安定性予測に関する研究(第3報)Shelf Conditionにおける薬剤の吸湿

概要

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Theoretical equations for the prediction of moisture sorption of pharmaceutical preparations under various conditions were derived and evaluated. They are useful for the design of moisture-proof packaging and the quality assurance of pharmaceutical preparations, as moisture sorption is one of the factors which affect physical properties, appearance, and chemical stability of pharmaceutical preparations. Moisture sorption under the shelf condition can be predicted accurately when the temperature change, relative humidity change, moisture sorption isotherm, activation energy of permeability, and heat of vaporization are taken into consideration. A method for the estimation of moisture sorption rate constant of pharmaceutical preparations is also described. Experiments were carried out for moisture sorption of packaged salt, plain tablets, or sugar-coated tablets under various conditions, and it was proved that calculated values were in good agreement with the observed values.
公益社団法人日本薬学会の論文
1978-08-25