Abstract

QBD APPROACH IN FORMULATION AND EVALUATION OF GELRITE BASED IN SITU OPHTHALMIC GEL OF BROMFENAC SODIUM SESQUIHYDRATE

Dr. Sadhana R. Shahi*, Priyanka D. Dabir, Dr. Rajesh B. Nawale, Deepak G. Wagh, Swati V. Deore

ABSTRACT

The present investigation was focused on application of QbD approach to see the effect of formulation variables on in situ ophthalmic gel containing NSAID drug, Bromfenac sodium. Risk assessment of critical material and process parameters are linked to critical quality attributes (CQAs) of the product with respect to obtain target quality product profile (TQPP). The effects of critical parameters (concentration of Gelrite, HPMC E 15LV) were investigated by executing design of experimentation (DoE) using 32 factorial designs. Drug release, viscosity at non physiological condition (NP) and viscosity at physiological condition (P) were considered critical quality attributes (CQAs). Gelrite based ophthalmic Bromfenac sodium sesquihydrate in situ gels were prepared and evaluated. Multiple regression analysis and ANOVA were employed to identify and estimate the effect of important parameters and establish their relationship with CQAs and to obtain design space for optimization purpose. The best in vitro drug release profile, viscosity at non physiological condition (NP), viscosity at physiological condition (P) and desired product quality was achieved with the formulation prepared in the region of design space. 3D response graph and overlay plots were successfully implemented to interpret effects and selection of significant parameters on CQAs. Formulation parameters which affect the Bromfenac sodium in situ ophthalmic gel can be successfully optimized.

Keywords: In situ ophthalmic gel, Bromfenac sodium sesquihydrate, Gelrite, Ion sensitive gelling system, HPMC E 15LV.