RT Journal Article SR Electronic T1 A General Assessment of the Physiochemical Factors That Influence Leachables Accumulation in Pharmaceutical Drug Products and Related Solutions JF PDA Journal of Pharmaceutical Science and Technology JO PDA J Pharm Sci Technol FD Parenteral Drug Association (PDA) SP 166 OP 176 VO 65 IS 2 A1 Dennis Jenke YR 2011 UL http://journal.pda.org/content/65/2/166.abstract AB 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. LAY ABSTRACT: 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.