Formulation and Evaluation of Herbal Crack Heel Repair Cream Containing Neem (Azadirachta Indica) and Turmeric (Curcuma Longa) Extract

The skin is the body's largest organ, covering approximately 20 square feet. The skin consists of three layers: the epidermis, which is the outer layer, provides a waterproof barrier and determines our skin color. Cosmetics are utility products widely used around the globe for enhancing and maintaining the overall appearance of the face and other body parts like the skin, eyes, hair, and hands. Herbal cosmetics are those formulations that contain active bio-ingredients, nutraceuticals, and pharmaceuticals. Cosmetics serve to cleanse and enhance the beauty of the skin. The earliest documented use of cosmetics dates back to the Egyptians around 4000 B.C. Pharmaceuticals are primarily classified as drug products designed to prevent, alleviate, treat, or cure diseases, as well as to impact the structure or function of the body. The skin on the soles of your feet tends to be dry, rough, and cracked. Conditions such as athlete's foot, psoriasis, eczema, thyroid disorders, diabetes, and various other skin issues can lead to cracked heels. Keeping your skin healthy is essential for overall body wellness. Natural remedies are affordable and are often considered safe. [1] Although fissures in the skin can appear anywhere on the body, the most typical locations are the edge of the heel and the spaces between the toes, as these areas are used most frequently. Dry skin, also known as xerosis, is one of the primary contributors to cracked heels. Another significant factor is the presence of thickened or calloused skin around the heel's edge. Many foot issues stem from a lack of attention and care when it comes to our feet. Cracked heels, corns, and other common foot conditions can be treated and are largely preventable. Cracked heels themselves are not dangerous unless the cracks become deep, causing pain and sometimes bleeding. This can lead to infections and is particularly concerning for individuals with chronic conditions such as diabetes or a weakened immune system due to aging or illness, which can hinder the recovery of cracked heels [2].

Semisolid dosage forms, including cream formulations, are considered the gold standard for topical drug delivery systems. Cream formulations consist of multiple phase systems that are particularly prone to instability issues [3]. Creams are also utilized to treat cracked heels in diabetic individuals. The effectiveness of creams in addressing fissures on the feet of diabetic patients has been established, as untreated fissures can allow bacteria to enter, leading to infections and more severe complications [4]. Human skin encounters numerous environmental factors throughout our daily lives and is also subjected to various unhygienic elements that can negatively impact skin health. These factors can lead to issues such as dryness, dehydration, wrinkles, fissures, and ultimately, sepsis. Individuals with diabetes are particularly at risk for these symptoms due to nerve damage in their feet [5].

Neem, turmeric and Aloe Vera are often used as main ingredients in herbal cream formulations nowadays due to their amazing healing abilities in addition to serving also to alleviate dryness. On top of this primary function each individual item has some anti-itching, anti-inflammatory or protective effect, providing all kinds of benefits for the skin. Each of these natural ingredients contains specific bioactive compounds that contribute significantly to the repair and maintenance of healthy skin, especially for cracked heels with a rich source of active plant compounds, neem can help prevent and cure infections in cracked skin. It protects against harmful bacteria and fungi which are able to infect the body through open cuts by reducing the risk of sores. Neem has strong anti-inflammatory properties, which soothe irritated skin, reduce swelling and promote healing. In herbal creams for treating cracked heels, neem, turmeric and aloe vera are frequently added in. With their healing, moisturizing, anti-inflammatory and protective properties it is believed that these ingredients can help restore natural oils back into the skin. Each of these natural compounds contains specific bioactive substances that can noticeably repair and maintain healthy skin; this is especially true for cracked heels. Neem is rich in compounds that help to prevent and treat infections that may arise in cracked skin. It counters harmful bacteria and fungi that may infect the skin through open cracks, reducing the risk of infection. It has very strong anti-inflammatory properties, which can reduce the swelling.

The goal of this herbal product for cracked heels is to combine the moisturizing, healing, anti-inflammatory and anti-microbial properties of natural ingredients such as neem, turmeric and aloe vera and thereby effectively treat, heal and prevent cracked skin on heels. The formula not only focuses on the underlying defects that cause the cracked heels but also improves the overall health of the feet by helping to restore the velvety, soft and healthy skin to the feet while receiving discomfort and preventing further damage.

MATERIALS AND METHODS:

Plant Materials:

1) Neem (Azadirachta Indica):

Neem belongs to the Meliaceae family, which includes mahogany. It is primarily grown in the Indian subcontinent. The scientific name for Neem is Azadirachta indica, and it is a rapidly growing evergreen tree commonly found in India, Africa, and the Americas. This tree is indigenous to East India and Burma, thriving in tropical and subtropical climates. Different parts of the Neem tree are renowned for their medicinal benefits and are recommended by practitioners of Ayurvedic, Siddha, and herbal medicine in India. The leaves of Neem possess several properties, including antibacterial, antiparasitic, anti-inflammatory, and antioxidant effects. Throughout history, neem has been widely utilized by people to address various health issues [6].

