ABSTRACT

Objective: The goal of this study was to formulate and optimize and evaluate a topical gel for Hirsutism containing Eflornithine hydrochloride and Allantoin using a Quality by Design approach (QbD). Methods: To obtain a quality target product profile, the effects of critical parameters (Carbopol 934 and Triethanolamine concentrations) were investigated using a design of experimentation (DOE) with a Randomized Central Composite Design. Viscosity and pH were chosen as CQAs. Multiple regression analysis and ANOVA were used to assess and identify the effect of formulation variables and generate their relationship with CQA and optimized formulation was obtained. The optimized formulated gel was evaluated for their physical appearance, pH, viscosity, spreadability, drug content, in vitro drug release and ex vivo drug permeation and skin irritation. Results: The pH of the optimized formulation was 5.68 ± 0.02 which was optimum and viscosity of 234.43±0.57 and spreadability of 4.33 ± 0.11 cm and drug content of 94.74±0.16. Drug release across a cellulose membrane for the formulation was carried out and showed 81.23% and the ex-vivo permeation study carried out showed drug release to be 76.88% and showed no signs of irritation. Conclusion: The topical gel containing Eflornithine hydrochloride along with Allantoin showed better therapeutic efficacy than conventional gel. Keywords: Eflornithine hydrochloride, Allantoin, Hirsutism, Topical Gel, Quality by Design
Publication date: 01/01/2025

https://ijbpas.com/pdf/2025/January/MS_IJBPAS_2025_8611.pdf

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https://doi.org/10.31032/IJBPAS/2025/14.1.8611