Abstract: A novel patient-convenient, cost effective pharmaceutical composition, comprising of thiazolidinediones and biguanide for controlling hyperglycemia manufactured as multilayer tablet and its process of manufacturing, for immediate release of thiazolidinediones or thiazolidinediones and biguanide and prolonged release of the biguanide only, the tablet comprising of minimum two layers wherein one outer layer comprises of a mixture of excipients and thiazolidinediones or thiazolidinediones and biguanide allowing immediate release of thiazolidinediones or thiazolidinediones and biguanide respectively and the other layer arranged in contact with the immediate release layer which comprises of a novel composition of excipients and a minimum one or more non-biodegradable, inert polymer(s) and the biguanide allowing pH independent prolonged release of the biguanide up to a period of 8-12 hours. The tablets are for once a day dosing.

Abstract: The present invention provides a multiple unit compositions comprising of enteric coated pellets and at least one tablet excipient, wherein each pellet comprises: i) a core comprising active ingredient(s); ii) optionally a separating layer coated on the core; iii) at least two enteric layers comprising of enteric polymers and plasticizer either coated on the core or on the separating layer to obtain enteric coated pellets, such that the last enteric layer is formed from a solution comprising of enteric polymer and plasticizer in organic solvent(s), resulting in no appreciable change in release profile of active ingredient on compression of enteric coated pellets into tablets.

Abstract: This invention relates to a process for the manufacture of a stable, oral, multiple unit pharmaceutical composition containing high concentrations of benzimidazole up to about 35 to 45% w/w, preferably up to about 40% w/w, a disintegrating agent, and one or more fillers. Surfactants in these compositions are in an enteric polymer layer and preferably not in contact with the benzimidazole. The process preferably involves sequential deposition of: (a) an alkaline material layer on non-pariel seeds to obtain treated non-pariel seeds; (b) a drug layer of the benzimidazole to obtain drug pellets; (c) a sealant polymer layer to obtain sealed pellets; and (d) an enteric polymer layer to obtain enteric-coated pellets.