Department of Bachelor of Pharmacy, Shivajirao pawar, college of pharmacy, pachegaon, Ahmednagar, 413725.
Acne vulgaris is a long-term inflammatory disorder of the pilosebaceous unit that leads to the formation of inflammatory lesions, seborrhea, comedones, etc. Natural remedies are more acceptable in the belief that they are suffering from fewer side effects than the synthetic ones. Herbal formulations have a growing demand in the global market. This present research work aims to formulate and evaluate herbal anti acne gel containing ethanolic extract of Neem (Azadirachta Indica) and onion (Allium Cepa). The formulation was evaluated for various parameters like physical appearance, PH, spreadability, extrudability, anti-acne activity assay against S.aureus was successfully studied. Ethanolic extract of Azadirachta Indica Allium cepa on combination show potential effect against acne vulgaris and also exert a synergistic effect on the bacteria.
SKIN:
Skin is the largest organ of the body, making up 16 % of body weight, with a surface area of 1.8m3. There are three structural layers of the skin: the epidermis, the dermis and subcutis. Hair, nails, sebaceous, sweat and apocrine glands are regarded as derivatives of skin. The epidermis the outer layer serving as the physical and chemical barrier between the interior body and exterior environment. The dermis is the deeper layer providing the structural support of the skin, below which is a loose connective tissue layer, the subcutis or hypodermis which is an important of fat. The Ph of the skin varies from 4 to 5.6. Sweat and fatty acids secreted from sebum influence the pH of the skin surface. It is suggested that acidity of the skin helps in preventing the growth of pathogens and other organism. The most topical preparation are meant to be applied to the skin and hence basic knowledge of skin and its physiological function and biochemistry is very important for designing topical formulations.
ANATOMY OF SKIN:
The skin is multilayered organ and anatomically has many histological layers. Skin is an anatomic barrier between the body and its environment and contributes to about 16 to 18 % of normal body weight. The over laying outer layer is called epidermis, the layer below epidermis is called dermis. Beneath the dermis are subcutaneous fatty tissues.
Acne- Acne vulgaris is also known as acne. Acne, from the Greek word “Akme”, means peak or apex, is genetic or acquired affections of the pilosebaceous units. It is a common chronic disease caused by abnormal sebaceous production within skin follicles. Acne is the most common disorder found among youngsters usually 18-25 years of age. Acne vulgaris, which is skin disorder of the pilosebaceous gland which is characterized by formation of seborrhea, comedones, inflammatory lesions and presence of bacteria Propionibacterium acnes, Staphylococcus epidermis and Staphylococcus aureus in the follicular canal and sebum production. It is almost a universal disease occurring in all races affecting 95% of boys and 83% of girls.
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 45 years. Acne vulgaris has a multifactorial pathogenesis, of which the key factors is genetics. Acne develops as a result of an interplay of the following four factors:
Various types of Acne:
-It’s the most common form of acne. Acne vulgaris is a general condition that is characterized by the development of seborrhea, comedones, nodules pustules, papules and cysts.
Acne Symptoms:
Causes of Acne:
Normally, extra oily skin is identified as one of the major factor inducing acne.
SEQUENTS OF EVENTS IN ACNE:
Hormones, environmental factors as well as genetic susceptibility may be the cause for acne. Acne happens when hair follicles becomes clogged with dead skin cells and a sticky substance called sebum is produced by the sebaceous gland. This excess sebum causes skin cells to stick together inside the follicle, causing an obstruction. This leads to comedone. Once bacteria nestle in to the clogged pore or comedone, they release factors that case inflammation. This causes comedones to turn in to the pimples and pustules. Some acne lesion become so inflamed that they rupture, which forms nodules. Due to confluence of affected glands nodules form cysts which may result in to scar formation after healing.
