Wanted by FDA – Gum Chewing Tester
January 6th, 2014 // 2:48 pm @ jmpickett
This is a story you don’t see every day out of the FDA. The agency currently is seeking a small business to supply FDA with a tester of chewing gum. No matter that the announcement sounds rather frivolous, this search is completely serious, and actually, is a growing need for FDA. Pharmaceuticals that are used in chewing gum, such as nicotine gums, are in wide use in the US today. FDA is looking for new ways to measure both the dosage and delivery (dissolution) of the drugs in these types of gums.
However, FDA is not just looking for any type of chewing gum tester, but something like the Erweka DRT 3, or something like it, which is made by Ereweka. This is a company based in Germany that makes many types of pharmaceutical equipment.
According to the FDA notice, the agency could be looking to set up a standard for testing pharmaceuticals in chewing gum. They could be assuming that the gum based delivery method could become more used in the future.
At this time, there is no FDA or USP method to test medical related chewing gum products. It is not clear for reviewers at FDA how they should go about approving these types of drug products.
FDA stated that it is going to evaluate the DRT 3 chewing gum dissolution tester, and will be used to devise methods for the release of drugs from chewing gum products. The instrument, according to FDA, will boost their dissolution testing efforts, as they will be able to evaluate new technology and validate new testing methods.
FDA has very specific ideas for its chewing gum tester, including these specifications:
- The upper jaw angular displacement has to be adjustable from 10 to 180 degrees, with the movement frequency adjustable from 20 to 60 cycles/minute.
- The distance of the lower and upper jaw in a closed position must be adjustable from between 0 to 10 mm.
