了解辅助剂在固体剂型中的水分管理中的作用
Natalia Veronica1, Paul W S Heng1,2, Celine V Liew3
1GEA-NUS Pharmaceutical Processing Research Laboratory, Department of Pharmacy and Pharmaceutical Sciences, National University of Singapore, 18 Science Drive 4, Singapore 117543, Singapore.
Molecular pharmaceutics
|April 22, 2024
概括
与化或酸共同处理玉米粉增强了其水分相互作用,改善了药物的稳定性. 这种方法提供了一种协同方法,以减轻制药配方中的水分影响.
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:
- 助剂对于制药产品的质量和稳定性至关重要.
- 药物中对水分的敏感性在储存期间带来了重大稳定性挑战.
- 与水分相互作用的辅助剂可能会提高产品的稳定性.
研究的目的:
- 为了增强玉米粉的水分互动行为.
- 研究粉与化 (NaCl) 或酸六酸盐共加工对水分相互作用和药物稳定性的影响.
- 与物理混合物相比,评估联合加工的辅助剂的疗效.
主要方法:
- 玉米粉与NaCl或Mg(NO3) 2·6H2O在5%和10% (w/w) 的比例上进行了共同处理.
- 乙盐酸被用作一种对水分敏感的模型药物来评估配方的影响.
- 在储存期间评估药物的降解和药片抗拉强度的变化.
主要成果:
- 联合处理改变了粉和水分分布上的水分子结合点的数量.
- 同处理的辅助剂显著降低了药物的降解和药片抗拉强度的变化.
- 粉和盐的物理混合物没有提供可比的稳定性益处.
结论:
- 与盐一起处理粉等常见辅助剂提供了一种协同策略,以增强水分管理.
- 这种方法有效地减轻了湿度对敏感药物的不利影响,促进了产品的稳定性.
- 这些发现有助于理解水分与辅助剂的相互作用,以便在药物配方中明智地选择辅助剂.
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