German OK clears way for greater use of BASF excipient
been granted its first registration in a finished drug product.
The excipient has reached the market in a 1,000mg formulation of the diabetes medication metformin - which is available in generic form but was originated by Merck KGaA - in Germany.
Germany will act as the rapporteur in for a European Union-wide approval of the product under a mutual recognition procedure.
"This registration will help our European customers to increase the speed of future registrations for their products containing Kollicoat IR," said Dr Tim Bölke, director of strategic marketing pharma solutions at BASF.
The Kollicoat instant-release (IR) range was first introduced in 2003, with the lead product, the first of a new generation of excipients based on polyvinyl alcohol-polyethylene glycol copolymer.
Kollicoat IR's major advantage compared to hypromellose and other instant release film-coatings is its low viscosity - even at polymer concentrations of up to 25 per cent - which reduces the spray time significantly.
This means that companies can increase coating capacity without investing in new coating equipment.
The resulting films have a very high flexibility, no tackiness and a smooth surface even without additional plasticiser.
The IR range has since been expanded to include Kollicoat IR White, which has the same properties as Kollicoat IR but has a different colour (and can function as a base for colorants) and Kollicoat Protect, which adds in moisture protection and taste-masking properties.
This development follows the recent signing of a marketing cooperation agreement between the German firm and French industrial chemist firm SEPPIC, a member of the Air Liquide Group, which enables both companies to offer ready-to-use coating systems based on Kollicoat IR to the pharmaceutical industry.
The Federal Institute for Drugs and Medical Devices (BfArM) Assessment Report on Kollicoat IR is now being sent to the UK and French health authorities, which will also comment on the application.
The pharmaceutical film coating market is valued at around €200 million and is growing at 5 to 6 per cent a year.
External links to companies or organisations mentioned in thisstory: BASF Pharma Solutions
