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      The Pharma Lab Show: The Importance of Amorphous Materials

      Simon Bates, Ph. D.

      For this inaugural episode of The Pharma Lab, we wanted to have a detailed discussion around amorphous APIs, why they’re so important, the misconceptions around amorphous materials, and the future of amorphous material development. 

      So we sat down with Ann Newman, a Pharmaceutical Consultant at Seventh Street Development Group, and Ken Morris, University Professor Emeritus at Long Island University, for a discussion all about: 

      • The differences between amorphous forms and crystalline polymorphs
      • Why amorphous forms are important for drug product development, and in particular, patient outcomes
      • The biggest challenges in dealing with amorphous materials for pharmaceuticals
      • What we really need to focus on for the future development of amorphous materials

      Key takeaways from this episode

      • "(From a solid-state perspective) I personally wouldn't consider amorphous a polymorph. But under the regulatory definition of polymorphs, amorphous forms are included (as polymorphs)" Ann Newman
      • “There's no viable USP directive on how you quantify amorphous content.” Ken Morris

      Learn more about amorphous materials from Simon. 
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      Simon Bates, Ph. D.
      Simon Bates serves customers as the VP of Science and Technology with Rigaku Americas. Simon Bates received his PhD in Applied Physics from the University of Hull, utilizing Neutron diffraction to study the magnetic properties of rare earth materials. The neutron diffraction work was performed at the Institute Laue Langevin in Grenoble. For his postdoctoral work in the Dept. of Physics at the University of Edinburgh, Simon helped design and build high-resolution triple axis X-ray diffraction systems for the study of solid-state phase transformations. Simon continued his work on high resolution X-ray diffraction systems at both Philips NV and Bede Scientific where he was focused on the development of X-ray diffraction and X-ray reflectivity methods for the measurement and modeling of advanced materials. Before moving to Rigaku, Simon spent the last 15 years working in contract research organizations (SSCI and Triclinic Labs) studying solid state pharmaceutical materials. In particular, he was directly involved in the development of advanced characterization methods for formulated pharmaceutical products based on the analysis of structure (crystalline, non-crystalline, meso-phase, polymorph, salt, co-crystal..), microstructure (texture, strain, crystal size, habit..) and their functional relationships in the solid state. Simon also holds an appointment as an Adjunct Professor at LIU in the Division of Pharmaceutical Sciences where he helps teach a graduate course on solid state materials analysis.