Chemical Specific Particle Sizing of the Active Pharmaceutical Ingredient in Complex Formulations by Hyphenated Spectro - Microscopies

Yousif Ayoub, Analytical Technologies Unit, Solid State Characterization, Global R&d, Teva Pharmaceutical Industries, Ltd, kfar Saba, Isarel (yousif.ayoub@teva.co.il)

The Particle Size Distributions of Active Pharmaceutical Ingredient (API) in final drug products is one of the most important and critical parameters for pharmaceutical end products function and bioavailability.

The delivery of low soluble API and nasal drugs is highly controlled by the particle size and its monitoring is even more crucial.

The regulatory agencies are requesting today more thorough characterization of the final products in general and more specifically of the size distributions of the API in drug product.

We will focus on chemical-specific particle size identification and distribution of multiple components in complex pharmaceutical matrixes of drug products, specifically on imaging Raman spectroscopy coupled with optical imaging and scanning electron microscopy (SEM). Additional approaches such as micro computational tomography will also be discussed.

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Abstract Reference & Short Personal Biography of Presenting Author

Yousif Ayoub PhD. is Associate Director & R&D Team Manager at Global R&D, Teva Pharmaceuticals. Where he is the director of the team specialized in Solid State Characterization, which include polymorphism, particle size distribution (PSD), advanced microscopy and spectroscopy technologies, thermal properties of the material as well as his responsibility for the reverse engineering team.

Yousif holds a PhD in Physical Chemistry from the Hebrew University of Jerusalem since 2009.