FMC improves on existing excipients

The subsidiary of New Jersey-based FMC Corporation, FMC BioPolymer executives have touted the new excipients, used for instant-release oral solid dose formulations, would add speed to the formulation and manufacturing process and reduce costs. The excipients, Avicel HFE-102 and Avicel PH-200 LM, are based on already existing excipients but have been generated to produce a different entity with improved benefits, FMC BioPolymer global excipient marketing director Victor Maurtua told in-PharmaTechnologist.com at the American Association of Pharmaceutical Scientists (AAPS) conference in San Diego last week. "Our customers continue to search for innovative ways to improve both formulations and manufacturing performance . . . Both products speed the development of robust formulations and enable a more efficient and reliable scale up,"​ he said. Avicel PH-200 LM, based on microcrystalline cellulose (MCC), has been formulated to reduce the amount of water added to the granulation process, which sees a move from wet granulation to moisture activated dry granulation (MADG) - a process that has experienced limited uptake in the industry because of the lack of efficient excipients. Avicel PH-200 LM is a step up from FMC BioPolymer's Avicel PH-200 which had a moisture level of five per cent. The new product has a moisture level of no more than 1.5 per cent and can absorb approximately three to four times as much water from the granule as the previous product. This advantage, along with enabling the use of MADG, meant the use of Avicel PH-200 LM could eliminate the extra steps of milling, drying and screening, thereby reducing manufacturing costs and energy used, Maurtua said. The process also produced a larger particle size for optimal flow. "This increases efficiencies to the manufacturing process. It takes aspects of wet granulation but eliminates the drawbacks of it,"​ Maurtua said. The MADG process and use of Avicel PH-200 LM would also be useful for the use of active pharmaceutical ingredients (APIs) which were sensitive to moisture. The other excipient, Avicel HFE-102 is a new, proprietary co-spray dried MCC/mannitol high functionality binding excipient for direct compression. Maurtua said the co-spray drying added extra benefits to the excipient as it changed its properties combining the high compactibility of MCC and the low lubricant sensitivity of mannitol. The outcome was a harder, less friable and faster disintegrating tablet. "Some APIs will be problematic for formulations. These excipients will improve on that performance which is currently unavailable with existing excipients,"​ Maurtua said. Because of the regulations and the regulatory process around excipients and the current methodologies big pharma already had, Maurtua said "it might take time"​ for the excipients to be taken up by the industry, but he was confident. The company's last product to be launched was a sugar coating process a couple of years ago.