New data show that Imitrex Tablets formulated with RT Technology disintegrated six times faster and were absorbed more quickly than conventional Imitrex Tablets. The findings of this study were presented at the 47th Annual American Headache Society Scientific Meeting in Philadelphia last month...
The four-way cross-over pharmacokinetic study of five migraine sufferers compared Imitrex Tablets formulated with RT Technology with conventional Imitrex Tablets. Patients were given a 100-mg radio-labeled tablet with radio-labeled water outside of a migraine attack. Images of the gastrointestinal tract were taken via gamma scintigraphy every minute for the first 30 minutes and every 10 to 15 minutes for four hours. Endpoints were time to disintegration, gastric emptying, and time to onset of absorption.
Results from the study showed that the mean time to disintegration was six times faster with Imitrex Tablets, formulated with RT Technology, (6.2 minutes vs 38.8 minutes) compared to conventional Imitrex Tablets. The mean time to 50 percent gastric emptying was about 30 minutes faster, and at 20 minutes, plasma levels were more than five times higher than conventional Imitrex Tablets.
Imitrex Tablets, formulated with RT Technology, are bioequivalent to conventional Imitrex Tablets as measured by AUC0-24 and Cmax. The clinical significance of the scintigraphy data is unknown.
“We conducted this study to evaluate if the tablet formulated with RT Technology could deliver faster disintegration and absorption,” said Shashidhar Kori, MD, director of clinical development, Neurosciences Medicine Development Center, North America, GlaxoSmithKline, who presented the study findings. “These findings are important because they provide insight into how this delivery technology works in the gastrointestinal tract.”
Imitrex Tablets, formulated with RT Technology, are designed to enhance the dispersion and dissolution of the active ingredient sumatriptan, even in the presence of gastric stasis. Gastric stasis can delay the disintegration of drugs in the stomach, causing slower absorption of the medication into the bloodstream.
“In my experience, many migraineurs prefer oral therapy to treat their migraines,” said Sheena Aurora MD, director of the Swedish Headache Center in Seattle, Wash. “However, gastric stasis, a common occurrence in migraine patients, has the potential to limit the efficacy of medicine that is swallowed. Therefore research to identify innovative ways to deliver migraine medication is crucial.”
These findings are consistent with earlier studies of Imitrex Tablets, formulated with RT Technology. In vitro dissolution studies have shown Imitrex Tablets formulated with RT Technology dissolve five times faster than conventional Imitrex tablets. The clinical significance of the in vitro dissolution data is unknown.
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