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
Patricia Van Arnum
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.
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
(IMAGE: GEORGE DIEBOLD, PHOTOGRAPHER'S CHOICE, GETTY IMAGES)
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.