MonoSolRx seeks DEA registration for film strip facility
analgesics in its dissolving films, an emerging dosage format for
the oral delivery of drugs and nutritonal products.
The company says it is started the process to get its Tennessee development facility and Indiana manufacturing facility for Class II-V scheduled drugs certified by the US Drug Enforcement Administration (DEA).
MonoSolRx, a subsidiary of US-based MonoSol specialising in the pharmaceutical applications of this technology, is one of a handful of companies developing edible film strips as a fast-dissolve oral drug delivery platform.
The company's FDTAB film oral dosage form looks like a postage stamp and dissolves readily on the tongue to deliver drugs to a patient, replacing the use of conventional tablets and capsules. The company acquired the technology along with all of the assets of Kosmos Pharma in January 2004.
The company's CEO, Scott Bening said the registration was required by 'increasing demand from pharmaceutical companies interested in scheduled drugs, including the pain category, to be placed in quick-dissolving film for oral delivery'.
"Quick dissolving film enables dose administration for individuals who are compromised by severe pain and have difficulty swallowing conventional tablets," he added.
Meanwhile, MonoSolRx's vice president of operations, Dr Tushar Misra said: "The ability to work with scheduled drugs, complemented by our work with higher loading films and controlled release delivery in film, strengthens our offering."
MonoSolRx is working with an undisclosed DEA consultant to help effect the registration.
In 2003, US company Zengen launched a strip delivering benzocaine, a local anaesthetic, for the treatment of sore throat. At the time, the company claimed this was the first time that this type of delivery system had been used for an active pharmaceutical ingredient (API). Since then, additional oral strip formulations have been introduced by Novartis Consumer Health.
