1. INTRODUCTION:

Skin diseases are numerous and a frequency occurring health problem affecting all ages from the neonates to the elderly and causes harm in number of ways. Maintaining healthy skin is important for a healthy body. Many people may develop skin diseases that affect the skin, including cancer, trauma, bacterial infection¹.

1.1 Common Skin Problems:

Skin disease is a common ailment and its affects all ages from the neonate to the elderly and cause harm in number of ways¹. there are more than a thousand conditions that may affect the skin but more skin disease can ne categorized into nine common types².

Rashes:

A rashe is an area of red, inflamed skin or a group of individual spots the inner layers of skin. Viral infections: These occurs when a virus penetrate the startum corneum and infects the inner layer of skin. Bacterial infection: such infections are cause by variety of bacteria, the most common types being staphylococci and streptococci. Fungal infection: harmless fungi present on surface of skin and causes infection include ringworm lock itch. Cracked heels: cracked heels are usually due to dry skin. When weight and pressure are applied to a fat pad under the heel, the skin expands sideways. Cancer and tumors: skin cancer is a most common cancer among all there are three types of skin cancer (1) basal cell cancer. (2) squamous cell cancer. (3) malignant melanoma. Trauma: trauma describes an injury to the skin caused by a blow, a cut, or a burn.

1.2 HERBAL DRUGS FOR SKIN DISEASES:

natural drugs from the plants are graining popularity because of several advantages such as often having fewer side-effects, better patient tolerance, being relatively less expensive and acceptable due to a long history of use.

1.2.3. Aloevera (Common name: Barbados aloe):

Aloe is found effective in treating wrinkles, stretch marks, and pigmentation. it also seems to be able to speed wound healing by improving blood circulation through the area and preventing cell death around a wound ³.

1.2.4. Cow urine:

cow urine is used as an Anti bacterial, Anti spectic and as a Disinfectant.cow urine is use to preserve a healthy and glowimg skin. It helps to kill the micro organism that cause the skin related disease⁴.

1.2.5. Azadirachta indica (common name: neem):

Leaf extract is applied externally on boils and blisters⁴.it was observed that the optimal formula of anti-acne indicating bacteria ie., staphylococcus epidermis⁵.

1.2.6. Rose water (Common name: damascene):

Rose water helps maintain the skin’s pH balance, and also controls excess oil. Rose water has anti inflammatory properties that can help reduce the redness of irritated skin, get rid of acne.

1.2.7. Curcuma Longa (Common Name: Turmeric):

turmeric has significant role in reducing tumours. it helps to glow the skin and inhibit the microbial infection.

USES:

This is a Multipurpose gel use to treat various skin problems such as rashes redness, dry skin and irritation heals due to the Aloe Vera and Turmeric actively responsible. Gel helps in treating skin ulcers, scars and acne by the effect of multiple natural ingredients (cow urine, neem) Also protects from bacterial infection and helps to heal up the burn marks and cut marks.

2. MATERIALS AND METHODS:

2.1 Materials:

Extract of Cow urine, Neem extract, Rose water, Aloe Vera, Turmeric, Carbopol, Polyethylene Glycol (PEG), Glycerin.

2.2 Method:

Preparation of Cow urine Extract:

10 % W/V of cow urine extract is prepared by taking 10% cow urine in 100 ml Distilled Water.

Preparation of Neem Extract:

10 % Fresh Neem Leaves are grind and boiled in 100 ml Distilled water. Filter the mixture.

Formulation of topical herbal gel:

Herbal gel was prepared using gelling agent Carbopol concentration with polyethylene glycol and glycerin (softening agent), also the Herbal drug Aloe and Turmeric is added to make gel soft with moisturizing and cleansing property. Both extracts were added as shown in Table 1 to the gel and stirred for sufficient time for homogeneous mixing of extract in gel base. Collapsible tubes were used for filling of prepared gel. These formulations were stored at a cool and dry place. Formulation was evaluated for following parameters⁶.

Fig. 1 Preparedtopical herbal gel

Anti acne study:

The prepared gel was applied directly to the affected part of the skin twice a day after cleaning the skin properly for two weeks. The Effect of the gel was analyzed after a period of 3 days and marked as ‘0’, ‘*’, ‘**’, ‘***’, ‘****’ for zero effect, minimum effect, minor effect, little effect, good effect and significant improvementrespectively¹⁷. No Side Effect is noted also the redness or rashes is not observed after application of gel.

3. ORGANOLEPTIC EVALUATION:

Physical parameters such as color and appearance were recorded.

3.1 Viscosity:

Viscosity of gel was measured using Brookfield viscometer (Brookfield viscometer RVT) with spindle number 7.

