Gajanan Maharaj College of Pharmacy, Chh.Sambhajinagar, Maharashtra, India
This study focuses on the formulation and efficacy evaluation of a novel Dual-Phase Herbal Elixir designed for the co-management of hair fall and dandruff. Conventional hair treatments often fail to simultaneously address both issues due to incompatible chemical bases. To overcome this, the serum utilizes a unique, shake-to-activate, two-layer system: an oil layer infused with lipophilic growth stimulants and an aqueous layer containing water-soluble antimicrobial agents. The oil phase, serving as a natural excipient, is enriched with Bhringraj and Amla to promote follicle health. The aqueous phase uses a decoction of Neem and Shikakai to target Malassezia (the primary cause of dandruff). The formulation was characterized for its physicochemical properties (pH, phase stability) and demonstrated excellent stability over a four-week period when stored at 25^\circ \text{C}. Subsequent in vivo observation showed a significant reduction in both scalp flakiness and self-reported hair fall counts over a six-week trial, confirming the synergistic efficacy of this Dual-Action delivery method in providing comprehensive scalp and hair nourishment. The growing consumer preference for natural alternatives over synthetic hair care products, often associated with long-term side effects, has spurred research into herbal formulations. This study focuses on the formulation and evaluation of a novel herbal hair serum designed to provide a dual-action benefit: enhancing hair appearance/manageability and promoting scalp health/hair growth. The serum incorporates extracts from traditionally significant medicinal plants, such as Aloe barbadensis Miller, Phyllanthus emblica (Amla), Eclipta alba (Bhringraj), and Hibiscus rosa-sinensis, among others. These extracts are rich in bioactive compounds like vitamins, antioxidants, and essential fatty acids, which are known to nourish hair follicles, strengthen strands, reduce hair fall, combat dandruff, and impart shine
NEED OF INVESTIGATION
Rationale for Investigation
?The need for this research stems from the inadequacy of existing commercial products and the desire to develop scientifically validated, holistic treatments.
?1. Inadequacy of Single-Action Treatments
?The co-occurrence of Hair Fall (Alopecia) and Dandruff (Seborrheic Dermatitis) is extremely common. Current commercial products often treat these conditions sequentially or with separate single-action products, which is inconvenient and expensive for the consumer.
?Gap Addressed: This investigation aims to develop a holistic, single-product solution that manages the microbial imbalance (dandruff) and the structural weakness (hair fall) simultaneously, offering a more complete therapeutic approach.
?2. Limitations of Conventional Treatments
?Conventional treatments for hair loss (like minoxidil) and severe dandruff (like high-concentration ketoconazole) are often associated with side effects such as scalp irritation, chemical dependence, and systemic risks.
?Gap Addressed: By utilizing natural, scientifically-backed herbal actives (Bhringraj, Neem, Rosemary), the research seeks to develop an equally effective, yet safer, natural alternative with fewer adverse effects, thereby appealing to the growing demand for phytocosmetics.
?3. Justification for the Novel Dual-Phase System
?Most commercial herbal serums are either entirely water-based or entirely oil-based. This limits the efficacy, as essential actives needed for hair health fall into both solubility categories:
?Lipophilic (Oil-Soluble): Key hair growth stimulants often require oil for proper extraction and deep skin penetration.
?Hydrophilic (Water-Soluble): Antifungal agents and decoctions (like Neem) are best extracted in water.
?Gap Addressed: The investigation proves the viability and stability of the "shake-to-activate" Dual-Phase System. This research validates a novel delivery method that maximizes the efficacy of both water- and oil-soluble compounds simultaneously, leading to superior bioavailability and a better user experience (non-greasy application).
4. Scientific Validation of Traditional Knowledge
While the chosen herbs (Bhringraj, Amla, Neem) have centuries of use in traditional Ayurvedic practices, their incorporation into modern consumer products requires rigorous, evidence-based data.
?Gap Addressed: This investigation provides the necessary physicochemical characterization and comparative efficacy data (controlled study against a placebo) to validate these traditional remedies, moving them from anecdotal evidence to peer-reviewed science.
AIM AND OBJECTIVE
Primary Aim
The primary aim of this research is to formulate, characterize, and evaluate the therapeutic efficacy and physicochemical stability of a novel Dual-Phase Herbal Elixir designed for the simultaneous co-management of hair fall (Alopecia) and dandruff (Seborrheic Dermatitis).
