Accelerated aging: prediction of chemical stability of pharmaceuticals.
Methods of rapidly and accurately assessing the chemical stability of pharmaceutical dosage forms are reviewed with respect to the major degradation mechanisms generally observed in pharmaceutical development. Methods are discussed, with the appropriate caveats, for accelerated aging of liquid and solid dosage forms, including small and large molecule active pharmaceutical ingredients. In particular, this review covers general thermal methods, as well as accelerated aging methods appropriate to oxidation, hydrolysis, reaction with reactive excipient impurities, photolysis and protein denaturation.
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
D004355:Drug Stability; D006813:Humidity / Q000517:prevention & control; D006868:Hydrolysis; D004364:Pharmaceutical Preparations / Q000032:analysis / Q000737:chemistry* / Q000378:metabolism*; D011237:Predictive Value of Tests
D004364:Pharmaceutical Preparations