Formulation and Evaluation of Anti-acne Gel Cleanser using Bael Leaves Extract

 

V.S. Tegeli, Sakshi P. Shete*, Jahanara R. Shaikh, Megha A. Savaisarje,

Sagar S. Satpute, Asad A. Sayyed

D.S.T.S Mandal’s College of Pharmacy, Solapur; Maharashtra, India, 413008.

 

ABSTRACT:

Now days Usage of herbal products has increased many folds an account of side effects observed with conventional products. In the world increases the demand for uses of herbal products. Acne is a chronic inflammatory condition of skin that causes pimples and spots, on the face, shoulders, back, neck, chest, and upper arms. In present study various attempts were made to develop and evaluate the herbal anti-acne gel containing Bael extract, Neem extract, Honey to facilitate the topical usage. The plants have been reported in literature having good anti-aging, anti-microbial, anti-oxidant, antiseptic, and anti-inflammatory activity. Various formulation batches i.e., F1 to F5 were prepared using Carbopol 940 as gelling agent. The Prepared formulations (F1 to F5) were evaluated for various parameters. Like colour, appearance, consistency, wash ability, pH, spread ability, grittiness, viscosity, homogeneity and skin irritation test. Thus, the topical antiacne gels were safe to apply on the skin without irritation.

 

 

 

INTRODUCTION:

Acne is an infection of the skin, caused by changes in sebaceous glands. The most common form of acne is called acne vulgaris, which means “common acne”. The redness comes from the inflammation of the skin in response to the infection. Oils from glands combine with dead skin cells to block hair follicles. Under blocked pore, oil builds up. Skin bacteria can then grow very quickly. This infection makes the skin becomes swollen and red, which becomes visible. The face, chest, back and upper arms are most common places for acne to happen¹.

 

Acne vulgaris is Characterized by various clinical conditions such as scaly red skin, erythematous papules and pustules, comedons, nodules, deep pustules and sometimes pimples. The pathogenicity mechanism of acne was the production of sebum’s, follicular hyper keratinization, bacterial colonization, and inflammation². P. acne plays a role in the development of inflammatory acne by activating complements and can metabolize sebaceous triglycerides into fatty acids, which neutrophils were attracted. In addition, S. epidermidis within sebaceous unit responsible in superficial infection. When bacteria colonize into the comedons, then the inflammatory factors are released by those bacteria. This made the comedons transformed into pustules and pimples. The inflamed acne becomes rupture and forms nodulus, also probably forms scars after healing³.

 

Acne is common during puberty, when a person is turning from a child into an adult, because of high levels of hormones. Acne becomes less common as people reach adulthood.

In male patients, acne generally clears by early adulthood. Five percent of men still have acne at age 25 years. Female patients frequently have adult acne. Twelve percent of women still have acne at age 25 years. Five percent of women still have acne at age of 45 years⁴.

 

Types of pimples⁵:

·       Whiteheads – Remain under the surface of skin and are very small.

·       Blackheads – Vividly look black and rise to the surface of the skin but are not formed due to dirt. Black heads are not black because of dirt they are black in colour. Generally, air oxidizes the protein called keratin.

·       Papules – They are small tender pink bumps which are clearly seen on the skin.

·       Pustules – Pustules (pimples or zits) are red at the bottom level consisting of pus at its top and can be looked on the surface of the skin.

·       Nodules – Clearly visible on the surface of the skin. They are painful, large, solid pimples existing deeply in the skin and can be seen on the skin surface.

·       Cysts – Clearly visible on the surface of the skin. They are deeply rooted, painful and pus filled and easily prone to form scar.

 

A gel is a solid jelly like material that can have properties ranging from soft & weak to hard & tough. Gels are defined as sub-standard dilute crossed linked system, which exhibits no flow when it is in steady state. By weight, gels are mostly liquid, yet they behave like solids due to 3-dimensional cross-linked network within the liquid. It is the cross linking within the fluid that gives a gel its structure and contributes to the adhesive stick track.

 

Advantages of gel cleansers⁶:

·       Deep cleansing.

·       Acne fighting.

·       Soothing and moisturizing.

·       Restoring vitality & balance to the skin.

·       Elimination oils & excess dirt.

·       Unclogs pores.

 

OBJECTIVES:

1.     To collect herbs.

2.     To extract active ingredients.

3.     Formulation of anti-acne gel cleanser.

4.     Evaluation of anti-acne gel cleanser.

5.     To remove oil and dirt from skin.

6.     To formulate economical and safe formulation.

7.     To formulate effective formulation.

 

MATERIALS AND METHODS:

Materials:

Table 1: The materials used and collected for formulation -

 

Methods:

Preparation of herbal extracts:

The herbs collected from the plants are washed under running water and are dried in indirect sunlight.

