DDL 2014: Chemically-specific Characterization of Particulate in Inhalable Drug Products using Raman and Laser-induced Breakdown Spectroscopy

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/ Laser-induced breakdown spectroscopy (LIBS) were used to investigate the Active Pharmaceutical Ingredients (API) Particle Size Distribution (PSD), degree of particles aggregation and presence of foreign particulate in commercial inhalable products. Automated Raman/LIBS analysis was used to investigative the contamination issues and to establish the size and chemical makeup (metallic, organic or inorganic) of foreign particulates. 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.