Generex: Metformin gum shows promise as an alternative drug delivery tool

By E. Janene Geiss

Philadelphia, Jan. 4 - Generex Biotechnology Corp. said results of a clinical trial comparing metformin tablets with the Generex Metformin Gum product, which delivers the drug through the buccal cavity, showed the gum as a promising alternative method of delivering the drug.

The study demonstrated that the metformin gum displayed a pharmacokinetic profile similar to that of the metformin tablets, according to a company news release.

The gum could avoid the significant adverse gastrointestinal side effects often accompanying the use of metformin tablets, which will improve patient compliance, officials said.

The gum also is expected to be an ideal companion product for Oral-lyn, the company's proprietary oral insulin spray designed to offer a simple and effective alternative to subcutaneous injections of prandial insulin, officials said.

Metformin is used to treat type-2 diabetes mellitus in adults and children, particularly when incidental obesity and insulin resistance are present. Metformin also is used to prevent the development of diabetes in people at risk, to treat polycystic ovary syndrome and non-alcoholic steatohepatitis (liver disease), officials said. Metformin was approved by the FDA in December 1994.

The study involved 10 healthy volunteers, six men with a mean age of 30 years and a mean Body Mass Index of 23.9 and four women with a mean age of 29.8 years and a mean Body Mass Index of 21.49.

The study used metformin tablets (Glucophage 850 mg per tablet) and Generex Metformin Gum pieces (214.5 mg per piece). Plasma metformin concentrations were sequentially measured over a 12-hour period after administration of an 850 mg metformin tablet, over a 24-hour period after administration of 429 mg Generex Metformin Gum (two pieces) and over a 24-hour period after administration of a 429 mg metformin tablet.

Generex is engaged in the research and development of drug delivery systems and technologies. The Toronto company has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity.

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