Labopharm Inc.

Francois Chouinard

Mircea Alexandru Mateescu

Vincent Lenaerts

Pompilia Ispas-Szabo

Wilfrid Jacques

The present invention relates to a solid slow release oral pharmaceutical dosage unit resistant to amylase which comprises a solid dosage unit made up of an admixture of a therapeutic dosage of an orally effective pharmaceutical agent, an optional polysaccharide or polyol, and high amylose starch, wherein the cross-linking of the high amylose starch has been carried out with a cross-linking agent with from about 0.1 g to about 40 g of cross-linking agent per 100 g of high amylose starch. In a preferred embodiment of the invention, the high amylose starch is modified with a functional group-attaching reagent that covalently bonds functional groups thereto.

Cross-linked high amylose starch having functional groups as a matrix for the slow release of pharmaceutical agents

Disclosed is a pharmaceutical controlled release tablet containing an active ingredient in combination with a carrier made of cross-linked amylose in which hydroxymethylpropylcellulose (HPMC) with a viscosity higher than or equal to 4000 cps is added as an adjuvant. The addition of HPMC to the tablet permits to control the effect of enzymes, and more particular alpha-amylase present in the intestinal medium, on the cross-linked amylose used as a carrier, and thus to reduce the dependence of the kinetics of release upon the concentration of enzymes present in the medium.

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Laval, Canada

Francois Chouinard