536 | P a g e International Standard Serial Number (ISSN): 2319-8141 International Journal of Universal Pharmacy and Bio Sciences 3(3): May-June 2014 INTERNATIONAL JOURNAL OF UNIVERSAL PHARMACY AND BIO SCIENCES IMPACT FACTOR 1.89*** ICV 5.13*** Pharmaceutical Sciences RESEARCH ARTICLE……!!!

FORMULATION AND EVALUATION OF A SKIN CREAM FROM THE HERBAL EXTRACT OF TINCTORIA Mr.A.J.Chacko1, Arya Soman1, Arathy P.A1, Archana Rajeev1, Haresh Regunath1, Flowerlet Mathew2 1University College of Pharmacy, Cheruvandoor, Ettumanoor 2 Nirmala College of Pharmacy, Muvattupuzha, Kerala.

KEYWORDS: ABSTRACT

The natural drug used in our study is Wrightia tinctoria. It is Psoriasis, Wrightia commonly used for the treatment of skin diseases like psoriasis and tinctoria, Cream. eczema. The main chemical constituent responsible for antipsoriatic For Correspondence: action is Tryptanthrin. Topical delivery of this drug is beneficial for A.J.CHACKO * Address: skin diseases because of the avoidance of the risk and inconvenience of Associate Professor i.v. therapy and of the varied conditions of absorption like pH changes, University College of presence of enzyme, gastric emptying etc. The purpose of making it as Pharmacy Puthupally, a cream is that it has the ability to cling to the surface of application for Kottayam. reasonable duration before they are washed or worn off. The main Email: ingredient of the formulation is the oil extract of Wrightia tinctoria and [email protected] is an excellent oil for psoriasis. The oil of Wrightia tinctoria is already m a marketed products and various formulations like gels, oils etc are

available in market. Psoriasis is characterized by scaly, reddened patches, papules and plaques which are usually itchy. The formulation was evaluated for its pH, drug content uniformity, stability studies.

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INTRODUCTION: Of the 2,50,000 species of the earth more than 80,000 are medicinal species. In drugs of herbal origin have been used in traditional system of medicines such as Unani, Siddha since ancient times. Even the allopathic system of medicine has adopted a number of plant derived drugs which form an important segment of the modern pharmacopeia. Some important chemical intermediates needed for the manufacture the modern drugs are also obtained from plant[1]. Many chronic and acute diseases are cured by using our medicinal , such as turmeric for its anti-inflammatory action, ginger and clove for toothache, digitalis for congestive heart failure, liquorice as an expectorant, neem for its anti-viral activity, anti-rheumatic activity and for skin diseases. In our study, we are formulating a cream using the herbal extract of Wrightia tinctoria and evaluating its efficiency in skin diseases like psoriasis, eczema and also for dandruff of hair[2]. PHARMACOGNOSTIC STUDIES The Plant – Wrightia tinctoria

Pharmacognostic Studies

Botanical name : Wrightia tinctoria

Kingdom : Plantae

Order :

Family :

Genus : Wrightia

Species : Wrightia tinctoria

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English : Ivory wood, pala indigo plant

Hindi : Duhi, mitaindarjau

Malayalam : Dhandappala, ayyapala, vettupala. A genuine, natural drug used in our study is Wrightia tinctoria. This oil is steroid free, chemical free and preservative free. It has no documented side effects and has rich history of use, throughout times. The oil of Wrightia tinctoria is excellent oil for psoriasis and other skin condition similar to it4. It is extracted from all natural Wrightia tinctoria and is a safe oil to use on the affected areas. It gives relief from psoriasis, dandruff, itching, scaling, and retrieves the skin texture. The oil is prepared without any hot process and hence it retains the original crude smell of the herb (Wrightia tinctoria) and coconut oil4. It retains the natural colour and smell. No additives are added in this oil. The action of oil is through immune system[3]. The present concept about the aetiology of psoriasis is that the antigen presenting cells take upon unknown antigen which in turn produces interleukin 1(IL-1) which stimulates the CD4+Tcells. CD4+Tcells produce IL-2, IL-6 and IL-8 and result in keratinocyte multiplication[4]. So after therapy with W. tinctoria oil, there is a decrease in the dermal infiltrate. This shows that action of the oil is either at the antigen uptake level or the production of IL-1. This hypothesis needs further studies to be confirmed[5]. Trial in psoriasis with the oil prepared from W.tinctoria is not new and was originally conducted as part of research in Siddha medicine by CCRAS in this study the same oil was used internally also. However in our study we used the oil or cream externally in the affected area6. MATERIALS AND METHOD MATERIALS Stearic acid Nice chemicals, Kochi Acetyl alcohol Nice chemicals, Kochi Borax Nice chemicals, Kochi Benzoic acid Nice chemicals, Kochi Propylene glycol Nice chemicals, Kochi Glycerine Nice chemicals, Kochi Triethanolamine Nice chemicals, Kochi Leaves of Wrightia tinctoria Collected locally (Cheruvandoor)

