制造,优化和表征透式推拉药物输送系统的帕利佩里
Sayali A Nangare1,2, Asif H Ali2, Kakasaheb R Mahadik1
1Department of Pharmaceutics, Poona College of Pharmacy, Bharati Vidyapeeth Deemed University, Pune, Maharashtra, India.
这项研究开发了一种新型的双层巴利佩里片,为现有的三层配方提供了更简单,更具成本效益的替代方案. 新药片实现了与Invega®相似的药物释放概况,增强了帕利皮里的输送.
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:
- 帕利佩里是一种BCSII类药物,具有较低的溶解性和高透性,需要控制释放配方.
- 当前的透式推拉三层平板电脑提供延长释放,但存在复杂的制造,高成本和内容统一性问题.
研究的目的:
- 开发一种简化的,具有成本效益的双层药片用于paliperidone.
- 为了实现与参考上市药物Invega®相比较的药物释放概况.
主要方法:
- 通过调整核心和半透膜特性来制定和优化BILAYER片.
- 评估了固化时间,孔径大小和溶解数量对溶解的影响.
- 聚乙烯氧化物被用作核心和推进层中的孔形成剂.
主要成果:
- 优化的参数包括5小时的固化时间,7%的密封层,13%的ER层,0.6毫米的孔径大小和2个孔径.
- 准备好的药片符合重量变化,易碎性和硬度的综合标准.
- 一个F2值75.67表示溶解形状类似于Invega®.
结论:
- 成功开发的paliperidone双层药片克服了市场上三层配方的局限性.
- 新配方在工艺简单性,成本效益和更快的平板电脑核心制备方面提供了优势.
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