TOPIAL DRUG DELIVERY SYSTEM:
The goal of any drug delivery system is to provide a therapeutic amount of drug to the proper site in the body to promptly achieve and then maintain the desired drug concentrations. The route of administration has a significant impact on the therapeutic outcome of a drug. Skin is one of the most readily accessible organ on human body for topical administration and is main route of topical drug delivery system. Topical delivery can be defined as the application of drug containing formulation to the skin to directly treat cutaneous disorders (eg. Acne) or the cutaneous manifestation of a general disease (eg. Psoriasis) with the intend of containing the pharmacological or other effect of the drug to the surface of the skin or within the skin. Semisolid formulation in all their diversity dominate the system for topical delivery, but foams, spray, medicated powder, solutions as well as medicated adhesive system are also in use.
ADVANTAGES OF TOPICAL DRUG DELIVERY SYSTEM:
GEL:
A gel is a solid or semisolid system of at least two constituents, consisting of condensed mass inclosing and interpenetrated by a liquid. Gels and gellies are composed of small number of solids dispersed in relatively large amount of liquid, yet they possess more solid like than liquid like character. The characteristic of gel and gelly is the presence of some form of cutaneous structure, which provide solid like properties.
TREATMENT OF ACNE:
Treatment of acne depends on its condition and degree of severity which may vary from a mild non-inflammatory comdones to an inflammatory papule or pustules. This usually signifies the presence of propionibacterium acnes. Topical as well as systemic therapy is available for the treatment of acne. While traditional treatment in the inflammatory phase are topical and systemic antibiotics acting as both antimicrobial and anti-inflammatory agents, modern acne therapy has been designed to interrupt the pathogenic pathway at one or more points. The excessive use of antibiotics for long periods has led to the increase resistance in acne causing bacteria i.e staphyloccus epidermis, propionibacterium acne against a number of antibiotics used to treat acne. WHO noted that majority of the worlds population depends on traditional medicine for primary health care.
Neem and Onion is very important component of cosmetics which is used to treat pigmentation, acne and other skin problems.
PLANT PROFILE:
Neem
Synonyms: Nira, Nimb, Vespa, Limba, Nimba.
Biological Source: Neem consist of fresh or dried leaves and seed oil of Azadirachta Indica belonging to family Meliaceae.
Chemical Constituents: Nimbin, 6- desacetylnimbinene, Nimbiene, nimbandiol, nimbolide, quercetin, Ascorbic acid, n-hexaacosanol, amino acid, nimbin and nimbidinin
Geographical Source: It is found in India, Pakistan, shrilanka, Malaya, Indonesia, japan, tropical region of Australia and Africa. In india, it is found in Uttar Pradesh, Maharashtra, tamil Nadu, rajastan and Madhya Pradesh.
Uses
Pharmacological Uses:
Antiulcer, antifertility, antifungal, antiviral, antipyretic.
Synonym: Top Onion, Allium Fistulosum.
Biological Source: Onion (Allium Cepa) , herbaceous biennial plant in the amaryllis family (Amaryllidaceae ) grown for its edible bulk .
Chemical Constituents: Allicin, Alline, Diallyl disulfide.
Geographical Source:
Onion is cultivated in India, South western asia,
Uses:
Pharmacological Uses:
Autoinflammatory, Antiplatelet, Antidiabetic’s Antibiotics.
AIM & OBJECTIVES:
The aim of this study was to formulate an herbal anti-acne gel containing extracts of Neem and Onion.
The objective of the study:
PLAN OF WORK
Phase I
Phase II
FORMULATION AND OPTIMIZATION OF GELLING AGENT
Phase III
EVALUATION OF HERBAL ANTIACNE GEL
MATERIAL & METHOD –
Material:
Ingredients of formulation-
Ingredients of formulation-
METHODS:
Procurement of plant material:
The fresh leaves of Neem ( Azadirachta indica ) were collected from the medicinal plant of S.P.C.O. Pharmacy , Pachegaon .District- Ahmednagar. and the bulb part of Onion ( Allium cepa ) were purchased from the local market of pachegaon.
Weight accurately the quantity of Neem and Onion powder.
i.e. Alcohol and Water in a ratio of 1:1.
