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Additive model for the evaluation of interactions between aqueous solutes and multi-component container materials.
1Baxter Healthcare Corporation, William B. Graham Science Center, Round Lake, Illionis.
Journal of Parenteral Science and Technology : a Publication of the Parenteral Drug Association
|September 1, 1991
Summary
Parenteral solution containers interact with solutes based on material properties. Composite material interactions are predictable averages of their components, crucial for drug stability.
Area of Science:
- Materials Science
- Pharmaceutical Science
- Physical Chemistry
Background:
- Parenteral solutions require stable containers to prevent solute interactions.
- Understanding solute-container interactions is vital for drug formulation and storage.
Purpose of the Study:
- To investigate the interaction between aqueous solutes and parenteral container materials.
- To establish a predictive model for solute-container interactions in composite materials.
Main Methods:
- Studied interactions of aqueous model solutes with various polymer materials (PVC, co-extruded composites).
- Determined equilibrium interaction constants (Eb) related to solute partition coefficients (octanol-water and hexane-water).
- Developed a bimodal Collander-type expression to model these interactions.
Main Results:
- Established a quantitative relationship between solute partition coefficients and material interaction constants.
- Demonstrated that composite material interactions are the weighted average of individual component interactions.
- Showcased that plasticizer dominates the interaction properties of plasticized PVC.
Conclusions:
- The interaction of parenteral container materials with aqueous solutes can be accurately predicted.
- Composite material behavior is a function of its constituent components' properties.
- This understanding aids in selecting appropriate container materials for parenteral formulations.