COPENHAGEN — Metformin in a chewing gum? It could happen.
The optimism comes from an analysis presented in a poster by Dr. Gerald Bernstein at the annual meeting of the European Association for the Study of Diabetes, showing that a chewing gum formulation of the glucose-lowering drug displays a similar pharmacokinetic profile to that of conventional tablets.
If further study proves that the metformin gum is as effective and safe as the pills but without the gastrointestinal side effects, it could hold particular promise in treating a wide range of patients, including both adults and children with type 2 diabetes or polycystic ovary syndrome who can't tolerate metformin's side effects, or who can't swallow the pills.
“Metformin is a great drug, but some people can't take it because of the gastrointestinal side effects. Maybe we can bypass that by buccal absorption,” Dr. Bernstein, vice president of medical affairs, Generex Biotechnology, Toronto, said in an interview.
Plasma metformin concentrations were measured in 10 healthy volunteers for 12 hours after ingestion of an 850-mg metformin tablet, for 24 hours following about 5–6 minutes of chewing a 429-mg dose of metformin gum (two pieces containing 214.5 mg each), and for 24 hours after swallowing a 429-mg metformin tablet. The two different metformin tablet dosages showed an expected doubling in area under the curve of parts per million. When the identical dosages of gum and tablet were compared, the curves were similar during 24 hours.
Generex, which is also developing an oral insulin spray, funded the study. The company plans to begin clinical trials of metformin gum in patients with type 2 diabetes in the next few months.