Fully-automated morphological imaging of a pharmaceutical formulation or product can deliver particle size and shape information in a single measurement, and with minimal user intervention. Simultaneous determination of chemical composition by Raman spectroscopy delivers the power to unlock complex particle characterization problems.
A knowledge and understanding of particle shape as well as particle size is essential in the development, control and optimization of pharmaceutical formulations and fi nal products. Particle characterization using image analysis-based systems can provide real insight into the nature of particulate materials, supporting each stage of pharmaceutical development, from the selection of raw materials, via formulation development, right through to QC. From an intellectual property perspective, this information can be used to tighten the specifi cation on a particular product and make it difficult to replicate. This type of detailed analysis is now easily achievable, thanks to a new generation of automated analyzers, the best of which provide size and morphological information by imaging individual particles and generating a variety of quantitative shape data.
A concurrent measurement by Raman spectroscopy of each particle can provide the complete picture of what is present in a multicomponent system, or perhaps what unwanted particle type or contaminant is present in a product. This powerful combination of technologies can also be used to speed the deformulation of the most complex pharmaceutical products, helping to establish in vitro bioequivalence with the reference product.