QBD APPROACH IN FORMULATION AND EVALUATION OF SUMATRIPTAN SUCCINATE BILAYER BUCCAL TABLETS

Dr. Sadhana R. Shahi, Swati V. Deore* and Priyanka D. Dabir

ABSTRACT

The present investigation was focused on application of QbD approach to see the effect of formulation variables on buccal mucoadhesive tablets containing anti‐depressant drug, Sumatriptan succinate to circumvent the first pass effect. 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 HPMC K100LV, Carbopol 974P) were investigated by executing design of experimentation (DoE) using 32 factorial designs. Drug release, mucoadhesive strength and mucoadhesion time were considered critical quality attributes (CQAs). Sumatriptan succinate buccal mucoadhesive tablets were prepared by direct compression method and were evaluated as per pharmacopoeia procedure. Multiple regression analysis and ANOVA were employed to identify and to 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, mucoadhesive strength, Mucoadhesion time and desired product quality was achieved with the formulation prepared in theregion of design space.3D response graph and Overlay plot were successfully implemented to interpret effects and selection of significant parameters on CQAs. Formulation parameters which affect the Sumatriptan succinate buccal mucoadhesive tablets can be successfully optimized.

Keywords: Sumatriptan succinate, Buccal tablets, HPMC K100LV, Carbopol 974P, Mucoadhesive.