使用质量设计原则将Xalkori儿科多颗粒物产品商业化
Jeremy Bartlett1, Natalie Culver1, Xiang Zhang1
1Pfizer, Eastern Point Road, Groton, CT 06340, USA.
Pharmaceutics
|August 29, 2024
概括
通过使用质量设计原则开发了crizotinib (Xalkori) 的新型儿科剂型. 这种节约材料的方法确保了在儿科患者灵活剂量的特殊含量统一性.
科学领域:
- 制药科学 制药科学
- 药物输送系统 药物输送系统
- 儿科配方 儿科配方 儿科配方
背景情况:
- 克里佐替尼 (Xalkori) 已被批准用于特定的儿科癌症,但需要一个合适的剂型.
- 现有的配方可能会给儿科的使用带来挑战,特别是在吞和精确剂量方面.
研究的目的:
- 开发和商业化使用质量设计 (QbD) 原则的儿童用克里佐替尼 (Xalkori) 剂型.
- 为儿科配方创建一个节约材料的制造工艺.
主要方法:
- 含有晶体crizotinib的球形多颗粒物 (微球/颗粒) 使用化喷雾凝固制造.
- 通过流体床涂层涂上屏障涂层,然后进行封装.
- 实验设计 (DOE) 和设备修改用于优化封装过程.
主要成果:
- 开发的剂型由涂层颗粒组成,具有较高的药物负载 (60%) 剂量灵活性.
- 该配方通过打开囊和结合强度,为儿科患者提供出色的吞性和剂量灵活性.
- 采用QbD和节约材料的方法使得内容的统一性异常高,超过了USP<905>标准.
结论:
- 一个QbD驱动的,节约材料的过程成功地产生了一种具有高含量均性的儿科crizotinib剂型.
- 这种创新的配方解决了在儿科瘤学中灵活剂量和易于管理的关键需求.
- 开发的制造工艺表现出稳健性,并为未来的批量生产充满信心.
关键词:
在商业化,商业化.实验的设计 (DOE)剂量灵活性 剂量灵活性脂质多颗粒物是一种多颗粒物.材料节约的方法.化喷雾凝结 (MSC) 是一种这些微球是微球.多颗粒物是一种多颗粒物.儿科 儿科 儿科 儿科颗粒 颗粒 颗粒过程优化优化过程优化设计中的质量 (QbD)味道掩饰是一种口味掩饰.一致性是一致性.容量测量剂量仪 容量测量剂量仪更多相关视频
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