为难溶性药物制备自我分散的欧混合物:热挤出与造造
Peter Schlosser1, Heike Bunjes1
1Technische Universität Braunschweig, Institut für Pharmazeutische Technologie und Biopharmazie, Mendelssohnstraße 1, 38106 Braunschweig, Germany; Technische Universität Braunschweig, Zentrum für Pharmaverfahrenstechnik, Franz-Liszt-Straße 35A, 38106 Braunschweig, Germany.
International journal of pharmaceutics
|May 5, 2025
概括
聚乙烯甘醇-40-酸盐与纤维酸盐或伊布罗芬的固体欧性混合物经过造和双螺丝挤出处理. 挤出增强了药物再结晶和溶解率,特定的螺丝配置影响了颗粒大小.
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
- 药物运输 药物运输 药物运输
背景情况:
- 固体体混合物提供了改善药物的可溶性和溶解的潜力.
- 聚乙烯甘醇-40-酸盐 (PEG-40-酸盐) 是一种适用于固体分散的自分散辅助剂.
- 费诺纤维酸和布洛芬是具有不同物理化学性质的模范活性药物成分 (API).
研究的目的:
- 为了比较PEG-40-酸盐与纤维酸盐或布洛芬的固体性混合物的可加工性和溶解率.
- 评估造与双螺丝挤出对混合物特性的影响.
- 为了研究在挤出过程中不同螺丝配置 (剪切与输送机) 的影响.
主要方法:
- 通过造和双螺丝挤出来制备固体欧性混合物.
- 处理能力的分析,重点是重结晶行为.
- 在挤出材料中的API颗粒大小 (d50) 的表征.
- 评估溶解速率在,低于和高于eutectic度.
主要成果:
- 挤出促进了布洛芬混合物的成功处理,克服了在造中观察到的不良再结晶.
- 挤出剂显示了API颗粒大小的减少与API度的增加,受益于ibuprofen的螺丝配置.
- 所有造样品和挤出材料的溶解率与物理混合物和纯API相比显著更高.
- 对于超出性度的费诺纤维酸挤出物,观察到更高的溶解率.
结论:
- 双螺杆挤出是一种可行的方法,用于制备具有增强溶解性质的固体欧性混合物.
- 挤出参数,包括螺丝配置,可以影响API粒子大小和可加工性.
- 固体体混合物,特别是当通过挤出制备时,证明了纤维酸和布洛芬的改善药物释放概况.
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