
Under the terms of the Joint Venture Agreement between the two drug delivery companies APR Applied Pharma Research s.a. of Switzerland (APR) and Labtec GmbH of Germany (Labtec) an Ondansetron RapidFilm is currently under final development.
APR and Labtec are currently comleting full development of a new oral formulation, generic to ZOFRAN® Zydis Lingual ODT (Oral Dispersible Tablet) marketed in Europe as well as in the US by Glaxo Smith Kline. It uses the proprietary RapidFilm® technology which is a novel, non-mucoadhesive, fast dissolving oral dosage form based on a water soluble polymer. The film disintegrates rapidly within seconds in contact with saliva, releases the drug in the oral cavity and promotes gastrointestinal absorption which is comparable to immediate release oral solid dosage forms. The RapidFilm® dosage form was especially designed for higher patient compliance. The application is easy. The patient does not face any swallowing difficulty. The fact that no water intake after administration is needed is very well accepted by patients with nausea.
The product is packed in a specially designed proprietary packaging system named RapidCard.
Dossier completion and submission is expected in Q3/2007; approval is expected sometime in 2008. The product will be registered as generic of Zofran ODT.
Internal evaluations suggests that RapidFilm can offer multiple competitive advantages over Zydis technology such as manufacturing costs, innovation, etc. so enabling RapidFilm to even successfully compete in a generic environment.
Patent Pending on either technology and packaging
Ondansetron RapidFilm is available for Licensing wherever Ondansetron is off-patent. We are looking for licensing Ondasetron RapidFilm at European or Worldwide level.