Advances in Solid-State Chemistry - Pharmaceutical Technology

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Advances in Solid-State Chemistry
Industrial and academic partnerships forge new territory in solid-state chemistry.


Pharmaceutical Technology
pp. 60-64


Patricia Van Arnum
Understanding the solid-state properties of an active pharmaceutical ingredient (API) is crucial in formulation development and in manufacturing a finished drug product. Several pharmaceutical companies, contract development and manufacturing organizations, and academic institutions recently have formed partnerships and launched specialized offerings to advance research in solid-state chemistry.

Building expertise

In August 2010, Catalent Pharma Solutions (Somerset, NJ) launched the Optiform compound optimization platform, a solid-state and-automated analysis platform for salt, crystal-form, and cocrystal screening. The platform was developed and refined during the past 10 years by GlaxoSmithKline (GSK, London) and has been applied to more than 500 compounds. GSK entered into an agreement with Catalent to use the Optiform platform to support its internal screening activities. The deal between Catalent and GSK was brokered by SR One, GSK's corporate venture fund. The Optiform compound optimization platform and team is part of Catalent's Development and Clinical Services team of 300 based in Research Triangle Park, North Carolina.


(IMAGE: GEORGE DIEBOLD, PHOTOGRAPHER'S CHOICE, GETTY IMAGES)
In May 2010, the University College Cork in Ireland and the contract research and manufacturing organization Almac (Craigavon, United Kingdom) launched an academic–industrial collaboration in solid-state chemistry. The partnership, which is principally funded by Science Foundation Ireland, a government entity to encourage scientific and business development, is focused on applying technologies to elucidate 3D molecular structures from powder X-ray data. Current X-ray technology typically requires a single crystal to be generated to extract such structural information, and the group is seeking alternative approaches. In late 2007, Science Foundation Ireland formed the Solid State Pharmaceutical Cluster (SSPC) to link scientists and engineers from academia and industry in solid-state chemistry. The five-year program includes initial funding of EUR 7 million ($9.8 million).

SSPC consists of five universities in Ireland and nine companies, each contributing various expertise in solid-state chemistry for pharmaceutical applications. The head of the project is Kieran Hodnent, professor at the University of Limerick. The university is contributing expertise in physical properties, polymorphism, and chemical engineering. The University College Cork is focused on synthetic organic chemistry and pharmaceutics, and the University College Dublin is centered on chemical engineering and process analytical technology. Trinity College Dublin is offering expertise in pharmaceutics, spray drying, and milling, and the National University of Ireland is contributing knowledge of analytics and chemometrics.

Companies in SSPC are GlaxoSmithKline (London), Roche (Basel, Switzerland), Merck & Co. (Whitehouse Station, NJ), Eli Lilly (Indianapolis), Covidien (Dublin, Ireland), Clarochem (Dublin, Ireland), Pfizer (New York), and Hovione, (Loures, Portugal). SSPC's research areas include, solution-mediated polymorphic transformation, crystal-structure determination, crystallization for design space, generation of amorphous content, agglomeration studies, and polymorph characterization.

Part of SSPC's activities include a best-practice portal (www.bxi.ie) for crystallization, which is intended as a practical guide for scientists developing pharmaceutical solids. The portal includes information and best practices in areas such as solvent selection, crystallization equipment, crystallization conditions, isolation and washing, drying and spray drying, powder handling, preformulation, and analytical techniques.

During 2010, SSPC has focused on several key goals. These objectives include advancing a center of excellence for continuous crystallization and developing best practices in the convergence between primary (i.e., drug substance) and secondary (i.e., finished product) pharmaceutical processing. The continuous crystallization project consists of five industrial collaborators and the University College Dublin and the University of Limerick. The University College Dublin is providing expertise in continuous plug flow reactors, process analytical technologies, and chemical engineering. The University of Limerick is providing expertise in chemical engineering, crystallization design and control, modeling, and computer fluid dynamics. From an overall organizational perspective in 2010, SSPC is looking to identify and deliver additional funding streams outside of nonmember contributions, provide training for students and industry members, and raise its overall profile.


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