Innovative and cost-effective SesZen-Bio™ with enriched Biotin and improved superior dissolution efficiency

Authors

  • Mihir Gadani Department of Phytochemistry, Zenherbs Lab Pvt Ltd, Mumbai, India
  • Sneha Badak Department of Phytochemistry, Zenherbs Lab Pvt Ltd, Mumbai, India
  • Ratna Upadhyay Department of Phytochemistry, Zenherbs Lab Pvt Ltd, Mumbai, India

DOI:

https://doi.org/10.69857/joapr.v12i3.446

Keywords:

Biotin, nutrition, natural, standardized, SesZen-BioTM

Abstract

Background: Micronutrient deficiencies, including biotin, iron, zinc, and vitamin D, can lead to hair problems such as loss and thinning. This study explores the improvement of SesZen-BioTM, a natural biotin supplement derived from Sesbania grandiflora leaves, to give NI- SesZen-BioTM. Materials: The nature and structure of biotin in SesZen-BioTM were evaluated using C14 analysis and 1H NMR. Further, Sesbania grandiflora was subjected to an improved economic process to give NI-SesZen-BioTM. HPLTC-aided phytochemical profiling was performed for SesZen-BioTM, NI- SesZen-BioTM, and standard S. grandiflora leaf extract. The purity of d-biotin was quantified using HPLC. The dissolution profile of SesZen-BioTM and NI- SesZen-BioTM was tested to determine bioequivalence and compared versus synthetic biotin. Results: NMR and C14 analysis revealed that SesZen-BioTM contained 100% natural d-biotin. The yield for SesZen-BioTM and NI- SesZen-BioTM was found to be 17% and 18%, respectively, and both exhibited phytochemical profiles similar to standard extract. The release rate for SesZen-BioTM was similar till a dose of 500 mg and slowly decreased at higher concentrations (800-100mg). A 350 mg NI- SesZen-BioTM showed bioequivalence to 250 mg and 500 mg for SesZen-BioTM. Percent d-biotin content was 0.5% in SesZen-BioTM and 0.81% in NI- SesZen-BioTM. Conclusion: This new economically driven process yielded NI-SesZen-BioTM, with similar yield, higher biotin (100%natural) content, and similar dissolution profile but at a reduced dosage as compared to SesZen-BioTM and surpassed synthetic biotin with its sustained release format. Thus, NI- SesZen-BioTM is a promising solution for individuals seeking natural supplements for maintaining hair and skin heath.

Downloads

Download data is not yet available.

References

Ahn DH, Kim H, Lee B, Hahm D. Psychological Stress-Induced Pathogenesis of alopecia areata: autoimmune and apoptotic pathways. International Journal of Molecular Sciences, 24, 11711 (2023).

DiBaise M, Tarleton SM. Hair, nails, and skin: Differentiating cutaneous manifestations of micronutrient deficiency. Nutrition in Clinical Practice, 34, 490–503 (2019).

Zempleni J, Wijeratne SS, Hassan YI. Biotin. BioFactors, 35, 36–46 (2009).

Trüeb RM. Serum biotin levels in women complaining of hair loss. International Journal of Trichology, 8, 73 (2016).

Almohanna HM, Ahmed A, Tsatalis JP, Tosti A. The role of vitamins and Minerals in hair loss: a review. Dermatology and Therapy, 9, 51–70 (2018).

Zempleni J, Mock DM. Bioavailability of biotin given orally to humans in pharmacologic doses. The American Journal of Clinical Nutrition, 69, 504–508 (1999).

Carr AC, Vissers MC. Synthetic or Food-Derived Vitamin C-Are they equally bioavailable? Nutrients, 5, 4284–4304 (2019).

Clemente HA, Ramalho HMM, Lima MSR, Grilo EC, Dimenstein R. Maternal supplementation with natural or synthetic vitamin E and its levels in human colostrum. Journal of Pediatric Gastroenterology and Nutrition, 60(4), 533–537, (2015).

Lindschinger M, Tatzber F, Schimetta W, Schmid I, Lindschinger B, Cvirn G, Fuchs N, Markolin G, Lamont E, Wonisch W. Bioavailability of a natural versus a synthetic vitamin B complex and their effects on metabolic processes. MMW – Advances in medicine, 162, 17–27 (2020).

Clinical trial Registry India (Internet). Assessment of safety and effectiveness of Plant Based Biotin in Healthy Human Subjects with thin, dry, and brittle hair. CTRI/2022/10/046324, 2022.

Patrício JPH, Santos CD, Cerdeira R. In vitro dissolution profile of two commercially available iron preparations. Drugs in R & D, 12(1), 35–40, (2012).

AOAC SMPR 2014.005: Biotin in Infant Formula and Adult/Pediatric Nutritional Formula. Journal of Aoac International, 98, 1044–1045 (2015).

Dange S, Jadhav RS, Vikhe S. Phytochemical and Pharmacological Review of Sesbania grandiflora. Asian Journal of Pharmacy and Technology, 12, 20–24 (2022).

Deepthi K, Renjith PK, Shameem K, Rahman KH, Chandramohanakumar N. Phytochemical screening of leaves and flower extracts of Sesbania grandiflora (L.) Pers. and its antimicrobial activity against fish pathogens. Vegetos, 36, 626–633 (2022).

Sreelatha S, Padma PR, Umasankari E. Evaluation of anticancer activity of ethanol extract of Sesbania grandiflora (Agati Sesban) against Ehrlich ascites carcinoma in Swiss albino mice. Journal of Ethnopharmacology, 134, 984–987 (2011).

Panigrahi G, Chhayakanta P, Patra A. Extract of Sesbania grandiflora Ameliorates hyperglycemia in high fat Diet-Streptozotocin induced experimental diabetes mellitus. Scientifica, 2016, 1–10 (2016).

Gupta RA, Motiwala MN, Mahajan UN, Sabre SG. Protective effect of Sesbania grandiflora on acetic acid induced ulcerative colitis in mice by inhibition of TNF-α and IL-6. Journal of Ethnopharmacology, 219, 222–232 (2018).

Baessa M, Rodrigues, MJ, Pereira C, Santos T, Neng NR, Nogueira J, Barreira L, Varela J, Ahmed H, Asif S, Boukhari S, Kayani WK, Ahmad KS, Zengin G, Mollica A, Custódio L. A comparative study of the in vitro enzyme inhibitory and antioxidant activities of Butea monosperma (Lam.) Taub. and Sesbania grandiflora (L.) Poiret from Pakistan: New sources of natural products for public health problems. South African Journal of Botany, 120, 146–156 (2019).

Coates PM, Betz JM, Blackman MR, Cragg GM, Levine M, Moss J, White JD, Moss J (Eds.). (2015). Encyclopedia of Dietary Supplements (2nd ed.), CRC Press, Taylor and Francis, Boca Raton (2010).

Upadhyay, R, Gadani, MC, Badak, S, Patel, N, Merja, A, Patel, M. A prospective, randomized double-blind, placebo-controlled study for safety and efficacy of SesZen-BioTM: a proprietary Sesbania grandiflora extract in managing hair and scalp health in healthy adults. International Journal, 11(2), 124 – 131 (2024).

Published

2024-06-30

How to Cite

Gadani, M., Badak, S., & Upadhyay, R. (2024). Innovative and cost-effective SesZen-Bio™ with enriched Biotin and improved superior dissolution efficiency. Journal of Applied Pharmaceutical Research, 12(3), 68-76. https://doi.org/10.69857/joapr.v12i3.446

Issue

Section

Articles