ELSIE CONTROLLED EXTRACTION STUDIES PILOT PROGRAM FOR PLASTIC MATERIALS: ACHIEVEMENTS, RECOMMENDATIONS AND FUTURE PERSPECTIVES

摘要

The Extractables and Leachables Safety Information Exchange (ELSIE) is a consortium of pharmaceutical, biotech and medical device companies that has established a comprehensive, web-based database of safety information on extractables - chemicals compounds from materials that come in contact with a drug product during its manufacturing, storage and use; and leachables - compounds that may migrate into the dosage form. An important related focus of the consortium has been identifying an efficient mechanism to generate extractables profiles from the plastic materials and share extraction study information. This purpose was addressed by a Pilot Program developed by ELSIE to design and implement a broad controlled extraction study protocol. In this paper we discuss the two main aspects of the Pilot Program: 1) extraction conditions, i.e., the types of solvents and extractions techniques that could be most efficient in maximizing the information for a variety of drug product developers; and 2) use of a common protocol to evaluate extractables profiles of molded versus unmolded plastic materials.