Monday, January 6, 2014

FDA Seeking Gum Chewing Tester

    The Food and Drug Administration is seeking a small business to potentially supply the federal agency with a chewing gum tester.  Despite the frivolous sounding nature of the announcement, the search is a serious one, and apparently a growing need.  Chewing gum-based pharmaceuticals (such as nicotine gum) are already in use in the United States, and the FDA is looking for a way to measure the dosage and delivery (dissolution) of the medication in such products.
    The FDA is not looking for just any chewing gum tester, but the Erweka DRT-3 (or its equal), manufactured by Erweka, a German company that produces pharmaceutical and life-science testing equipment.  The DRT-3 can be seen in action here.
    According to the documents accompanying the notice, the FDA may be looking to establish a standard for testing chewing gum-based pharmaceuticals on the assumption that the gum-based method of drug delivery may become more widely used:
Currently, there is no official method (USP or FDA) to test medicated chewing gum products, and it is unclear for FDA reviewers on how to approve such drug products if similar applications are coming in the future...
The DRT-3 chewing gum dissolution tester will be evaluated and used to develop methods for drug release from commercial chewing gum products. The requested instrument will greatly enhance our dissolution testing efforts by evaluating new technology and validating testing methods. All these efforts will greatly support CDER’s NDA/ANDA review process on this special dosage form in the future.  
    The FDA has some very specific criteria in mind for its gum chewing tester, including:
  • The angular displacement of the upper jaw shall be adjustable between 10° – 180°, movement frequency adjustable between 20 - 60 cycles per minute.
  • Distance of upper and lower jaw in closed position adjustable -between 0-10 mm.
  • Jaws shall be acid proofed stainless steel with blasted surface for a better grip.
There is no requirement that the machine must be able to walk and chew gum at the same time.

Note: A version of this article first appeared at The Weekly Standard.

No comments:

Post a Comment