Germany paves the way for BASF
A polymer excipient that reportedly reduces spray time has received its first registration in a finished drug product.
A polymer excipient that reportedly reduces spray time has received its first registration in a finished drug product. The German health authorities registered a 1000 mg metformin formulation - a diabetes medication - containing Kollicoat instant release (IR). The Federal Institute for Drugs and Medical Devices Assessment Report on Kollicoat IR is now being sent to the UK and French health authorities.
Compared with hypromellose and other instant release film-coatings, BASF's excipient has a low viscosity, which significantly cuts spray time. Therefore, companies can increase coating capacity without investing in new coating equipment. Furthermore, BASF claims that the resulting films have a very high flexibility, no tackiness and a smooth surface.
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