Diltiazem controlled release formulation and method of...

Details Diltiazem controlled release formulation and method of... Diltiazem controlled release formulation and method of...

A - Human Necessities

61

K

A61K 9/16 (2006.01) A61K 9/50 (2006.01) A61K 9/58 (2006.01) A61K 9/62 (2006.01) A61K 31/554 (2006.01)

Patent

CA 2338070

A controlled release diltiazem dosage formulation comprising a plurality of active pellets coated with an extended release coating wherein the active pellets contain diltiazem or a pharmaceutically acceptable salt, a pharmaceutically acceptable inert seed and a binder and the extended release coating contains a water insoluble water permeable polymer, a channeling agent, a lubricant and optionally a surfactant. A single batch intermittent method and manufacturing a heterogeneous population of extended release pellets for use as a dosage formulation is also disclosed.

L'invention concerne une formulation posologique à libération lente à base de diltiazem. Cette formulation comprend une pluralité de granules actifs recouvert d'un revêtement à libération lente. Ces granules actifs contiennent du diltiazem ou un sel pharmaceutiquement acceptable, une graine inerte pharmaceutiquement acceptable et un liant tandis que le revêtement à libération lente contient un polymère perméable à l'eau et non soluble dans l'eau, un agent de canalisation, un lubrifiant et éventuellement un tensioactif. L'invention concerne également un procédé intermittent en un seul lot permettant de fabriquer une population hétérogène de granules à libération lente destinés à être utilisés comme formulation posologique.

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