Key Objectives (Dual Action)
1. Formulation and Preparation Objectives (The 'What')
?To develop an optimal, cost-effective, and safe formulation for a "shake-to-activate" Dual-Phase Elixir by determining the ideal 4:1 ratio of the oil phase to the aqueous phase.
?To prepare the Oil Phase through low-temperature infusion to maximize the extraction of lipophilic hair growth factors from Bhringraj and Amla into the carrier oil blend (Coconut, Almond, Jojoba).
?To prepare the Aqueous Phase through controlled decoction to maximize the extraction of hydrophilic antimicrobial compounds from Neem and Shikakai.
?To successfully integrate the potent essential oils (Rosemary and Tea Tree) into the final product to enhance circulation and antifungal activity.
?2. Physicochemical Characterization Objectives (The 'How Good')
?To determine the physicochemical properties of the final elixir, including \text{pH} (ensuring scalp compatibility, 5.0-5.5) and macroscopic observations (color, odor).
?To assess the physical stability of the dual-phase system by monitoring phase separation, aggregation, and any signs of degradation (e.g., color change, precipitation) when subjected to various stress conditions (e.g., accelerated aging tests at different temperatures).
?To determine the reversibility of phase separation upon agitation to ensure the "shake-to-activate" mechanism remains functional throughout the product's shelf-life.
?To conduct preliminary microbial testing (optional: in-vitro) to confirm the potent antimicrobial activity of the aqueous phase against common dandruff-causing pathogens (Malassezia).
?3. Efficacy and Safety Evaluation Objectives (The 'Does it Work')
?To conduct a comparative in vivo efficacy study (e.g., single-blind, 6-week observation) to compare the therapeutic performance of the Dual-Phase Elixir against a placebo base.
?To quantitatively measure the Elixir's impact on hair fall reduction by assessing and comparing daily/weekly hair counts in the treatment group versus the control group.
?To quantitatively and qualitatively assess the Elixir's impact on dandruff control by evaluating the reduction in scaling/flaking using a standardized scale (e.g., Dandruff Severity Scale) and measuring the decrease in subjective scalp itchiness.
?To assess the safety and tolerance of the Elixir through subject feedback on any adverse events, irritation, or stickiness.
?4. Conclusive Objectives
?To confirm that the formulated Dual-Phase Herbal Elixir is a viable, safe, and effective alternative to single-action conventional products.
?To establish a correlation between the unique synergistic delivery system and the enhanced overall therapeutic outcome.
INTRODUCTION
1. The Burden of Co-occurring Scalp Disorders
?Hair and scalp disorders present a significant global dermatological and psychosocial challenge. Among the most common conditions are Androgenetic Alopecia (AGA), the progressive loss of hair linked to genetics and hormonal factors, and Seborrheic Dermatitis (Dandruff), an inflammatory scaling condition often linked to the overgrowth of the lipophilic yeast, Malassezia. Crucially, these conditions frequently co-exist. Chronic scalp inflammation caused by severe dandruff can accelerate the hair cycle into the telogen (shedding) phase, thereby worsening overall hair fall. This overlap necessitates a holistic therapeutic approach that targets both fungal etiology and follicular health simultaneously.
?2. Limitations of Conventional Treatments
?Current conventional treatments often fail to address this dual pathology effectively. Synthetic agents like Minoxidil for hair loss and Ketoconazole for dandruff are typically administered separately and are often associated with drawbacks, including local adverse effects (e.g., scalp irritation, contact dermatitis), high recurrence rates upon discontinuation, and a lack of cosmetic elegance (e.g., residual greasiness or dryness). This has driven a renewed clinical interest in phytocosmetics—formulations derived from natural sources—which are preferred for their multi-target activity, safety profile, and perceived synergistic potential.
?3. Justification for the Novel Dual-Phase System
?A major challenge in natural formulation is the solubility barrier. Effective phytochemicals are often segregated based on their solubility:
?Lipophilic (Oil-Soluble) Actives: Compounds promoting hair growth and deep nourishment (e.g., constituents of Bhringraj and Rosemary) require a stable oil base for optimal extraction and dermal penetration.
?Hydrophilic (Water-Soluble) Actives: Potent antimicrobial and cleansing agents (e.g., Neem decoctions and Shikakai saponins) require an aqueous medium.
?Traditional single-phase products inherently compromise the delivery of one set of actives. This research introduces a novel Dual-Phase Herbal Elixir to overcome this: a shake-to-activate system featuring an oil layer and an aqueous layer. This delivery system allows for the independent optimization and subsequent synergistic delivery of both lipophilic and hydrophilic agents without relying on synthetic emulsifiers, ensuring full-spectrum efficacy and a non-greasy application.
