Effect of solution phase composition on the interaction between aqueous model solutes and polymeric container...

Area of Science:

• Materials Science
• Pharmaceutical Science
• Analytical Chemistry

Background:

• Polyolefin laminate polymers are used in intravenous (IV) product packaging.
• Understanding container-solution interactions is crucial for IV product stability and safety.
• Marker solute interactions can predict potential issues with IV formulations.

Purpose of the Study:

• To investigate the interaction between polyolefin laminate polymers and various IV solutions.
• To determine factors influencing these interactions.
• To identify suitable model solvents for container compatibility testing.

Main Methods:

• Studied interactions of marker solutes with polyolefin laminate polymer in diverse solutions.
• Included sodium chloride/dextrose mixtures and actual IV products (e.g., Lactated Ringer's, Dianeal, Travasol).
• Correlated interaction properties with solute octanol-water partition coefficient and solution composition (pH).

Main Results:

• Container/solution interaction correlated with solute octanol-water partition coefficient.
• Nonionic solute interactions were independent of solution composition.
• Solution pH significantly influenced ionic solute interactions by affecting speciation.

Conclusions:

• The octanol-water partition coefficient is a key predictor of polyolefin laminate polymer-solute interactions.
• Solution pH is critical for ionic solutes, impacting their interaction with the polymer.
• Water or weak buffer solutions are recommended as appropriate model solvents for IV container compatibility evaluations.