3.2Extrudability:

The gel formulations were filled in standard capped collapsible aluminum tubes and sealed by crimping to the end. The weights of the tubes were recorded. The tubes were placed between two glass slides and were clamped. 500g was placed over the slides, and then, the cap was removed. The amount of the extruded gel was collected and weighed. The percent of the extruded gel was calculated (>90% extrudability: Excellent, >80% extrudability: Good, and >70% extrudability: Fair)⁷.

3.3 Spreadability:

Spreadability was determined by the apparatus which consists of a wooden block, which was provided by a pulley at one end. By this method, spreadability was measured on the basis of slip and drag characteristics of gels. An excess of gel (about 2g) under study was placed on the ground slide. The gel was then sandwiched between this slide and another glass slide having the dimension of fixed ground slide and provided with a hook. A 1kg weight was placed at the top of the two slides for 5 min to expel air and to provide a uniform film of the gel between the slides. Excess of the gel was scrapped off from the edges. The top plate was then subjected to pull of 80g with the help of string attached to the hook, and the time (in seconds) required by the top slide to cover a distance of 7.5cm was noted. A shorter interval indicated better spreadability⁸. Spreadability was calculated using the following formula

S=M×L/T

Where,

S = Spreadability

M = Weight in the pan (tied to the upper slide)

L = Length moved by the glass slide

T = Time (in sec.) taken to separate the upper slide from the ground slide

3.4 Measurement of pH:

The pH of developed gel formulations was determined using digital pH meter. The measurement was performed at 1, 30, 60, and 90 days after preparation to detect any change with time. 1g of gel was dissolved in 100ml distilled water and kept aside for 2 h. The measurement of pH of formulation was done in triplicate, and average values are calculated^9-11.

3.5 Homogeneity:

All developed gels were packed in containers and then tested for homogeneity by visual inspection. They were tested for their appearance and presence of any aggregates.

3.6 Grittiness:

All the formulations were evaluated microscopically for the presence of any appreciable particulate matter which was seen under light microscope. Hence, obviously the gel preparation fulfills the requirement of freedom from particular matter and form grittiness as desired for any topical preparation^11-13.

Stability study:

ICH guidelines were followed for stability study. The formulated gel was filled in collapsible tubes and stored at different temperatures and humidity conditions, namely 25±2°C/60±5% RH, 30±2°C/65±5% RH, and 40±2°C/75±5% RH for a period of 3 months and studied for appearance, pH, and spreadability^12,13.

3.7 Skin irritation test:

The intact skin of Wistar rats of either sex with average weight 150–200g was used. The hairs were removed from the rat 3 days before the experiment. Prepared gel formulations were used on the test animal and gel base on control group. The animals were treated daily for 7 days, and erythema and edema on the treated skin were examined¹⁴.

3.8 Cracked heels:

cracked heels test was done by applying the gel once a day and leave it there¹⁵.

4. RESULTS:

4.1 Physical evaluation:

The herbal gel was prepared using Carbopol, Polyethylene glycol and Glycerin by using various concentrations of cow urine extract, neem extract from neem leaf, Turmeric, Aloe and Rose water which were subjected for appearance, viscosity, spreadability, pH, and homogeneity. The prepared Gel formulation have Brown color with a translucent appearance and have smooth feel on application which was remain same on stability testing period. All these formulations have shown optimum viscosity. The pH value of prepared formulation ranged 7 which is considered acceptable to avoid the risk of irritation on application to the skin. The formulation when prepared and after 3 months remain homogeneous without any gritty particle. Furthermore, the stability study’s results revealed that the preparation was stable under normal storage conditions.

Table 2

Abbreviation	EvaluationTime Period	Effect of Substance
0	1^st Day	Zero Effect
*	2^nd Day	Minimum Effect
**	3^rd.Day	Minor Effect
***	4^th Day	Little Effect
****	5^th Day	Good Effect

Table 3: Physical evaluation of gel formulation.

Evaluation time period	Appearance	Viscosity	Spreadability	pH	Homogeneity
0 month	Brown	4520	24.36	6.3	Homogeneous
After 1 month	Brown	4260	22.35	6.5	Homogeneous
After 2 month	Brown	4300	24.83	6.8	Homogeneous
After 3 month	Brown	4500	19.32	7	Homogeneous
After 4 month	Brown	4580	19.14	6.7	Homogeneous
After 5 month	Brown	4583	19.11	6.6	Homogeneous
After 6 month	Brown	4585	19.09	6.7	Homogeneous

4.2 Extrusion of the gel:

The extrusion of the gel from the tube is an important during its application and in patient acceptance. Gel with high consistency may not extrude from tube, whereas low viscous gels may flow quickly, and hence, suitable consistency is required to extrude the gel from the tube. Extrudability of gel formulation was found to be good.

4.3 Acute skin irritation study:

Results of skin irritation test indicate that prepared gels were not produce irritation, redness, or edema on application and free from dermatological reaction.

