Bend Research Inc., a leading independent drug-formulation development and manufacturing company and The Dow Chemical Company, a global leader in designing, manufacturing, and supplying polymeric excipients for enabling drug-delivery systems, have formed an exclusive collaboration to provide science-based spray-dried dispersion (SDD) solutions and select enabling new polymers for poorly soluble oral drugs.
Dow and Bend Research will work together to provide the industry with fully characterized polymers supported by complete Quality-by-Design (QbD) principles and the ability to tailor materials to meet the performance needs of specific drugs. In addition, the two companies will develop and commercialize new materials for SDDs that address technology gaps in manufacturability and delivery, providing greater drug-product utility and therapeutic performance.
Dow will provide hypromellose and hypromellose acetate succinate, as well as options to tailor these materials, and next-generation cellulosic and noncellulosic polymers for enhanced performance.
The collaboration between Bend Research and Dow reduces drug-development risk by seamlessly combining materials development and optimization early in the formulation development process for SDDs to achieve optimal clinical outcomes and robustness in drug-product manufacturability. The collaboration will combine Dow’s fundamental materials design, high-throughput screening, and pilot-plant, and commercial scale-up capabilities with Bend Research’s proven SDD screening, formulation, scale-up, and technology-transfer capabilities.
“We welcome the opportunity to further focus Dow’s proven excipient and materials science expertise in the area of enhancing drug solubility, and we are enthusiastic about working with the world leader in spray-dried dispersions to ensure that our customers receive the best possible polymer solutions,” said Bob Maughon, Senior R&D Director for Dow. Maughon noted that Dow is fully supporting this collaboration with an array of technologies, including high-throughput synthesis with API/polymer screening, laboratory-scale product development, and structure/property optimization, as well as a fully cGMP market-development plant capable of supporting clinical development of optimized solutions.
“We are proud to announce the collaboration between Bend Research and Dow,” said Rod Ray, Bend Research CEO. “Our two companies have used rigorous science, grounded in fundamentals, to develop new excipients that improve the performance of our solubilization technologies. It is extremely important to us not only to develop new technologies for our clients, but to use cutting-edge research to enhance our existing technologies. Our collaboration with Dow is part of that initiative. It also ensures our clients access to a reliable supply of solubilization excipients that meet the critical-to-quality properties that are key to the performance of their compounds.”
Source: http://www.dow.com/