Abstract
AbstractThe solubility of form I (hydrate) and form III (anhydrous form) of donepezil hydrochloride (DHCl) in methanol/isopropyl ether mixtures was determined at different temperatures by a synthetic method with laser monitoring observation. The experimental data were correlated with the modified Apelblat equation. Dissolution enthalpy and entropy were predicted by this equation. The mechanisms involved in solution‐mediated transformation of a hydrate (form I) to its anhydrous form (form III) was investigated and characterized by in situ and offline measurement technologies, such as focused‐beam reflectance measurement (FBRM), powder X‐ray diffraction (PXRD), differential scanning calorimetry analysis (DSC), and moisture analyzer. The transformation involves nucleation of the metastable solid (form I), dissolution of the metastable solid, self‐recognition of the molecular units to nucleate a more stable solid phase (form III), and growth of the stable phase. The results indicate that the rate of transformation increases with increasing temperature and driving force.
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