在固定剂量组合单层片剂中增强了蒙特卢卡斯特和利沃西的稳定性和兼容性
Tae Han Yun1, Moon Jung Kim1, Jung Gyun Lee1
1Department of Pharmaceutical Engineering, Gyeongsang National University, 33 Dongjin-ro, Jinju 52725, Republic of Korea.
Pharmaceutics
|July 27, 2024
概括
这项研究开发了一种含有蒙特卢卡斯特和莱沃提里津的稳定定剂量组合 (FDC) 片. 优化的配方和分离颗粒剂确保了药物兼容性,并满足了稳定性要求.
科学领域:
- 制药科学 制药科学
- 药物的配方 药物的配方
- 药用化学 医学化学
背景情况:
- 蒙特卢卡斯特和莱沃提里津通常用于过敏症.
- 开发固定剂量组合 (FDC) 药片可以提高患者的服药量.
- 确保FDC中的两个活性药物成分 (API) 的稳定性和兼容性至关重要.
研究的目的:
- 开发一种稳定的固定剂量组合 (FDC) 单层蒙特卢卡斯特和莱沃西片.
- 评估药物辅助剂的兼容性,并优化配方以提高稳定性.
- 确保FDC平板电脑符合与商业产品相比的质量和性能标准.
主要方法:
- 药物兼容性通过在60°C储存蒙特卢卡斯特和勒沃西里辛混合物来评估.
- 辅助剂的选择是基于对杂质形成的最小贡献.
- 蒙特卢卡斯特-莱沃提里津FDC片使用单独的湿颗粒与酸作为pH稳定剂进行制备.
- 进行了比较溶解和加速稳定性研究 (40°C/75%RH6个月).
主要成果:
- 单独的颗粒和使用特定的辅助剂 (曼尼托,微晶纤维素,克罗斯卡梅洛斯,高,酸) 最小化药物相互作用和杂质增加.
- 准备好的FDC药片表现出与商业产品相比的溶解概况.
- 稳定性测试证实,药物含量,溶解率和杂质水平在6个月后仍然符合接受标准.
结论:
- 一个稳定的蒙特卢卡斯特-莱沃提利津FDC单层药片成功开发.
- 配方策略,包括分离颗粒和pH稳定,有效地提高了药物的稳定性.
- 开发的FDC药片为现有的商业配方提供了可行的替代方案.
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