An oral preparation having improved bioavailability

Details An oral preparation having improved bioavailability An oral preparation having improved bioavailability

A - Human Necessities

61

K

A61K 31/426 (2006.01) A61K 47/02 (2006.01) A61K 47/30 (2006.01) A61P 19/10 (2006.01)

Patent

CA 2585003

The present invention relates to an oral preparation of N-hydroxy-4- {5- [4- (5-isopropyl-2 -methyl- 1, 3-thiazol-4-yl)p henoxy] pentoxyl -benzamidine having improved bioavailability . More particularly, the present invention relates to an oral preparation comprising: N-hydroxy-4- {5- [4- (5-isopropyl-2- methyl-l, 3-thiazol-4- yl) phenoxy] pentoxy} -benzamidine or pharmaceutically acceptable salt thereof; and one or more carbonates selected from the group consisting of alkalimetal carbonate, alkalimetal bicarbonate and alkaline earth metal carbonate, and/or one or more disintegrants selected from the group consisting of sodium starch glycolate, carmellose calcium and croscarmellose sodium. The oral preparation according to the present invention inhibits gelation of N-hydroxy-4- {5- [4- (5-isopropyl-2-methyl-l, 3-thiazol-4- yl) p henoxy] pentoxy} -benzamidine or pharmaceutically acceptable salt thereof in the early stage of release, which increases dissolution rate and remarkably raises bioavailability.

Cette invention concerne une préparation orale de N-hydroxy-4- {5- [4- (5-isopropyl-2 -methyl- 1, 3-thiazol-4-yl)phenoxy] pentoxyl -benzamidine présentant une biodisponibilité améliorée. Cette invention concerne en particulier une préparation orale renfermant: N-hydroxy-4- {5- [4- (5-isopropyl-2-methyl-l, 3-thiazol-4- yl) phenoxy] pentoxy} -benzamidine ou ses sels pharmaceutiquement acceptables ainsi qu'un ou plusieurs carbonates sélectionnés dans le groupe constitué de carbonate de métal alcalin, de bicarbonate de métal alcalin et de carbonate de métal alcalino-terreux et/ou d'un ou plusieurs désintégrateurs sélectionnés dans le groupe constitué de glycolate d'amidon sodique, de calcium de carmellose et de sodium de croscramellose. La préparation orale selon l'invention inhibe la gélification de N-hydroxy-4- {5- [4- (5-isopropyl-2-methyl-l, 3-thiazol-4-yl) phenoxy] pentoxy} -benzamidine ou de ses sels pharmaceutiquement acceptables à un stade précoce de libération, ce qui augmente la vitesse de dissolution et améliore remarquablement la biodisponibilité.

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