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双螺丝湿颗粒剂的扩大规模:配方特性的影响

Marcel Franke^1,2, Thomas Riedel¹, Robin Meier³

¹Department of Pharmaceutical Technologies, Merck Healthcare KGaA, Darmstadt, Germany.

Pharmaceutical development and technology

|October 27, 2023

概括

这项研究探讨了不同药物配方在扩展过程中如何响应工艺变化. 通过配方实现了强大的颗粒和平板电脑性能,证明了独立于药物性能的成功扩展.

科学领域:

制药技术制药技术制药技术
工艺工程的过程工程.
药物的配方药物的配方

背景情况:

扩大制药制造工艺的规模需要了解配方对工艺参数的敏感性.
双螺丝湿颗粒是一种对配方成分和工艺控制敏感的关键单元操作.

研究的目的:

调查三种不同的药物配方在扩大过程中对处理参数变化的敏感性.
评估API溶解度和助剂成分对颗粒化行为和最终药片质量的影响.
评估不同配方类型的扩展过程的稳定性.

主要方法:

使用QbCon®设备进行了扩大规模的实验,从16mm转变为25mm的螺丝直径.
测试了三种配方:两种具有不同API溶解度的配方和一种具有高HPMC含量的受控释放配方.
测量了颗粒尺寸分布 (GSD) 和平板电脑的抗拉强度,以评估工艺结果.

主要成果:

在研磨前观察到颗粒大小分布的显著差异,表明了依赖规模的行为.
在研磨后,颗粒性质和平板拉伸强度在所有配方中保持一致和稳固.
成功实现了扩展,在200MPa压缩压力下,平板电脑的抗拉强度超过1.8MPa.

结论:

双螺丝湿颗粒加工过程证明了强度,允许成功扩展,无论配方类型或API溶解度如何.
精心优化液体/固体 (L/S) 比率对于每个配方至关重要,因为水吸收和颗粒化行为的变化.
开发的扩展战略确保了产品质量的一致性,强调了磨削后表征的重要性.

关键词:

连续制造连续制造制造连续流体床干燥连续流体床干燥连续的湿颗粒处理.过程缩放过程缩放.扩大规模的扩大规模双螺丝颗粒剂的颗粒化方法

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