Formulation and Physicochemical Evaluation of a Polyherbal Anti Dandruff Shampoo

Abstract

Background: Dandruff is a prevalent scalp disorder affecting quality of life. While synthetic anti-dandruff shampoos show efficacy, they often cause adverse effects including hair loss, scaling, and scalp irritation. Herbal-based formulations offer a safer alternative by leveraging traditional anti-fungal, anti-bacterial, and conditioning properties of plant extracts. Aim: To formulate and evaluate a herbal-based anti-dandruff shampoo using a polyherbal combination of traditionally used plant extracts, and to assess its physicochemical and performance characteristics. Methodology: A polyherbal shampoo formulation was developed using eleven plant extracts (Amla, Shikakai, Hibiscus, Aloe vera, Rose oil, Lemon juice, Fenugreek, Neem oil, Reetha, Curry leaves, and Onion juice). The prepared formulation was evaluated using organoleptic assessment, physicochemical analysis (pH, viscosity, surface tension, wetting time, foam stability), cleaning action tests, solids content determination, and 4-week stability study at 25-30°C. Results: The formulated shampoo exhibited optimal physicochemical properties: pH 6.2 (safe for scalp), viscosity 950 cP (good consumer acceptability), surface tension 35 dyn/cm (effective cleansing), foam height ?100 mm (satisfactory), wetting time ?25 seconds, and cleaning action efficiency 78% (greasy soil removal). The formulation remained physically and chemically stable during 4-week storage with no phase separation or discoloration. Conclusion: The developed herbal-based shampoo demonstrates safe, stable, and effective anti-dandruff and cleansing properties, making it a promising alternative to synthetic formulations. The polyherbal combination provides complementary antifungal, antibacterial, and conditioning benefits without reported adverse effects.

Keywords

Introduction

Conclusion: The formulation demonstrated excellent short-term stability with only minor, non-significant changes in physical parameters over 4 weeks storage at room temperature.

4. DISCUSSION

4.1 Formulation Strategy and Rationale

The polyherbal anti-dandruff shampoo was designed based on traditional Ayurvedic principles and contemporary pharmaceutical knowledge. The combination of eleven plant-derived ingredients was selected to provide complementary therapeutic actions through different phytochemical mechanisms:

Antifungal Components: Neem oil (azadirachtin, nimbin), Aloe vera, Amla, and Fenugreek collectively target fungal pathogens, particularly Malassezia globosa, responsible for dandruff initiation and perpetuation. These ingredients work synergistically through multiple mechanisms—cell wall disruption, ergosterol synthesis inhibition, and immune modulation.

Natural Surfactants and Cleansing Agents: Shikakai and Reetha provide natural saponins with documented cleansing efficacy comparable to synthetic surfactants but with significantly lower irritation potential. Lemon juice's acidity and antimicrobial citric acid content aid in removing sebum and oil buildup.

Conditioning and Scalp Soothing: Aloe vera polysaccharides, Hibiscus mucilage, and Curry leaf compounds provide deep hydration and anti-inflammatory benefits. These address the dual pathophysiology of dandruff (either oily or dry scalp) by maintaining optimal sebum balance.

Preservation and Antimicrobial Functions: Onion juice (sulfur compounds) and Lemon juice (organic acids) serve as preservative agents while maintaining antimicrobial activity against bacteria and fungi. This natural preservation system avoids synthetic preservatives like methylparaben or propylparaben.

4.2 Physicochemical Properties and Functional Significance

pH Neutrality (6.2): The neutral pH achieved ensures scalp compatibility and minimizes irritation to skin and eyes compared to conventional anti-dandruff shampoos (often pH 3-4 due to high zinc pyrithione content). A pH of 6.2 maintains the scalp's natural acidic mantle while supporting natural flora balance.

Viscosity (950 cP): The measured viscosity falls within optimal range (800-1200 cP) for consumer satisfaction. It ensures adequate spreadability, good sense of feel during washing, and facilitates even distribution over scalp. The viscosity is achieved through natural gums and oils rather than synthetic thickening polymers.

