Quantification and Control of Amorphous contents by Raman, Application and Case Studies in Pharmaceutical Processing


02nd October 2020 | 10:00 am EST | Michelle Raikes, M.S., Scientist IV and Dr. Fredrik Nordstrom, Sr Research Fellow at Boehringer Ingelheim and Dr Julia Griffen, Product Manager Transmission Raman Products, Agilent Technologies Inc. |WATCH FOR FREE

Amorphous regions in crystalline material can have significant impact on bioavailability, processability and stability. Conversely, crystalline material can act as nuclei for recrystallization and resulting in instability of amorphous systems. Raman spectroscopy is sensitive to polymorphic differences and amorphous content in pharmaceutical materials. This make Raman spectroscopy a powerful process analytical technology (PAT), when combined with multivariate modelling, to control the amorphous content in a pharmaceutical process. We will present pharmaceutical case studies showing process-induced amorphization of crystalline drugs across the DS and DP processing steps. In addition, we will compare the kinetics of crystallization of amorphous material when stored at various relative humidity and temperature conditions. The results clearly demonstrate that Raman spectroscopic techniques combined with multivariate methods is a powerful and effective tool for quantitation of amorphous content in crystalline material with applications ranging from API isolation, milling and to multiple unit operations in DP manufacturing. The information generated was critical to determine the root-causes and outline appropriate mitigation measures.

Presented by Michelle Raikes, M.S, Senior Scientist at Boehringer Ingelheim

Michelle Raikes holds Masters of Science degree in Chemistry from the Polytechnic Institute of NYU. She is currently a Senior Scientist in the Material and Analytical Sciences Department at Boehringer Ingelheim Pharmaceuticals in Danbury, Connecticut. Her lead role in the organization is to support investigations in drug substance and drug product development related to process-induced phase transformation (PIPT) using spectroscopic tools such as IR, Raman and confocal Raman spectroscopy. In addition she is responsible for introducing new technologies to enhance process development and understanding and to promote these technologies within the BI organization.

And Dr. Fredrik Nordstrom, Sr Research Fellow at Boehringer Ingelheim

Fredrik Lars Nordstrom received his Ph.D. degree from the Royal Institute of Technology in Stockholm, Sweden in 2008. His dissertation was in the area of solvent effects on crystallization of small molecules. His research interests are in the area of solid state chemistry, including process-induced amorphization and form conversion. He recently ventured into investigating impurity purge mechanisms in crystallization. He currently works in Ridgefield, CT, as a senior research fellow at Boehringer-Ingelheim where he is the head of a technology group in the area of solid state chemistry, crystallization and agitated drying. He also leads projects addressing solid form and isolation related issues in DS or DP from pre-clinical phase up to production for market supply. Before 2016 he was with AbbVie in the Solid state chemistry group leading the Center of excellence in particle design and PAT. He has more than 30 journal publications and patents.

Followed by an Industry Perspective

Presented by Dr Julia Griffen, Product Manager Transmission Raman Products, Agilent Technologies Inc.

 

Julia has been working with transmission Raman for over 7 years, working with Agilent’s global customer base to further the technology and applications; including content uniformity and solid-state analysis. An expert in the field she has jointly published many peer reviewed articles. Julia’s background is that of a synthetic organic chemist with pharmaceutical experience, later turned chemometrician and spectroscopist. Today Julia helps Agilent’s customers find smarter analytical workflows for solid oral dose medicines using Transmission Raman.

Sponsored by Agilent

Agilent is a leader in life sciences, diagnostics and applied chemical markets. The company provides laboratories worldwide with instruments, services, consumables, applications and expertise, enabling customers to gain the insights they seek. Agilent’s expertise and trusted collaboration give them the highest confidence in our solutions.


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