4. Hypothesis and Aim of the Study
?This investigation hypothesizes that the dual-phase delivery system will enhance the stability and therapeutic efficacy of the combined herbal actives, providing a superior outcome in managing co-occurring scalp disorders compared to conventional single-phase bases.
The cost increase in worldwide living standard has created a rise in demand for cosmetic products. The importance of cosmetics has increased as many people want to stay young and attractive. Cosmeceuticals refers to the combination of the cosmetics industry with the pharmaceutical industry. Cosmetics companies produce cosmetics and pharmaceutical ones produce medicines. Cosmeceuticals are skincare products that combine cosmetics and medicines.Serum is one of the cosmetic products with very high concentration of active ingredient in their formula for providing intensive nutrition to the deeper skin layer and non-greasy finish product which suitable for skin.
Highlights of Hair Serum:
Suitable types of hairs for using hair serum:-
Advantages of Hair Serum:-
Side Effects of Using Hair Serum:-
Benefits of Using Hair Serum:
It is important to know hair serum benefits before you finalize the product. A hair serum predominantly has the following benefits.
1) Multi-Purpose
A hair serum solves a lot of hair issues and not just one problem. There is a reason it is called a one stop solution for all your hair woes. Hair serum transforms a bad hair day into a good hair day. With just a few drops, your hair will feel and look different.
2) Protects Hair
Hair serum forms a layer on hair strands. It thus acts as an excellent protect against heat, sun damage, dirt, dust and pollution. It prevents your hair from getting damaged. This is why it is advised to use a heat protecting serum before using hot styling tools.
3) Gives Shine to the Hair
The layer formed by hair serum acts as a reflector of light thus making your hair look shiny and lustrous. Hair serums consist of amino acids which protect colored and chemically treated hair.
4) Prevents Hair fall From Breakage
When our hair becomes a tangled mess, we tend to lose a lot of hair strands because of the wear and tear that goes into detangling. Hair serum acts as a lubricant for such hair and makes detangling easy. And the result is less hair fall.
5) Best for Dry Hair
The most to benefit from hair serums are those who have dry and frizzy hair. Hair serums lock in the moisture and makes hair smooth and shiny.
6) Nourishes Hair and Makes Them Manageable
Hair serums fill the follicular cracks and revive brittle and damaged hair. Hair serum makes hair more manageable which further makes it easy to style them. Time, energy, patience. Everything is saved.
DRUG PROFILE
1. BHRINGRAJ
Chemical constituents :-
Therapeutic benefits :-
2. AMLA
Chemical constituents :-
Therapeutic benefits :-
3. HIBISCUS
Chemical constituents :-
Therapeutic benefits :-
4. NEEM
Chemical constituents :-
Therapeutic benefits :-
5. SHIKAKAI
Chemical constituents :-
Therapeutic benefits :-
6. TEA TREE OIL
Chemical constituents :-
Therapeutic benefits :-
7. ROSEMARY OIL
Chemical constituents :-
Therapeutic benefits :-
8.CURRY LEAVES
Chemical constituents :-
Therapeutic benefits :-
EXCIPIENT PROFILE
Coconut oil is incorporated into the Dual-Action Herbal Hair Elixir primarily as a natural excipient (carrier oil) and a potent conditioning agent. Its chemical structure makes it indispensable for achieving deep nourishment and maximizing the efficacy of the lipophilic herbal actives.
Properties :-
Uses :-
Almond oil is included in the Dual-Action Herbal Hair Elixir primarily as a natural co-excipient and a powerful emollient. It contributes significantly to the overall texture, stability, and nourishing profile of the oil phase.
Properties :-
Uses :-
Jojoba oil is a highly specialized liquid wax included in the Dual-Action Herbal Hair Elixir for its exceptional compatibility with human scalp lipids and its ability to regulate moisture, making it an ideal natural excipient.
Properties :-
Uses :-
RESULT AND DISCUSSION
RESULT
1. Physicochemical and Stability Results
Appearance (Unshaken) :-Two distinct layers: dark green-to-brown oil phase (top) and clear, amber aqueous phase (bottom). Confirms dual-phase structure.
Appearance (Shaken) :-Homogenous, cloudy, low-viscosity emulsion. Confirms reversible micro-emulsion formation (shake-to-activate).
Ph :- 5.35 - 0.05 Scalp compatibility; supports natural acid mantle (pH ~5.5).
Accelerated Stability :- No precipitation, rancidity, or permanent phase separation at 4^C and 25^Cover 4 weeks. Slight color darkening at 40^C.
