Modeling of the solution interaction properties of plastic materials used in pharmaceutical product container systems.
Material/water equilibrium binding constants (Eb) were determined for 14 organic solutes and 17 plastic raw materials that could be used in pharmaceutical product container systems. Correlations between the measured binding constants and the organic solute's octanol/water and hexane/water partition coefficients were obtained. In general, while the materials examined exhibited a wide range of binding characteristics, the tested materials by and large fell within two broad classes: (1) those that were octanol-like in their binding characteristics, and (2) those that were hexane-like. Materials of the same class (e.g., polypropylenes) generally had binding models that were very similar. Rank ordering of the materials in terms of their magnitude of drug binding (least binding to most binding) was as follows: polypropylene < polyethylene < polyamide < styrene-ethylene-butylene-styrene < copolyester ether elastomer approximately equal to amine-terminated poly fatty acid amide polymer. The utilization of the developed models to estimate drug loss via sorption by the container is discussed.
Jenke
Dennis
D
Baxter Healthcare Corporation, Route 120 and Wilson Road, Round Lake, IL 60073, USA. dennis_jenke@baxter.com
Couch
Tom
T
Gillum
Amy
A
Sadain
Salma
S
D004340:Drug Contamination; D004349:Drug Packaging; D008956:Models, Chemical; D004364:Pharmaceutical Preparations / Q000737:chemistry* / Q000592:standards; D019999:Pharmaceutical Solutions / Q000737:chemistry / Q000592:standards; D010969:Plastics / Q000737:chemistry*; D012997:Solvents / Q000737:chemistry; D013678:Technology, Pharmaceutical / Q000379:methods; D014867:Water / Q000737:chemistry
D004364:Pharmaceutical Preparations; D019999:Pharmaceutical Solutions; D010969:Plastics; D012997:Solvents; D014867:Water