滚筒压缩对同时压缩的微型和微型板的质量属性的影响
Bilge Selvi1, Naseer Alam2, Saikishore Meruva1
1Drug Product Development, Bristol Myers Squibb, NJ, USA.
International journal of pharmaceutics
|October 2, 2024
概括
使用一种新的同时压缩方法,开发低剂量小药片是可行的. 滚筒压缩显著改善了内容统一性和剂量准确性,证明了优质小平板生产的可行方法.
科学领域:
- 制药技术 制药技术 制药技术
- 药物输送系统 药物输送系统
- 固体剂量形式 固体剂量形式
背景情况:
- 开发低剂量迷你药片在实现统一的药物含量和重量方面存在挑战.
- 布洛芬 (IBU) 被用作模型化合物来研究关键过程参数.
研究的目的:
- 评估一种新的同时压缩方法的可行性,用于生产多个小平板尺寸.
- 系统地研究易布洛芬颗粒大小,度,滚子压缩力和迷你片大小对质量属性的影响.
主要方法:
- 布洛芬粉末的滚筒压缩,然后同时压缩成不同尺寸 (1.2,1.5,2毫米) 的小盘子.
- 带,颗粒和微粒的物理-机械性能,重量均性和含量均性 (CU) 的表征.
主要成果:
- 滚筒压缩力是影响带特性和颗粒大小的主要因素.
- 通过滚筒压缩生产的小盘显示,与直接压缩相比,内容均性得到了改善.
- 迷你药片大小是唯一一个在统计学上显著的因素,可以提高效能和内容统一性.
结论:
- 新型的同时压缩方法与滚筒紧缩相结合,可用于生产高质量的低剂量小盘.
- 对于强大的下游处理和剂量统一性,建议每剂量单位至少25分贝.
- 精确的工具控制对于在同时生产时保持一致的小平板质量至关重要.
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