Formulation And Evaluation Of The Effectiveness Of A Herbal Cleanser

Introduction to Cosmetics

According to Section 3 of the Drugs and Cosmetics Act, 1940, and the rules made thereun-der, a cosmetic is any product which has been manufactured for the purpose of being applied to the body or a part of the body of a human being and is intended for the purpose of being used to: to cleanse, to beautify, to enhance attractiveness, or to otherwise change the appear-ance of the human being. Examples of cosmetic products include creams; lotions; powders; perfumes; lipsticks; nail polishes; eye and facial makeup; hair products (including gels and sprays); deodorants; and cleaning products. [1].

In the past, cosmetics were typically applied simply for the purpose of improving a person’s appearance; however, now many new cosmetic brands and products are being created that have active (therapeutic) ingredients along with the aesthetic benefit of beautifying the skin. Many formulations were designed to enhance, protect, nourish, or heal the skin and allow for both aesthetic and dermatologic improvement. Guidelines and definitions for the Cosmetic Indus-try are different from Pharmaceuticals in that Cosmetics do not affect the physical structure or function of the body or its function. As consumers become more knowledgeable about health and environmentally- friendly products, there has been a large increase in the amount of research being conducted into herbal and botanical- based formulas. [18].

Cosmetics manufactured from natural materials (plant and mineral based) sourced from plants, herbs and minerals are known as herbal cosmetic. Such products do not contain any harmful chemicals and can improve your appearance and benefit both your skin and hair. According to the Indian Standards (IS), cosmetic products (herbal or otherwise) have to contain all the ingre-dients required to achieve a certain benefit (i.e., they must be formulated using appropriate and legal ingredients).

Introduction to Cleansers

Cleansers are topical products designed to eliminate impurities, excess oils, makeup, pollutants, dead skin cells, and microorganisms from the surface of the skin. Cleansers are the fundamental first step in every skincare routine and play a vital role in maintaining the skin’s hygiene, health and appearance.e [21]. Cleansers are typically formulated as emulsions, gels, foams, balms, or liquids and may include surfactants, emollients, humectants, and active ingredients based on the target skin concern.

Purpose of a cleanser:

1. Remove dust, dirt, and environmental pollutants
2. Eliminate excess oil (sebum)
3. Wash away makeup and sunscreen residues
4. Prevent acne and clogged pores
5. Prepare the skin for other skincare products (toner, moisturiser)

Types of cleansers include: foaming cleansers (ideal for oily/acne-prone skin), cream cleansers (for dry or sensitive skin), gel cleansers (for oily or combination skin), micellar water (no-rinse, all skin types), oil-based cleansers (dissolve makeup and sebum), and herbal/natural cleansers (plant-based gentle cleansing) [22].

A good cleanser will help keep your skin’s moisture barrier intact while also keeping it at the proper pH balance (between 4.5 and 6.5) for preservation of the skin microbiome. Because of increased awareness concerning both ,more focus has been placed on creating less aggressive cleaning ingredients (e.g., fewer or no surfactants) or on switching to milder, more natural ingredients (i.e.,herbs) to clean the skin. Herbal cleansers provide all three (i.e., antimicrobial, anti-inflammatory, and/or antioxidant) benefits without using chemical cleaning agents (e.g., surfactants). [7, 8].

Physiology of Skin

Your skin is the largest organ of your body; it covers your external body and provides your primary physical defence against the elements around you. Your skin regulates your body temperature, protects you from the sun, protects you from injuries/traumas, protects against in-vaders (bacteria, viruses, etc.), protects against toxins, provides immune surveillance, provides sensory perception, and contributes to your body having homeostasis (an overall equilibrium between your body and your environment). In the average adult, the total surface area of your skin is 1.5 – 2.0 m². In one square inch of skin, there are approximately 650 sweat glands, approximately 20 blood vessels, approximately 60,000 melanocytes, and approximately 1,000 nerve receptors.

Your skin consists of three main layers:

1. Epidermis

The epidermis is a stratified squamous epithelial layer. The primary cell types in the epidermis include keratinocytes; melanocytes, which manufacture melanin; Langerhans cells, which help provide a defense against infections; and Merkel cells, which are tactile/pressure receptors. The epidermis is divided into five layers (or strata), enumerated from the outermost to the innermost: stratum corneum, stratum lucidum (Palm and sole), stratum granulosum, stratum spinosum, and stratum basale (or stratum germativum). As a whole, the functions of the epidermis are primarily: skin barrier, water barrier and regeneration (approximately every 28 days).

