期刊
EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES
卷 35, 期 5, 页码 447-456出版社
ELSEVIER SCIENCE BV
DOI: 10.1016/j.ejps.2008.09.007
关键词
Stability; Simulation; Humidity; Packaging; Prediction
An attempt was made to predict the stability of a moisture sensitive drug product based on the knowledge of the dependence of the degradation rate on tablet moisture. The moisture increase inside a HDPE bottle with the drug formulation was simulated with the sorption-desorption moisture transfer model, which, in turn, allowed an accurate prediction of the drug degradation kinetics. The stability prediction, obtained by computer simulation, was made in a considerably shorter time frame and required little resources compared to a conventional stability study. The prediction was finally upgraded to a stochastic Monte Carlo simulation, which allowed quantitative incorporation of uncertainty, stemming from various sources. The resulting distribution of the outcome of interest (amount of degradation product at expiry) is a comprehensive way of communicating the result along with its uncertainty, superior to single-value results or confidence intervals. (C) 2008 Elsevier B.V. All rights reserved.
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