FDA to assess drug release of medicated chewing gums

FDA aims for method to assess future health claim applications for medicated chewing gums

The US Food and Drug Administration (FDA) is working towards a method to validate the effectiveness and safety of medicated chewing gums such as nicotine gum.

It is looking to buy a Erweka DRT-3 chewing gum dissolution tester that will it allow it to conduct dissolution testing for products.

The equipment will allow the US regulator to measure the in vitro release of medicated gums by mimicking a chewing action.

Validating test methods

“Currently, there is no official method (U.S. Pharmacopeial Convention 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," said the FDA in a solicitation note.

“…The requested instrument will greatly enhance our dissolution testing efforts by evaluating new technology and validating testing methods. All these efforts will greatly support Center for Drug Evaluation and Research’s (CDER) New Drug Application review process on this special dosage form in the future.”

CDER is a division of the FDA that reviews new drug applications to ensure they are effective and safe.

Active ingredients in gum

Nicotine gum is a common medicated gum approved in US. There are other products sold in pharmacies and health stores claiming to guard against ailments such as the common cold, or gums that aid weight loss. Most of these carry a disclaimer to say their claims have not been evaluated by the FDA.

Private label gum maker Fertin Pharma previously told this site that chewing gums had a big advantage over other delivery systems because active ingredients were delivered locally. Functional ingredients in gum are absorbed in the buccal cavity in the mouth rather than the gastrointestinal system, meaning the effect takes a few minutes compared to more typical 30-40 minutes.

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