2. Dermis

Beneath the epidermal layer, is the dermal layer containing collagen and elastic fibres, blood vessels, nerves, sweat glands, sebaceous glands and hair follicles. The dermis allows the ex-change of nutrients, is responsible for sensation, and serves a role in temperature regulation. The dermis consists of two regions: a superficial papillary region and a deeper reticular region.

3. Hypodermis (Subcutaneous Tissue)

The hypodermis consists of a mixture of fat and connective tissue. It provides insulation, energy storage (as fat), and cushioning to absorb bumps or impacts. The hypodermis serves as a physical and vascular (blood and nerve) connection of the skin to the underlying bony or muscular structures (through an attachment called an adhesion). In fact, about 50% of total body fat is found in the hypodermis.

Topical Drug Delivery System

Topically applied drug formulations provide a means of delivering medications to the skin to achieve local and/or systemic effects. The design of topical pharmacological delivery systems limits the pharmacological action to the skin or extends the pharmacological action systemi-cally (through the skin) into the body by entering the body’s circulation. Most topical formula-tions are semi-solid in consistency, and primarily include gels, creams, ointments, and lotions, with the majority of topical drugs found in one of these semi-solid forms.

Advantages: Prevention of first-pass metabolism; ability to stop therapy fast; large application area; targeted delivery; improved patient compliance; suitable for drugs with short biological half-life.

Disadvantages:Possible development of contact dermatitis or irritation; Some molecules have a poor ability to cross; Possibility of developing an allergy; Restricted to low plasma concen-tration drugs; Epidermal enzymes can break down the active molecule.

Historical Background of Herbal Cosmetics

For as long as humankind has existed, herbs and other plants were used for their beauty and health. Therefore, the history of humanity is directly linked to that of herbs. India was most likely the first culture to document the use of herbs for cosmetic remedies—more than 4,000 years ago. Ancient texts dating back thousands of years also document the usage of various forms of cosmetics, including tilak, kajal and alita; they are found in the Abhijnana Shakuntala and Meghadootam by Kalidasa, among other pieces of ancient literature. [2]. Today, with the recognition of the safer and holistic approach offered by herbal products, interest has again surged worldwide.

Significance of the Present Work

Typically, commercial cleaning agents contain a wide variety of chemical additives including harsh surfactants (soap), parabens, synthetic fragrances, and other potentially irritating sub-stances. These types of products can cause some short and long -term negative effects on the skin such as irritation, dryness, allergies and other possible dermal issues. Currently there is no established scientifically validated polyherbal cleaning agent that provides the same level of effectiveness and preference from consumers as traditional commercial cleaning products. In this report we present developing and testing a new polyherbal cleaner formulated from the use of three traditional Indian medicinal plants; Hibiscus rosa-sinensis, Glycyrrhiza glabra, and Trigonella foenum-graecum. [6].

