Effects of temperature excursions on mean kinetic temperature and shelf life

Authors
Kommanaboyina, B Rhodes, C
Citation
B. Kommanaboyina et C. Rhodes, Effects of temperature excursions on mean kinetic temperature and shelf life, DRUG DEV IN, 25(12), 1999, pp. 1301-1306
Citations number
8
Categorie Soggetti
Pharmacology & Toxicology
Journal title
DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY
ISSN journal
03639045 → ACNP
Volume
25
Issue
12
Year of publication
1999
Pages
1301 - 1306
Database
ISI
SICI code
0363-9045(1999)25:12<1301:EOTEOM>2.0.ZU;2-T
Abstract
The international acceptance of the definition of controlled room temperatu re (CRT) has given additional impetus to the use of mean kinetic temperatur e (MKT) as a method of quantifying temperatures during transport and storag e and consequent possible effects on drug product stability. The present pa per explores some of the implications of the MKT concept and considers the effect of temperature excursions on MKT values and hence on stability of dr ug products.