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Posted 09.09.04

NU Researcher Produces new Drug for Acid Reflux Disease

Zagerid™ Works Faster, Lasts as Long as Current Drugs

COLUMBIA, Mo. -- It affects one out of every 20 people and might result in severe ulcers and cancer. Gastroesophageal Reflux Disease, otherwise known as heartburn or acid reflux disease, also is a large problem in trauma patients and young children. Now, University of Missouri-Columbia researchers have developed a new drug delivery system for proton pump inhibitors (PPIs), a class of drugs used to fight acid reflux disease, that avoids problems traditionally associated with treatment using these drugs. Santarus, a specialty pharmaceutical company, is developing the drug, better known as Zagerid™, and bringing it to the market.

"Zagerid™ is unique, because it combines immediate neutralization of stomach acid with rapid and sustained inhibition of acid production," said Tom Sharpe, director of the Office of Technology and Special Projects. "Some trauma patients can't swallow pills because they have tubes in their throat. In the end, it was a little bit of baking soda and a lot of ingenuity that made the difference."

Currently, PPIs must pass through the stomach to the intestines before entering the bloodstream in the intestine because stomach acid destroys the drug before it can be absorbed. To protect it from the stomach acid as it passes through the stomach, the drug has a special outer coating. However, when administering the drug to trauma patients with tubes inserted in their throats, researchers discovered that the drug would stick to the walls of the tube. MU researchers thought about crushing the drug granules into small pieces, but that would destroy the protective coating and the drug would be destroyed by the stomach acid before it could enter the bloodstream.

To stop the destruction, scientists used a potent antacid, sodium bicarbonate or baking soda, as a buffer. The baking soda was administered to neutralize the stomach acid and then the crushed granules were washed down the tube with additional baking soda. This protects the drug from the stomach acid and allows it to be absorbed more quickly, reaching peak blood levels in 30 minutes versus 11⁄2 to 3 hours for current delayed-release PPIs.

Not only does Zagerid™ begin working immediately, but the duration of acid inhibition is similar to the slower onset, delayed-release PPIs. The Food and Drug Administration approved Zagerid™ 20mg Powder for Oral Suspension for marketing earlier this summer.

"This is a wonderful example of how a serendipitous discovery that came from trying to solve a real life problem in the intensive care unit resulted in a discovery that now has the potential of impacting millions of lives," Sharpe said. "We were able to link our researchers and the technology to a very aggressive drug development company that has moved this product quickly and is about to launch the drug into the marketplace where it will have a positive impact on people's lives."

Part of the proceeds from the sales of Zagerid™ will be reinvested into research and technology innovation programs at the University.


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