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通过热挤出而没有进一步的下游工艺来制备无形固体分散的创新载体:用印梅他辛进行的案例研究

S P Lacerda¹, S Del Confetto¹, L Haurie¹

¹Centre RAPSODEE, Université de Toulouse, Albi, France.

Pharmaceutical development and technology

|January 18, 2024

概括

一种新型载体SepitrapTM显示出使用热挤出 (HME) 创造无形固体分散的潜力. 这种方法提高了水溶性较差的药物的溶性,并简化了制造工艺.

科学领域:

制药技术制药技术制药技术
材料科学材料科学材料科学

背景情况:

水溶性较差的药物往往需要诸如无形固体分散 (ASD) 等配方策略来提高生物可用性.
热挤出 (HME) 是产生ASD的高效技术,但载体选择至关重要.
塞皮特拉普 (SepitrapTM) 是一种微封装粉末溶解剂,此前未经测试用于基于HME的ASD配方.

研究的目的:

调查SepitrapTM作为通过HME制造的ASD载体的适用性.
评估SepitrapTM在提高水溶性较差药物的溶性方面的表现.

主要方法:

使用双螺杆挤出机进行热挤出加工.
使用两种SepitrapTM组合,用印米他辛作为模型药物,制备的无形固体分散剂.
改变了印梅他辛的药物负载,以评估不同条件下的载体性能.

主要成果:

塞皮特拉普TM证明了作为ASDs的HME处理载体的成功应用.
使用SepitrapTM有助于形成具有增强溶解性的无形固体分散物.
使用SepitrapTM加工可能会减少对下游加工步骤 (如研磨) 的需求.

结论:

塞皮特拉普 (SepitrapTM) 是一种可行的新载体材料,用于通过热挤出开发无形固体分散.
这种载体为水溶性较差的药物提供了简化制造途径.
进一步的研究可以探索SepitrapTM与更广泛的难溶性活性药物成分.

关键词:

无形固体分散物 (ASDs;),SepitrapTM (西皮特拉普TM) 是一种无形固体分散.溶解溶解是一种解体.热化挤出热化挤出可溶性增强提高可溶性稳定的稳定性稳定的稳定性

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