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Formulation Development of a Patient Friendly Dosage Form for Eye Drug Delivery: Kajal

  • TVES's Honorable Loksevak Mdhukarrao Chaudhari College of Pharmacy Faizpur

Abstract and Figures

Traditionally, kajal is known as kohl or surma and is used as eyeliner. Designing herbal kajal with medicinal plants as a cosmetics product is considered to bea novel, innovative technique. The main advantages of such a product are that it is patient friendly, water resistant, stable, and economical to formulate. Two medicinal plants, viz., Rosa rubiginosa and Triphala, were evaluated for their potential for sustained ocular delivery with the aim of formulating herbal kajal. Standardization of the herbs was performed based on different physiochemical parameters, and the obtained values were within the prescribed limits. On the basis of the selected parameters and its antimicrobial potential, herbal kajal was evaluated in comparison with comparable products.
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Formulation Development of Patient Friendly Dosage Form for Eye Drug delivery: Kajal
Sandeep Waghulde, Archana Pawar*, Minal Kadav, Pratiksha Khade, Mohan Kale, Bharat
Tekade, Nilesh Gorde, Pravin Naik
Konkan Gyanpeeth Rahul Dharkar College of Pharmacy and Research Institute, Karjat,
University of Mumbai
Traditionally kajal is known as kohl or surma which is used as an eye liner. Designing herbal kajal with
medicinal plants as a cosmetic product for beautification was thought of an innovative technique and as a
novel . More patient compliance ,water resistant property , stability and of cource economical to formate
are the main advantages of these cosmetics products .with the help of two medicinal plants viz. Rosa
rubiginosa and Triphala and evaluate their potentional for sustained ocular delivery for looking
at the present study was carried out with the aim of formulation of herbal kajal . revealed the
values were within the prescribed limits by Standardization of the herbs was performed based on
different physiochemical parameters . On the basis of selected parameters and its anti-microbial
potential was compare with comparator products the herbal kajal was evaluated.
Kohl, kajal, Rosa rubiginosa, Triphala ,herbal kohl.
Eyes are the important connections between the outer and inner worlds. for the element of fire
and light that governs our eyes pitta dosha stands for that in Ayurveda. Hence eyes are very
important organ in our body system. For care and beautification of eyes vedic science offers
several natural,safe and effective techniques.. With the help of science of ayurveda, several herbs
and floras were used to make Ayurvedic cosmetics that not only beautified the skin but as well as
act as the shield against any kind of external affects for the body. In cosmetics for useful
purposes such as moisturizing, whitening, coloring, sunscreen, antioxidant, immunostimulant,
cleansing, preservatives, thickeners, etc.plants products are also used.Role of kajal in eye
products can’t be ignored as it is one of those products[1].
Kajal is worn for many reasons including tradition, beautification, to ward off the “evil eye,” .It
is the widespread belief that kohl is medically beneficial for the eyes, and finally because
wearing kohl is encouraged within the sunna, the traditional behavioral guidelines of the Islamic
religion [2]. There are number of plants which are used opthalmic disorders,either single or in
compound formulations are present in the Ayurvedic system of medicine, as mentioned in
ancient Indian books like Charak Samhita, Sushrut Samhita, Bhav prakasha, Ras Tarang, Nayan
Drastam and Astanghriday.Various eye disorders and diseases like Abhishyand (Conjunctivitis),
Adhimanth (Glaucoma), Timir (Cataract), etc. have been described in great details1 in
Ayurveda.(Indian system of medicine).Their etiology and treatments have also been described.
Use of Various herbal drugs in different dosage forms like extract, arkas (aqueous distillate),
kajal (collerium), and fomentation and washing with different extracts have also been prescribed
frequently [3]. not only the use of animals for laboratory testing but also with the use of materials
and ingredients derived from animal sourcesis the concern in this area.for the standards and
quality of drugs and cosmetics manufactured and sold in India the Drugs and Cosmetic act is
concerned [1] .