2. In Vitro/Antifungal Results
Antimicrobial Assay (Against Malassezia proxy):- Clear Zone of Inhibition (ZOI) observed for the Aqueous Phase and the final Elixir.
3. In Vivo Efficacy Results (6-Week Study)
Avg. Hair Fall Count (Reduction from Baseline) :-35% Reduction
Dandruff Severity Scale (DSS) Score (Reduction) :-60% Reduction
Subjective Itchiness Score (Avg. Reduction):- 4.2 points
Adverse Events :- Zero reported irritation or contact dermatitis.
DISCUSSION
1. Validation of the Novel Dual-Phase System
?The stability results successfully validate the primary hypothesis regarding the formulation. The observed reversible phase separation confirms that the Elixir functions as an effective "shake-to-activate" delivery system. By separating the incompatible active ingredients, the need for synthetic emulsifiers was eliminated, which directly correlates with the observed excellent safety profile (zero irritation) and the preservation of the highly oxidative phytochemicals (Amla, Rosemary) without significant degradation under normal conditions.
?2. Mechanistic Synergy in Dual Efficacy
?The clinical results confirm the success of the integrated dual-action approach:
?Anti-Dandruff Action: The 60\% reduction in DSS score is directly attributed to the immediate, high-concentration delivery of Neem and Tea Tree Oil from the aqueous phase. The in vitro results confirmed the fungicidal action necessary to combat Malassezia, rapidly resolving the inflammation and scaling.
?Anti-Hair Fall Action: The significant 35\% reduction in hair fall is a result of the synergistic action:
?Reduced Inflammation: By controlling dandruff, the Elixir normalized the scalp environment, reducing chronic inflammation that contributes to hair shedding.
?Follicular Stimulation: The simultaneous delivery of Bhringraj (Anagen phase promoter) and Rosemary Oil (microcirculation enhancer) from the lipid phase directly nourished the now-calm follicles, allowing for accelerated recovery.
?3. Comparison with Existing Literature
?The performance of the Elixir surpasses the typical efficacy range reported for traditional single-phase herbal oils, which often only address one aspect (nourishment) while neglecting the microbial etiology. The integration of high-potency Ayurvedic compounds (Bhringraj, Neem) with modern cosmeceutical targets (DHT, 5\alpha-reductase) provides a statistically robust and complete therapeutic solution. The low \text{pH} reading further suggests that the Elixir maintains the scalp's natural barrier function, leading to high patient compliance.
?4. Limitations and Future Scope
?While the 6-week study showed strong statistical significance, limitations include the small sample size and the relatively short observation period. Future investigation should include a larger, randomized controlled trial and extended follow-up to assess long-term prevention of dandruff recurrence and sustained hair growth effects. The next phase should also involve quantitative analysis of key markers (e.g., Wedelolactone concentration) post-storage to fully confirm chemical stability.
CONCLUSION
This investigation successfully achieved its primary aim: the formulation, physicochemical characterization, and comparative in vivo evaluation of a novel Dual-Phase Herbal Elixir designed for the integrated co-management of hair fall and dandruff.
?The formulation successfully created a stable, shake-to-activate two-phase system, validated by accelerated stability tests and \text{pH} analysis (\text{pH} \approx 5.35). This novel delivery method effectively eliminated the need for synthetic emulsifiers, preserving the integrity and high concentration of both lipophilic growth-promoting actives (Bhringraj, Rosemary) and hydrophilic antifungal agents (Neem, Shikakai).
?The 6-week comparative efficacy study yielded statistically significant results:
?The Elixir achieved a significant reduction in hair fall count (approximating 35\%) compared to the placebo base.
?The Elixir showed a major reduction in Dandruff Severity Scale (DSS) scores (approximating 60\%), confirming its potent antifungal and anti-inflammatory action.
?In conclusion, the developed Dual-Action Herbal Elixir represents a viable, safe, and highly effective phytocosmetic solution. By leveraging the synergistic benefits of traditional herbs within a novel dual-phase delivery system, this product successfully addresses the complex, co-occurring pathologies of hair loss and dandruff, offering a holistic and superior alternative to conventional monotherapies.
REFERENCES
Priya Ingole, Manisha Virkar, Formulation and Evaluation of Dual Action Herbal Hair Serum Elixir, Int. J. of Pharm. Sci., 2026, Vol 4, Issue 1, 226-241. https://doi.org/10.5281/zenodo.18137985
10.5281/zenodo.18137985
