Kim-Kang H, Gilbert S G, Malick A W, Johnson J B
Department of Food Science, Rutgers University, Cook College, New Brunswick, NJ 08903.
J Pharm Sci. 1990 Feb;79(2):120-3. doi: 10.1002/jps.2600790209.
The compatibility of the pharmaceutical product with packaging materials is an important parameter which must be evaluated during the product development process. This paper discusses the possibility that pertinent FDA methodology can be modified in a more efficient way using currently available analytical techniques. Several studies on potential migrants from packaging materials, such as heat-seal adhesives, amber polyethylene terephthalate (PET) containers, and rubber gaskets of aerosol valves, are presented to show that commonly encountered questions with regard to packaging materials used during product stability studies can also be answered in the same way.
药品与包装材料的兼容性是产品开发过程中必须评估的一个重要参数。本文讨论了利用现有分析技术以更高效的方式修改美国食品药品监督管理局（FDA）相关方法的可能性。文中介绍了几项关于包装材料潜在迁移物的研究，如热封粘合剂、琥珀色聚对苯二甲酸乙二酯（PET）容器和气雾阀的橡胶垫圈，以表明在产品稳定性研究中遇到的有关包装材料的常见问题也可以用同样的方式解答。
