FORMULATION AND EVALUATION OF EFLORNITHINE GEL FOR HIRSUTISM BY QBD APPROACH

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 234.430.57and spreadability of 4.33 0.11 cm and drug content of 94.740.16.