制造工艺对局部药膏配方微观结构,稳定性和感官特性的影响
Pui Shan Chow1, Ron Tau Yee Lim1, Febin Cyriac1
1Institute of Sustainability for Chemicals, Energy and Environment, Agency for Science, Technology and Research (A*STAR), 1 Pesek Road, Jurong Island, Singapore 627833, Singapore.
Pharmaceutics
|September 28, 2023
概括
制造乳膏需要仔细控制加热,冷却和混合. 冷却期间的均质化速度显著影响膏的稳定性和性能,较低的温度对增强稳定性有好处.
科学领域:
- 制药制造业 制药制造业 制药制造业
- 材料科学 材料科学 材料科学
- 类风病学 类风病学 类风病学
背景情况:
- 药膏制造涉及至关重要的加热,冷却和混合步骤.
- 精确控制均化和冷却速度对于药膏的质量,稳定性和性能至关重要.
研究的目的:
- 研究植物加工条件对药膏微观结构,稳定性和感官属性的影响.
- 应用实验设计 (DOE) 方法来优化药膏制造.
主要方法:
- 利用实验设计 (DOE) 方法研究一个模型膏剂系统.
- 在制造过程中变化的均质化速度和乙烯糖醇 (PG) 添加温度.
- 评估了微观结构,稳定性,风湿学,感官和体外释放性质.
主要成果:
- 在冷却过程中均质化速度被确定为影响膏稳定性,质和感觉特征的关键参数.
- 降低PG添加温度改善了膏剂的稳定性,可能是由于增强的单和二甲化封装.
- 实验室释放概况不受研究的加工参数的影响.
结论:
- 通过设计质量 (Quality-by-Design,简称QbD) 的方法,可以为稳定的药膏建立强大的制造工艺.
- 处理条件显著影响膏的微观结构和特性,但不一定在体外释放.
- 优化均质化和冷却参数是实现所需药膏属性的关键.
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