PROJECT WORK PROTOCOL-8TH SEMESTER B.

PHARM

“PREPARATION AND EVALUATION OF MEDICATED LIPSTICK

USING KOJIC ACID DIPALMITATE FOR LIP PIGMENTATION”

By
Name of Students Register No

KAVANA KP 20P5189
PAI SWATHI SURESH 20P5206
SHRADDHA S MARLA 20P5226
SHREYAS D 20P5227

PROJECT WORK
PROTOCOL SUBMITTED TO
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
KARNATAKA, BENGALURU – 560 041

IN PARTIAL FULFILLMENT OF DEGREE OF

BACHELOR OF PHARMACY
UNDER THE GUIDANCE OF

MRS. VINEETHA K M. Pharm

ASSOCIATE PROFESSOR

DEPARTMENT OF PHARMACEUTICS.
SRINIVAS COLLEGE OF PHARMACY, VALACHIL, MANGALORE
KARNATAKA –574 143.
2024
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 PROJECT WORK PROTOCOL
SRINIVAS COLLEGE OF PHARMACY, VALACHIL, MANGALORE

Name Register No
1 Name and KAVANA KP 20P5189
Address of the 1
Candidates :
PAI SWATHI SURESH 20P5206
2
SHRADDHA S MARLA 20P5226
3
SHREYAS D 20P5227
4

8th Semester B. Pharm,

Srinivas College of Pharmacy, Valachil,
Mangalore, Karnataka –574143

2 Name of the Srinivas College Of Pharmacy,

Institution: Valachil, Farangipete Post,
Mangalore, Karnataka –574 143

3 Course of study 8th Semester B. PHARM

and year

4 Title of the Project

“Preparation and evaluation of medicated
lipstick using kojic acid dipalmitate for lip
pigmentation.”

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5 BRIEF RESUME OF INTENDED WORK

5.1. NEED FOR THE STUDY:

In ancient times cosmetics were only used as a beauty fix. These were derived from various
natural sources. In the present scenario beauty along with personal care is the trend.
Cosmeceuticals combination of cosmetics and drugs has come into picture, which imparts
decorative, attractive and eye appealing impressions along with therapeutic activity. These
products not only add glamorous touch to an individual but also heal different pathological
conditions such as inflammation, cracking, chapping and dryness of the skin. Face is the
important part which is exposed to the environment and one must take a great care of it.
Lipsticks are cosmetic formulations for the modification or accentuation of lip color and are
prepared by molding a dispersion of colors in a waxy base, in the form of stick/crayon. Any
preparations used in beauty treatments for lip make-up also known as sticks or more
commonly known in beauty treatments by the name of lipsticks. When these preparations
contain active ingredients, they are also known as medicated lipsticks or medisticks which
may contain synthetic drugs or herbal dugs.1

Lip darkening has been a common problem among people. Wide variety of conditions that are
associated with the darkening of lips are physiologic changes, some non-melanotic conditions,
inflammatory diseases, genodermatoses, drugs and chemicals, endocrinologic disorders,
benign and malignant neoplasm. Factors influencing lip colour changes may include sun
exposure, smoking, vascular lesions, anaemia, syndromes, medications, antimicrobial
antifungals, topical chemicals, hormones, skin colour etc.2

Kojic acid (KA) has emerged as a prominent tyrosinase inhibitor with considerable potential
in cosmetic applications; however, its susceptibility to instability during storage poses a
challenge to its widespread use. Strategies such as esterification, hydroxy-phenyl ether
formation, glycosylation, and incorporation into amino acid or tripeptide derivatives have
been employed to enhance stability and efficacy. Among these derivatives, Kojic Acid
Dipalmitate (KDP), a palmitic ester derivative of KA, stands out for its notable improvements
in stability, permeability, and low toxicity. Recent developments indicate a growing
utilization of KDP in cosmetic formulations, with over 132 available products on the market,
encompassing various formulations. In skincare products, kojic acid dipalmitate was used at
concentrations ranging from 0.01% to 25%. Typically, it was employed at concentrations
between 0.2% and 8.0%, with the most frequent usage occurring at concentrations of 0.4% to
4.0%.3

