关于原材料属性的对流程行为和产品质量的影响,在连续WET颗粒制剂片片生产线中
Ožbej Zupančič1, Aygün Doğan1, Rúben Martins Fraga1
1Research Center Pharmaceutical Engineering GmbH, Inffeldgasse 13, 8010 Graz, Austria.
International journal of pharmaceutics
|June 2, 2023
概括
这项研究表明,原材料特性和配方如何影响连续口服固体制造. 工艺设置显著影响颗粒和片质量,这对于药物产品的一致性性能至关重要.
科学领域:
- 制药技术 制药技术 制药技术
- 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:
- 口服固体的连续制造整合了关键材料属性 (CMA),配方和关键过程参数 (CPP).
- 评估这些因素对中间和最终产品的关键质量属性 (CQA) 的影响是具有挑战性的.
研究的目的:
- 评估原材料特性和配方成分如何影响颗粒和片的可加工性和质量.
- 为了在连续的粉末到平板制造线上研究这些效应.
主要方法:
- 使用集成连续制造线 (ConsiGmaTM 25) 进行粉末到平板电脑的加工.
- 使用了四种配方,药物负载不同 (2.5%和25%w/w) 和生物制药分类系统 (BCS) 类 (I和II).
- 调整了液体/固体比率和颗粒干燥时间,以创建标称,干燥和湿颗粒条件.
主要成果:
- 生物制药分类系统 (BCS) 的类别和药物剂量显著影响了可处理性.
- 干燥损耗和颗粒大小分布等中间属性与原材料特性和工艺参数直接相关.
- 平板电脑的特性,包括硬度,分解时间,可湿性和多孔性,都受到工艺设置的深刻影响.
结论:
- 原材料属性和配方设计是连续制造中可加工性的关键决定因素.
- 优化过程参数对于控制中间和最终产品质量至关重要.
- 这项研究为开发口服固体剂型的稳健连续制造工艺提供了宝贵的见解.
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