The companies, APR Applied Pharma Research and Labtec, have completed a pilot study demonstrating the product's bioequivalence with GlaxoSmithKline's (GSK) Zofran Zydis (ondansetron) orally dissolving tablets for the treatment of chemotherapy related nausea and vomiting.
The oral film, based on the companies' RapidFilm drug delivery platform, is the size of a postage stamp and consists of a very thin polymeric film strip impregnated with the active ingredient.
The film dissolves in the mouth within a few seconds and does not need to be taken with water.
The ondansetron product under development by the companies is also aspartame-free, unlike GSK's Zofran, and so makes the product suitable for patients suffering from phenylketonuria and unable to metabolise phenylalanine, one of the amino acids present in aspartame.
According to the companies, the new oral formulation of ondansetron has several advantages over the standard tablet form traditionally used.
Aside from eliminating the need for water, the oral film enhances patient compliance by removing issues such as swallowing difficulties, and is also combined with taste-masking technology to make the treatment more user friendly.
The RapidFilm system, based on technology used in transdermal drug delivery patches, also beats other rapidly dissolving drug formulations from a manufacturing point of view, according to the two companies: "In contrast to other existing rapidly dissolving dosage forms, which mainly consist of liophylisates, the RapidFilm can be produced with a manufacturing process that is competitive with the manufacturing costs of conventional tablets," say Dr Ulrike Vollmer, director of pharmaceutical development at Labtec, and Dr Paolo Galfetti, head of licensing and business development at APR.
The manufacture of the RapidFilm strips relies on a coating process used in the production of transdermal systems, say the companies.
A carrier is coated with a suspension or solution of the desired drug, and the solvent (mainly water or a water/alcohol mix) is then dried.
The resulting laminate can then be cut into the required form and packaged.
According to the firms, the manufacturing costs for a single film are comparable to those of a compressed film.
The film itself has an area of around 5-10cm 2 , and can be loaded with up to 30mg of drug per unit.
The oral film strips can also be packaged in the APR-Labtec's proprietary packaging system, RapidCard, which is the size and shape of a credit card and holds three individually sealed films on each side.
The ondansetron oral strip products in development are 4mg and 8mg doses, and the companies plan to initiate a pivotal bioequivalence study with a larger number of participants early this year with a view to submitting the registration dossier in the fourth quarter and obtaining marketing authorisation in Q2 2009.
APR is currently in the process of identifying and securing licensing partners for the product worldwide.
According to the company, the market for ondansetron in the top five European countries (Germany, Spain, France, UK and Italy) in 2006 was worth €65m. Before patent expiry at the end of 2006, ondansetron was one of the top 20 selling branded drugs in the US, and Zofran generated sales of £847m (€1.2bn) for GSK in 2006.
The market for oral thin films could be set to grow, proving a valuable replacement for orally dissolving tablets which can be costly to produce and tricky to store.
The collaborating companies believe that oral films, such as their RapidFilm product, represent a cost-effective, consumer-friendly alternative, which also offers the benefit of non-patent infringement of orally dissolving tablet formulations.