Ozaprozin Microsponges using EC and ERS 100 polymers for Preformulation, Preliminary selection of formulation and process variable, CQAs, QbD approach, DoE, Characterization of MS, Check Point Analysis and MS loaded Gel. Further, this chapter describes preparation of Ozaprozin microsponges and evaluation for % yield, % Entrapment efficiency, % drug content, SEM, FTIR spectral studies, and % CDR. Preparation of optimized microsponges gels was evaluated for In vitro diffusion studies, Anti- Fungal Study and primary skin irritation studies. It also describes the results and discussion of the thesis. Production yield and loading efficiency were calculated for all the microsponge formulations average of three determinations was considered and was found to be reproducible. The loading efficiency of the microsponge formulations were from 80%-90%. The FTIR spectrum of microsponge formulations shows the characteristic bands and all other peaks observed with individual compound have remained unaffected in microsponges formulations indicates microsponges formed were not a chemical reaction product, hence, the drug exists in original form and available for the biological action. SEM suggests the optimized microsponges were finely spherical, uniform in shape, no intact drug crystals are seen visually and inner structure was consisted of porous in nature with void spaces. The comparative dissolution profiles and regression coefficient values were also discussed.

Keyword: Microsponge, In Vitro Release, Preformulation and Oxaprozin