Actonel has been approved in blister packaging using COC film.
|Actonel has been approved in blister packaging using COC film.|
Much has been made of the arrival of a new entry, cyclic olefin copolymer (COC), into the pharmaceutical blister materials market. Now, FDA has given its first approval for a drug packaged in a film containing COC.
The application, for a drug called Actonel, uses Klöckner Pentaplast of America Inc.’s (Gordonsville, VA) Pentapharm COC 240 P/03 film. The film is a clear, multilayer laminate film with outer layers (30 microns each) of polypropylene and an inner layer of 240 microns of the Topas brand of COC. Topas is made by Ticona (Summit, NJ), the technical polymers business of Celanese AG (Kelsterbach, Germany).
“The COC-based blister film processes much like polyvinyl chloride (PVC) film,” says Kent Sides, Klöckner’s business manager for pharmaceutical films. “It forms uniform blister cavities and can be run on blister machines without new tooling. It has many times the water vapor barrier of PVC. It is also halogen-free and has a better combination of moisture barrier and processability than films made from such halogen-free polymers as polyethylene terephthalate (PET) and PP.”
Now that Topas has been used with an approved new drug application (NDA), it will be easier for it to be used interchangeably with other blister films, as per FDA’s guidance on postapproval changes, says Mike Maguire, global marketing and sales director for the product.