Influence of solute degradation on the accumulation of solutes migrating into solution from polymeric parenteral containers.

Solute stability in solution, in addition to solute-polymer interaction properties and the total solute available pool, impacts the interaction between a polymeric container and a parenteral product, specifically in terms of the migration of trace polymer components into the contained solution. A specific solute/polymer system has been studied with respect to properties impacting the magnitude and rate of solute migration from the polymer into solution. The solute, an alkyl ester, originates in a polyolefin composite packaging material. Solute degradation kinetics were studied as a function of solution temperature and pH. Solute-polymer interaction properties including the equilibrium binding constant and diffusion coefficient were obtained. An accumulation rate model is developed for the determination of the solution phase concentration of the liberated solute as a function of storage time and conditions. Coupling the model with the properties of the polymer-solute system studied provides a tool that accurately predicts solute accumulation behavior in a representative parenteral product configuration.