METHODS FOR PREDICTING MIGRATION TO PACKAGED PHARMACEUTICALS

被引：7

作者：

KIMKANG, H ^{[1
]}

GILBERT, SG ^{[1
]}

MALICK, AW ^{[1
]}

JOHNSON, JB ^{[1
]}

机构：

[1] HOFFMANN LA ROCHE INC, DEPT PHARMACEUT RES & DEV, NUTLEY, NJ 07110 USA

来源：

JOURNAL OF PHARMACEUTICAL SCIENCES | 1990年 / 79卷 / 02期

关键词：

D O I：

10.1002/jps.2600790209

中图分类号：

R914 [药物化学];

学科分类号：

100701 ;

摘要：

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. Copyright © 1990 Wiley‐Liss, Inc., A Wiley Company

引用

页码：120 / 123

页数：4

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