Oral sustained-release preparation of fasudil hydrochloride

Details Oral sustained-release preparation of fasudil hydrochloride Oral sustained-release preparation of fasudil hydrochloride

A - Human Necessities

61

K

A61K 31/55 (2006.01) A61K 9/50 (2006.01) A61K 31/551 (2006.01)

Patent

CA 2334120

Disclosed is an oral sustained-release preparation which contains at least one active ingredient selected from the group consisting of fasudil hydrochloride and a hydrate thereof, the preparation comprising at least one sustained-release coated particle comprising a core having a surface and a coating formed on the surface of the core, wherein the core contains the active ingredient and the coating comprises a coating base material and a specific insoluble auxiliary material, and wherein the preparation exhibits, with respect to the active ingredient, a specific dissolution rate, as measured by the dissolution test. By using the oral sustained-release preparation of the present invention, it becomes possible to surely control the release of fasudil hydrochloride from the preparation, so that the effect of the active ingredient is maintained for a long period of time. Therefore, the burden of the patient who has to take the preparation can be decreased and the compliance with :respect to the administration of the preparation can be improved. Also disclosed is a method for evaluating an oral sustained-release preparation containing the active ingredient, wherein the evaluation is conducted with respect to the sustained-release ability of the active ingredient.

L'invention concerne des préparations orales à libération prolongée, contenant au moins un principe actif choisi dans le groupe constitué du chlorhydrate de fasudil et de son hydrate. Ces préparations se caractérisent en ce qu'elles contiennent au moins une particule enrobée, à libération lente, consistant en un noyau comportant une surface et en un film enrobant la surface ; le noyau contenant le ou lesdits principes actifs et le film contenant une base d'enrobage et un substance insoluble spécifique ; et en ce qu'elles présentent une vitesse d'élution spécifique du ou des principes actifs lorsqu'ils sont soumis à un essai d'élution. Grâce à ces préparations, on peut maîtriser de manière sûre l'élution du ou des principes actifs desdites préparations et on peut prolonger les effets du ou des principes actifs sur une longue période, ce qui permet de rendre moins lourde la prise de médicaments par le patient, et d'améliorer l'observance médicamenteuse. Un procédé d'évaluation des propriétés de libération du ou des principes actifs des préparations orales à libération prolongée est également décrit.

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