BOX-BEHNKEN DESIGN APPROACH (BBDA) IN DEVELOPMENT AND OPTIMIZATION OF METFORMIN EXTENDED RELEASE TABLETS (MERT)

Objective: The present research outlines the use of quality by design (QbD) method to formulate MERT using Box-Behnken Design approach (BBDA). Based on quality target product profile (QTPP) to achieve tablets hardness and % cumulative Drug Release (% CDR) (at 2 hour and 10 hour), Critical quality attribute (CQA)were identified and selected as independent variable. In this present work, HPMC K 100M, Eudragit RL 100, and excipients MCC are selected as independent variables at their high and low levels in development of MERT. Material and Method: As per Design-Expert® prediction, total 19 formulations are prepared where each tablets of weight of 850 mg prepared by direct compression method. For each formulation, responses are determined and analyzed to find most optimized concentration. Result and Discussion: HPMC K 100 M, Eudragit RL 100 and MCC have antagonistic effects on the % CDR after 2 hour and 10 hours. From diagnostic plot it has been observed normal distribution of all data points near to straight line for normal plot of residuals, and predicted vs. actual. The desirability cube and the contour graph showing maximum desirability for optimized values of 76.75 mg, 203 mg and 58 mg for HPMC K 100M, Eudragit RL 100 and MCC respectively which are selected as independent factors in formulation of MERT. Prepared optimized tablets of MERT releases drug for more than 10 hr.