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Vitamin E is an important fat-soluble antioxidant and has been in use for more than 50 years
in dermatology. It is an important ingredient in many cosmetic products. It protects the skin
from various deleterious effects due to solar radiation by acting as a free-radical scavenger.
Experimental studies suggest that vitamin E has antitumorigenic and photoprotective
properties. There is a paucity of controlled clinical studies providing a rationale for well-
defined dosages and clinical indications of vitamin E usage in dermatological practice.4

Due to various problems faced by synthetic dyes people prefer to use natural colorants in
cosmetics. The use of natural colorants in cosmetics is increasing nowadays. Natural colorants
are obtained from a biological source and these natural colorants are mostly eco-friendly and
do not cause any problems. Natural pigments are obtained from various biological sources
such as plants, microbes, and so on. Natural colorants are obtained from plant parts such as
fruits, flowers, stems, bark, leaves, seeds, etc. Henna, Teak, Annatto, Carrot, Red Cabbage,
Turmeric, etc. are used as natural sources of color. The advantages of natural colorants include
non-toxic, no side effects, non-carcinogenic, ecofriendly, causes reduced pollution, and it has
health benefits such as anticancer, anti-oxidant, vitamin A rich, and so on.5

In this context, the present study is aimed at formulating medicated lipstick using Kojic acid
dipalmitate, Vitamin E and incorporating a natural pigment in order to treat lip pigmentation
and reduce the side effects of synthetic colourants used in lipstick.

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REVIEW OF LITERATURE:
Review of literature on Medicated lipstick was carried out. The literatures which were
found relevant are as follows:

 Rajalakshmi SV et al.,6 formulated, evaluated and optimized medicated Lip rouge

containing acyclovir encapsulated inside a novel vesicular carrier, niosome so that the
formulation can improve its membrane penetration. Formulating as a cosmetic Lip
rouge formulation improved patient compliance in the treatment of herpes labialis.
Acyclovir niosomes were prepared by thin film hydration method. Niosomes were
evaluated and were optimized by considering the entrapment efficiency and in -vitro
release profile. The optimized niosomes were incorporated into lipstick, lip balm and
lip rouge for selecting the best lip formulation. Based on the in vitro release profile, ease
of application and properties of prepared formulations lip rouge was selected and
further evaluations were carried out. Hence it can be concluded that the prepared lip
rouge formulation showed better physicochemical properties and drug release compared
to the marketed formulation.
 Shah P et al.,7 formulated a topical Medistick of Antifungal, the New future of drug
cosmetic. Main aim of developing medicated stick as to cure topical problems and also
for beauty purpose by natural ingredients. This formulation is combination of both
branches (drug-cosmetic). The drug used in the formulation is Ketoconazole which is
used for antifungal therapy. Pre formulation studies revealed that API and excipients
were found to be compatible. For the formulation of medstick self-emulsify drug
delivery system (SEDDS) was used. A solubility profile then three basic preliminary
trials were taken for making SEDDS. Optimized the SEDDS. This selection was done
by concentration of bees wax, concentration of carnauba wax, concentration of castor
oil and concentration of Isopropyl myristate. Evaluation test like breaking load test,
softening point, permeability, melting point and antifungal activity was performed on
the finalized formulation. It was concluded that the prepared Medistick had several
advantages in beauty and fungal diagnosis.
 Kukudkar PG et al.,8 formulated and evaluated Medicated Lipstick for the Treatment
of Chapped Lips Using Beta Vulgaris as Natural colouring Agent. The objective of the
present study involved the formulation and evaluation of herbal lipsticks using color
matter from natural sources such as carrot and beetroot. Different natural ingredients
such as beeswax, castor oil, white beeswax, Acacia, vitamin B12(almond oil), coconut
oil, rose oil, mineral oil, and beetroot (Beta vulgaris) were used to formulate herbal
lipstick. Prepared lipstick was evaluated for different evaluation tests such as color,
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 texture, pH, melting point, breaking point, surface anomalies, aging, and perfume
stability. Results have shown that different evaluation parameters of prepared herbal
lipstick. It can be concluded that the use of natural colorants in lipstick formulations has
fewer or no side effects.
 Dede R et al.,9 formulated and evaluated medicated lipstick using Pioglitazone. The
medicated lipstick was created with (04 percent w/w) pioglitazone. Preformulation
investigations, such as drug characterisation and stability testing, were carried out.
Lipstick was evaluated for melting point, Softening point, breaking point, pH,
solubility and Percent drug content. Melting point, softening point, breaking point, pH,
solubility and percent drug content were found as 64-68ºC, 50-57ºC, 80-110g, 6.6-7.0,
methanol, 97- 102% respectively. In the future, it will be necessary to conduct a
permeation research across the mucosal membrane in order to determine if a medication
can be released over an extended period of time. It can be concluded that Medicated
lip formulations offer feasible and attractive benefits for systemic drug delivery and
offer an interesting area of research for pharmaceutical scientists to design Medistick
with diverse effects.
 Hole SM et al., 10
reviewed on Herbal medicated lipstick. Frequent use of synthetic
lipstick colors can have major negative effects, including cancer, skin irritation,
discoloration, and acne. Using herbal color extracts from various herbal sources helps
lessen the negative effects. The background, types, formulation process, various color

