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响应表面方法 (RSM) 方法来制定和优化二层组合片剂的tamsulosin和finasteride
Muneeba Akhtar1, Muhammad Zaman1, Ahsan Zamir Siddiqi2
1Faculty of Pharmaceutical Sciences, University of Central Punjab, Lahore, Pakistan.
概括
这项研究使用响应表面方法开发了一种双层药片,用于坦素 (TAM) 持续释放和芬asteride (FIN) 立即释放. 优化的配方表现出有效的药物释放动力学,表明异常扩散.
科学领域:
- 制药科学 制药科学
- 药物输送系统 药物输送系统
背景情况:
- 比拉耶 (Bilayer) 片为具有不同释放特征的药物同时使用提供了一个有前途的方法.
- 坦素 (TAM) 用于良性前列腺增生症,需要持续释放 (SR).
- 费纳斯特 (FIN) 用于治疗雄激素性脱毛症,需要立即释放 (IR).
研究的目的:
- 制定和优化一个口服的双层药片,含有TAM (SR) 和FIN (IR).
- 为了研究药物释放动力学和优化双层药片配方的机制.
主要方法:
- 用中央复合材料设计的响应表面方法用于配方优化.
- 独立变量包括基甲基纤维素 (HPMC),阿维塞尔PH102,Triacetin和塔尔克.
- 药片是通过直接压缩制造的,并对物理性质和体外药物释放进行了评估.
- 药物释放数据使用各种运动模型 (例如,科尔斯迈耶-佩帕,希古奇) 进行分析.
主要成果:
- 优化的配方在体外药物释放率为24.63% (0.5小时),52.96% (2小时) 和97.68% (6小时).
- 药物释放跟随第一阶动力学,最好的解释是科尔斯迈耶-佩帕模型 (R2 = 0.9693).
- 药物释放机制被确定为异常扩散 (n=0.4),表明扩散与侵蚀相结合.
结论:
- 成功开发了一种稳定有效的双层药片配方,用于同时使用坦素和费纳斯特.
- 优化的配方表现出适合治疗应用的受控药物释放特征.
- 这项研究提供了对双释放双层药片的药物释放机制的见解.
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