Nomenclature associated with chemical characterization of and compatibility evaluations for medical product delivery systems
Jenke, D.R.
PDA Journal of Pharmaceutical Science and Technology 57(2): 97-108
2003
ISSN/ISBN: 1079-7440 PMID: 14674511 Document Number: 9441
Delivery systems are used to store, contain, and/or administer liquid pharmaceutical products. Gaining an understanding of the chemical composition of such a delivery system is necessary with respect to effective system development, registration, and production. Additionally, the ability of the delivery system to impact the chemical composition of the contacted product may define the safety and/or efficacy of the product. Assessing the compatibility of the delivery system and the product is thus both necessary and desirable. The nomenclature associated with compatibility assessments has not been standardized, oftimes leading to conflicting or confusing information. This manuscript puts forth a nomenclature which classifies those chemical entities which participate in the system/product interaction and delineates the various extraction strategies which may be used in compatibility assessments.
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