Abstract

The conditions of hydration of the stable and metastable theophylline phases were determined. Two-phase metastable phase/monohydrate and stable phase/monohydrate equilibrium pressures were measured at 25, 30, and 35°C. The metastable phase began to react with water vapor at lower relative humidities than the stable phase. Processes that occurred with the metastable and stable theophylline phases over various water pressure ranges were considered. The metastable phase exhibited an unusual behavior at 25°C and relative humidity 47%. At constant water vapor pressure and temperature, theophylline was initially hydrated and then lost water and again became anhydrous. Two consecutive processes occurred in the system, the formation of theophylline monohydrate from the metastable phase and its decomposition to the stable phase. The ratio between the rates of these processes determined the content of the monohydrate at the given time moment.

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