DOW-COLORCON Alliance will commercialize next-generation HPMC excipient by year-end to help lower tablet manufacturing costs by up to 60 percent
Posted: 9 October 2014 | | No comments yet
The Controlled Release Alliance of Dow Pharma & Food Solutions and Colorcon Inc. announced that it is planning to have global commercial availability of its next-generation METHOCEL™ DC2 polymer by year end…
The Controlled Release Alliance of Dow Pharma & Food Solutions, a business unit of The Dow Chemical Company (NYSE: DOW), and Colorcon Inc. announced, today, that it is planning to have global commercial availability of its next-generation METHOCEL™ DC2 polymer by year end. The Dow Team is finalizing the installation of its new manufacturing line in Midland, MI where METHOCEL™ DC2 will also be produced. At CPhI Worldwide 2014 in Paris (France), the Controlled Release Alliance is showcasing the technology, which was first presented in the fall of 2013 and is quickly gaining traction with pharmaceutical manufactures looking for higher economy and formulation versatility in matrix tablet applications.
“We are strongly committed to helping drug companies save time and money in tablet production with our innovative and reliable solutions,” said Christophe Massip, global marketing director, Dow Pharma & Food Solutions. “METHOCEL DC2 has garnered tremendous interest from the day it was launched and we are thrilled to move forward into commercialization so decisively to realize the full potential of this innovation,” he added.
Lower manufacturing cost, reduced waste, shorter development time
METHOCEL DC2 polymers are pure, pharmacopeial HPMC and deliver exceptional properties to powder blends, facilitating roller compaction and direct compression. By offering pharmaceutical manufacturers a welcome, reliable option to replace wet granulation in matrix tablet production, the technology has been shown to save as much as 60 percent in manufacturing costs, while also reducing waste and shortening development time. Last but not least, direct compression methods open up a path to more desirable formulation options for heat- and moisture-sensitive active pharmaceutical ingredients (APIs).
“The designed morphology of METHOCEL DC2 notably improves the flow and processability of powder blends to be compressed to matrix tablets,” explains Dr. True Rogers, Technologies Leader for Dow Pharma & Food Solutions. “By improving flow, our next generation METHOCEL DC2 polymeric excipient helps the drug product manufacturer produce higher quality tablets using streamlined manufacturing processes. In multiple model formulations, we have demonstrated higher reproducibility in tablet weight and tensile properties with dependable unit-dose uniformity of API content from tablet-to-tablet.”
Controlled Release Alliance gains further momentum
METHOCEL™ DC2 will be commercialized under the DOW-COLORCON Controlled Release Alliance, which combines Dow polymer chemistry expertise and manufacturing capability with Colorcon’s extensive specialist technical support for samples, trials, scale-up and global supply chain.
“Colorcon is perfectly positioned to bring this latest innovative solution to the market and help our customers to shorten development time and reduce manufacturing cost. Through the Controlled Release Alliance, Colorcon and Dow bring joint resources to accelerate pharmaceutical product development efforts and reach markets throughout the world” adds Shannon Kelly, General Manager for the CR Alliance at Colorcon Inc.
The three direct compression grades of METHOCEL™ DC2 that were commercialized are: K100 LV, K4M and K100M, each chemically identical to current METHOCEL™ Premium products meeting US, European and Japanese pharmacopoeia specifications. Additional viscosity grades will follow.