A Comprehensive Technology of Particle Characterization that Automatically Measure Particle Size, Shape and Chemical Identity in One Single Platform

The Morphologi G3-ID combines the capabilities of a Morphologi G3 particle analyzer with the Kaiser RamanRxn 1 spectrometer, resulting in a single platform measuring particle size, shape, and chemical identity. In addition to reporting the standard morphological parameters, the Raman capability on the Morphologi G3-ID enables the chemical identification of particulates in a dispersed sample. The extra chemical information permits creation of chemical classifications from which component-specific particle size distributions are determined. In order to show that a generic drug is bioequivalent to an innovator drug it must display comparable bioavailability when studied under similar experimental conditions. The particle size distribution of each of the active pharmaceutical ingredients upon tablet disintegration was investigated, as this would be expected to have a significant effect on the subsequent bioavailability of the drug.