Process for producing an oral sustained-release preparation of fasudil hydrochloride
申请人:ASAHI KASEI PHARMA CORPORATION
公开号:US20040131679A1
公开(公告)日:2004-07-08
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.
本发明公开了一种口服缓释制剂,其含有从羟氯喹硫酸盐和其水合物组成的群中选择的至少一种活性成分,该制剂包括至少一种缓释包被粒子,其包括具有表面的核心和形成在核心表面上的涂层,其中核心含有活性成分,涂层包括涂层基材料和特定的不溶性辅助材料,且该制剂展现出特定的溶解速率,如溶解测试所测量的。通过使用本发明的口服缓释制剂,可以确保控制羟氯喹硫酸盐的释放,从而使活性成分的效果持续较长时间。因此,可以减轻服用制剂的患者的负担,并提高对制剂的管理的遵从性。还公开了一种评估口服缓释制剂的方法,该方法与活性成分的缓释能力有关。