Improved dissolution behaviour of steam-granulated piroxicam.

In this paper we prepared and characterized improved release granulates containing Piroxicam and beta-cyclodextrins (1:2.5 molar ratio), obtained by steam-aided granulation, using a one-step rotogranulator, Rotolab. These granulates were compared to those prepared by traditional wet granulation, to the physical mixture, and to the kneaded and dry granulates. The experimental data showed a significant reduction of the water amount required (50%) and of the working time, with respect to traditional wet granulation. The samples examined by scanning electron microscopy and fractal analysis revealed morphological differences related to the method of preparation: the steam-granulated material showed a diffuse porosity, as confirmed by the porosity test. Differential scanning calorimetry, infrared and X-ray analysis revealed the absence of polymorphs in the solid state of the drug. The results of the dissolution tests suggest that the steam-aided granulation may be considered a useful method to improve the in vitro dissolution rate of Piroxicam, enabling also a considerable reduction in the processing time.