4.4 Cracked heels:

cracked heels are usually due to dry skin. When weight and pressure are applied to a fat pad under the heel, the skin expands sideways. During our study the gel was found effective in reairing of heels.

Fig. a) cracked heels (before) b) application of gel on cracked heels(after)

5. DISCUSSION:

Different concentrations of Carbopol, Polyethylene glycol, Glycerin, Neem water, Cow urine extract, Turmeric, Aloe vera, Rose water were used for preparation of topical gel formulation, and they were stable during the period of stability testing.

All formulations were subjected for investigations of Anti-acne and anti crack activity by the trial on human volunteer's affected part.

6. CONCLUSION:

Results shown that gel formulations are good in appearance, homogeneity, extrudability, and spreadability. The poly-herbal Gel was successfully prepared using carbopol as a gelling agent. Gel was evaluated for clinical study, skin irritation study and other physiochemical test. The gel was foundusefull in the treatment of acne (pimple), skin rashes, injury, boils, cracked heelss, dry skin etc; The gel was found stable for the study period of six months. The gel can be used for different skin related problems without any side effects due to its herbal origin.

7. REFERENCE:

1. Marks JG, Miller J 4^th ed. Elsevier Inc; 2006. Lookingbill and Marks Principles of Dermatology.ISBN no. 1416031855.

2. http://www.essentialdayspa.com/skin_Anathomy_And_Physiology.htm.

3. Kim J, Lee Is, Park s, Choue R. Effects of Scutellariae radix and Aloe vera gel extracts on immunoglobulin E and cytokine level in atopic dermatitis NC/Nga mice J Ethnopharmacol. 2010; 132:529-32. [PubMed] [GoogleScholar].

4. Ipsita Mohanty, Manas Ranjan Senapati, Deepika Jena and Santwana Palai, Diversified uses of Cow Urine, International Journal of Pharmacy and Pharmaceutical Sciences,6(3)2014,20-22.

5. Rasheed A, Shama SN, Joy JM, Reddy BS, Roja c. Formulation and evaluation of herbal anti acne moisturizer. Pak J Pharma Sci 2012 ;25 :286 -70[ PubMed] [Google Scholar]

6. EI –Desouky SK, Ryu, Kim. A new cytotoxic acylated apigenin glucoside from Phyllanthus emblica L. Nat Prod Res 2008; 22:91-5.

7. Sudipta D, Haldar PK, Pramanik G. Formulation and evaluation of herbal gel containing Clerodendrum infortunatum leaves extract. Int J Pharmtech Res 2011; 3:140-3.

8. Wood JH, Catacalos G, Liberman SV. Adaptation of commercial viscometers for special applications in pharmaceutical rheology – Severs extrusion rheometer. J Pharm Sci 1963; 52:375-8

9. Goyal S, Sharma P, Ramchandani V, Shrivastava SK, Dubey PK. Novel anti-inflammatory topical herbal gels containing Withania somniferaand Boswellia serrata. Int J Pharm Biol Sci Arch 2011; 2:1087-94.

10. Mishra US, Murthey PN, Mishra D, Sahu K. Formulation and standardization of herbal gel containing methanolic extract of Calophyllum inophyllum. Am J Pharmtech Res 2011; 1:276-89.

11. Jyothi D, Koland M, Priya S. Investigation of anti-inflammatory activity of ointments containing fenugreek extract. Asian J Pharm Clin Res 2014; 7:66-9.

12. Dixit G, Misal G, Gulkari V, Upadhye K. Formulation and evaluation of polyherbal gel for anti-inflammatory activity. Int J Pharm Sci Res 2013; 4:1186-91.

13. ICH Guidelines. Stability Testing of New Drug Substances and Products; 27 October, 1993.

14. Singh M, Mittal V. Formulation and evaluation of herbal gel containing ethanolic extract of ipomoea fistulosa. Int J Sci Res 2014;3: 25-9.

15. V Jigar, G Vishal, G Tejas, C Vishal, U Umesh. Formulation and characterization of topical gel of erythromycin entrapped into niosomes. International Journal of PharmTech Research 3 (3), 1714-1718,2011.

Received on 04.03.2020 Modified on 19.03.2020

Res. J. Pharma. Dosage Forms and Tech.2020; 12(2): 73-77.

DOI: 10.5958/0975-4377.2020.00013.0

Sr. No.	Formulation Ingredients	Category	Proportion
1.	Extract of Cow urine	Germicidal and healing agent	10%
2.	Neem Extract	Antimicrobial and Antibacterial Agent	10%
3.	Rose Water	Solvent	28.75%
4.	Aloe Vera	Moisturizer andCleansing	10%
5.	Carbopol	Gelling Agent	1.0%
6.	Polyethylene Glycol	Gel Smoothing Agent	5%
7.	Glycerin	Gel Smoothing Agent	5%
8.	Turmeric	Moisturizer and Gelling Agent	10%