Figure 1: Azadirachta indica (Plant representation)

Various components of the Neem tree possess a wide range of compounds, including azadirachtin, nimbolinin, nimbin, nimbidin, nimibidol, sodium nimbinate, gedunin, salannin, and quercetin. The leaves of the Neem tree are rich in substances like nimbin, nimbanene, nimbandiol, ascorbic acid, 6-desaacetylnimbinene, nimbolide, n-hexacosanol, and amino acids, as well as 7-desaacetyl-7-benzoylgedunin, 7-desaacetyl-7-benzoylazadiradione, 17-hydroxyazadiradione, and nimbiol [6]. Quercetin and Beta-sitosterol, which are polyphenolic flavonoids, have been isolated from fresh Neem leaves, and they are recognized for their antibacterial and antifungal effects [7]. The isolated chemical components from various parts of the neem tree comprise numerous biologically significant compounds, such as triterpenoids, alkaloids, phenolic compounds, flavonoids, carotenoids, ketones, and steroids. Azadirachtin is the most biologically active compound found in these extracts. This compound is categorized as a C-seco limonoid and is classified as tetranortriterpenes. It possesses significant medicinal properties and is found extensively across the globe. Originally from India, it has become well-established in many tropical and subtropical regions. The recognition of its medicinal uses comes from the various active compounds that can be extracted from all parts of the plant [8]

2) Turmeric (Curcuma longa):

Turmeric is a spice that comes from the rhizomes of Curcuma longa, which belongs to the ginger family (Zingiberaceae). Rhizomes are underground stems that grow horizontally and produce both shoots and roots. The vibrant yellow hue of turmeric is largely due to fat-soluble, polyphenolic pigments referred to as curcuminoids. Curcumin, the main curcuminoid present in turmeric, is typically regarded as its most active component. Other curcuminoids found in turmeric include demethoxycurcumin and bisdemethoxycurcumin. Besides being used as a spice and colorant, turmeric has been utilized for medicinal purposes in India for centuries [9].

Figure 2: Turmeric powder representation

Properties of curcumin: Curcumin possesses properties that are anti-bacterial, antioxidant, anti-inflammatory, antiviral, and antifungal. Curcumin is safe for human consumption .It exerts its anti-inflammatory effects by inhibiting several key molecules involved in inflammation. Extracts of turmeric and the essential oil from Curcuma longa suppress the growth of various bacteria, parasites, and harmful fungi [9]

3) Aloe Vera:

The scientific name for Aloe vera is Aloe barbadensis miller. This plant is part of the Asphodelaceae (formerly Liliaceae) family and is a shrubby or tree-like, perennial, drought-resistant, succulent plant with a pea-green hue. The aloe plant features elongated leaves that can grow up to 20 inches in length and 5 inches in width, which are triangular and have spikes along their edges. The clear gel found in the center of the leaf is often extracted and can either be dried to produce aloe vera concentrate or mixed with water to create aloe juice products. The sticky latex, which is drawn from the yellowish-green pericyclic tubules that line the leaf, is also collected. The flowers of the aloe plant, which are not utilized for medicinal purposes, are yellow in color [10]

Figure 3: Aloe Vera (Plant representation)

The gel or mucilage derived from the leaf's flesh comprises notably different substances compared to the bitter latex sourced from the leaf’s lining. Aloe gel consists of 99% water with a pH level of 4.5 and is commonly found in various over-the-counter skin ointments. This gel includes an emollient polysaccharide known as glucomannan, which serves as an effective moisturizer, explaining its prevalence in numerous cosmetic products. Acemannan, the primary carbohydrate component of the gel, is a water-soluble long-chain mannose polymer that promotes wound healing, influences immune responses (especially macrophage activation and cytokine production), and exhibits both antitumor and antiviral properties. Additionally, the gel features bradykinase, which has anti-inflammatory properties, along with magnesium lactate to help alleviate itching, and salicylic acid [10].

Scientific classification:

Table No. 1: Scientific classification of plants used in the crack heel repair cream

Methodology:

The leaves of Neem (Azadirachta Indica) were collected from our college campus i.e. from Chhatrapati Shivaji Maharaj University in Shedung, while the turmeric powder was obtained from pharmacognosy lab of the college and were authenticated by the herbarium for further process.

Extraction Procedure:

Aqueous Extraction Method:

• For extraction we need fine powder of neem which was prepared by collecting the leaves then drying it in shade for 7 days and grinding it into mechanical grinder then sieve and collect fine powder, store in an appropriate container.
• The extraction of the powdered mixture was conducted by taking 5gm of neem powder and 5gm of turmeric powder in a 250ml of beaker adding 90ml of distilled water, heating on water bath at 60°C for 3hrs until the quantity of water is reduced to less than half and then filtering off the water using Whattman Filter paper to get the final extract.

Phytochemical tests for identification of extract:

After the preparation of the plant extract some phytochemical tests were carried out for confirming the presence of Alkaloids, Flavanoids and Triterpenoids.

