通过设计优化异热干颗粒涂层的质量,以增强万科米的口腔透
Anthony Rajabi1, Affiong Iyire2, David Wyatt3
1Aston Pharmacy School, College of Health and Life Sciences, Aston University, Birmingham, B4 7ET, UK.
Scientific reports
|November 25, 2025
概括
同热干颗粒涂层 (iDPC) 提供了一种可扩展的,无溶剂的方法,用于增强口传递的生物制剂,如万科米. 这种技术可以改善药物透率和含量统一性,用于非侵入性治疗应用.
科学领域:
- 制药技术 制药技术 制药技术
- 生物材料科学 生物材料科学
- 药物输送系统 药物输送系统
背景情况:
- 巨分子口服由于高分子量和降解而面临挑战,需要对大多数生物制剂进行侵入性管理.
- 口腔分娩提供了一个非侵入性的替代方案,绕过第一通代谢并改善患者的服从性.
研究的目的:
- 评估异热干颗粒涂层 (iDPC) 作为一种可扩展的,无溶剂的方法,用于增强菌素的口腔透.
- 使用设计质量 (QbD) 框架和实验设计 (DoE) 来优化iDPC处理参数.
主要方法:
- 使用实验设计 (DoE) 方法与中央复合面 (CCF) 设计来调查影响关键质量属性 (CQA) 的关键过程参数 (CPP).
- 评估了预处理时间,处理时间,流量,鼓速度和氨基酸度对内容均性和口腔透性的影响.
- 采用回归建模和4D设计空间,以确定万科米辛口腔输送的最佳操作条件.
主要成果:
- 增加L-谷氨酸度和鼓速度显著增强口腔透.
- 处理时间和鼓速度是提高内容统一性的关键因素.
- 优化条件实现了高透率 (高达60%) 和优异的内容均性 (0.93-6.29% RSD).
结论:
- 异热干颗粒涂层 (iDPC) 是一种强大的,无溶剂的制造方法,用于生物制品的口腔输送.
- 由QbD驱动的DoE为开发控制策略提供了一个框架,并支持对非侵入性大分子疗法的监管灵活性.
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