Abstract
DESIGN AND OPTIMIZATION OF ACECLOFENAC MICROSPONGES CONTAINING ETHYL CELLULOSE FOR TOPICAL DELIVERY SYSTEM USING QUALITY BY DESIGN APPROACH

Bhumi B. Patel* and Dr. Chainesh N. Shah

ABSTRACT

MDS technology has been introduced in topical drug products to facilitate the controlled release of active drug into the skin in order to reduce the systemic exposure and minimize local cutaneous reactions to active drugs. Micro-sponges are porous, polymeric microspheres that are designed to deliver pharmaceutical active ingredient or bioactive material. Formulations of topical agents utilizing the MDS technology have shown little or no irritancy in patients with acne, photo damaged skin, hyper pigmentation, without sacrificing the efficacy of the agents. Microsponge drug delivery systems offers entrapment of ingredients and is believed to contribute towards reduced side effects, improved stability, reduces systemic exposure and minimize local cutaneous reactions, increased elegance, and enhanced formulation flexibility. Optimization of Aceclofenac loaded Microsponge was done by Application of 24 Factorial Designs. Independent variable of formulation was Drug Concentration, PVA Concentration, Internal phase volume and speed. The selected dependent variables Were % Drug Content (Y1), % E.E (Y2), Particle Size(Y3) and %CDR (Y4).The optimized batch of Aceclofenac loaded Microsponge was evaluated by particle size, surface morphology and topography by SEM, Drug-Excipients compatibility study using FTIR Spectrum and DSC thermogram. The prepared optimized batch of Microsponge contains particle size 1068 nm and the SEM Study showed porous and spherical nature. The prepared optimized batch of Microsponge was incorporated in to Carbopol 934 gel. The prepared Microspongic gel showed desired % Drug Content, Spreadability, PH, Viscosity, Diffusion Study, Sensitivity Study on animal and Kinetic Model Study of gel.

Keywords: Microsponge, QbD, Factorial design, Aceclofenac, Microspongic gel.


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