Application of Quality by Design: Development of Generic Modified Release Novel Dividable Matrix Tablet of Gliclazide

Ajit Rajpoot; Birendra Shrivastava; Pankaj Sharma

Volume : VIII, Issue : VII, July - 2018

Application of Quality by Design: Development of Generic Modified Release Novel Dividable Matrix Tablet of Gliclazide

Ajit Rajpoot, Birendra Shrivastava, Pankaj Sharma

Abstract :

The purpose of this study was to develop and optimize the matrix based generic dividable modified release formulations of Gliclazide through quality by design approaches. The quality target product profile was decided and critical quality attributes were identified for whole and halved tablet. Two formulation variables: the content of HPMC K100LV (X1), and the content of HPMC K4M (X2) added in extragranular phase were optimized using the design of experiments. 3 level 2 factor (3²)factorial design was used considering in vitro drug release of the drug after 2, 4, 6, 8, 10 and 12 hours as responses. Response surface plots and contour plots were drawn, and optimum formulations were elected by feasibility and grid searches. The p values were statistically significant (<0.5)for all models generated for different responses. The predicted and observed values were closely matched. Matrix tabletexhibited Korsmeyer–Peppas demonstrated that diffusion along with erosion could be the mechanism of release, as the value of release rate exponent (n) varied between 0.9102 and 0.9890, resulting in regulated and complete release until 12 hours. Validationof optimization study, performed using 9 confirmatory runs,indicated a very high degree of prognostic ability of responsesurface methodology, with mean percentage error (± SD)as 0.2775 ± 4.249.Matrix tablets have essentially similar drug release as the reference product in multimediaand can be divided into equal doses by hands.Response surface methodology is an efficient tool in the optimization experiments.