US FDA approves BASF excipient Kollicoat

The US Food and Drug Administration has approved the use of German chemicals giant BASF's pharmaceutical excipient Kollicoat IR for instant-release tablet coatings. The decision was made following the registration of ibuprofen tablets coated with Kollicoat IR in an Abbreviated New Drug Application process. It was the first time a regulatory safety evaluation of the new polyvinyl alcohol-polyethylene glycol graft copolymer was carried out in the USA. Both the functionality and safety of Kollicoat IR received a positive assessment, said BASF.

"Kollicoat IR allows manufacturers to benefit from more robust, much shorter production processes, which means they end up saving costs as well," says Inge Rademacher, product manager responsible for the excipient at BASF. The reason is that Kollicoat IR dissolves exceptionally rapidly and well in water. Because of its low viscosity, the Kollicoat IR solution can be sprayed on to the tablets with a high polymer and color pigment content. Film coatings based on Kollicoat IR are also extremely flexible and do not require additional plasticizers. The considerable disadvantages of using conventional polymers are now a thing of the past.

"But in addition to having advantages for the manufacturer, Kollicoat IR also benefits the patient," continued Mr Rademacher. For example, a particular film coating of the Kollicoat IR range masks the bitter taste or unpleasant odor of active pharmaceutical ingredients."