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药品HME中的液体API料:固体剂量制造中的新选项

Lisa Kuchler¹, Martin Spoerk², Simone Eder¹

¹Research Center Pharmaceutical Engineering GmbH, Inffeldgasse 13, 8010 Graz, Austria.

International journal of pharmaceutics

|December 11, 2023

概括

药品热挤出 (HME) 中的液体侧料提供了准确和灵活的活性药物成分 (API) 交付. 这种先进的方法保证了挤出剂中均的API含量,使灵活的连续制造和个性化剂型成为可能.

科学领域:

制药科学制药科学
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:

热挤出 (HME) 是一个关键的制药制造工艺.
传统的粉末养方法在HME缺乏灵活性,并可能导致API不均性,特别是低剂量配方.
连续制造需要敏捷和精确的养策略.

研究的目的:

为了证明液体侧在制药HME中的普遍适用性.
为了评估液体养对API含量统一性,残留水分和固体状态的影响.
建立液体侧作为连续制药制造的灵活和灵活的替代方案.

主要方法:

各种活性药物成分 (API) 被悬浮或溶解在水中.
这些液体配方 (悬浮剂,溶液) 被侧向输入挤出机前部.
对挤出物进行了API含量,残留水分和API固态分析.

主要成果:

通过不同的液体料策略 (悬浮,各种度的溶液),在挤出物中实现了统一的API含量.
挤出剂中的残留水分含量足够低,可以进行进一步加工.
嵌入式API的固态状态不受影响,确保药物产品的质量.

结论:

液体侧料是一种通用且有效的方法,可以通过HME将API纳入聚合物.
这种技术增强了过程控制,为连续制造提供了准确和敏捷的API交付.
它支持个性化药物的开发,并整合了药物和药物制品的制造.

关键词:

连续制造连续制造制造热挤出 (HME) 是一种热挤出技术.液体养液体养液体养液体养固态状态的固体状态

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