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Published on August 22, 2007

Kollicoat IR was granted approval as a new excipient for instant-release film coatings in Japan - the world's second largest pharmaceutical market. The Osaka Prefectural Government registered the new polyvinylalcohol polyethyleneglycol graft copolymer shortly after its approval by the Pharmaceuticals and Medical Devices Agency (PMDA).

The registration of a new chemical entity in Japan is exceptional - most excipients are physical modifications or combinations of existing products. To convince the authorities new products have to clearly prove safety and technical superiority.

The approval gives customers in Japan first-time access to this innovative coating material.

Kollicoat IR allows pharmaceutical manufacturers to overcome major drawbacks of conventional polymers for instant-release film coating. The polymer is characterised by its exceptional solubility in water as well as by the speed of its dissolution. Due to the low viscosity of the polymer solutions, Kollicoat IR for spraying onto tablets can be applied with a high content of solids. Pharmaceutical manufacturers benefit from a significant reduction in coating times and production costs. Furthermore, Kollicoat IR films are characterised by enormous flexibility and do not require a plasticiser.

Kollicoat IR has been registered in Germany since 2005 and in France, Britain, Spain and Portugal since May 2007 via a mutual recognition procedure (MRP). The draft monograph was submitted to the European Directory of Quality of Medicines (EDQM) and has been accepted by the European Pharmacopoeia Commission.

Kollicoat IR is produced in Germany according to cGMP and marketed by BASF worldwide.

BASF produces and markets a broad range of active ingredients and excipients, as well as exclusive synthesis services for the pharmaceuti-cal industry. These products are made using the latest technologies, to the highest quality standards and in compliance with cGMP guidelines.

Further information can be found at: www.pharma-solutions.basf.com