Prediction of Stability of Drugs. III. Application of Weibull Probability Paper to Prediction of Stability

概要

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The degradation rate of active ingredient of drugs in homogeneous or heterogeneous system was found to conform to a rate equation within a range of degradation ratio. The equation was obtained by using a Weibull probability paper [numerical formula] where α is degradation ratio, t is time, and m and k are parameters. The rate equation was corresponded to usual reaction rate equations. As a result, it exhibits good approximation within the range of degradation ratio of 1-30%, and the Arrhenius equation can be applied to these parameters. In the present investigation, acetylsalicylic acid solution, ascorbic acid solution, ascorbic acid-mannitol powder, and pyridoxal phosphate solution were used to exemplify those points. As a result, the degradation ratio predicted was in good agreement with those observed. It may be concluded that a method by the Weibull probability paper suggested in the present paper is useful on account of its convenience and accuracy of the prediction compared with usual ones by reaction kinetics.
公益社団法人日本薬学会の論文
1975-04-25