Formulation of gel: The gel is prepared by using a 1% concentration of the extracts. In separate beaker, Carbopol 940 was dispersed uniformly in distilled water with continuous stirring, avoiding air entrapment and allowed to soak overnight. In another beaker, methyl paraben was dissolved in the remaining amount of distilled water by gently heating. To this solution, the herbal extract were added and triturate well. The above mixture was then added to the Carbopol mixture and stirred well. Finally, propylene glycol and triethanolamine were added and the pH was adjusted to 6.8-7. The prepared formulation was filled in a suitable container and labeled.
Evaluation of Gel:
Physical appearance such as Colour, Odor, and consistency were checked visually.
Formulation were applied on the skin and then easy and the extent of washing with water was checked manually.
The pH of 1% aqueous solution of the formulation was measured by using a calibrated digital pH meter at a constant temperature.
Spreadability denotes the extent of area to which the gel readily spreads on application to skin or the affected part. Two sets of glass slides of standard dimensions were taken. The gel formulation was placed over one of the slides. The other slides was placed on the top of the gel , such that the gel was sandwiched between the two slides in an area occupied by a distance of 6.0 cm along the slide.100gm weight was placed upon the upper slides so that the gel between the two slides was presses uniformly to form a thin layer. The weight was removed and the excess of gel adhering to the slides was scrapped off. The slides in position were fixed to a stand without slightest disturbance and in such a way that upper slides slip off freely by the force of weight tried to it. A 20gm weight was tried to the upper slide carefully. The time taken for the upper slide to travel the distance of 6.0 cm and separated away from the lower slide under the influence of the weight was noted. The experiment was repeated three times and the mean taken for calculation. Spreadability was calculated by using the following formula,
(M*L)/T
Where,
S= spreadability
M= Weight in the pan (tied to the upper slide)
L= Length of the glass slide
T= Time (in sec) taken to separate the slides.
5. Stability study:
Stability of the gel formulation were studied at different storage condition (8 and 40 degree Celsius) Sample were withdrawn at 7,15 and 30 days checked for their physical characteristics like appearance, Homogeneity, pH, Viscosity and Spreadability.
6. Extrudability:
The gels were incubated at room temperature for 2 hrs before measuring their extrudability using an HDP/FE forward extrusion cell of the TA-XT2 Texture Analyzer equipped with a 5 kg load cell. Prior to measurement, the gel was measured at the following condition: Pre-test speed 1mm/s,test speed 1mm/trigger force 10 g, post-test speed 10 mm/s, compression distance 20mm,and outlet diameter of extrusion cell 3mm.
7. Anti-Acne activity:
The antiacne and antibacterial activities of different formulation were determined by a modified agar well diffusion method. In this method, nutrient agar plates were seeded with 0.2 ml of 24-hour broth culture of S. aureus. the agar plates were allowed to solidify. A sterile 8 mm borer was used to cut wells of equidistance in each of the plates. 0.5 ml of formulations, the herbal gel was introduced into the wells at randomly. The plates were incubated at 37 degrees Celsius for 24 hours. The anti-acne activities were evaluated by measuring the zones of inhibitions (In mm).
RESULTS AND DISCUSSION:
The results of the evaluation are shown in below: the gels were slight yellowish to brownish with a specific odor. All formulations were found homogenous easily washable. All the formulation has slightly alkaline Ph. Amongst all the formulation F3 showed very optimum spreadability. All formulation shows better drug content.
Table no. 3: Evaluation of Gels
CONCLUSION:
Natural remedies are boon to any disease. In the world market, herbal formulations are in great demand. Herbal medicines are believed to be safer than allopathic medicines. All the formulations were optimized based on evaluation parameters such as physical appearance, washability, PH, spreadability, anti-acne activity. After evaluation, this study concludes that formulation.
REFERENCES
Ritu Pandore, Rohan Londhe, Dnyaneshwar Vyavhare, Megha Salve, Formulation and Evaluation of Anti-acne Gel, Int. J. of Pharm. Sci., 2024, Vol 2, Issue 5, 1317-1324. https://doi.org/10.5281/zenodo.11296324
10.5281/zenodo.11296324
