Abstract
AbstractThe effects of grinding and the excipients used on the solid state stability of warfarin in ground mixtures with β‐cyclodextrin or microcrystalline cellulose have been investigated by using x‐ray powder diffractometry, IR spectrophotometry and differential scanning calorimetry. The grinding process did not result in warfarin‐excipient interaction, but caused a crystalline form of warfarin to transfer to an amorphous state in the presence of β‐cyclodextrin. The stability of this amorphous state of warfarin in tablets made from the ground mixtures stored at 37°C and 75% RH (relative humidity) was also studied. There was only a small amount of amorphous warfarin in tablets that recrystallized under storage conditions. The recrystallization of amorphous warfarin might be due to moisture adsorption. β‐cyclodextrin possesses an ability to prevent the recrystallization of large amounts of amorphous warfarin in tablets stored at 37°C and 75% RH.
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