DEVELOPMENT OF GENERIC CONTROLLED RELEASE TABLET: AN INDUSTRIAL APPROACH

The purpose of this study was to develop a generic prolonged release tablet formulation using Gliclazide for Europe market, which is stable and bioequivalent to Diamicron MR 30 mg tablet of Servier laboratories, France. This paper will provide a summary of the different development stages of gliclazide prolonged release tablet and elloborate formulation and process factors impacting drug release pattern. Tablets were prepared through wet granulation in high shear granulator by using Hypromellose K 4 M and Hypromellose E 15 LV with hydrophobic diluent dibasic calcium phosphate. A non aqueous solution of low viscosity Hypromellose 2910 (5cps) (HPMC E-5) is used as binder. The manufacturing process (Effect of Active particle size distribution, Effect of dry mixing in RMG, Effect of Kneading time, Effect of Loss on drying (LOD), Sifting and milling, Effect of pre lubrication and Lubrication time and hardness challenges were carried to check the desired impact on drug release of prolonged release tablet in order to recommend Control strategy. Tablets were analyzed for multimedia dissolution in pH 7.4, pH 6.8 and pH 5.5 phosphate buffer, assay, related substances initially as well as in stability study. Similarity factor (f2) value of generic tablet to marketed product in pH 7.4, 6.8 and 5.5 phosphate buffer is 70.15, 68.36 and 61.59 respectively. Final formulation showed similar dissolution profile in multimedia with the marketed formulation.