Then converted into coarse powders and sieved through sieve no. 60 mesh. Then the extracts were prepared by decoction method and the prepared extracts were stored in well closed containers⁶.

 

Decoction process:

Decoction is a method of extraction by boiling plant material to dissolve the chemicals of the material. It is the most common preparation method in various herbal-medicine systems. Decoction involves first drying the plant material; then mashing, slicing, or cutting the material to allow for maximum dissolution; and finally boiling in water to extract various chemical substances.

 

Fig 1: Bael extract

 

Authentication of herbs:

The naturally collected and dried herbs were authenticated from Dayanand College of Arts and Science, Solapur; department of botany. All the herbs were evaluated as per Ayurvedic Pharmacopeia of India.

 

Preparation of gel base:  

Carbopol 940 weighed and dissolved in water and kept overnight for soaking. Once the Carbopol is swollen stirring should be done to mix the Carbopol 940 to form the gel.

 

Preparation of formulation:

Accurately weighed amount of both extracts of Bael and neem are added to the gel base. Honey is added as humectant and rose water as perfuming agent. Then triethanolamine is added drop wise to the formulation for adjustment of required pH (5-6). Methyl paraben and propyl paraben are added as preservatives.

 

COMPOSITION OF DEVELOPED FORMULATION:

Table 2: Formulation table -

 

EVALUATION OF FORMULATION:

The prepared formulations evaluated for following tests.

 

Physical appearance:

The physical appearance of the formulation was checked visually which comprised.

 

Colour:  

The colour of the formulations was checked out against white background.

 

Odour:

The odour of the face washes was checked by manually.

 

Consistency:

The consistency was checked by applying on skin.

 

Greasiness:

The greasiness was assessed by the application onto the skin.

 

pH:

An amount of 20mg of the formulation was taken in a beaker and was subjected to the pH measurement using a digital pH meter within 24hrs. of manufacture. The range of pH should be 4–6

 

Wash ability:

Formulations were applied on the skin & then ease & extent of washing with water were checked manually.

 

Homogeneity:

Homogeneity was tested by visual inspection after allowing them to set in a container. They are evaluated for their appearance and presence of aggregates.

 

Viscosity:

Viscosities of formulated gels were determined using Brookfield viscometer spindle # 7 at 50 rpm and 25°C. The corresponding dial reading on the viscometer was noted. Then the spindle was lowered successively. The dial reading was multiplied by the factor mentioned in catalogue.

 

Spreadability:

Spreadability denotes the extent of area to which a gel readily spreads on the application to the skin or affected part. The bioavailability efficiency of the gel also depends on spread ability value. spreadability is defined in terms of time in seconds required taken by the upper slide to slip off the gel placed between the two slides, under certain load. The lesser the time taken for the separation of two slides, the better the spreadability. An amount of 500 mg of the formulation was sandwiched between the two slides, each with dimensions of 6 cm × 2 cm. A weight of 100 g was placed upon the upper slide so that the formulation between the two slides get pressured uniformly to form a thin layer. The weight was removed, and the excess of the formulation adhering to the slides was scrapped off. The lower slide was fixed on the board of apparatus, and the upper slide was held to the non-flexible string to which 20g load was applied with the help of a simple pulley which was in horizontal level with the fixed slide. The time taken by the upper slide to slip off the lower slide was noted.

 

Spreadability = m × l/t

 

Where,

m = Weight tied to upper slide,

l   =  Length of the glass slide,

t   =  Time in seconds.

m =  100gm

l   =  7.5cm

t   =  5 sec

 

Skin irritancy test:

This test was performed on 10 healthy human volunteers of either sex after obtaining consent for the same. About 0.5gms. of gel was applied to an area of about 6cm2 on skin of hand covered with a gauze patch. The patch was held in contact with the skin by means of a semi- occlusive dressing for an hr. At the conclusion of exposure period of 1hr, the gauze was removed and residual test substance was scrapped, without altering the existing response or integrity of the epidermis. The skin was observed at 1hr, 6hrs, 12hrs, 24hrs, 48hrs and 72 hrs. for any visible response on the skin.

 

Stability studies:

The physical stability of the formulations was studied by placing in plastic containers and they were placed in a humidity chamber at 45⁰C and 75% relative humidity. Their appearance and physical stability were inspected per a period of 3 months at interval of one month.

