Assessing the Impact of Formulation Variables on Dissolution Profile of Sustained Release Tablet of Metformin Hydrochloride by Quality by Design Approach

In the present study, sustained release tablet of metformin hydrochloride were formulated and analyse the impact of material and process attributes on dissolution profile employing Quality by design (QbD) approach. Taguchi design was employed to screen the critical factors and amount of HPMC, amount of compritol and compression force was selected as critical factors. The effect of critical factors on the critical quality attributes (CQAs) of sustained, such as cumulative drug release at 2 hr (CDR 2), at 5 hr (CDR 5) and 8 hr (CDR8) was evaluated using Box-Behnken design. The optimised formulation was achieved with set of variable, such as a amount of HPMC (24.9%), amount of compritol (6.93%) and compression force (7.09 KN) and resulted into a tablet with a cumulative drug release 18.53%, 47.10% and 85% at 2, 5 and 8 hr respectively which was close to predicted value.