Solvent Selection for Controlled Extraction Studies of Pharmaceutical Packaging - ERP Spain.com - España y América Latina

Solvent Selection for Controlled Extraction Studies of Pharmaceutical Packaging Components: An Experiment-Based Approach The 2006 recommendations from the Product Quality Research Institute (PQRI), Leachables and Extractables Working Group stated that extraction studies accomplished on pharmaceutical container closure/delivery system components should include “multiple extracting solvents of differing polarity”. This recommendation was later incorporated into USP General Chapter <1663>.  The intent of the recommendation was to ensure that extraction studies were comprehensive, and therefore had the greatest opportunity of discovering all potential leachables that could accumulate in a drug product over its shelf-life.  Since the laboratory studies accomplished by this PQRI working group focused on inhaled drug products and particularly on metered dose inhalers, the solvents used were dichloromethane, isopropyl alcohol, and hexane.  A second PQRI working group studied injectable and parenteral drug products which are aqueous-based, and therefore their laboratory work included water (with bracketing pHs) as an extracting solvent.  This presentation will summarize the scientific basis for extracting solvent selection for packaging components for all drug product types, including a discussion of the use of polarity index and other physical-chemical parameters.  Data obtained from extraction studies on various plastics and elastomers will be discussed. The possibility of developing standard methods for extraction studies will also be explored.