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设计合溶性三级胰岛素-糖-聚合物系统,增强无形玻璃稳定性
Claudia Giannachi1, Evin Allen2, Sonja Vucen1
1SSPC, the Research Ireland Centre for Pharmaceuticals, School of Pharmacy, University College Cork, T12 YT20, Ireland.
概括
高玻璃过渡温度 (Tg) 的聚合物增强了口服剂型的无形配方的稳定性. 优化的配方显示了Tg和RHg的改善,这对于制造和储存至关重要.
科学领域:
- 制药科学 制药科学
- 材料科学 材料科学 材料科学
- 生物技术是生物技术.
背景情况:
- 解热化无形配方需要稳定,以获得口服剂型.
- 温度和湿度的挑战会影响制造,储存和处理期间的配方稳定性.
研究的目的:
- 使用高玻璃过渡温度 (Tg) 聚合物增强胰岛素-糖配方的玻璃稳定性.
- 研究胰岛素,糖糖和聚合物组成对配方Tg和初始玻璃过渡湿度 (RHg) 的影响.
主要方法:
- 用实验方法的混合设计来研究配方成分效应.
- 通过实验确定了玻璃过渡温度 (Tg) 和初始玻璃过渡湿度 (RHg).
- 建立了统计回归模型来分析组成-参数关系.
主要成果:
- 胰岛素含量对Tg和RHg都有负面影响.
- 胰岛素-糖和胰岛素-聚合物相互作用增加了Tg和RHg,提高了玻璃的稳定性.
- 在PVPVA配方中的相隔影响了模型的准确性.
结论:
- 三级胰岛素-糖-聚合物配方显著提高玻璃的稳定性.
- 优化的配方 (26%的胰岛素,40%的糖,34%的PVP) 预测Tg为82°C和RHg为60%的RH.
- 增强的稳定性为基于的口服剂型提供了优势.
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