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Compatibility and stability tests of risperidone with soft-drinks by isothermal titration microcalorimetry
Authors:H Aki  Y Okamoto  T Kimura
Institution:(1) Faculty of Pharmaceutical Sciences, Fukuoka University, Fukuoka Japan, 814-0180, 8-19-1 Nanakuma, Jonan-ku;(2) Janssen Pharmaceutical K. K., Shizuoka Japan, 411-0932, 600-8 Minami-isshiki, Nagaizumi-cho, Sunto-gun;(3) Faculty of Science and Technology, Kinki University, Osaka Japan, 577-8502, Kowakae 3-4-1, Higashi-Osaka
Abstract:Isothermal titration microcalorimetry has been applied to investigate the compatibility testing of risperidone oral solution with soft-drinks and the interaction with tea tannin such as (–)-epigallocatechin, (–)-epicatechin, theaflavin and their gallates. In aqueous solution, risperidone was exothermically bound to tea tannin with binding affinity (103–104 M–1), small enthalpy and entropy changes reflecting van der Waal’s interaction to form an insoluble complex at 1:1 molar ratio. The heat effect of risperidone titrated into soft-drinks containing tannin was exothermic and proportional to the quantity of the complex. While, no significant heat effect was found for risperidone titrated into a pet-bottled water and an infusion of parched barley without tea tannin. These results were agreed with stability testing of risperidone in some soft-drinks by HPLC method.
Keywords:compatibility  epicatechin  epigallocatechin  isothermal titration microcalorimetry  risperidone  theaflavin
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