Raman Mapping Application One: Chemical Mapping-single product
Unlike most analytical techniques, Raman mapping does not require drug product samples, like tablets or granules, to be rendered into powders to be analyzed. The samples can be analyzed as-is. This technique allows for the acquisition of detailed knowledge of the distribution of chemical entities of interest across an exposed inner surface of a manufactured sample (tablet/granule). A Raman map can provide valuable information about the different processes and all the materials used in making the sample. Uniform distribution of an API across a tablet or the chemical consistency of one granule compared to another in a granulated drug product are but two examples of uses that this technique can help address. Raman mapping of drug products is also a very useful way to probe for patent infringement, whether it be to find evidence of an infringing polymorph or to detect coatings or co-localization of ingredients defined in the patent. An example of a Raman mapping application of a tablet is shown to the right. In this case, the client wanted to understand why a certain batch of tablets was failing dissolution. The red/green areas in the image represent the API. Whereas most of the API areas are rather small and likely represent individual API particles, there is a large cluster (or agglomeration) of API particles on the far left portion of the image. The agglomeration was determined to be the cause of the failed dissolution results.