 

Test for microbial growth:

The formulated gel was inoculated on the plates of agar media by streak plate method and a control was prepared by omitting the cream. The plates were placed in to the incubator and are incubated at 37℃ for 24 hours. After the incubation period, plates were taken out and checked for the microbial growth by using colony counter and then comparing it with the control.

 

RESULTS AND DISCUSSION:

 

Stability test -

 

DISCUSSION:

The formulation produces semisolid consistency and this was confirmed by visual observation. Formulations do not show any greasiness upon application on the skin. PH of the formulation was found to be satisfactory and in the range of 4.5 - 6. It is near to the skin pH which indicates that the prepared formulation can be compatible with skin.

 

Formulations were easily washable. Under visual inspection it is indicated that no lumps are formed and have uniform colour dispersion, free from any fibre and particle. Prepared formulation shows no grittiness. Brookfield viscometer was used to measure the viscosity of gel.

 

Small amount of the gel was applied on the skin and kept for few minutes and found to show no redness, inflammation and irritation during irritancy studies.

 

Formulation was slight yellowish orange in colour. Formulation F1, F2, F3, F4, F5 was found to have semisolid consistency. All the formulations were homogeneous, easily washable and had optimal pH which is well suited with normal skin physiology. Out of five formulations, F1 and F2 formulation had the optimum stability and it had better fragrance, better appearance, and better consistency, there was no lumps in the formulation and was found most appropriate. Parameters of F1 and F2 were found to have more appropriate and better result than other, hence F1 and F2 was finalized.

 

CONCLUSION:

The world market is also moving towards poly herbal medicines for health care, health and for cosmetics purposes including dermal preparations like face washes gels anti acne preparations etc. A survey of global skin care market trends indicates that consumer use of herbal products has significantly increased over the past years. Natural remedies are boon to any disease. It is safe as well as having less side effects. In the world market, herbal formulations are in a great demand. It is a very good attempt to establish the herbal face wash containing extracts of Bael leaves and Neem. In the present study, an attempt was made to formulate anti acne gel cleanser using different natural ingredients like Bael leaves, Neem leaves, honey, and to evaluate the prepared formulations for the desired parameters. Prepared formulations were evaluated for physical parameters like colour, odour, grittiness, greasiness, PH, viscosity, consistency, spreadability, washability, skin irritation test and stability studies. Carbopol 940 produces desired gel strength to formulations. Honey produces humectants activity during stability studies. These preparations are having good spreadability results. It indicates easy apply on the skin. There was not any microbial growth shown in the test done for microbial growth for formulated product. So, from this study it can be concluded that the developed formulation of batch F1 and F2 was comparatively better than other formulations.

 

ACKNOWLEDGEMENT:

We indebted to principal Dr. R. Y. Patil and the management of D.S.T.S. Mandal’s college of Pharmacy for providing us facilities to carry out the work.

 

We are thankful to our guide Dr. Varsha Tegeli for helping us in selecting an interesting topic for the work and also for helping us to carry out the work by giving valuable comments and suggestions at appropriate time and while preparing the report.

 

We express our gratitude to Mr. Chincholi and Mr. Sachin for supporting us by providing required chemicals and glass wares at the hour of need and helping us to complete the work in time.

 

Last but not the least we are grateful to our family for their constant encouragement and financial support.

 

REFERENCES:

1.      Sri Agung Fitri Kusuma, et al. Formulation and evaluation of anti-acne gel containing Citrus aurentifolia fruit using carbopol as gelling agent. International Journal of Applied Pharmaceutics. 2018; 10(4):0975-7058

2.      Samiksha Yadav et al. Formulation and Evaluation of Anti-Acne Herbal Face Wash Gel. Journal of Drug Delivery and Therapeutics. 2019; 9(4):523-525.

3.      K. Kameswararao et al. Formulation and evaluation of anti-acne face wash gel. World Journal of Pharmacy and Pharmaceutical Sciences. 2017; 6(5): 2278-4357.

4.      Poonam Ankush Jadhav. Formulation and evaluation of anti-acne face wash gel. World Journal of Pharmacy and Pharmaceutical Sciences. 2017; 6(5): 2278-4357.

5.      Harsharan Pal Singh et al. Anti-acne synergistic herbal face wash gel: formulation, evaluation and stability studies. World Journal of Pharmaceutical Research. 2015; 4(9): 2277-1705.

6.      Arun Rasheed et al. Formulation and comparative evaluation of poly herbal anti-acne face wash gels. Pharmaceutical Biology. 2011; 49:8, 771-774.

 

Received on 17.05.2022         Accepted on 25.06.2022        

Accepted on 16.07.2022         ©A&V Publications all right reserved