发展肠道结肠药物输送系统用于关疾病:一个QbD方法
Roberto Arévalo-Pérez1, Cristina Maderuelo2, José M Lanao2
1Pharmaceutical Sciences Department - Pharmacy and Pharmaceutical Technology, Faculty of Pharmacy, University of Salamanca, C/ Licenciado Méndez Nieto s/n. 37007 Salamanca. Spain.
概括
这项研究优化了使用"设计质量"来治疗膜炎的结肠涂层甲基二醇片. 确定了聚合物比率和涂层重量等关键因素,以控制药物释放,以提高治疗疗效.
科学领域:
- 制药技术 制药技术 制药技术
- 药物输送系统 药物输送系统
- 结肠药物输送 结肠药物输送
背景情况:
- diverticulitis 治疗需要有效的结肠药物输送.
- 开发持续释放的甲尼达片,以向结肠作用至关重要.
- 设计质量 (QbD) 为制药产品开发提供了一种系统的方法.
研究的目的:
- 为了推进结肠涂层持续释放的美尼达矩阵片用于膜炎的开发.
- 应用QbD原则进行风险评估和流程优化.
- 建立一个可复制药物释放的设计空间.
主要方法:
- 使用的QbD方法,包括风险分析 (石川,RPN) 和风险评估.
- 使用的实验设计 (DOE) 具有分数因数设计 (28批).
- 通过直接压缩制造的片剂,并用pH或时间依赖的聚合物涂覆它们;使用ANOVA进行分析.
主要成果:
- 确定HPMC/奇托桑比率,混合时间,涂层聚合物和体重增加是影响药物释放的重要因素.
- 建立了10%和20%的体重增加配方的设计空间,定义了最佳参数范围.
- 制造工艺的稳定性已被证明,并确定了24小时控制性释放甲尼达的配方.
结论:
- 该研究使用QbD成功优化了metronidazole的结肠输送系统.
- 定义了关键工艺参数和材料属性,以实现强大的平板电脑制造.
- 开发的配方显示出在治疗分泌体炎时增强疗效的潜力.
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