Polymorph Analysis

Polymorph Mixture

Figure 1. Color Composite Image Created from PCA analysis. Shown with optical reflectance image.

Pure Component Raman Spectra
Figure 2. Pure component Raman spectra determined from a PCA analysis.

Images from the article, “Combining Raman Spectroscopy and Microscopy to Support Pharmaceutical Development”  by Gary McGeorge, (Bristol-Myers Squibb) that appeared in American Pharmaceutical Review, Fall 2003, Volume 6, Issue 3 on pages 94-99.

ChemImage  chemical imaging instrumentation is especially useful for polymorphism studies in drug products.  The specificity of Raman detection combined with the spatial detail in an image provides an avenue for studying polymorphism in the presence of other undissolved materials.  In some cases, a drug product may be unstable and polymorphs can develop over time.  The ability to image and detect spatially variable changes in drug substance is important.  Ultimately, understanding why these polymorphs develop can help drug developers and formulators to engineer a process that will ensure stability of the right drug substance (or API).

Raman Chemical Imaging Provides:

  • High spectral specificity
  • High spatial detail
  • Detection of spatially variable changes in drug substance
  • Evaluation of polymorphic transformations

ChemImage RCI polymorphism evaluation studies can be performed in almost any drug delivery type, including nasal spray suspensions, metered dose inhalers, semi-solids, solid oral drugs, medical devices, transdermal drugs and more.  ChemImage wide-field RCI provides identification of drug substance in formulated products and enables the ability to count and measures only these particles. Because of this, RCI is a powerful additional methodology during pharmaceutical development in the analysis of mixtures.