pigment extractions, natural oils, bases, flavors, physical evaluation,quality control

of lipsticks in industries, molding, and lipstick flaws were all covered in this review.
Synthetic colouring agents may cause allergic reactions. Hence it can be concluded that
use of herbal extracts in lipstick helps to lessen the negative effects.

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 OBJECTIVES OF THE STUDY:

The objective of the present investigation is to formulate and evaluate Medicated lipstick
using Kojic acid Dipalmitate for lip pigmentation.
Specific objectives of the present investigation are as follows:
 To carry out the preformulation studies of the drug.
 To study drug – excipient interaction using FT-IR studies.
 To formulate a medicated lipstick containing Kojic acid dipalmitate
 To evaluate medicated lipstick containing Kojic acid dipalmitate.
 To carry out the stability studies.

6 MATERIALS AND METHODS

Materials:
 Drug: Kojic acid Dipalmitate, Vitamin E
 Excipients: Beeswax, Hard paraffin wax, Castor oil, Rose oil, Coconut oil, Ozokerite,
Carnauba Wax, Lanolin, Liquid paraffin, Natural pigment
Equipments:
 Weighing balance
 Soxhlet apparatus
 pH meter
 Hot air oven
 UV Visible spectrophotometer
 Magnetic stirrer

6.3 .Methods :

Formulation of Medicated lipstick :

The medicated lipstick is formulated as per general method of lipstick formulation. In this
method bees wax is melted in a beaker at 70°C on a water bath. Similarly white soft paraffin,
castor oil, coconut oil, rose oil and almond oil will be taken in another beaker and melted at
70°C on a water bath in decreasing order of their melting point. Kojic Acid Dipalmitate was
added to the oil phase and stirred well. The colored pigment (beet root) will be added to the oil
phase until a homogenous mixture is obtained. Then it is added to the wax phase at the same
temperature. The mixture is cooled to 40°C and tocopherol (vit E) will be added. The molten
mixture is poured into lipstick moulds. Upon solidification it is separated from the moulds

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and fitted in lipstick case.9

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Method Of Collection Of Data:

An Overview of Kojic Acid Dipalmitate Medicated lipstick.

 Drug – Excipient Interaction by FT-IR Spectroscopy.
 Formulation of Medicated lipstick using kojic acid dipalmitate.
 Evaluation of the medicated lipstick for various parameters:

 Melting point

 Solubility

 pH

 Breaking point

 Force of application

 Aging stability

 Content uniformity

 Drug release

 In vitro testing

Source Of Data:

a) Review of literature from Journals such as-

 Research Journal of Topical and Cosmetic Science.

