Effect of process variables on the Small and Wide Angle X-ray Scattering (SWAXS) patterns of powders, granules and pharmaceutical tablets

Abstract

This paper reports that the small-angle X-ray scattering (SAXS) pattern of pharmaceutical granules and tablets is affected by the number of granulation steps and the compaction force and that SAXS-based parameters for powder, granules and tablets correlate with tablet hardness. The fact that changes in the value of SAXS parameters for powder and granules are reflected on the value of the same parameters for tablets suggests that these SAXS parameters could be used as a predictor of powder and granule tabletability. A powder blend was used to make tablets at three compaction forces. Subsequently, tablets were milled and the granules were used to make new tablets under the same compaction forces. The milling of the tablets and the tableting of the granulation was repeated one more time. The powder, granules and tablets were all analyzed with SAXS. The X-ray scattering curves for the powders and granules show the effect of the number of granulation steps. The X-ray scattering curves for tablets show the effect of the different compaction forces. Wide-angle X-ray scattering (WAXS) spectra of powders, granules and tablets show that process variables do not affect the crystalline state of components in these samples.