Chemically-specific Characterization of Particulate in Inhalable Drug Products using Raman/LIBS

O Olkhovyk, C Vernall, R Price, J Shur

The impact of foreign particulate and agglomerates on dissolution profile and permeability of the inhalable drug particles within the sites of action (i.e. patient’s lungs) is critical. In this study, Raman Chemical Imaging (RCI) and Raman/LIBS spectroscopy were used to investigate the Active Pharmaceutical Ingredients (API) Particle Size Distribution (PSD), degree of particles aggregation and presence of foreign particulates in commercial inhalable products. Automated Raman / Laser Induced Breakdown Spectroscopy (LIBS) analysis was used to investigative the contamination issues and to establish the size and chemical makeup (metallic, organic or inorganic) of foreign particulate. The particulate population results obtained by Raman/LIBS analysis are shown to be advantageous in an investigation of non-conformance/safety of the inhalable products.

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