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539 | P a g e International Standard Serial Number (ISSN): 2319-8141

Methodology Preparation of oil extract Mature leaves of Wrightia tinctoria were collected & cleaned using water & air dried immediately. Collected 20 of Wrightia tinctoria were put in 200 ml of coconut oil in a stainless steel container after making size reduction. It was then kept under sunlight for 5-6 hours/ day for 7 days. At night the oil was stored in dark room devoid of moisture[6]. Formula of cream

Table 1:

Ingredients control test Stearic acid 12g 12g Oil extract - 10 ml Cetyl alcohol 0.5g 0.5g Borax 1g 1g Propylene glycol 2 ml 2 ml Glycerine 2ml 2ml Triethanolamine 2 ml 2 ml Water 70.4 ml 70.4 ml Benzoic acid 0.1g 0.1g Coconut oil 10 ml -

Procedure

Table 2:

Aqueous phase Oil phase Borax Stearic acid Triethanolamine Oil extract Propylene glycol Cetyl alcohol Glycerine Benzoic acid Water

Determination of pH: Weigh accurately 5 gm of the cream in 100 ml beaker. Add 45 ml of water and disperse the cream in it. Determine the Ph of the suspension at 270c using the Ph meter. Drug content uniformity The formulation equivalent to 50 mg of drug was taken and dissolved in small quantity of methanol. Then the formulation is warmed on the water bath, so that the drug present in the formulation was

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completely dissolved. Then the solution is filtered through the whattmann filter paper into 50 ml volumetric flask. The volume is made up to the mark which gives concentration of 1000 mcg/ml. From this different concentration of solution was taken in 10 ml volumetric flask and the volume was made upto 10 ml with methanol and absorbance was measured by UV spectrophotometer at 231.6 nm against blank. Viscosity Viscosities of the formulations were determined using Brookefield synchroelectric viscometer (RTV model) at 100rpm with spindle no 7. Homogeneity Creams were evaluated for homogeneity by visual inspection. Spreadability Glass slide apparatus was used to determine the spreadability (6). An excess of cream was placed in between two glass slides and 1000gm weight was kept on the slide for 5min to compress the sample to uniform thickness. Stability studies The prepared wrightia tinctoria o/w cream formulation were filled in the collapsible tubes and stored at ambient temperature (30 0C & 40 0C) for the span of three months. 1gm of cream formulation was taken out at different time intervals (one month interval) and analyzed for drug content, physical appearance, pH and rheological properties. RESULT & DISCUSSION 1. Extraction

Leaves were collected from the leaves of Wrightia tinctoria. 20 leaves were collected for 200 ml oil & extracted after 7 days. The extract had a violet colour with characteristic odour.

2. Cream formulations

Table 3 : Physiochemical evaluation of developed cream

Formulations pH Viscosity Homogeneity spreadability (CPS) F1 5.64 7400 Excellent 10.55 F2 5.91 7000 Excellent 11.17 F3 6.1 7200 Excellent 11.87 F4 6.1 7600 Excellent 10.85 F5 6.1 6800 Excellent 12.66

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Free from grittness The oil extract containing cream was slightly dull than the control cream. Both the cream resulted in a shiny film upon application on the skin. 3. pH: The pH of the formulation was shown nearly neutral pH(6.1) 4. Drug content The percentage drug content of the prepared cream formulaion was found to be 95.00%. 5. Stability studies Evaluation is done for 3 months visually & found that there is no phase separation & microbial attack. Table 4:

Sl.no Storage temp Time interval appearance pH Drug content 1 300c 30 White 6.1 95.00% 2 300c 60 White 6.1 95.00% 3 300c 90 White 6.1 94.97%

CREAM FORMULATION The formulated creams were found to be off white and free from grittiness. The oil extract containing cream was slightly dull than the control cream. Both the creams resulted in a shiny film. 7.3 Tabular column for determining anti psoriatic effect on skin. Table 5: Left leg Name of patient :volunteer 1 Age :75 Sex : female Duration of treatment : 2 months Disease description: psoriasis disease with symptoms like redness, dry silvery skin and itching, flaky skin patches from 10 years. Symptoms Weekly observation 1st 2nd 3rd 4th 5th 6th 7th 8th