Hence, for the “natural” products used in various preparations there is a prime need for
regulation. Oflate, the primary concept that can create trust and confidence in the products and
increase market relevance is standardization.The consumer as well as the practitioner now seeks
assurance from the manufacturer about quality, safety and efficacy of products. Hence the earlier
recommendations related to any cosmetic preparations with herbs for specific condition states
may not hold true today unless validated properly [4]. In this study Rosa rubiginosa and Triphala
herbs were selected to formulate Kajal by carried out different extracts.well known from
Ayurveda Triphala is polyherbal formulation.Triphala is a Rasayana Drug used in Indian System
of Medicine (ISM) [5]. It is A mixture of three fruits as described in Ayurvedic formulary of
India whichconsist of dried fruits of Emblica officinalis Gaertn (Euphorbiaceae), Terminalia
bellerica Linn (Combertaceae) and Terminalia chebula (Combertaceae) with equal proportions
of (1:1:1).[6]. The most commonly found polyphenolic compounds in plant extracts are Tannin,
Gallic acid, Chebulagic acid, Ellagic acid, Phenols and Glycosides. Phenolic acids, flavonoids
and tannins are most commonly found in triphala.[7] Triphalais also widely taken for all eye
diseases including the treatment of conjunctivitis, progressive Myopia, theearly stages of
glaucoma and cataracts as described by the Mahajan et al., protection against delaying the onset
and progression of cataract is given by Triphalaghrita at a dose of 1080 mg. antioxidant
activityof Gallic acid, ellogic acid and ascorbic acid may also give anticataract effect.[8]
for the cure of constipation, inflammation, and swelling and for easing throat infection rose
water was used traditionally. However, when used as eye drops it worked in curing eye issues as
per observations in study.For preparation of eye drops and used it on patients suffering from dry
eyes, conjunctivitis, and pterygium study used herbal preparation that also included rose extracts.
In postoperative cataract patients the drops are also used by them. And a significant
improvement in their condition is noticed. Needless to say, for the eyes rose water is good.
Benefits Of Rose Water For The Eyes are: It Soothes the Eyes, Helps In Treating Skin Irritation,
Prevents Cell Damage, Lightens Dark Circles , Is A Soothing Eye Wash[9].
Formulating medicated Kajal as a cosmeceutical product to combat eye infections and
beautification was thought of an innovative approach as kajal is most important in eye makeup
but still the medicinal use of kajal is limited. Looking at that the present study was aimed to
prepare a contemporary formulation from the preliminary Ayurvedic Kajal called soot/Lamp
black, prepared by two herbs namely Rosa rubiginosa and Triphala and standardize in terms of
identity, physical evaluation and toxicity study for safety usage.
2. 1. Collection of plant materials & Proximal analysis
The fresh fruits of triphala such as amala, baheda, haritaki and flowers of rosa rubigenosa
were collected.quantitative standards for the fruits of of triphala and petals of flower rosa
rubigenosa, in terms of moisture content, total ash, acid insoluble ash, alcohol and water soluble
extractive values for both the samples were performed by Preliminary macroscopical
identification of both the raw plant materials were carried out as per the method described by
the World Health Organization (WHO) guidelines [10]
2. 2. Preliminary Ayurvedic formulation of Kajal
Take the required quantity of rose petals and
dried powder of triphala fruits for preparing the extract.
Extract was prepared hygienically & clean, unbleached cloth was
soak in the rose extract & dried in the hot air oven.
The cloth piece which is dried was used as a wick and
was lighted in a mud lamp containing cow ghee.
The black soot was collected in a clean, dry porcelain dish.
The powder then mixed with cow ghee to form a paste form i.e. kajal.
2. 3. Contemporary formulation of Kajal
Modern Kajal was formulated as the preliminary Ayurvedic Kajal with the ingredient given in
below Table 1:
Table 1. Quantitative composition of formulation of Kajal
Quantity Taken
Kajal powder
10 gm
Cow ghee
15 gm
Rose water extract
0.5 ml
Triphala extract
0.5 ml
12 gm
12 gm
2. 4. Standardization of ingredients, process and products
The standardization of quality of the ingredients used in the product was done by using
TLC. Physiochemical characters that includes Moisture content (using Karl Fischer method),
Penetrometer test (the pressure at which the needle penetrates), microbial contamination , TLC,
and toxicity study of the product were performed for the Lamp black, plant extracts, and Kajal
products of two separate Herb plant.
2. 4. 1. TLC of extracts
Both the Rosa rubiginosa and Triphala extracts were to begin with, checked by Thin
Layer Chromatography (TLC) on analytical plates over silica gel. The isolation of the
principle components that were present in most effective extracts of plant and the final products
carried out by using TLC. The different polarities solvents were prepared and for better
resolution TLC studies were carried out to select the suitable solvent system [11]. Based on
that, 6 g of the product (prepared from Rosa rubiginosa) was subjected to soxhlet extraction
with water as solvent. Further65 g of whole plant Triphala refluxed with 100 ml of alcohol for
one hour and then evaporated with water bath to reduce the volume. Crude extract then diluted
to sufficient volume of alcohol.
