Nomenclature associated with chemical characterization of and compatibility evaluations for medical product delivery systems.
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.
Jenke
Dennis R
DR
Technology Resources, Baxter Healthcare Corporation, Round Lake, IL 60073, USA. dennis_jenke@baxter.com
D002626:Chemistry, Pharmaceutical; D004339:Drug Compounding; D016503:Drug Delivery Systems; D004349:Drug Packaging; D004355:Drug Stability; D005069:Evaluation Studies as Topic; D019999:Pharmaceutical Solutions; D012995:Solubility; D009626:Terminology as Topic
D019999:Pharmaceutical Solutions