RT Journal Article
SR Electronic
T1 Nomenclature Associated with Chemical Characterization of and Compatibility Evaluations for Medical Product Delivery Systems
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 97
OP 108
VO 57
IS 2
A1 Dennis R. Jenke
YR 2003
UL http://journal.pda.org/content/57/2/97.abstract
AB 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 defi ne the safety and/or effi cacy 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 classifi es those chemical entities which participate in the system/product interaction and delineates the various extraction strategies which may be used in compatibility assessments.