Feb. 25, 2004 When his wife suffers from debilitating migraine headaches, University of Rhode Island Pharmacy Professor Hossein Zia brings her to South County Hospital for an injection of the pain medication Ketorolac and an anti-nausea medicine.
But Zia hated to see her suffer while waiting for relief, and since he was researching nasal drug delivery formulations, he thought he could help her and others like her.
Zia, a pharmacy colleague and two graduate students have found success. Now, all they need is a company interested in licensing the patented formulations for clinical trials and eventual sale.
Zia worked with fellow URI Professor Thomas Needham and former graduate students Muhammad Quadir and Pratik Sheth to develop a nasal formulation of Ketorolac tromethamine to eliminate pain and a nasal formulation of metoclopramide hydrochloride to combat intense nausea and vomiting that can accompany migraines.
"Most pharmaceutical companies are trying to develop pain medications in spray formulations," Zia said. "Two are available on the market, but I still believe this is the best approach for migraines because Ketorolac and anti-nausea medicines are what patients get in the emergency room."
According to an article in the journal Drug Delivery, which was written by Zia and his colleagues, Ketorolac tromethamine is a potent non-narcotic analgesic with moderate anti-inflammatory effects.
"Clinical studies indicate that Ketorolac has a single dose efficacy greater than morphine for post-operative pain and has excellent applicability in the emergency treatment of pain," the article says.
Another article in the journal S.T.P Pharma Sciences, also-co-authored by members of the team, describes formulations of the drug with an anti-nausea agent, metoclopramide hydrochloride.
The journal says that the painkiller is usually given orally three or four times a day to deliver a range of 30 to 60 milligrams. But higher doses cannot be given because of gastrointestinal side effects. It is also given as an intramuscular injection three times a day, but that limits availability to clinical settings, such as hospital emergency rooms.
"A nasal formulation seems to be an attractive alternative, especially when repeated doses of the drug could be easily self-administered," the journal says.
The anti-nausea medication can offset effects related to certain disease states, such as migraines, cancer chemotherapy and post-operative periods.
The researchers said the nasal formulation is a promising alternative to traditional approaches.
"With the accessibility and familiarity of the nasal spray pump, this formulation would significantly reduce visits by patients to physicians or emergency rooms," the journal says.
Needham, professor in the Department of Applied Pharmaceutical Sciences, said nasal drug delivery is effective because absorption rates are almost as high as those with intravenous injections. "There are two important advantages to nasal drug delivery; it eliminates the pain and inconvenience of injections and it allows patients to administer relief on their own. Everyone of us would like to spray something in our noses instead of getting an injection."
Needham said researchers measure a drug’s effectiveness by its bio-availability, that is the amount of drug available in the bloodstream to treat the condition. "With our formulation, we achieve 95 percent bio-availability," he said. Needham said the researchers were able to develop a formulation that keeps the medication in the nose longer for great absorption.
"Research shows that when pain is established, it becomes hard to eliminate," Needham said. "With these formulations, the patient can attack the problems as the symptoms first develop, giving him or her a leg up on the fight against pain."
Needham added that such formulations could be applied to other medications.
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