 International Journal of Creative Research Thoughts.
 International Journal of Applied Pharmaceutics.
 International Journal of Pharmaceutical Research and Applications.
 International Journal of Novel Research and development.
 Research and Reviews on Healthcare.
 Indian Dermatology Online Journal.
 Journal of Dental Specialities.
 International Journal of Health Science.

b) Library and Laboratory based studies :

References from library of Srinivas College of Pharmacy, Valachil, Mangalore.
c)Internet browsing and Helinet

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 6.6 Does the study require any investigation to be conducted on patient or other humans
or animals?
‘NO’
6.7 Has ethical clearance been obtained from your institution in case of 6.6
----Not applicable-----

7.0 REFERENCES:

1. Tirunagari M, Nerella N, Koneru A, Baig AN, Begum A. Formulation and Evaluation of

Medicated Lipstick using Natural Coloring Agent. Res J Topical Cosmetic Sci.
2020;11(1):20–23.

2. Singh A, Dubey S, Kaur B, Chandra J, Sekhar V, Malhotra S. Journey to a confident smile:

Management of hyperpigmented lips with 940 nm diode laser along with topical vitamin C -
A case series. J Dental Specialities. 2022;10(2):62-66.

3. Ayuhastuti A, Syah ISK, Megantara S, Chaerunisaa AY. A Comprehensive Review of

the cosmetic application of kojic acid dipalmitate: kojic derivative with improved
properties. Cosmetics. 2024;11(1).

4. Abid K, Hassan J. Vitamin E in dermatology. Ind Derma Online J. 2016;7(4):311-315.

5. Ansai S, Ghildiyal H, Mukopadyay S. A brief review on herbal lipsticks using natural

colorants over synthetic colorants. Int J Health Sci. 2022;6(S3):11064-76.

6. Rajalaxmi SV, Vinaya OG. Formulation Development, Evaluation and Optimization of

Medicated Lip Rouge containing Niosomal Acyclovir for the management of recurrent
Herpes Labialis. Int J App Pharm. 2017;9(6):21-27.

7. Shah P, Prajapati BG. Topical “Medistick” Of Antifungal, the New Future of Drug- Cosmetic.
Res Rev Health Care Open Acc J. 2018;1(3).

8. Kukudkar PG, Patle HP, Bisen JS, Pardhi D, Kharole D. Formulation and Evaluation

of Medicated Lipstick for the Treatment of Chapped Lips Using Beta Vulgaris as

Natural Colouring Agent. Int J Pharm Res App. 2023;8(4):1424-34.

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9. Dede R, Kasabe A, Bhosale A, Gupta H, Bhalerao A. Formulation and Evaluation

of Medicated Lipstick using Pioglitazone. Int J Pharm Res App. 2024;6(5):693-696.

10. Hole HS, Holkar NR, Hambir UG, Khade PH, Bhosale A. A Review on Herbal Medicated
lipstick. Int J Novel Res Dev. 2024;9(1).

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8 Signature of the candidates (Name and Signature)
No Name Sign
KAVANA KP
1
PAI SWATHI SURESH
2
SHRADDHA S MARLA
3
SHREYAS D
4
9
Remarks of the Guide The above given information is true and this work will
be done under my supervision

Mrs. VINEETHA K M. Pharm

9.1 Name and Associate Professor
Designation of the Department of Pharmaceutics,
Guide Srinivas College Of Pharmacy
Valachil, Mangalore- 574143

9.2 Signature

Ms. VINDHYA V S M. Pharm

9.3 Name and Designation of the Co- Assistant Professor
Guide Department of Pharmaceutics
Srinivas College Of Pharmacy
Valachil, Mangalore- 574143

9.4 Signature

Dr. KRISHNANDA KAMATH K M. pharm, Ph. D

9.5 Head of the Department Professor and Head
Department of Pharmaceutics
Srinivas College of Pharmacy,
Valachil, Mangaluru-574143

9.6 Head of the Department

Signature

10 10.1 Remarks of the Principal Above mentioned information are correct and I
recommend the same for approval.

10.2 Signature of the Principal

Dr. A. R. SHABARAYA M. Pharm., Ph.D., MBA.
Principal and Director
Srinivas College Of Pharmacy,
Valachil, Mangalore- 574143

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