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AssigneePanacea Biotec Limited
InventorsRajesh Jain, Sarabjit Singh, Shivanand Puthli
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The present invention relates to stable once daily sustained release pharmaceutical compositions comprising pregabalin or pharmaceutically acceptable salts thereof and a pharmaceutically acceptable excipient wherein pharmaceutical composition is bioequivalent to conventional immediate release formulation of pregabalin administered twice daily. The present invention further relates to a composition comprising pregabalin and sugar esters as release retarding agent for maintaining uniform release rate of the drug and process for the preparation of such oral sustained release formulations.
A sustained release pharmaceutical composition adapted for once daily dosing, comprising pregabalin or a pharmaceutically acceptable salt, complex, solvate or hydrate thereof, release retarding agent(s) and optionally other pharmaceutically acceptable excipients thereof, wherein said pharmaceutical composition is bioequivalent to immediate release formulations of pregabalin administered twice daily.
A sustained release pharmaceutical composition adapted for once daily dosing, comprising pregabalin or a pharmaceutically acceptable salt, complex, solvate or hydrate thereof, release retarding agent(s) and optionally other pharmaceutically acceptable excipients thereof, wherein said pharmaceutical composition is bioequivalent when compared in terms of total exposure (AUC) to conventional immediate release composition of pregabalin administered thrice daily.
A sustained release composition as herein above described in the specification with reference to the accompanying drawing.
Dependencies are inferred from the claim text.