Finally, the leaf extract of Rosa rubiginosa, Lamp black, Kajal products and alcoholic
plant extract of Triphala, Lamp black, Kajal products were performed by TLC using two
separate mobile phases viz. Toluene: Acetone: Formic acid (11:6:1) and Toluene: Ethyl acetate
(95:5) for Rosa rubiginosa and Triphala respectively. Both the samples were visualized at 254
nm and 366 nm and band of similar Rf value was identified.
Table 2. TLC for ingredients (Water extract, Lamp black extract) and product (Water Kajal
extract) of Rosa rubiginosa at different wavelength.
Water extract
Kajal extract
254 nm
T1: 0.67 (Rf)
T2: 0.67 (Rf)
T4: 0.09 (Rf)
366 nm
T1: 0.67 (Rf)
T2: 0.67 (Rf)
T4: 0.09 (Rf)
T1, T2, T3 and T4 are the tracks of respective extracts
Table 3. TLC for ingredients (alcoholic extract, Lamp black extract) and product (alcoholic
Kajal extract) of Triphala at different wavelength.
Alcoholic extract
Kajal extract
254 nm
T1: 0.58 (Rf)
T2: 0.60 (Rf)
T4: 0.60 (Rf)
366 nm
T1: 0.58 (Rf)
T2: 0.60 (Rf)
T4: 0.60 (Rf)
T1, T2, T3 and T4 are the tracks of respective extracts
1 a. UV at 254 nm 1 b. UV at 366 nm
Figure 1. TLC plates at different wavelength for Rosa rubiginosa Kajal extracts
2. 4. 2. Microbial contamination
The Kajal products were performed to check quality with the microbial test to find out
the microbial count, total fungal count and E. coli count through cylindrical plate method using
nutrient agar (for total bacterial count), MacConkey agar (for total E. coli count) and Sabouraud
dextrose agar (for fungal and yeast count) method by incubated 37° over night, 43° over night
and 25°C for 4 days respectively. Finally the growth were observed and by colony counter,
counted in per volume plated and results expressed as cfu/g (Colony forming unit per gram of
the sample).
2. 5. Evaluation Of Allergenic Studies OnKajal Products
Physical Evaluation: The formulated product is of a shiny black color, with a characteristic
odour. It was non-gritty and smooth in texture with a semisolid consistency.
2 a. UV at 254 nm 2 b. UV at 366 nm
Figure 2. TLC plates at different wavelength for Triphalka Kajal extracts.
PH Determination: From Ph meter read as 7.2
Viscosity Determinations: By Using Brookfield Viscometer.
Evaluation of Base: For acid value, Saponification value and ester value Vegetable ghee was
evaluated as per I.P. 1996.
Acid Value: Acid Value = 5.61 x n/w; where n = no. of Ml of 0.1 M KOH required and w =
weight in grams of solvent; where n = 0.5 and w = 2.0 Hence Acid value equals to 5.61 x 0.5/2 =
Saponification Value: Saponification value equals to 28.05 (b-a) / w ; Where w = weight in
grams of substance, b = blank solution reading, a = sample solution reading; b = 21, a = 4.6, w =
2.0 Therefore, Saponification value = 28.05 (21-4.6) / 2 = 230.01 Ester Value: Ester value =
Saponification value Acid value Hence Ester value = 230.01 1.4025 = 228.6075.
Standardization of Triphala and Rosa rubiginosa plants were carried out with respect to
organoleptic characters and founded same characters reported for both the drugs in the official
Pharmacopoeia. Revealed similarities in the values for both the herbs by carrying out various
proximate parameters.Chromatographic profile of extracts of the plants showed that there are
compounds present had similar Rf values in the duos when they were identified and separated
with different mobile phase. Thereafter microbial tests showed in both the plant products,
absence of microbial load which showed safety of the Kajal products. These studies concluded
that the formulated herbal Kajal is safe and can be used as one of the herbal cosmetic products.
[1] T. Srikanth, S. S, Hussen, A. Anand, S.G. Vasantharaju, Sandeep, Der Pharmacia Lettre
3 (2011) 334-341.
[2] Parry C, Eaton J. Kohl: A lead- hazardous eye makeup from the third world to the first
world. Environmental Health Perspectives 1991; 94: 121-123.
[3] Shastri Ambika Dutt. Hindi Commentary, Susruta Samhita, vol. II, Chaukhamha
Publications, New Delhi 2009; 1-108.
