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片剂温度对热敏配方的片剂特性和溶解行为的影响
Hanna Dorothea Grumann1, Peter Kleinebudde1
1Heinrich Heine University, Institute of Pharmaceutics and Biopharmaceutics, Universitaetsstraße 1, 40225 Duesseldorf, Germany.
在药片制造过程中温度升高会提高药片的可取性. 在发生温度变化时,配方调整,特别是粘合剂选择和度,对于稳定的药片质量至关重要.
科学领域:
- 制药科学 制药科学
- 材料科学 材料科学 材料科学
背景情况:
- 片制过程将机械能量转化为热能,影响药物配方行为.
- 了解温度对药片特性的影响对于工业规模的制药生产至关重要.
研究的目的:
- 为了研究温度升高对药物配方的片剂行为的影响.
- 评估粘合剂类型,度和填充剂成分如何影响可表化,分解和在热应力下溶解.
主要方法:
- 使用一个带有热控制模具的平板机来模拟工业热量演变.
- 检查了六种含有低玻璃过渡温度结合剂的配方,并将降解作为活性药物成分.
- 评估了可表化,分解时间和溶解概况的变化.
主要成果:
- 温度的升高显著提高了可食性.
- 粘合剂类型和度是影响平板电脑性能的关键因素;填充剂成分的影响较小.
- 较高的粘合剂度和较低的玻璃过渡温度延迟了分解和持续溶解.
结论:
- 温度显著影响平板电脑的使用行为,影响平板电脑的质量.
- 结合剂的选择和度对于减轻温度诱导的变化至关重要.
- 建议在高温的情况下调整粘合剂类型或度以获得可重复的平板质量.
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