Nasal Drug Product Development

Analysis, Device Selection and Product Characterisation Nasal sprays (and also most nasal aerosols) typically produce droplets in the range 20-200 microns, with most sprays typically deliver a proportion (typically <5%) of fine droplets in the <10 micron range, which must be quantified. Our experts conduct particle / droplet size distribution testing and spray pattern / plume geometry using current, industry standard inhaled or nasal drug product analytical testing techniques with validated methods (e.g., cascade impaction, laser diffraction and high-speed laser imaging). Using morphologically-directed Raman spectroscopy (MDRS) we can directly measure the active pharmaceutical ingredient (API) particle size in the nasal suspension with robust identification of both drug and excipient. This technique has become key to generic suspension product development, where equivalent MDRS data, compared with the reference product, may be used in-lieu of clinical, pK end-point data. We also test the physicochemical properties of the formulation, including; viscosity, aqueous solubility and pH. Our laboratories quantify visible and sub-visible particulates via light obscuration, electron microscopy and other microscope-based techniques. We continually invest in cutting edge nasal drug product equipment, including: Proveris SprayView system for spray pattern and plume geometry Proveris Vereo automated actuators Malvern Spraytec Laser Particle and Droplet sizing InnovaSystems automated actuators Malvern Morphologi G3-ID with MDRS Next Generation Impactor (NGI) and Andersen Cascade Impactor (ACI) for analysis of drug in small droplets/particles (DISP) Various spray content uniformity / emitted dose apparatus Electronic rotational viscometers (Brookfield)