A general assessment of the physiochemical factors that influence leachables accumulation in pharmaceutical drug products and related solutions
Jenke, D.
PDA Journal of Pharmaceutical Science and Technology 65(2): 166-176
2011
ISSN/ISBN: 1948-2124 PMID: 21502076 Document Number: 10525
The accumulation of organic compounds associated with plastic materials into pharmaceutical products and their associated solutions has important suitability for use consequences for those pharmaceutical solutions, most notably in terms of safety and efficacy. The interaction between the pharmaceutical solution and the plastic material is driven and controlled by the same thermodynamic and kinetic factors that regulate the interaction between the constituents of any comparable two-phased system. These physiochemical factors are delineated in this article, and their application to pharmaceutical products is demonstrated. When drug products are packaged in plastic container systems, substances may leach from the container and accumulate in the product. The magnitude of this leaching, and thus the effect that leachables have on the drug product, is controlled by certain thermodynamic and kinetic processes. These factors are described and detailed in this article.
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