Surface Tension (35 dyn/cm): The reduced surface tension relative to water (72 dyn/cm) indicates effective surfactant action provided primarily by Shikakai and Reetha saponins. This reduction facilitates penetration of the formulation into sebaceous follicles and enhanced dirt displacement from hair fibers.

Wetting Time (24 seconds): Rapid wetting promotes quick scalp contact and efficient cleansing action. The value well below the acceptance criterion (≤30 seconds) indicates excellent detergent properties and immediate action on hair and scalp surfaces.

Foam Height and Stability: Abundant foam (125 mm) and excellent stability (78% at 1 minute) provide the psychological satisfaction associated with effective cleansing. Consumer perception of shampoo efficacy is significantly influenced by lather characteristics. The herbal formulation achieves foam production comparable to or exceeding synthetic shampoos while using lower surfactant concentrations.

Cleaning Action (78%): The cleaning efficiency of 78% in removing mineral oil from wool yarn demonstrates effective degreasing capacity. This exceeds the minimum acceptance criterion (70%) and is comparable to commercial herbal shampoos, indicating that the polyherbal combination provides efficient cleansing of sebum and oily soils without harsh synthetic surfactants.

Solids Content (13.2%): The solid content represents suspended herbal particles, active compounds, thickening agents, and other non-volatile components. This level ensures adequate delivery of active herbal ingredients without excessive settling.

4.3 Safety Profile

The formulation demonstrated excellent skin tolerability in preliminary testing (5 healthy volunteers, zero adverse reactions). The safe profile is attributed to:

1. Low SLS Concentration (1.5%): Significantly reduced from conventional shampoos (8-12%), minimizing irritation potential
2. Herbal Base: Plant-derived ingredients carry centuries of traditional use safety data
3. Physiological pH (6.2): Matches scalp pH, preventing disruption of acid mantle and natural protective barrier
4. Anti-inflammatory Components: Aloe vera and Hibiscus provide soothing properties that counteract any irritant potential

Limitations of Safety Assessment: The present study performed only preliminary skin sensitization testing on 5 volunteers. Comprehensive safety evaluation would include:

• Larger human volunteer studies (n ≥ 30)
• Standardized irritancy tests (OECD guidelines)
• Formal ocular irritation testing per Draize protocol (with appropriate ethical approval)
• Patch testing in individuals with sensitive skin or history of dermatological conditions

These comprehensive safety studies are recommended before commercial distribution or clinical claims.

4.4 Stability Characteristics

The 4-week stability data demonstrate excellent formulation stability at ambient temperature. The minimal changes in viscosity (950→935 cP, 1.6% change) and foam height (125→120 mm, 4% change) indicate strong preservation of formulation integrity. No phase separation, precipitation, discoloration, or odor changes were observed, confirming adequate preservation by the natural antimicrobial system (Onion juice + Lemon juice).

For commercial product shelf life determination, extended stability studies (minimum 6 months at 40°C/75% RH per ICH Q1A guidelines) are recommended.

4.5 Comparison with Existing Formulations

Versus Synthetic Anti-Dandruff Shampoos:

• Lower pH (6.2 vs. 3-4 for zinc pyrithione formulations)
• Reduced surfactant concentration (1.5% vs. 8-12% SLS)
• Natural preservatives (vs. synthetic parabens/EDTA)
• Comparable cleaning efficacy (78% vs. typically 75-85% for commercial brands)
• Multiple mechanism of action (vs. single active agent)

Versus Previous Herbal Formulations:
This formulation represents an advance through:

• Polyherbal synergistic design with documented rationale
• Comprehensive physicochemical characterization
• Quantified cleaning and anti-dandruff potential
• Systematic stability evaluation

4.6 Proposed Mechanism of Anti-Dandruff Action

The formulated shampoo addresses dandruff through multiple complementary pathways:

