FORMULATION AND EVALUATION OF MICROSPONGES LOADED CAPSULE OF BENFOTIAMINE

Objective: The goal of this study was to formulate, develop, and evaluate a microsponge-based capsule formulation of Benfotiamine using Box-Behnken design for enhanced solubility, protect from rapid metabolism, and controlled release of the drug. This approach aimed to improve the therapeutic efficacy of benfotiamine, which suffers from low solubility, and to optimize its delivery for better patient compliance in managing diabetic neuropathy. Materials and Methods: Benfotiamine-loaded microsponges were prepared using the quasi-emulsion solvent diffusion technique with ethyl cellulose and PEG 4000. A BBD was employed to optimize the formulation, with three independent variables: drug to polymer ratio, concentration of plasticizer, and stirring speed. The formulations were evaluated for production yield, entrapment efficiency, particle size, and drug release properties. Result and Discussion: The optimized formulation, based on the results from the BBD, demonstrated significant improvements in entrapment efficiency and particle size, with a gradual and sustained release of Benfotiamine. The formulation exhibited favorable characteristics, such as enhanced solubility and bioavailability, with a good correlation to the theoretical model derived from the Box Behnken analysis. The microsponge formulation was stable, showing no significant changes in drug content during stability studies. Conclusion: The microsponge-based capsule formulation of Benfotiamine developed through BBD offers an efficient method for enhancing drug solubility, providing sustained release, and improving patient compliance. The study demonstrates the potential of microsponge drug delivery systems to optimize the pharmacokinetic profile of Benfotiamine, making it a promising strategy for the treatment of diabetic neuropathy.