REVIEW OF LITERATURE

1. Kumar et al. (2016) Herbal cosmetics have proven to be more popular than synthetic cos-metics. They are perceived to be effective, are routinely used, and do not expose the body to toxic chemical compounds found in most synthetic products. [1].
2. Korac´ and Khambholja (2011) Presented the Herbs have shown promise when it comes to how they could protect our skin from the UV light produced by the sun and aid in the resolution of various skin disorders. They mentioned that aloe vera helps improve skin health and encourages the generation of new skin cells; accordingly, functional applica-tions of traditional herbal practices used to enhance beauty are increasingly seen in modern cosmetics. [2].
3. Srinivasan (2005) studied Fenugreek seeds have received recognition as a natural element to be included as a regular part of your diet because of the numerous benefitss they provide. Fenugreek seed contains many highly fibrous and bioactive ingredients therefore, they are considered safe for the general public at large. [3].
4. Ali, Al Wabel, and Blunden (2005) studied Hibiscus sabdariffa has phytochemical, phar-macological, and poison potential. The calyx is also high in nutritional content with ascorbic acid (Vitamin C) found in it. Extracts from the calyx have exhibited properties of being an-tihypertensive, antipyretic, and anticholesterolemic. The toxicity of the various extracts of this plant appears to be relatively low. [4].
5. Cornara et al. (2018) reviewed Several phytochemicals from Glycyrrhiza glabra (licorice) have been evaluated in the literature including glycyrrhizin, 18-glycyrrhetinic acid, and isoflavones, demonstrating different biological activity. The evaluation concluded with the use of licorice for potential applications in cosmetic and pharmaceutical product develop-ment [5].
6. Sharma et al. (2018) reported that There has been a resurgence in interest regarding herbal formulations due to an increasing consciousness about the negative by-products from using synthetic cosmetic products. For example, Azadirachta indica has proven to be a successful agent in treating acne and other skin related infections, due mainly to its cervicial and anti-inflammatory qualities [6].
7. Surjushe et al. (2008) reported that aloe-vera is known for its soothing and moisturising effects and is commonly included in herbal cleansers for its hydrating properties and ability to promote skin healing [7].
8. Singh et al. (2012) reported that Ocimum sanctum (Tulsi) has strong antimicrobial and antioxidant activity, helping protect the skin from oxidative stress and microbial invasion [8].
9. Chainani-Wu (2003) documented that Curcuma longa (Turmeric) contains curcumin, a bioactive compound with powerful anti-inflammatory and antimicrobial properties, making it beneficial in skin protection and rejuvenation [9].
10. Patil et al. (2020) demonstrated that polyherbal face cleanser formulated with neem, tulsi, and aloe vera showed significant cleansing efficiency and antimicrobial activity against Staphylococcus aureus and Pseudomonas aeruginosa [10].
11.  Mali et al. (2010) highlighted the use of herbal formulations in skincare because of their lower side effects and better skin compatibility compared to synthetic products [11].
12.  Kaur and Kaur (2013) reviewed the antimicrobial and antioxidant properties of Hibiscus rosa-sinensis, widely used in cosmetics for its cleansing and astringent properties [12].
13.  Parveen et al. (2015) explained that fenugreek seeds (Trigonella foenum-graecum) contain natural saponins and mucilage that help cleanse and soften the skin [13].
14.  Sagar and Kumar (2014) described the role of xanthan gum as a stabiliser and thickener in cosmetic gels, increasing user acceptance and product stability [14].
15.  Barel et al. (2014) discussed essential role of preservatives such as parabens in preventing microbial contamination in cosmetic products [15].
16.  Sharma et al. (2011) discussed the role of rose water as a mild astringent with cooling, soothing, and anti-inflammatory effect for skin care [16].
17.  Shinde et al. (2013) stated that glycerine is a common hydrator used in cleansers for main-taining skin hydration and softness [17].
18.  Dhiman et al. (2012) described the consumer trend shifting toward natural herbal products due to their safety,eco-friendliness, and effectiveness [18].
19.  Bhatt and Sharma (2015) reviewed formulation techniques of herbal gels, highlighting their ease of application and non-greasy texture [19].
20.  Chaudhary et al. (2016) evaluated different herbs in cosmetics and found that herbal face washes effectively remove dirt and excess oil while being gentle on the skin [20].

AIM AND OBJECTIVES

Aim:

To formulate and evaluate the effectiveness of a herbal cleanser containing Hibiscus rosa-sinensis, Glycyrrhiza glabra (Liquorice), and Trigonella foenum-graecum (Fenugreek) for im-proving overall skin appearance.

Objectives:

1. To clean the face, remove makeup, dead skin cells, oil, dirt, and other environmental pollutants.
2. To help clear pores and stop skin issues like acne.
3. To create a unique skin-lightening and brightening formula.
4. To attract and absorb dirt, we use natural saponins and mucilage found in herbal extracts.
5. To protect skin against inflammation using herbal bioactives.
6. To evaluate the safety and tolerability of the herbal cleanser in healthy volunteers.

PLANT PROFILE

Fenugreek (Trigonella foenum-graecum) Synonyms: Methi, Green clover, Methika, Chandrika

Biological Source: Dried ripe seeds of Trigonella foenum-graecum Linn.

Family: Leguminosae

Macroscopic Characteristics: Colour: light to dark yellow/brown; Odour: characteristic; Taste: mucilaginous and slightly bitter; Size: 5–8 mm long, 1–2 mm thick; Shape: rhomboidal, smooth.

Chemical Constituents: Saponin glycosides (diosgenin, trigogenin, yamogenin, gitogenin); coumarin derivatives (trigocoumarin, trigoforin); alkaloids (trigonelline); choline; proteins; flavonoids (quercetin, luteolin).

Pharmacological Benefits for Skin:

• Reduces blemishes and dark circles: Fenugreek contains vitamins K and C that reduce dark spots and blemishes.
• Anti-aging properties: Flavonoids neutralise free radicals that cause wrinkles and dark spots; help firm and tighten skin.
• Anti-acne: Enriched with antibacterial properties.
• Cleansing: Removes excess oils and dirt from skin via natural saponins.
• Exfoliation: Excellent exfoliating property.
• Moisturisation: Nourishes and moisturises skin by removing dryness [3, 13].

