The Morphologi G3-ID particle characterization system from Malvern Instruments is able to generate component-specific particle size information for orally inhaled and nasal drug products (OINDPs), to support both abbreviated and new drug applications.
By combining automated particle imaging with Raman spectroscopy, the Morphologi G3-ID provides a single platform for the measurement of particle size, shape, and chemical identity. For OINDP formulations, this enables the differentiation of morphologically identical active ingredients and extraction of the particle size information needed to more exactly understand and control product performance. Particle size data for a single active ingredient rather than for the complete formulation are required to fulfill a number of regulatory requirements and, in some instances, to prove bioequivalence. Furthermore, the detection of foreign particles within the formulation, which is also essential, can be achieved in a strictly analogous way.
In an experimental study, a dry powder inhaler containing two active ingredients was characterized. Raman spectroscopy was applied to particles in the sub-ten micron fraction of the dose, as identified on the basis of size data, and the results were compared with reference spectra to identify particles as one active or the other. Particle size distribution data and shape parameters proved closely similar for both actives, but by enabling chemical differentiation, the Morphologi G3-ID was able to quantify the amount of each in the respirable dose.