Jabbar Gardy, Caroline Aiken & Caroline German
Cormica Bradford Limited, Campus Road, Listerhills Science Park, Bradford, BD7 1HR, UK
Summary
This study investigated the impact of temperature on the particle size, shape and chemical identity of beclomethasone dipropionate (BD) in a commercial nasal spray formulation using a novel cold-stage coupled with morphologically-directed Raman spectroscopy (MDRS). A bespoke temperature-controlled platform was designed, manufactured and combined with MDRS to enable in situ analysis of particle size and shape across a clinically and environmentally relevant ranges (25, 37 and 50 °C). Results confirmed temperature-dependent morphological changes in BD API, including particle agglomeration and shape distortion at elevated temperatures, whilst cellulose excipients remained morphologically stable. Number- and volume-based size distributions highlighted clear differences in thermal response, with BD API exhibiting increased Dv(0.9) values and formation of larger agglomerates at 50 °C. These findings demonstrate the utility of cold-stage MDRS as a powerful orthogonal technique for characterising thermally sensitive nasal formulations under real-world storage and use conditions.