发明申请
US20100215744A1 Hydroxypropyl Substitution Used to Regulate Dissolution of a Chemical
审中-公开
用于调节化学溶解度的羟丙基取代基
- 专利标题: Hydroxypropyl Substitution Used to Regulate Dissolution of a Chemical
- 专利标题(中): 用于调节化学溶解度的羟丙基取代基
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申请号: US12756962申请日: 2010-04-08
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公开(公告)号: US20100215744A1公开(公告)日: 2010-08-26
- 发明人: David Watt , Steven B. Newhard
- 申请人: David Watt , Steven B. Newhard
- 专利权人: MEDICIS PHARMACEUTICAL CORPORATION
- 当前专利权人: MEDICIS PHARMACEUTICAL CORPORATION
- 主分类号: A61K9/22
- IPC分类号: A61K9/22 ; A61K31/65 ; A61P43/00
摘要:
A method of producing a batch of a tetracycline-class component HPMC extended release pharmaceutical product having a desired dissolution profile, comprising: selecting a dissolution rate-controlling polymer comprising an HPMC component, the HPMC component having a selected % HP value; validating that the % HP in the selected HPMC component is such that a mean sample of the product complies with the desired dissolution profile over each time point in the dissolution profile, and preparing the product by preparing a formulation comprising a pharmaceutically effective amount of the tetracycline-class chemical and the selected HPMC component with the % HP value. There is also provided a method of predicting the dissolution rate profile over a number of dosage forms.
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