发明申请
- 专利标题: Multiple Unit Oral Sustained Release Preparation and Production Method Thereof
- 专利标题(中): 多单位口服缓释制剂及其制备方法
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申请号: US11795792申请日: 2006-01-30
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公开(公告)号: US20080107727A1公开(公告)日: 2008-05-08
- 发明人: Katashi Nakashima , Yoshinobu Aoki , Kazuo Kazama , Toshihiro Ishizaki
- 申请人: Katashi Nakashima , Yoshinobu Aoki , Kazuo Kazama , Toshihiro Ishizaki
- 优先权: JP2005-022797 20050131
- 国际申请: PCT/JP06/01401 WO 20060130
- 主分类号: A61K31/417
- IPC分类号: A61K31/417 ; A61K9/24 ; A61K9/52 ; A61K9/16
摘要:
A multiple-unit oral sustained release preparation is provided which allows controlled release of imidafenacin [4-(2-methyl-1-imidazolyl)-2,2-diphenylbutylamide]. The preparation serves to ensure a prolonged effect of imidafenacin and prevent rapid elevation in the blood levels of imidafenacin.Specifically, granules or powders comprising imidafenacin dispersed in a water-insoluble polymer or a higher alcohol are used in the preparation. These preparations achieve sustained release of imidafenacin since the molecular network structure that the water-insoluble polymer or the higher alcohol forms during the preparation of the granules or powders serves to control the rate of diffusion of imidafenacin in water. Granules comprising a core granule having two layers of an inner imidafenacin coating and an outer water-insoluble polymer coating are used in the preparation. The water-insoluble polymer coating serves to control the rate of diffusion of imidafenacin in water and ensure sustained release of imidafenacin. The multiple-unit oral sustained release preparation is provided in the forms of capsules and tablets containing the granules or powders that allow controlled release of imidafenacin. The preparation achieves controlled release of imidafenacin over a prolonged period of time.
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