Methods for predicting migration to packaged pharmaceuticals.
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.
Kim-Kang
H
H
Department of Food Science, Rutgers University, Cook College, New Brunswick, NJ 08903.
Gilbert
S G
SG
Malick
A W
AW
Johnson
J B
JB
D055598:Chemical Phenomena; D002621:Chemistry; D002849:Chromatography, Gas; D002855:Chromatography, Thin Layer; D004349:Drug Packaging; D008401:Gas Chromatography-Mass Spectrometry; D011093:Polyethylene Terephthalates; D011108:Polymers; D013055:Spectrophotometry, Infrared
D011093:Polyethylene Terephthalates; D011108:Polymers