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Updated: Sep 15, 2025

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固体自我分散的欧特基挤出物的球体化:一个小规模的可行性研究.

Peter Schlosser¹, Heike Bunjes¹

¹Technische Universität Braunschweig, Institut für Pharmazeutische Technologie und Biopharmazie, Mendelssohnstraße 1, 38106 Braunschweig, Germany; Technische Universität Braunschweig, Zentrum für Pharmaverfahrenstechnik - PVZ, Franz-Liszt-Straße 35A, 38106 Braunschweig, Germany.

International journal of pharmaceutics

|July 15, 2025

概括

挤出/球体化成功地从聚乙烯糖醇-40-酸盐和像布洛芬这样的API中产生了脂质颗粒. 工艺温度调整和API度影响了颗粒质量和API颗粒大小.

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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:

双螺丝挤出是有效的创建自我分散的eutectics.
脂质颗粒是难溶活性药物成分 (API) 的宝贵载体.
由于可变的化范围,欧特克挤出材料在球化方面存在挑战.

研究的目的:

为了研究脂质颗粒的挤出/球体化的可行性.
评估API度对挤出物质和球体化的影响.
评估球化对API颗粒大小的影响.

主要方法:

小规模挤出/球体化 (10和20g批) 聚乙烯甘-40-酸盐与纤维酸盐或布洛芬.
研究的挤出物在,低于,和高于eutectic度.
分析了机械性能和API粒子大小的变化.

主要成果:

在没有API的挤出物中,成功地实现了球体化,使用易布洛芬,以及在欧特克度以下的费诺纤维酸.
降低工艺温度是必要的,因为API度增加以防止粘附.
与布洛芬一起出的物质比与芬诺纤维酸一起的物质表现出更好的圆形.
在球化过程中,API粒子大小 (d50) 减少了1-3微米.

关键词:

优德策略是什么意思优德策略聚乙烯甘的 Ester 是一种聚乙烯甘的.自己分散的自我分散.球体化是指球体化.双螺丝挤出双螺丝挤出双螺丝挤出

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结论:

挤出/球体化是一种可行的方法,用于生产含有API的脂质颗粒.
API类型和度显著影响球化参数和结果.
该过程可以减少API颗粒大小,潜在地增强溶解.