A new approach for testing drug sensitivity to autooxidative degradation in the solid state is demonstrated in this work. A novel solid-state form of stressing agent for autooxidation has been proposed, based on azobisisobutyronitrile loaded into mesoporous silica carrier particles. The new solid-state form of the stressing agent was applied in degradation studies of two active pharmaceutical ingredients: bisoprolol and abiraterone acetate. The effectiveness and predictivity of the method were evaluated by comparing impurity profiles with those obtained by traditional stability testing of commercial tablets containing the investigated APIs. The results obtained by the new solid-state stressor were also compared with those obtained by an existing method for testing peroxide oxidative degradation in the solid state using a complex of polyvinylpyrrolidone with hydrogen peroxide. It was found that the new silica particle-based stressor was able to effectively predict which impurities could be formed by autooxidation in tablets and that this new approach is complementary to methods for testing peroxide oxidative degradation known from the literature.

Department of Analytical Chemistry Faculty of Science Charles University Prague Czech Republic

Department of Analytical Chemistry University of Chemistry and Technology Prague Technická 5 166 28 Prague Czech Republic

Department of Chemical Engineering University of Chemistry and Technology Prague Technická 5 166 28 Prague 6 Czech Republic

Zentiva k s Praha U Kabelovny 130 102 37 Praha 10 Czech Republic

Zentiva k s Praha U Kabelovny 130 102 37 Praha 10 Czech Republic; Department of Chemical Engineering University of Chemistry and Technology Prague Technická 5 166 28 Prague 6 Czech Republic

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