Test for Alkaloids:

Wagner’s test: This test involved adding of 3 drops of Wagner’s Reagent in 1ml of prepared extract. The formation of reddish brown colour confirms the presence of Alkaloids [11] [12].

Test for Flavanoids: We have performed two chemical tests for identification of                         Flavanoids which are as follows:

Alkaline reagent test: This test is carried out by adding 2 to 3 drops of sodium hydroxide to 2ml of extract in which initially a deep yellow colour appeared but gradually became colorless by adding a few drops of dilute HCL, indicating the presence of Flavanoids [13] [14]

Hydrochloric acid test: In this test few drops of conc. HCL is added in the extract resulting in red colour indicating the presence of Flavanoids.

Test for Triterpenoid:

Salkowski test: This test for identification of the presence of Triterpenoid was conducted by adding 1ml of chloroform in 2ml of the extract and few drops of conc. Sulphuric acid to the side of the test tube, shaked the test tube well yellow colour appeared at the lower layer which effectively indicates the presence of Triterpenoids [13] [14].

Figure 4: Phytochemical tests results of the plant extract samples

Formulation of herbal crack heel repair cream:

Table No.02: Composition of formulation of crack heel repair cream

Procedure for preparation of herbal crack heel repair cream:

Step-1: Preparation of Oil phase: The oil phase ingredients such as Bees wax, Glycerin, Tea tree oil, Coconut oil and Vitamin E oil were weighed accurately and heated in 250ml borosilicate beaker on a heating mantle at a temperature of 70°C to form a uniform liquid.

Step-2: Preparation of water phase: The water phase ingredients such as Stearic acid, Methyl paraben, Aloevera gel, prepared plant extract and Distilled water were weighed accurately and heated with continuous stirring in the 250ml borosilicate beaker on heating mantle at a temperature of 70°C to form a uniform liquid.

Step-3: The content of oil phase was mixed in the water phase with continuous stirring till the uniform dispersion is achieved. Three different formulations were prepared and allowed to equilibrate for 24 hours at room temperature. The prepared cream was filled and stored in an airtight glass container.

Figure 5: Preparation of crack heel repair cream

Evaluation Parameter:

Organoleptic Evaluation: All the 3 batches of the formulated crack cream were evaluated for its organoleptic properties i.e. color, odor, appearance, texture and other sensory characteristics. The external characteristics of the formulations were examined thoroughly [15].

Determination of pH: The pH value of the formulation was determined by the means of a glass electrode, reference electrode and a digital pH meter. Initially the apparatus was calibrated using a buffer solution of pH values 4, 7, 9  and 1gm of cream was dissolved in 10ml of demineralized water, then the electrodes were immersed in the solution and the pH was measured [16].

Spreadability: The spreadability of the formulations was assessed by applying 0.25 g of cream formulation on a glass slide, which was then covered with a second glass slide. A weight of 100 g was placed on the top glass slide for 5 minutes. Spreadability pertains to the area that a consistent amount of cold cream sample covers after it has been uniformly spread on the glass slide. The diameter of the cream spread on the slide was measured.

The formula for spreadability (S) is given by

S = M*L/T

Where,

M represents the weight (g) suspended from the upper glass slide,

L is the distance (cm) moved across the glass slide,

T denotes the time taken (sec). [17]

Irritancy: The cream was applied to the specified area on the left hand dorsal surface. After the application the time was noted and the specific area was monitored for any signs of irritation, erythema, or edema for up to 24 hours [18].

Stability: The physical stability of the prepared cream was assessed over a four weeks period at different temperature conditions of 20°C, 25°C and 37°C [19].

Washability: A small amount of cream was applied to the skin surface and washed under running tap water to assess its washability parameter [15].

Homogenecity: Homogenecity of the cream formulations was evaluated by applying 1gm of the cream sample onto a transparent glass slide and placing another glass slide over it. The cream should be evenly spread without any unmixed particles or lumps present [20].

Phase separation: The prepared cream was stored in a sealed container at temperatures ranging from 25-100°C, shielded from sunlight. Phase separation was noted every 24 hours for duration of one month. None of the formulations displayed any phase separation [18].

Test for microbial growth: To test the microbial growth of the cream streak plate method was employed, wherein the prepared creams were introduced onto a plate containing agar media and a control was created by excluding the cream. The plates were placed in an incubator and left to incubate for 24 hours at 37°C. After the incubation period the plates were removed and examined for the microbial growth by comparing it with control. The aim was to determine if the product exhibited results of not exceeding 100 microbial counts, indicating preliminary evidence of its antimicrobial properties [21].

OBSERVATION AND RESULT:

Table No. 03: Test results of the plant extract samples

CHEMICAL TESTS	AQUEOUS EXTRACT	RESULT
Alkaloid Test	PASS
Flavonoid Test (1)	PASS
flavonoid Test (2)	PASS
Terpenoids Test	PASS

Table No. 04: Observation of organoleptic evaluation parameter of herbal crack cream formulations

Table No. 05: Observation of evaluation parameter of herbal crack cream formulations