The contribution of differential scanning calorimetry to pharmaceutical development

Judith Aronhime, J.A.Consulting, Rehovot, Israel (juditharonhime@gmail.com)

Successful formulation development requires fundamental knowledge of the physicochemical properties of the active pharmaceutical ingredients.

Differential scanning calorimeter (DSC) has been traditionally a valuable element in the physicochemical analysis of active pharmaceutical ingredients. It is being used for some decades as a complementary tool to X-ray powder diffraction and spectroscopic methods for understanding and characterizing polymorphic systems, in particular their thermodynamic stability. Other uses include quick screening of drug-excipient interactions, characterization of racemic mixtures, purity determinations and quantitative analyses.

The use of the DSC technique is very common due to the cost accessibility and its wide range of uses. Also, it requires only very small amounts of material for analysis and practically no sample treatment prior to analysis.

This presentation will review some of the important applications of DSC to identify the most critical solid-state parameters of active pharmaceutical ingredients, including those applications aimed at characterizing polymorphic systems.

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Abstract Reference & Short Personal Biography of Presenting Author

Dr Judith Aronhime is a consultant in the field of pharmaceutical polymorphism and pharmaceutical solid state science.  She has accumulated 27 years experience in her former position in Teva TAPI global R&D management as responsible for all the solid state aspects of the active pharmaceutical ingredients (APIs). In this key role she gained expertise in scientific analysis, characterization, development and research of polymorphism and all solid state attributes of API's, along with the scientific support provided to patent litigations, prosecutions and clearances.

She was a key contributor to TEVA worldwide leadership position in the intellectual property domain by searching new crystal forms of APIs.  Part of those became API ingredients in the marketed TEVA products.

Author and contributor to more than 100 patents and current applications.