Modified release gemfibrozil composition

A - Human Necessities – 61 – K

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167/262

A61K 31/19 (2006.01) A61K 9/20 (2006.01)

Patent

CA 2009135

967-114 PD-3831-01-RAD ABSTRACT OF THE DISCLOSURE A disintegratable formulation of gemfibrozil providing both immediate and sustained release and com- prises a tablet compressed from a mixture of a first and second granulation, and a disintegration excipient operable to effect partial or complete disintegration in the stomach. The first granulation comprises finely divided particles of pure gemfibrozil granulated with at least one cellulose derivative and the second granu- lation comprises finely divided particles of pure gem- fibrozil granulated with a pharmaceutically acceptable water soluble or insoluble polymer which are then uni- formly coated with a pharmaceutically acceptable (meth)acrylate copolymer prior to admixture with the first granulation. The first and second granulations are present in the final composition in a ratio of from about 10:1 to about 1:10.

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