Industry News: ChemImage and FDA Collaborate to Characterize Highly Unstable Polymorph of Pharmaceutical Compound

12 Nov 2008

ChemImage is pleased to announce publication of the results of a collaborative study with the FDA to characterize the thermodynamics of a highly unstable polymorph of acetaminophen. The Journal of Pharmaceutical and Biomedical Analysis, a peer-reviewed journal, published Raman detected differential scanning calorimetry of polymorphic transformations in acetaminophen (doi: 10.1016/j.jpba.2008.09.008).

This publication outlines the application of a method for polymorph characterization which combines differential scanning calorimetry (DSC) and Raman microscopy. Interest in the polymorphic forms of acetaminophen comes as a result of the poor compression properties of the form used commercially in common pain relievers. An understanding of thermally driven polymorphic transformations is essential to the development and, ultimately, the use of another form that has improved compression properties with the same pharmacological effects.

“This is an important achievement as it opens the door to study other polymorphic transitions within the pharmaceutical arena,” stated David Tuschel, co-author and Principal Materials Scientist at ChemImage.

Through the simultaneous use of these individual methods, scientists from both organizations have worked to unambiguously identify polymorphic transitions, including the presence of a third form which is highly unstable and to date has not been isolated for powder X-ray diffraction.

This work comes as a product of the Cooperative Research and Development Agreement (CRADA) which ChemImage and the FDA signed in 2006, and was entered into for the design of protocols for validating Raman Chemical Imaging for applications in pharmaceutical research and process control.