Comparison of the Extraction Properties of Binary Polysorbate 80/Water and Isopropanol/Water Solutions for Organic Substances Originating from a Parenteral Infusion Pump

摘要

Pharmaceutical products come into contact with a diverse range of materials during their manufacture, storage, and administration. As a consequence of this contact, substances can leach from these materials and into the product, which may negatively affect its quality. It has been shown that leaching is increased for drug products that contain the nonionic surfactant polysorbate 80. However, the specific extraction properties of this surfactant are not well characterized. To address this deficiency in the knowledge base, the goal of this study was to determine the quantitative profile of 10 compounds extracted from a parenteral infusion pump by aqueous polysorbate 80 solutions. For comparison purposes, the extractable profiles of isopropanol/water solutions, which were utilized as a representative nonsurfactant solvent system, were also determined. The results obtained in this study have shown that relatively low (<0.1%) concentrations of polysorbate 80 were capable of facilitating leaching, consistent with previous reports. More importantly, it was found that the full quantitative extractable profiles obtained for the polysorbate 80 solutions were not comparable to those obtained for isopropanol/water. However, when considering extractables as subsets based on their polarity, it was found that 10% and 45% isopropanol solutions could be used to simulate the quantitative profile of poly-sorbate 80 for polar and non-polar substances, respectively.