[4] B.C Stone, Micronesica 6 (1970) 1-659.
[5] R. Govindarajan, Vijaykumar M, Pushpangadan P. Antioxidant approach to disease
management and the role of Rasayan herbs of Ayurveda; Journal of Ethnopharmacology,
2005; 99: 165-178.
[6] The Ayurvedic Formulary of India, Part II, Department of Indian System of Medicine
and Homeopathy, New Delhi, 2002.
[7] DP. Singh, Govindarajan R, Rawat AKS. High Performance Liquid Chromatography as a
tool for the Chemical Standardisation of Triphala an Ayurvedic Formulation,
Phytochemical Analysi, 2008;19: 164-168.
[8] KN. Mahajan, Singhal AK, Vadnere GP; Investigation on anti-cataract activity of
Triphala ghrita, E-journal of chemistry, 2011; 8(3): 1438-1443.
[10] WHO. Quality Control Methods for Medicinal Plants Materials. Geneva, 1998, p. 1115
[11] J.B. Harborne, Phytochemical methods: A Guide to Modern techniques of plants Analysis.
Chapman and Hall London, UK. 1998.
ResearchGate has not been able to resolve any citations for this publication.
The disease preventive and health promotive approach of 'Ayurveda', which takes into consideration the whole body, mind and spirit while dealing with the maintenance of health, promotion of health and treating ailments is holistic and finds increasing acceptability in many regions of the world. Ancient Ayurvedic physicians had developed certain dietary and therapeutic measures to arrest/delay ageing and rejuvenating whole functional dynamics of the body system. This revitalization and rejuvenation is known as the 'Rasayan chikitsa' (rejuvenation therapy). Traditionally, Rasayana drugs are used against a plethora of seemingly diverse disorders with no pathophysiological connections according to modern medicine. Though, this group of plants generally possesses strong antioxidant activity, only a few have been investigated in detail. Over about 100 disorders like rheumatoid arthritis, hemorrhagic shock, CVS disorders, cystic fibrosis, metabolic disorders, neurodegenerative diseases, gastrointestinal ulcerogenesis and AIDS have been reported as reactive oxygen species mediated. In this review, the role of free radicals in these diseases has been briefly reviewed. 'Rasayana' plants with potent antioxidant activity have been reviewed for their traditional uses, and mechanism of antioxidant action. Fifteen such plants have been dealt with in detail and some more plants with less work have also been reviewed briefly.
Triphala is an anti-oxidant-rich herbal formulation containing fruits of Emblica officinalis, Terminalia chebula and T. belerica in equal proportions. The preparation is frequently used in Ayurvedic medicine to treat diseases such as anaemia, jaundice, constipation, asthma, fever and chronic ulcers. Anti-mutagenic effects of the polyphenolic fractions isolated from Triphala have been reported, thus indicating that the phenols present in the formulation might be responsible for its therapeutic efficacy. A simple high-performance liquid chromatography method for the separation and quantitative determination of the major antioxidant polyphenols from Triphala has been developed. The use of an RP18 column with an acidic mobile phase enabled the efficient separation of gallic acid, tannic acid, syringic acid and epicatechin along with ascorbic acid within a 20 min analysis. Validation of the method was performed in order to demonstrate its selectivity, linearity, precision, accuracy and robustness. In addition, optimisation of the complete extraction of phenolic compounds was also studied.
  • T Srikanth
  • S S Hussen
  • A Anand
  • S G Vasantharaju
T. Srikanth, S. S, Hussen, A. Anand, S.G. Vasantharaju, Sandeep, Der Pharmacia Lettre 3 (2011) 334-341.
  • Dutt Shastri Ambika
Shastri Ambika Dutt. Hindi Commentary, Susruta Samhita, vol. II, Chaukhamha Publications, New Delhi, 2009, 1-108.
  • B Stone
B.C Stone, Micronesica 6 (1970) 1-659.
Investigation on anti-cataract activity of Triphala ghrita, E-journal of chemistry
  • Kn
  • Mahajan
  • A K Singhal
  • G P Vadnere
KN. Mahajan, Singhal AK, Vadnere GP. Investigation on anti-cataract activity of Triphala ghrita, E-journal of chemistry. 2011; 8(3):1438-1443.
  • T Srikanth
  • S S Hussen
  • A Anand
  • S G Vasantharaju
  • Sandeep
Srikanth T, Hussen SS, Anand A, Vasantharaju SG, Sandeep, Der Pharmacia Lettre. 2011; 3:334-341.