探索散装模块材料和在制药化合物的湿珠磨削过程中磨削效率之间的关系
Zahra Salahshoor1, Parind M Desai1, Sayantan Chattoraj1
1Drug Product Development, Medicine Development & Supply, GSK R&D, PA, USA.
International journal of pharmaceutics
|June 23, 2024
概括
本研究确定了活性药物成分 (API) 属性,可以预测湿珠磨削 (WBM) 中的磨削效率. 大量Young's Modulus是影响颗粒大小减少的关键因素,有助于在制造长效注射悬浮剂的早期风险评估.
科学领域:
- 制药制造业 制药制造业 制药制造业
- 材料科学 材料科学 材料科学
- 化学工程是化学工程的重要组成部分.
背景情况:
- 湿珠磨粉 (WBM) 对于通过减少活性药物成分 (API) 颗粒大小来生产长效注射剂 (LAI) 悬浮剂至关重要.
- 在WBM过程中高效地达到目标颗粒大小,往往会受到长时间的削时间的阻碍,从而影响整体工艺效率.
研究的目的:
- 为了确定内在的活性药物成分 (API) 属性,可以预测湿珠磨削 (WBM) 过程中磨削效率.
- 建立LAI暂停开发早期风险评估的基础.
主要方法:
- 对九种不同的API进行物理和机械性质的表征.
- 使用湿珠磨粉 (WBM) 制造API配方.
- 使用实证函数评估削效率,削阻力 (φ).
主要成果:
- 大量年轻模块被确定为影响WBM过程中粒子磨损速度的重要因素.
- API Young的模块的排名顺序与其削效率相关,用削阻力 (φ) 来衡量.
- 磨阻力 (φ) 整体考虑了磨时间,尖端速度,珠子负载和批量与室内体积比.
结论:
- 内在的材料特性,如Bulk Young's Modulus,可以预测WBM过程中的削效率.
- 对API属性的早期评估有助于识别和减轻制药产品开发中的扩展挑战.
- 这种方法允许对有限量的材料进行风险评估,优化LAI悬浮制造.
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