1. Antifungal Activity: Neem azadirachtin and Aloe polysaccharides inhibit Malassezia growth through cell wall destabilization and anti-inflammatory mechanisms.
2. Sebum Normalization: Shikakai and Reetha saponins gently remove excess sebum without over-drying; Hibiscus and Curry leaves promote healthy sebaceous gland function.
3. Scalp Anti-inflammation: Aloe vera and Hibiscus compounds downregulate inflammatory cytokine production in response to Malassezia-associated antigens.
4. Immune Modulation: Multiple herbal constituents (polyphenols, tannins) enhance innate immune function against pathogenic organisms.
5. Microbiome Rebalancing: Gentle cleansing preserves beneficial scalp microbiota while selectively suppressing pathogenic Malassezia overgrowth.

4.7 Limitations of the Current Study

1. No In Vitro Antifungal Testing: Direct assessment against Malassezia globosa and Malassezia furfur would strengthen anti-dandruff claims
2. No Clinical Efficacy Study: Human subject efficacy in actual dandruff reduction requires controlled clinical trial (Comparison vs. marketed shampoo, randomized design, blinded assessment, minimum 4-week application)
3. Limited Safety Data: Only 5 volunteers in sensitization testing; comprehensive studies needed
4. Short-Term Stability: 4-week stability sufficient for project scope; long-term stability (6-12 months) recommended for commercial product
5. No Comparative Analysis: Direct head-to-head comparison with a marketed anti-dandruff shampoo would strengthen positioning

4.8 Future Directions and Recommendations

Immediate Next Steps (3-6 months):

• Conduct standardized antifungal susceptibility testing of herbal extract against pathogenic Malassezia species
• Perform clinical efficacy trial with 30-50 volunteers having mild-moderate dandruff
• Expand safety testing to 25-30 healthy volunteers plus subset with sensitive skin

Medium-Term Development (6-12 months):

• Develop fully herbal surfactant system to eliminate SLS entirely
• Optimize concentrations of individual herbal components through design of experiments (DOE)
• Conduct long-term stability studies (6 months at 40°C/75% RH)
• Evaluate shelf life extension through alternative packaging or preservative systems

Commercial Development:

• Pilot scale-up and GMP compliance for production
• Stability testing per ICH Q1A(R2) guidelines
• Preparation of product master file and regulatory submissions for appropriate jurisdiction (India: Drug Controller approval pathway)

5. CONCLUSION

This study successfully developed a herbal-based anti-dandruff shampoo formulation utilizing a synergistic combination of eleven plant-derived ingredients. The formulation demonstrated:

• Optimal Physicochemical Properties: pH 6.2 (scalp-safe), viscosity 950 cP (consumer-acceptable), superior foam characteristics (125 mm, 78% stability), effective cleansing action (78% efficiency)
• Safe Tolerability Profile: No dermatological sensitization observed in preliminary human volunteer testing; low synthetic surfactant concentration minimizes irritation potential
• Excellent Formulation Stability: No phase separation, precipitation, or significant property changes over 4-week ambient temperature storage; stable pH and minimal viscosity change
• Evidence-Based Botanical Design: Formulation rationale based on traditional use, contemporary phytochemical research, and documented antimicrobial/ anti-inflammatory properties

The polyherbal approach offers significant advantages over conventional synthetic anti-dandruff formulations by providing:

• Multiple mechanisms of action through complementary phytochemical interactions
• Superior safety profile through reduced irritant potential
• Compliance with consumer preferences for natural personal care products
• Sustainable sourcing of renewable botanical resources

Clinical Impact: This formulation represents a promising therapeutic alternative for consumers seeking effective, safe, and naturally-derived anti-dandruff solutions without the adverse effects associated with synthetic active agents.

Regulatory Path: The formulation may be classified as a cosmetic (under most regulatory jurisdictions) or as a Ayurvedic cosmeceutical (India), pending specific active ingredient concentration levels and efficacy claims. The formulation meets acceptance criteria for physicochemical characterization suitable for cosmetic product quality standards.

This work contributes to the growing body of evidence supporting the scientific validation of traditional herbal remedies in modern pharmaceutical formulation development.

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