Ph independent extended release pharmaceutical formulation

Details Ph independent extended release pharmaceutical formulation Ph independent extended release pharmaceutical formulation

A - Human Necessities

61

K

A61K 9/20 (2006.01)

Patent

CA 2361496

Pharmaceutical formulations of acidic pharmacologic agents which demonstrate improved uniformity of release over the wide range of pH values encountered between the stomach and intestinal tract comprise an acidic pharmacologic agent dissolved or dispersed in a matrix comprising about 10 weight percent to about 40 weight percent of a neutral water-swellable hydrophilic polymer and 20 weight percent to about 50 weight percent of an acid-soluble polymer which swells in water at pH values above about 5. A particularly preferred formulation comprises divalproex sodium. Also disclosed are pre-tablet granulations and process for preparing both the pre-tablet granulation and the tablet unit dosage form.

L'invention porte sur des préparations pharmaceutiques d'agents pharmacologiques acides présentant une régularité améliorée de libération lorsque soumis aux grandes variétés de pH rencontrées entre l'estomac et l'intestin comportant un agent pharmacologique acide dissous ou dispersé dans une matrice comprenant d'environ 10 à 40 % en poids d'un polymère hydrophile neutre gonflant dans l'eau, et d'environ 20 à 50 % en poids d'un polymère soluble dans l'acide et gonflant dans l'eau à des pH supérieurs à 5. Une préparation nettement préférée comprend du sodium divalproex. L'invention porte également sur des granulés précurseurs de comprimés, sur leur procédé de préparation, et sur des comprimées dosés.

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