Hydrolysis in pharmaceutical formulations.
This literature review presents hydrolysis of active pharmaceutical ingredients as well as the effects on dosage form stability due to hydrolysis of excipients. Mechanisms and measurement methods are discussed and recommendations for formulation stabilization are listed.
Waterman
Kenneth C
KC
Pfizer Global Research and Development, Eastern Point Road, Groton, CT 06340, USA. ken_waterman@groton.pfizer.com
Adami
Roger C
RC
Alsante
Karen M
KM
Antipas
Amy S
AS
Arenson
Dan R
DR
Carrier
Rebecca
R
Hong
Jinyang
J
Landis
Margaret S
MS
Lombardo
Franco
F
Shah
Jaymin C
JC
Shalaev
Evgenyi
E
Smith
Scott W
SW
Wang
Hai
H
D002021:Buffers; D002384:Catalysis; D002626:Chemistry, Pharmaceutical; D004304:Dosage Forms; D004349:Drug Packaging; D004355:Drug Stability; D005079:Excipients / Q000737:chemistry; D006863:Hydrogen-Ion Concentration; D006868:Hydrolysis; D008956:Models, Chemical; D011355:Prodrugs / Q000378:metabolism; D013535:Suspensions
D002021:Buffers; D004304:Dosage Forms; D005079:Excipients; D011355:Prodrugs; D013535:Suspensions