The development of a pharmaceutical drug product requires - an extraordinary amount of time and effort to ultimately develop the final drug product. During its entire lifecycle, the quality of the pharmaceuticals is one of the most critical steps, as it continually faces challenges from government and regulatory agencies to ensure the quality and efficacy.

From drug discovery to post-marketed products, the scientific fields and technologies involved require fast and innovative characterization tools. Today, many techniques are used in pharmaceutical laboratories to ensure the quality of a product. Several tests, such as dissolution profiles, stability studies or control of active content are required to follow the pharmaceutical guidelines and authorities, ensuring that the analyzed product  adheres to pre-determined specifications. In a quality control laboratory, most of the analytical tools are based on chemical analyses (liquid chromatography, dissolution apparatus…) which generally damage the sample, require solvent and a lot of time and important human resources. Accordingly, analytical methods based on optical technologies are increasingly appreciated. Therefore, the use of vibrational spectroscopy has grown quickly and has appeared as an alternative analytical tool to the usual techniques. By allowing fast and non-destructive analysis, without needing sample preparation in most cases, these analytical tools are particularly appreciated by the analysts.

Since its discovery, Raman spectroscopy, which is based on  inelastic scattering of light, has attracted increasing attention due to its numerous advantages, such as not needing to use organic solvents, the reduced sample preparation step, and the ability to perform qualitative, as well as quantitative analyses with relatively short data acquisition times. It has been combined with optical microscopy, giving rise to Raman hyperspectral imaging. The use of the latter has expanded in the pharmaceutical and biomedical fields since microspectroscopic techniques present several advantages by combining the acquisition of spatial and spectral information from a sample. Raman hyperspectral imaging characterizes the sample in terms of chemical (actives and excipients identification, distribution and content, for example), and physical properties (solid state/polymorphism, particle size, etc.) by adding information on the spatial distribution.

Raman spectroscopy can be very helpful throughout the entire lifecycle of a drug, and especially during the steps below:

HORIBA Scientific supports the research, development and quality control of the product with various analytical instruments. HORIBA Scientific’s analytical tools contribute to the reduction of time in research, provide information on the product during development, and ensure product quality of the post-marketed products.