Estimation of Polymorphic Transition Degree of Pharmaceutical Raw Materials

概要

論文の詳細を見る
To investigate kinetically the polymorphism of pharmaceutical raw materials which has been widely recognized as one of the main factors affecting the physical stability or clinical efficacy of pharmaceutics, the quantitative evaluation of the polymorphic transition degree from powder X-ray diffraction measurements was examined. Wakelin's correlation method and the integration method, which were developed to determine the crystallinity index of crystalline materials, and the relative intensity method (I_R method), which was shown in our previous paper to be effective for evaluating the transition degree of semisynthetic fatty suppository bases, were chosen, and the validity of each method was studied both theoretically and experimentally. Physical mixtures of stable and unstable crystals of tripalmitin, glyceryl monostearate (MGSB) and Witepsol W-35 were prepared and the applicability of each method were examined. The correlation method gave precise values for all three cases whereas the integration method gave values slightly higher than the expected values. The I_R method is an easy method and gave precise results if suitable angles for the measurement were chosen, but they could not always be found, so its applicability seems to be restricted.
1984-04-25