Disappearance of + + + ++ +++ +++ +++ lesions ++

Itching - - + + ++ ++ +++ +++

Reduction in + + ++ ++ ++ +++ +++ +++ scaling

Redness - - - - + + ++ +++

- no effect , + good , ++ better , +++ best

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542 | P a g e International Standard Serial Number (ISSN): 2319-8141

Table 6: Right leg

Name of patient :volunteer 1 Age :75 Sex : female Duration of treatment : 2 months Disease description: psoriasis disease with symptoms like redness, dry silvery skin and itching, flaky skin patches from 10 years. Symptoms Weekly observation 1st 2nd 3rd 4th 5th 6th 7th 8th Disappearance of ------lesions Itching - - - + + + ++ ++ Reduction in - - + + + ++ ++ ++ scaling Redness ------+ - no effect, + good, ++ better, +++ best

Fig.2 Before the use of cream. Fig.3 After the use of cream Table 7: Right leg

Name of patient :volunteer 2 Age :68 Sex : male Duration of treatment : 2 months Disease description: psoriasis disease with symptoms like redness, dry silvery skin, itching, flaky skin patches exacerbation from 10 years. Symptoms Weekly observation 1st 2nd 3rd 4th 5th 6th 7th 8th Disappearance of - - - + + + ++ ++ lesions Itching - + + + ++ +++ +++ +++ Reduction in + + + ++ ++ +++ +++ +++ scaling Redness - - - + + ++ ++ - no effect, + good, ++ better, +++ best

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Table 8: Left leg Name of patient : volunteer 2 Age :68 Sex : male Duration of treatment : 2 months

Disease description: psoriasis disease with symptoms like redness, dry silvery skin and itching, flaky skin patches from 7 years.

Symptoms Weekly observation 1st 2nd 3rd 4th 5th 6th 7th 8th Disappearance of ------lesion Itching - - - + + + + ++ Reduction in - + + + + ++ ++ ++ scaling Redness ------no effect, + good, ++ better, +++ best - Tabular column for determining anti dandruff effect

Table 9 Name of patient : volunteer 3 Age : 22 Sex : male Duration of treatment : Two weeks Disease description :Flaky skin ,itching , hair loss , increased baldness Symptoms Twice daily observation 2nd 4th 6th 8th 10th 12th 14th Flaky skin - - + + ++ ++ +++

Itching - + + ++ ++ ++ +++ Hair loss ------no effect, + good, ++ better, +++ best Table 10 Name of patient : volunteer 4 Age : 42 Sex Female Duration of treatment : Two weeks Disease description :redness, itching , exacerbations Symptoms Twice daily observation 2nd 4th 6th 8th 10th 12th 14th Redness - + ++ ++ ++ +++ +++ Itching + + ++ ++ +++ +++ +++

Exacerbations - + ++ ++ +++ +++ +++

- no effect, + good, ++ better +++ best

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Table 11 Name of patient : volunteer 5 Age : 38 Sex : male Duration of treatment : Two weeks Disease description :exacerbations ,itching , redness

Symptoms Twice daily observation 2nd 4th 6th 8th 10th 12th 14th - + + ++ +++ +++ +++ Exacerbations Itching + + ++ +++ +++ +++ +++ Redness - + + ++ ++ +++ +++ - no effect, + good, ++ better, +++ best

Fig.4 before use Fig.5 After use Conclusion The leaves of Wrightia tinctoria were collected & oil was prepared 7 extracted from the collected leaves. A cream with 10% of extract was prepared & a control with 10% coconut oil was also prepared. The cream was evaluated for stability for 3 months at room temperature & found stable. The cream was found to have good anti psoriatic activity & anti dandruff activity when compared to control. The cream was also found to be good for various mild skin conditions. References: 1. Susan budavari.ed(1989).Merck index 11th edition Railway New jersey , Merck and co., page 8761 2. David.j Anneken,sabine both,Georg fieg ,udo stenberner,Alfred Westfechtel et al., „fattyacid in ullmanan‟s Encyclopedia of industrial chemistry 2006 3. Recommended n Moore J.B (1869[1870]) on “cold cream” American journal of pharmacy.

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4. Wrightial , a new terpene from wrightia tinctoria .Ramchanda p. Basheermiya M;Krupadam G L P ,Sriman narayana journal of natural products 1993 vol 56 page no.1811-1812. 5. Stern Rs.psoralen and u.v a light therapy for psoriasis N Engj Med 2007;357;page no.682-690. 6. Piearad – Franchimont C, HermannJF, Degreet H,Pierard G E. From axioms to new insight into Dandruff .Dermatology 2000;200:93-98.

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