5 and 10 mg Donepezil are under final development using the proprietary RapidFilm drug delivery Technology securing fast dissolution in the oral cavity without the need of water

RapidFilm consisiting of a polimeric film strip dissolves quickly wihtout any need of water when it comes in contact with the saliva releasing the drug in the oral cavity.

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) a Donepezil RapidFilm is currently under final development.

APR and Labtec are currently completing full development of a new oral formulation, generic to ARICEPT® ODT marketed in Europe as well as in the US by Eisai and Pfizer.
It uses the proprietary RapidFilm® technology which is a novel, non-mucoadhesive, fast dissolving oral dosage form based on a water soluble polymer. The fi lm 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 high patient compliance. The film features an easy application and is not accompanied by swallowing difficulties which is an important issue for elderly people. Once the film is applied it cannot be spit out again because of the rapid disintegration. The fact that no water intake after administration is needed is very well accepted by the patients.

Submission in EU and US is expected within Q3/2010

The Marketing Application in Europe is intended to be an Abridged Application vs. Aricept Tablets.

The Marketing Application in the US is intended to be a NDA under section 505(b)(2). Prior to the NDA an IND will be filed with FDA to discuss the CMC and clinical requirements of the NDA. 

The pilot (fasting) bioequivalence of the study test products (Donepezil 10 mg RapidFilm, prototype E & Donepezil 10 mg RapidFilm, prototype F ) versus the reference products (Aricept® 10 mg ODT and Aricept® 10 mg Tablet) following the administration of a single dose of 10 mg to healthy adults was demonstrated and thus equal therapeutic efficacy can be concluded.

The pilot (fed) bioequivalence study, shows bioequivalence between RapidFilm prototype and Aricept ODT.

Pivotal BE studies for US and Europe are expected to be completed by Q1/2010.

Technical development of the product has been completed.

 

Phase I

Patent Pending on either technology and packaging

Donepezil RapidFilm is available for Licensing wherever Donepezil is off-patent. We are looking for licensing Donepezil RapidFilm at Global/ Regional or local level