Offers improved process control for matrix tablet production
The Controlled Release Alliance between Colorcon and Dow Pharma & Food Solutions is planning to have global commercial availability of its next-generation Methocel DC2 polymer by the end of this year.
The Dow Team is finalising the installation of its new manufacturing line in Midland, MI in the US where Methocel DC2 will also be produced.
At CPhI in Paris, the Controlled Release Alliance is showcasing the technology, which was first presented in autumn 2013. Dow says the technology is quickly gaining traction with pharmaceutical manufacturers 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 at Dow Pharma & Food Solutions.
‘Methocel DC2 has garnered tremendous interest from the day it was launched and we are thrilled to move forward into commercialisation so decisively to realise the full potential of this innovation,’ he added.
Methocel DC2 polymers are pure, pharmacopeial HPMC and deliver exceptional properties to powder blends, facilitating roller compaction and direct compression, the partners say.
The designed morphology of Methocel DC2 notably improves the flow and processability of powder blends to be compressed to matrix tablets
By offering pharmaceutical manufacturers a reliable option to replace wet granulation in matrix tablet production, the technology has been shown to save as much as 60% in manufacturing costs, while also reducing waste and shortening development time.
Direct compression methods also 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 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.’
Methocel DC2 will be commercialised under the Dow-Colorcon Controlled Release Alliance, which combines Dow polymer chemistry expertise and manufacturing capability with Colorcon’s 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.
The three direct compression grades of Methocel DC2 to be commercialised 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.