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KMID : 1007519960050020112
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Food Science and Biotechnology
1996 Volume.5 No. 2 p.112 ~ p.118
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Modeling the Temperature Dependency of the Shelf Life of a Packaged Moisture Sensitive Product
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Lee, Chong Hyun
Hernandez, Ruben J/Giacin, Jack R/Lee, Myung Hoon
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Abstract
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A mathematical model for predicting the changes in the moisture content of a packaged solid dosage form, which takes into consideration the effect of fluctuating temperature and relative humidity during prolonged storage is described. The model combines the moisture sorption characteristics of the product and the water vapor permeability of the package system as a function of temperature. A modified Brunauer, Emmett and Teller (B.E.T.) equation was used to accurately describe the experimental sorption isotherm of the product, and a cubic polynomial expression was used to fit the constants of the B.E.T. equation to allow temperature interpolation. The expression of the isotherm as a function of temperature, and the expression of package permeability as a function of temperature were combined with the equation for predicting moisture uptake, to give the shelf life simulation model. The model was verified by conducting storage stability studies. Experimental data demonstrated that the prediction by the simulation model of the changes in moisture content of packaged tablets over time was accurate, within a practical range of temperatures and humidity values.
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