Hibiscus (Hibiscus rosa-sinensis) Synonyms: China rose, resella, cotton rose

Biological Source: Flowers of Hibiscus rosa-sinensis Linn.

Family: Malvaceae

Macroscopic Characteristics: Colour: red to pink, lavender, white, or combinations; Odour: sweet, tropical, floral; Taste: sweet; Size: 4–18 cm broad; Shape: trumpet-shaped.

Chemical Constituents: Tannins, anthraquinones, quinones, phenols, flavonoids, alkaloids, terpenoids, saponins, cardiac glycosides, proteins, free amino acids, carbohydrates, reducing sugars, mucilage, essential oils, and steroids. Additionally contains anthocyanins, malic acid, alpha-hydroxy acids, citric acid, and Vitamin C.

Pharmacological Benefits for Skin:

• Anti-aging: Anthocyanins promote elastin production and cell turnover; protects against UVB-induced photoaging.
• Improves uneven skin tone: Malic acid, alpha-hydroxy acids, and citric acid control melanin production and even skin tone.
• Hydrates skin: Powerful hydrating properties; improves skin texture.
• Cleanses skin pores: Saponins cleanse skin naturally; organic acids aid elimination of dead skin cells.
• Tightens open pores: Astringent properties control sebum production; Vitamin C pro-motes collagen production.
• Prevents acne: Acids act as chemical exfoliators and clear clogged pores; antibacterial activity fights acne-causing bacteria.
• Moisturises skin: Mucilage acts as a moisturiser and locks moisture in skin tissue [4, 12].

Liquorice (Glycyrrhiza glabra)

Synonyms: Jethi madh, Mulethi, Glycyrrhiza

Biological Source: Peeled and unpeeled roots, stolons, and stems of Glycyrrhiza glabra Linn.

Family: Leguminosae

Macroscopic Characteristics: Colour: externally yellowish-brown or dark brown, internally yellow; Odour: faint and characteristic; Taste: sweet; Size: 10–50 cm length, 2 cm diameter; Shape: straight, nearly cylindrical.

Microscopic Characteristics: T.S. reveals yellow-brown cork layers and phelloderm 1–3 cells thick; phloem exhibits groups of phloem fibres surrounded by crystal cells with thick, incom-pletely lignified walls; xylem fibres surrounded by crystal cells and xylem parenchyma cells; parenchyma cells contain starch grains and calcium oxalate crystals.

Chemical Constituents: Glycyrrhizin (6–8%, 50 times sweeter than sucrose); liquiritin and isoliquiritin (responsible for yellow colour); glucose, sucrose, asparagine, gum, protein, fats, resins, tannin traces; glabridin; glycyrrhetinic acid.

Pharmacological Benefits for Skin:

• Brightens skin: Inhibits melanin synthesis and reduces hyperpigmentation.
• Treats sun damage: Reduces dark spots, fine lines; UV-blocking enzymes prevent pre-mature ageing.
• Fades dark spots: Prevents melanin synthesis; effectively fades acne scars.
• Soothes skin conditions: Anti-inflammatory properties reduce eczema and psoriasis symp-toms.
• Calms inflammation: Glycyrrhizin reduces redness and swelling; acts similarly to hydro-cortisone.
• Heals acne: Regulates sebum production; reduces redness from acne and rosacea.
• Reduces wrinkles: Rich in antioxidants; fights free radicals and environmental dam-age [4, 5].

MATERIALS AND METHODS

Materials

Plant Materials: Hibiscus rosa-sinensis flowers, Glycyrrhiza glabra root powder (Liquorice/Mulethi), and Trigonella foenum-graecum seeds (Fenugreek/Methi) were procured from a local herbal supplier and authenticated at the Department of Pharmacognosy, KSS College of Pharmacy, Shikrapur, Pune.

Excipients: Glycerine (pharmaceutical grade), xanthan gum (food grade), methylparaben (an-alytical reagent grade), rose water, and distilled water were procured from authorised chemical suppliers.

Apparatus: Beakers, stirrer, petri dishes, porcelain dish, spatula.

Instruments:

• Mechanical Stirrer (Remi, India RQG-126/D [10-5])
• Digital Weighing Balance (Thoenix GOLD-300P)
• Digital pH Meter (calibrated with standard buffers at pH 4, 7, and 9)

Excipient Profile

Glycerine

Synonyms: Croderol; E422; glycerine; Glycon G-100; 1,2,3-propanetriol

Chemical Name: Propane-1,2,3-triol [CAS: 56-81-5]

Molecular Formula: C₃H₈O₃   Molecular Weight: 92.09

Description: Glycerine is a clear, colourless, odourless, viscous, hygroscopic liquid with a sweet taste (approximately 0.6 times as sweet as sucrose).

