acne) – it is extremely constructive and protective.
Aloe vera is good for irritated or inflamed skin. Aloevera helps repair your skin from the most
tender of wounds. Aloevera helps speed the process of healing to burns and other wounds.
Aloevera is hydrating, rejuvenating and toning for your skin. Aloevera moisturizes and softens
your skin.
4.6 Stearic acid
Structure:
Form Liquid
Colour Colourless
Odour Odourless
Structure:
Form Solid
Colour Yellow to dark brown
Odour Characteristic
Melting point 62-64°C
Solubility Insoluble in water
Because of its anti-inflammatory properties, beeswax has been found to help encourage
the healing of wounds. Studies have even found that it is effective against
hemorrhoids. It is also being used in hospitals to heal wounds and sores caused by
chemotherapy.
4.9Stearyl alcohol
Structure:
Structure:
Form Liquid
Colour Amber
Odour Characteristic
Boiling point 100°C
Flash point 148°C
Structure:
Form Crystal
Colour Colourless
Odour Odourless
Melting point 125 - 128°C
Boiling point 270 - 280°C
Structure:
Humectants draw water to the surface of the skin from the environment when there's
adequate moisture in the air.
4.13 Potassium hydroxide
Structure:
5.4.1 Formulation of the herbal skin care cream using the extracts
The formulation trails were done as per formula given in table No.10.The formulation
containing Azadirachtaindica, Samaderaindica , Curcuma longa, Glycyrrhizagalbraith and
Aloe vera extract was formulated by the method of Nazir et al. The aqueous and oil phases
were taken into beakers and heated to 75ºC over a water bath. The oil phase was comprised
of extracts of Azadirachtaindica, Samaderaindica , Curcuma longa, Glycyrrhizagalbraith and
Aloe vera , liquid paraffin, bees wax, stearyl alcohol, Tween-80 and stearic acid while the
aqueous phase was composed of methyl parabens, sorbitol solution and potassium
hydroxide. Drop wise addition of the aqueous phase to the oil phase was done with constant
stirring at 2000 rpm in a homogenizer for a period of 15 min. The homogenizer speed was then
reduced to 1000 rpm and homogenization was continued for another 5 min. The speed was
further reduced to 500 rpm and the homogenization extended for 5 min. Herbal skin cream
containing Azadirachtaindica, Samaderaindica , Curcuma longa, Glycyrrhizagalbraith and
Aloe vera extract was formulated.
Table No.10: Formula for preparation of cream
b) Measurement of pH
The pH was measured using a pH meter, which was calibrated before each use with
standard buffer solutions at pH 4, 7, 9. The electrode was inserted into the sample 10 minutes
prior to taking the reading at room temperature.
c) Viscosity
The viscosity of the formulations was checked using a Brookfield Viscometer (DV-I
PRIME, USA). The gels were rotated at 0.3, 0.6, 1.5 rotations per minute. The viscosity of the
gel was obtained by multiplying the corresponding dial reading with the factor given in the
Brookfield Viscometer catalogue.
d) Spreadability
Spreadability is measured in terms of time in seconds taken by two slides to slip off
from the gel when placed in between the slides under the direction of a certain load. The
excess amount of sample was placed between the two glass slides and a definite amount of
weight was placed on these glass slides to compress the glass slides of uniform thickness. A
weight of 70 g was added and the time required to separate the two slides was noted.
Spreabability was calculated using the formula
S = M.L / T
where,
e) Stability
Stability testing of drug products begins as a part of drug discovery and ends with the demise
of the compound or commercial product. To assess the drug and formulation stability, stability
studies were done according to ICH guidelines. The stability studies were carried out as per
ICH guidelines. The cream filled in bottle and kept in humidity chamber maintained at 40 ±
2°C / 75 ± 5 % RH for three months. At the end of studies, samples were analyzed for the
physical properties,pH and viscosity.
6. RESULTS AND DISCUSSIONS
Accelerated stability testing of prepared formulations were conducted at 40° ± 2°C temperature
and 75± 5% relative humidity and studied for 90 days.
7. SUMMARY
The objective of the present work was to formulate and evaluate a skin cream for
wound healing. Although various types of cream is considered for wound healing but
these are still appears to be limited in rate of tissue regeneration. Plants are more
potent healers because they promote the repair mechanism in the natural way.In this
modern era, the knowledge and experience of usage of herbs are being blend with
advanced cosmetic technology to develop a safe and effective product.
In the present study, skin cream was prepared using herbal plants such as
Azadiractaindica ,Samaderaindica, Curcuma longa , Glycyrrhizagalbraith and Aloe vera
.Initially, the research work started with a wide and thorough literature survey .Various
formulations were prepared by varying the amount of excipients such as stearic acid,
bees wax, stearyl alcohol, tween-80, methyl paraben , sorbitol solution , potassium
hydroxide ,deionised water ect. Formulation of Herbal Skin Cream for wound
healing was successfully developed that met the relevant pharmaceutical
characteristics. The prepared formulations are then evaluated for parameters like
physical properties, pH , viscosity, spreadability and stability of the formulated cream.
The prepared formulations showed good spreadability, no evidence of phase separation
and good consistency during the study period. Stability parameters like visual
appearance, nature, viscosity and pH of the formulations showed that there was no
significant variation during the study period. The prepared formulations showed proper
pH range that is approximately pH 6; it confirms the compatibility of the formulations
with skin secretions. The creams were found to be stable during stability study
according to ICH guidelines (40 ± 2 °C/ 75 ± 5 % RH) for 3 months. From the present
study it can be concluded that it is possible to develop creams containing herbal
extracts and can be used as a barrier to protect skin.
8. CONCLUSION
Formulation of Herbal Skin Cream for wound healing was successfully developed that
met the relevant pharmaceutical characteristics. The prepared formulations showed good
spreadability, no evidence of phase separation and good consistency during the study period.
Stability parameters like visual appearance, nature, viscosity and pH of the formulations
showed that there was no significant variation during the study period. The prepared
formulations showed proper pH range that is approximately pH 6; it confirms the compatibility
of the formulations with skin secretions. The creams were found to be stable during stability
study according to ICH guidelines (40 ± 2 °C/ 75 ± 5 % RH) for 3 months. From the present
study it can be concluded that it is possible to develop creams containing herbal extracts and
can be used as the provision of a barrier to protect skin.Plants are more potent healers
because they promote the repair mechanism in the natural way. The wound healing property
of the formulated herbal skin cream has yet to be experimented and will be done in future.
9. BIBLIOGRAPHY