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描述双螺丝湿颗粒工艺的设计空间:延长释放片的案例研究
Nobel O Sierra-Vega1, Fahd M Alsharif1, Thomas O'Connor1
1Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20903, USA.
International journal of pharmaceutics
|December 9, 2023
概括
双螺丝湿颗粒优化是延长释放 (ER) 片的关键. 了解螺丝设计和操作参数可以确保所需的颗粒和平板性能,同时最大限度地降低加工风险.
科学领域:
- 制药技术 制药技术 制药技术
- 化学工程是化学工程的重要组成部分.
- 材料科学 材料科学 材料科学
背景情况:
- 双螺旋湿颗粒是一种先进的连续制造方法,用于固体口服剂型.
- 虽然即时释放片是成功的,但含有高聚合物含量的延长释放 (ER) 配方会带来开发挑战.
- 确定最佳设计空间对于一致的ER产品制造至关重要.
研究的目的:
- 系统地定义双螺丝湿颗粒化ER配方的最佳设计空间.
- 研究螺丝设计和操作参数对颗粒和平板特征的影响.
- 了解参数之间的相互作用及其对关键质量属性的影响.
主要方法:
- 使用了最终的选设计来评估螺丝速度,粉末料率和元素配置 (结和大小).
- 采用半机械模型来计算和验证使用追踪器的居住时间分布参数.
- 分析了工艺参数对颗粒流量,散装性质,平板电脑机械强度和药物释放概况的影响.
主要成果:
- 增加螺丝转速减少了平均停留时间;较高的粉末料率或制元件增加了它.
- 螺丝设计和操作参数显著影响了颗粒流量和散装特性.
- 螺丝速度是影响平板破裂强度的主要因素,颗粒性质影响了药物早期释放.
结论:
- 同时优化操作和螺丝设计参数对于生产高性能ER颗粒和平板至关重要.
- 这种方法有效地减轻了加工风险,例如材料胀.
- 该研究为复杂的ER配方的稳健连续制造提供了一个框架.
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