通过设计指导的质量系统开发和优化粘粘膜口膜的优化
Alharith A A Hassan1,2, Katalin Kristó1, Yousif H-E Y Ibrahim1,3
1Institute of Pharmaceutical Technology and Regulatory Affairs, University of Szeged, Eötvös u. 6., H-6720 Szeged, Hungary.
Pharmaceutics
|October 28, 2023
概括
这项研究优化了基于酸盐的粘粘膜口膜,使用质量设计 (QbD) 和实验设计 (DoE). 优化的电影展示了药物的统一分配和模型药物的立即释放.
科学领域:
- 制药科学 制药科学
- 材料科学 材料科学 材料科学
背景情况:
- 粘粘性口腔膜为药物药物输送提供了优势.
- 基于基托桑的薄膜因其粘膜粘合性而越来越受欢迎.
研究的目的:
- 根据设计质量 (QbD) 原则,开发和优化基于酸盐的粘膜口膜.
- 确定影响电影质量的关键材料属性和工艺参数.
主要方法:
- 通过设计质量 (QbD) 原则被应用来确定关键质量属性 (CQA).
- 风险评估确定了七个关键材料属性和过程参数.
- 三个实验设计 (DoE) 调查了这些参数对破裂硬度和粘粘度的影响.
- 选择了中等分子量奇托桑和甘油作为可塑剂.
主要成果:
- 酸盐度是影响薄膜CQAs,厚度和水分含量的最重要因素.
- 确定了最佳的干燥条件和造溶液量 (0.364 g/cm2).
- 为和酸度建立了一个设计空间,其中含有35%的甘油.
- 经过优化后的电影显示了药物的均分发和两个模型药物的立即释放.
结论:
- 通过设计质量 (QbD) 和实验设计 (DoE) 有效地促进了基托基粘膜口膜的优化.
- 开发的电影显示了有效的药物输送的潜力,尽管对于特定的药物配方可能需要进一步细化.
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