在聚乙烯化物上对基合物的机械洞察力
Clara E Correa-Soto1, Rajarshi Sengupta1, Isaiah Gonzales1
1Drug Product Technologies, Process Development, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA.
Journal of pharmaceutical sciences
|April 5, 2024
概括
由于对聚乙烯化物表面的吸附,propylparaben的功效从配方中丧失. 这种吸附遵循伪二次运动模型和多层吸附,影响药物成分的兼容性.
科学领域:
- 制药科学 制药科学
- 材料科学 材料科学 材料科学
- 化学工程是化学工程的重要组成部分.
背景情况:
- 药物产品的稳定性对于有效性和安全性至关重要.
- 活性药物成分 (API) 和包装材料之间的相互作用可能导致功效丧失.
- 了解这些相互作用对于配方开发和监管合规至关重要.
研究的目的:
- 为了阐明与聚乙烯 (PVC) 接触后甲的功效损失的机制.
- 描述甲在PVC上的吸附动力学和平衡.
- 建立一种方法来评估药品成分与包装材料的兼容性,包括吸附.
主要方法:
- 研究了甲在PVC表面上的吸附.
- 应用伪二次运动模型来描述吸附率.
- 将吸附平衡数据与使用非线性回归的Langmuir,Freundlich和Temkin等温模型相匹配.
- 使用案例研究方法来展示开发的方法.
主要成果:
- 甲的功效损失是由于对PVC表面的吸附造成的.
- 吸附动力学最好用伪二阶模型来描述.
- 吸附率随着甲的散装度增加而增加.
- 弗洛伊德利希和特姆金模型提供了最适合平衡数据的模型,表明了多层吸附.
结论:
- 该研究成功确定了由于PVC吸附而导致甲损失的机制.
- 这些发现提供了对制药成分-包装材料相互作用的机制性见解.
- 提出的方法可用于评估涉及在药物配方中吸附的兼容性问题.
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