Improved Protocol and Data Analysis for Accelerated Shelf-Life Estimation of Solid Dosage Forms


Posted on November 23, 2016 in

Improved Protocol and Data Analysis for Accelerated Shelf-Life Estimation of Solid Dosage FormsThe concept of an isoconversion paradigm, where times in different temperature and humidity-controlled stability chambers are set to provide a critical degradant level, is introduced for solid-state pharmaceuticals. Reliable estimates for temperature and relative humidity effects are handled using a humidity-corrected Arrhenius equation, where temperature and relative humidity are assumed to be orthogonal. Imprecision is incorporated into a Monte-Carlo simulation to propagate the variations inherent in the experiment. In early development phases, greater imprecision in predictions is tolerated to allow faster screening with reduced sampling. Early development data are then used to design appropriate test conditions for more reliable later stability estimations. Click here to access the article