Patent ID: 8911781
Filing Date: 2014-12-16
Classification: A61K

Abstract:
1. A process for the manufacture of a bi-layered tablet dosage form for once a day administration, the process comprising: a) preparing a first granule formulation comprising at least one non-biodegradable inert polymer and a biguanide, or a pharmaceutically acceptable salt thereof, of particle size less than 100 microns to achieve pH independent prolonged in-vitro release of the biguanide or pharmaceutical acceptable salt thereof, wherein the non-biodegradable inert polymer is present in an amount of at least 35% by weight of biguanide in the dosage form; b) preparing a second granule formulation comprising (i) one or more active pharmaceutical ingredients for immediate release selected from thiazolidinediones, sulfonyl ureas, alpha-glucosidase inhibitors, aldose reductase inhibitor inhibitors, statins, squalene synthesis inhibitors, fibrates, angiotensin converting enzymes inhibitor, LDL catabolism enhancers, and pharmaceutically acceptable salts thereof; and (ii) a non-biodegradable inert polymer; c) treating the first and second granule formulations with lubricants; and d) compressing the first and second granule formulations to form the bilayered tablet dosage form; wherein the content of non-biodegradable inert polymer in the second granule formulation is not more than 1.2% by weight of the lubricated second granule formulation, the tablet dosage form contains layers of the first and second granule formulations, and the tablet dosage form provides monophasic prolonged release of the biguanide.