DOW-COLORCON Controlled Release Alliance Launches METHOCEL™ DC2 To Help Reduce Development Time And Lower Manufacturing Costs At The 2013 AAPS Annual Meeting And Expo

Dow Pharma & Food Solutions, a business unit of The Dow Chemical Company (NYSE: DOW) and Colorcon Inc., will present the next-generation METHOCEL™ DC2 polymer at the American Association of Pharmaceutical Scientists (AAPS) Annual Meeting and Expo in San Antonio, Texas from November 10 to 14, 2013. Designed to help the pharmaceutical industry shorten development time and lower manufacturing costs, the DOW-COLORCON Controlled Release Alliance supports pharmaceutical manufactures looking to switch to roller compaction and direct compression for matrix tablet applications.

“Our customers count on us to continually develop customized solutions to address their needs, help them remain competitive and support their growth,” said Dago Caceres, marketing leader, Dow Pharma & Food Solutions. “Our innovative solutions for tablet production will help drug companies save time and money,” he added.

Exceptional flow properties help lower manufacturing cost by up to 60 percent

METHOCEL DC2 will help manufacturers replace wet granulation in matrix tablet production, lowering manufacturing costs by as much as 60 percent, reducing waste, and shortening development time. Furthermore, direct compression methods offer better formulation options for heat- and moisture-sensitive active pharmaceutical ingredients (APIs).

Spheroidal particles and fewer fines

METHOCEL™ DC2 polymers deliver exceptional flow properties and process capability, as well as consistent modified-release performance for matrix formulations. They maintain the same viscosities, degrees of methoxyl and hydroxypropyl substitution, and other important properties of their CR grade equivalents while optimizing processability.

“Compared to METHOCEL™ CR, next generation METHOCEL™ DC2 notably improves the flow properties of powder blends, facilitating roller compaction and direct compression. Differences in morphology drive the improved flow,” explains Dr. True Rogers, technologies leader for Dow Pharma & Food Solutions. “Regarding processability, METHOCEL™ DC2 produces tablets exhibiting higher reproducibility in weight and hardness as well as more accurate and precise API content uniformity from tablet-to-tablet.”

A portfolio that meets US, European and Japanese pharmacopoeia specifications

Three direct compression grades of METHOCEL™ DC2 are now available: K100 LV, K4M and K100M, each chemically identical to current METHOCEL™ Premium products meeting the harmonized monograph specifications.

METHOCEL™ DC2 will be commercialized under the DOW-COLORCON Controlled Release Alliance. Dr Ali Rajabi-Siahboomi, Vice President and Chief Scientific Officer, Colorcon Inc. adds, “this is a significant advancement in METHOCEL CR for matrix formulation, providing excellent functionality of the polymer with improved flow and mechanical properties. The CR Alliance will leverage Colorcon’s application specialists and global network of technical centers to bring this advancement to customers around the world.”

Controlled Release Alliance offers more resources than ever to accelerate pharmaceutical product development efforts and reach markets throughout the world, delivering the following customer benefits:
  • Dow polymer chemistry expertise and manufacturing capability,
  • Colorcon formulation expertise,
  • Colorcon local technical support for trials, scale-up and troubleshooting,
  • Colorcon global supply and logistics.

About the Controlled Release Alliance

Since July 2007, Colorcon and Dow Pharma & Food Solutions formed a global Controlled Release Alliance bringing joint resource to accelerate pharmaceutical product development efforts and reach markets throughout the world. Colorcon has exclusive, global sales and distribution rights for the following Dow Pharma & Food Solutions' products used in controlled release applications: METHOCEL™ Premium hydroxypropyl methylcellulose (HPMC), ETHOCEL™ Premium Ethylcellulose Polymers and POLYOX™ Water Soluble Resins.

About Colorcon

Colorcon is a world leader in the development, supply and technical support of formulated film coating systems, modified release technologies, and functional excipients for the pharmaceutical industry. Our best-in-class products and technologies are complemented by our extensive application data and value-added services to support all phases of solid oral dose design and development. Our focus on market issues and technology development has earned Colorcon an international reputation as a pharmaceutical supplier of choice. That reputation is based on the superior product quality, unparalleled technical support, and extensive regulatory assistance we provide.

About Dow Pharma & Food Solutions

Dow Pharma & Food Solutions designs differentiated solutions that enable pharmaceutical delivery & nutritional benefits to customers around the world. Formerly known as Dow Wolff Cellulosics, this business continues to efficiently and reliably manage the manufacturing assets for high-performance cellulose derivatives and companion chemistries used for formulating solutions across a broad variety of applications, including auto-honeycomb and other industrial applications. Cellulosics and their derivatives are produced from renewable raw materials, mainly wood pulp and cotton, sourced primarily from suppliers that implement certified sustainable forestry practices. Dow Pharma & Food Solutions employs 1,200 people across nine sites and 15 manufacturing plants, with six cGMP's, serving customers in around 160 countries. Additional details can be found at www.dowpharmaandfood.com.

About Dow

Dow (NYSE: DOW) combines the power of science and technology to passionately innovate what is essential to human progress. The Company connects chemistry and innovation with the principles of sustainability to help address many of the world's most challenging problems such as the need for clean water, renewable energy generation and conservation, and increasing agricultural productivity. Dow's diversified industry-leading portfolio of specialty chemical, advanced materials, agrosciences and plastics businesses delivers a broad range of technology-based products and solutions to customers in approximately 160 countries and in high growth sectors such as electronics, water, energy, coatings and agriculture. In 2012, Dow had annual sales of approximately $57 billion and employed approximately 54,000 people worldwide. The Company's more than 5,000 products are manufactured at 188 sites in 36 countries across the globe. References to "Dow" or the "Company" mean The Dow Chemical Company and its consolidated subsidiaries unless otherwise expressly noted. More information about Dow can be found at www.dow.com.

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