Purpose Temozolomide dry powder formulations for inhalation, performed with no excipient or with a lipid or lactose coating, have been evaluated. MethodsThe particle size of raw Temozolomide in suspension was reduced by means of a high-pressure homogenizing technique and the solvent was evaporated by spray-drying to obtain a dry powder. Physicochemical properties (crystalline state, thermal properties, morphology, particle size and moisture and drug content) were determined by means of X-ray powder diffraction, differential scanning calorimetry, scanning electron microscopy, laser light scattering, thermogravimetric analysis and high-performance liquid chromatography, respectively. Aerodynamic properties and release profiles were also evaluated using a multistage liquid impinger and a modified USP type 2 dissolution apparatus adapted to inhaler products, respectively. ResultsThe dry powder formulations for inhalation had a high temozolomide content that ranged from 70 % to 100%, remains the temozolomide crystalline state and had a low moisture content. Aerodynamic evaluations showed high fine particle fractions of up to 51% related to the metered dose. The dissolution profile revealed a similarly fast temozolomide release from the formulations. Conclusions
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