Stability: Glycerine is stable and not prone to atmospheric oxidation under ordinary storage conditions. Mixtures with water, ethanol, and propylene glycol are chemically stable. It should be stored in an airtight container in a cool, dry place.

Role in Formulation: Glycerine acts as a humectant, retaining moisture and increasing skin hydration. It is also an emollient, softening the skin. It additionally exhibits antimicrobial properties and enhances spreadability and texture of the formulation [17].

Xanthan Gum

Synonyms: Corn sugar gum; E415; Keltrol; Merezan; polysaccharide B-1459; Rhodigel

Chemical Name: Xanthan gum [CAS: 11138-66-2]

Molecular Weight: Approximately 2 × 10⁶

Description: Xanthan gum is a cream or white-coloured, odourless, free-flowing, fine pow-der. It is a high-molecular-weight polysaccharide gum containing D-glucose and D-mannose

as dominant hexose units along with D-glucuronic acid, prepared as sodium, potassium, or calcium salt.

Stability: Xanthan gum solutions are stable over a wide pH range (3–12) and temperatures between 10–60^◦C. Solutions are also stable in the presence of enzymes, salts, acids, and bases. Bulk material should be stored in a well-closed container in a cool, dry place.

Role in Formulation: Used as a thickening and stabilising agent to achieve the desired viscosity and gel consistency [14].

Preparation of Herbal Extracts

Five grams each of Hibiscus rosa-sinensis flower powder, Glycyrrhiza glabra root powder, and Trigonella foenum-graecum seed powder were separately weighed. Each powder was added to a beaker containing 10 mL of distilled water. The mixtures were boiled for 20–30 minutes, then transferred to petri dishes and dried for 24 hours. The dried extracts were collected by scraping with a spatula and stored in airtight containers until use.

Plan of Work

Phase 1: Market survey and research regarding cleansers; literature review of herbal ingredi-ents beneficial for skin; collection of Hibiscus flowers, Liquorice powder, and Fenugreek seeds; extraction of active constituents.

Phase 2: Evaluation of herbal extracts; physical characterisation of extracts.

Phase 3: Formulation and development of herbal cleanser by trial-and-error method.

Phase 4: Evaluation of herbal cleanser — physical appearance, pH, viscosity, and spreadability.

Formulation Composition

The optimised formulation composition is presented in Table 1.

Table 1: Optimised Formulation Composition of the Polyherbal Cleanser

Developmental Trials

Three trials were conducted to optimise the xanthan gum concentration and achieve the desired consistency:

• Trial 1: Formulation was excessively viscous (unpourable) and slightly gritty. Quantity of xanthan gum was too high.
• Trial 2: Formulation was too watery and ran off the skin. The amount of xanthan gum was insufficient.
• Trial 3 (Selected): Xanthan gum concentration of 0.3125 g/100 mL yielded appropriate viscosity, smooth appearance, and good spreadability. This trial was adopted as the final formulation.

Formulation Procedure

The preparation of the herbal gel followed a precise and systematic process to ensure consis-tency, stability, and effectiveness:

1. Preparation of herbal extract solution: 0.2 mg each of hibiscus, liquorice, and fenu-greek extracts were dissolved in 10 mL of rose water. Rose water acts as a natural solvent and provides additional soothing, anti-redness, and fragrance-enhancing properties.
2. Preparation of xanthan gum gel base: 0.3125 g of xanthan gum was slowly added to warm distilled water under continuous stirring to avoid clumping and to form a smooth, uniform gel base.
3. Addition of glycerine: 7.5 mL of glycerine was added to the xanthan gum preparation to improve hydrating properties, texture, and spreadability.
4. Mixing to form a homogeneous gel: The mixture was stirred thoroughly until a viscous, homogeneous liquid was obtained, ensuring uniform distribution of all ingredients.
5. Incorporation of herbal extract solution: 2 mL of each herbal extract solution was added gradually to the gel base with continuous stirring to maintain consistency.
6. Preservative addition: 0.5 mg of methylparaben was added to prevent microbial growth and prolong shelf life.
7. Volume adjustment: Distilled water was added to make the final volume to 100 mL, ensuring accurate concentration of each ingredient.

EVALUATION PARAMETERS AND RESULTS

Physical Appearance

The prepared herbal cleanser was evaluated for appearance, colour, homogeneity, and texture by visual and tactile assessment. Results are presented in Table 2.

Table 2: Physical Appearance of Formulated Herbal Cleanser