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Title: Extended-Release Metformin Formulation Shows Promise as Once Daily Regimen: Presented at ACCP

"Extended-Release Metformin Formulation Shows Promise as Once Daily Regimen: Presented at ACCP"

By Bruce Sylvester Special to DG News SAN FRANCISCO, CA -- September 25 -- The pharmacokinetic properties of extended-release (ER) metformin are consistent with its formulation compared to immediate release tablets, according to research reported here Sept. 24th at the annual meeting of the American College of Clinical Pharmacology (ACCP). Researchers also reported that the bioavailability of the ER formulation of metformin -- an oral anti-hyperglycemic agent -- was higher and less variable when taken after an evening meal than after breakfast. "Oral absorption of metformin is variable and incomplete, with about 50 percent of an oral dose from the immediate-release formulation being absorbed following a 500 mg dose and with proportionally less of the drug being absorbed at higher doses," reported lead researcher, Michael Lamson, PhD, director of pharmacokinetics at Andrx Labs in Hackensack, New Jersey, United States. "Andrx developed an extended release formulation to be used once a day. We designed this study to compare the pharmacokinetics of the extended release formulation to the immediate-release formulation," he explained. In the single-dose, crossover study involving 12 healthy subjects (5 males and 7 females) the investigators compared the safety and pharmacokinetics of ER metformin 2000 mg once daily after breakfast or dinner compared to immediate-release metformin 1000 mg given after both meals (BID). The investigators found a maximum plasma concentration (Cmax) of 2127 ng/mL for ER metformin post-breakfast, 2053 ng/mL for ER metformin post-dinner and 1814 ng/mL for immediate-release metformin BID. The bioavailability of post-breakfast ER metformin was slightly below that of the post-dinner ER regimen and for the immediate-release BID. Measured by area-under-the-curve (AUC 0-24), post-dinner ER metformin was 98 percent that of immediate-release BID. Pharmacokinetic parameter values remained comparable for the extended-release formulation after it was given to males and females. "ER metformin was well tolerated and there were no serious adverse events or patients who discontinued due to an adverse event," Dr. Lamson noted. The study was supported by Andrx Pharmaceuticals, of Hackensack, New Jersey.

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