Submitted:
11 February 2025
Posted:
12 February 2025
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Abstract

Keywords:

Introduction
2. Methods
2.1. Preparation of Fermented Extracts and Their Formulation
- S1: pomegranate and beetroot (1:1),
- S2: banana and papaya (1:1),
- S3: pomegranate, beetroot, banana, and papaya (1:1:1:1).
2.2. Preparation of Test Microorganisms
2.3. Antifungal Susceptibility Assay of Fermented Extracts
2.4. Comparative Inhibition of FERMENZA® with Marketed Products
2.5. Evaluation of Physico-Chemical and Microbial Properties of FERMENZA®
2.6. Minimum Inhibitory Concentration (MIC) Assay
2.7. Time-Kill Assay
2.8. FERMENZA® Efficacy Assessment
2.9. FERMENZA® Sensory and Safety Assessment
3. Results
3.1. Inhibitory Activity of Fermented Extracts Against M. furfur(MTCC 1374)
3.2. Comparative Activity of of Investigational Formulation on M. furfur(MTCC 1374) Growth Inhibition
3.3. Physico-Chemical Properties of FERMENZA® Hair Tonic
| MIC assay parameters | Fermented extract concentration (mg/ml) in FERMENZA® | |||||||||
| 2 | 4 | 6 | 8 | 10 | 12 | 14 | 16 | 18 | 20 | |
| ZOI (mm) | 3.0±0.14 | 3.7±0.02 | 6.1±0.05 | 9.2±0.11 | 12.7±0.08 | 18.2±0.04 | 20.2±0.15 | 21.0±0.15 | 22.5±0.03 | 23.0±0.02 |
| % ZOI (w.r.t. 2% Ketoconazole API) | 12±0.02 | 14±0.15 | 24±0.04 | 36±0.08 | 51±0.08 | 72±0.14 | 80±0.12 | 84±0.03 | 90±0.04 | 92±0.01 |
| Parameter | Result | Limit |
|---|---|---|
| Description | Pale yellow colour oily liquid filled in plastic bottle | - |
| pH Value | 6.71 | - |
| Specific Gravity | 1.136841 gm/ml | - |
| Polyphenol | 5.05% | - |
| Sodium Benzoate | 0.73 ppm | - |
| Gallic Acid | 19.90 ppm | - |
| Ethyl Alcohol | 0.0078% | - |
| Heavy Metals | ||
| - Lead (as Pb) | <10 ppm (LDL 0.4) | NMT 10 ppm |
| - Arsenic (as As) | Not Detected (LDL 0.4) | NMT 3 ppm |
| - Mercury (as Hg) | Not Detected (LDL 0.4) | NMT 1 ppm |
| - Cadmium (as Cd) | Not Detected (LDL 0.4) | NMT 0.3 ppm |
| Total Parabens | Not Detected | - |
| Microbiological Test | ||
| - Total Viable Aerobic Count | <10 cfu/ml | NMT 10 cfu/ml |
| - Total Fungal Count | <10 cfu/ml | NMT 10 cfu/ml |
| - E. Coli/ml | Absent | Should be absent |
| - Salmonella/ml | Absent | Should be absent |
| - S. Aureus/ml | Absent | Should be absent |
| - P. Aeruginosa/ml | Absent | Should be absent |
| Key: LDL: Lower Detectable Limit; NMT: Not More Than | ||
3.4. FERMENZA® Potency Findings from MIC
3.5. FERMENZA® Mechanism of Action
3.6. Efficacy of FERMENZA® in Addressing Dandruff and Scalp Concerns
3.7. Sensory and Safety Profile of FERMENZA®
4. Discussion
5. Limitations of the Study
6. Conclusion
Acknowledgments
References
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| Formulation S4 Composition | Formulation S5 Composition | Formulation S6 Composition | Quantity % |
| Fermented extract S1 Pomegranate:Beetroot (1:1) | _ | _ | 50 to 70 |
| _ | Fermented extract S2 Banana:Papaya (1:1) | _ | 50 to 70 |
| _ | _ | Fermented extract S3 Pomegranate: Beetroot: Banana: Papaya (1:1:1:1) | 50 to 70 |
| Propylene Glycol | Propylene Glycol | Propylene Glycol | 5 to 20 |
| Glycerin | Glycerin | Glycerin | 5 to 10 |
| Menthol | Menthol | Menthol | 0.1 to 5 |
| Camphor | Camphor | Camphor | 0.1 to 5 |
| Sodium Benzoate | Sodium Benzoate | Sodium Benzoate | 0.01 to 0.1 |
| Water | Water | Water | to 50 |
| Fermented extract | Zone of Inhibition in mm (w.r.t Ketoconazole) | %ZOI inhibition(w.r.t Ketoconazole) | Zone of Inhibition in mm (w.r.t Zinc pyrithione) | %ZOI inhibition(w.r.t Zinc pyrithione) |
| S1 | 24±0.15 | 96±0.01 | 26±0.19 | 86.7±0.03 |
| S2 | 21±0.09 | 84±0.04 | 22±0.14 | 73.4±0.05 |
| S3 | 23±0.11 | 92±0.02 | 24±0.07 | 80±0.04 |
| FERMENZA® Formulation samples | Zone of Inhibition in mm (w.r.t Marketed product A lotion) | %ZOI inhibition(w.r.t Marketed product A lotion) | Zone of Inhibition in mm (w.r.t Marketed product B lotion) | %ZOI inhibition (w.r.t Marketed product B lotion) |
| Formulation S4 | 28±0.12 | 93±0.04 | 27±0.14 | 60±0.09 |
| Formulation S5 | 22±0.05 | 73±0.09 | 21±0.08 | 48±0.11 |
| Formulation S6 | 26±0.15 | 86±0.06 | 24±0.05 | 54±0.04 |
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