Abstract
Active pharmaceutical ingredients in dry powder inhaler (DPI) formulations need to have well-defined material properties. These can be influenced by the choice of processing parameters. The impact of methanol, ethanol, 1-propanol, 2-propanol, 1-butanol, 1-pentanol, and acetone on the crystallization of beclomethasone dipropionate (BDP), an anti-inflammatory agent, was studied using X-ray powder diffraction, thermal analysis, gas chromatography with mass spectrometry, scanning electron microscopy, and atomic force microscopy. Crystallization from methanol, 1-butanol, and 1-pentanol resulted in particulate BDP with a predominantly anhydrous character. In contrast, BDP solvates were formed using ethanol, 1-propanol, 2-propanol, or acetone. The solvates had different crystalline structures depending on the solvent used. Distinct thermal properties confirmed the inclusion of ethanol, 1-propanol, 2-propanol, and acetone within the crystalline BDP host. Furthermore, the size, shape, and surface characteristics o...
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