用于局部应用的半固体剂型的配方,采用设计质量 (QbD) 方法
Eni Bushi1,2, Ledjan Malaj1, Piera Di Martino3
1Department of Pharmacy, University of Medicine Tirana, Tirana, Albania.
Drug development and industrial pharmacy
|April 26, 2025
概括
本研究引入了设计质量 (QbD) 框架,用于开发局部半固体配方,超越经验方法. 实施该框架有助于开发稳定有效的局部产品.
科学领域:
- 制药科学 制药科学
- 药物输送系统 药物输送系统
- 制定 发展 制定 发展
背景情况:
- 局部半固体配方的开发传统上依赖于经验方法.
- 尽管取得了进展,但目前还缺乏用于局部半固体设计的系统框架.
研究的目的:
- 为合理设计和开发局部半固体产品建立设计质量 (QbD) 框架.
- 从经验方法转向以科学和风险为基础的方法.
主要方法:
- 进行了全面的文献审查,以确定使用QbD开发局部半固体配方的关键因素.
- 基于定义质量目标产品配置文件 (QTPP),确定关键质量属性 (CQA),关键材料属性 (CMA) 和关键过程参数 (CPP) 的基础上构建了一个QbD框架.
主要成果:
- 局部产品的QTPP通常包括剂型,施用途径和保质期.
- 确定了关键的CMA (API和辅助物特性) 和CPP (温度,混合速度) 对CQA的影响.
- 该框架概述了了解CMA和CPP对CQA的影响以及建立控制策略.
结论:
- 一个QbD框架为局部半固体配方开发提供了一个结构化的方法.
- 对API和药物输送系统的彻底描述对于成功的配方至关重要.
- 这种系统方法最大限度地降低了开发风险,并提高了产品的稳定性,可接受性和耐受性.
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