Granulation tech foaming good

The terms of the contract are undisclosed but US-PharmaTechnologist.com understands BMS will use the new granulation technology in the production of a new tablet for use in clinical trial. "We are very excited as this is our first major agreement of this technology and it is with a major pharmaceutical manufacturer who has taken great pains to evaluate the technology and its benefits. I personally see this as a validation of our efforts,"​ Dow spokesman Michael Altmann told US-PharmaTechnologist.com. Dow's FGT is an advance on the traditional technologies which have been used for about 50 years and according to Dow Wolff Cellulosics, a newly developed business unit of the Dow Chemical Company, the technology promised to make tablet manufacturing faster. "When tablets are produced, they are often mixed with an excipient, often Methocel, to hold them together and evenly distribute the API [active pharmaceutical ingredient] through the mix to ensure the final, compressed tablets are equally potent with medication,"​ Altmann said. Where traditionally, the excipient and water are sprayed into the mix, FGT produces a foam "much like shaving cream"​ by injecting air at controlled pressure and volume into the excipient and water, Altmann said. The result is a low-moisture, high surface area mix that when combined with APIs and other ingredients, rapidly coats all surfaces in a thorough manner. Meanwhile, the technology uses approximately 40 per cent less water than traditional wet granulation processes, Altmann said. "The technology has a low soak to spread ratio, and particle surfaces are quickly and completely covered. In contrast, spraying is a cumulative process that requires considerably more water and longer processing time to achieve particle agglomeration." ​ The reduced amount of water being used means process time and drying time is reduced, making tablet manufacture faster. The flow-on effect is reduced manufacturing costs. The method also reduced the need for spray nozzles that can be problematic, such as clogging during the process, Altmann said. Other advantages to the Foam Granulation Technology included: improved granulation yield and flowability, reduced variation in particle size distribution, improved tablet strength and hardness, and allows for the granulation of water-sensitive formulations. Dow Wolff Cellulosics global market manager for pharmaceuticals Philip Pilnik said in a statement: "Tablets of all kinds have been manufactured the same way for nearly 50 years. This new technology allows for fast, simple, and cost effective granulation and could minimize issues associated with conventional processes. Without modifying existing equipment and using a low-cost foam generator, the manufacturing process uses less water than traditional wet granulation processing while rapidly coating particle surfaces and shortening processing time." ​ BMS was unavailable for comment. Dow Wolff Cellulosics was created in July this year as a new business encompassing the activities of Wolff Walsrode and Dow's Water Soluble Polymers business.