Research scientists at Purdue University have developed what they’re describing as a reliable and affordable way for pharmacies to dispense medicine in personalized amounts.
The technology could change the way doctors treat their oldest and youngest patients, who don’t need as much medicine as the average adult.
The prototype also could help oncologists prescribe cancer patients enough chemotherapy drugs to effectively target tumors without triggering significant side effects.
The project has two crucial pieces. By working across disciplines, researchers were able to create both the machine that can produce personalized pills and the mathematical formula that allows health care providers to determine how large – or small – dosages should be for specific patients.
Now, when a patient needs more or less than the standard dosage, doctors have to guess how much to prescribe. After a few weeks, the patient has blood drawn and returns to the doctor’s office. The physician will tweak the prescribed amount … again and again … until the perfect amount is found.
”It’s kind of a seesaw. You go back and forth for about three to six months until you find the right amount,” said Arun Giridhar, an associate research scientist in Purdue’s School of Chemical Engineering. He is a member of the research team.
The personalized system requires two or three blood tests at specific times on the first day. The results show how quickly his body absorbs a small amount of the drug being prescribed and lead to the personalized prescription.
Precision can be important, depending on the patient and the drug being used. Someone who needs 60 milligrams of medication might respond best to three daily doses of 20 milligrams each, for example.
Because timing for the blood draws is important, Purdue researchers expect the technology will first be used in hospitals, which have pharmacy departments and easy access to patients.
The researchers would like to work with some Indiana hospitals on a pilot program. Lutheran Health Network officials are eager to participate, but rival Parkview Health is more reluctant.
“My answer would be, yeah, if it works the way they say it will,” said Gordon Bokhart, director of Lutheran Health Network’s research department and a pharmacist by training. “We would love to be involved.”
Bokhart, who has already contacted Purdue about the new technology, sees a need for hospitals and pharmacies to personalize the amount of active drug in some prescriptions.
”We have patients who are cutting pills in half and quarters to get the right dose, he said. “And for our seniors, it’s hard for them to see to do that.”
Chris Jellison, Parkview Health’s pharmacy services director, declined to be inerviewed because he wants to do more homework on personalized dosages. But he sent a statement.
“The technology is intriguing and is definitely something we would take a look at if it ever came to market,” he wrote.
Parkview spokesman Eric Clabaugh said the Fort Wayne health care provider hasn’t talked to Purdue researchers about participating in a trial program.
But Jellison didn’t rule out the possibility that Parkview might participate if the program proved safe and improved patient care.
The machine that prints personalized dosages is about the size of a large laser printer – though researchers are working to make it smaller – and uses removable cartridges filled with drugs. It takes less than five minutes to make pills or gel capsules for each patient, Giridhar said.
The researcher thinks that in a city with, for example, six CVS pharmacies and four Walgreen stores, at least one of each retailer’s locations will eventually have the ability to print personalized dosages.
Spokesmen from CVS and Walgreens declined to comment, citing a lack of knowledge of the technology.
The Food and Drug Administration reviewed the technology in November, Giridhar said. FDA officials also are scheduled to visit Purdue for a full day next month for a closer look.
Christopher Kelly, an FDA spokesman, said he’s not allowed to comment on devices or drugs in development.
FDA, which reviews drugs for safety and effectiveness, doesn’t have to approve specific manufacturing processes as long as high-quality products are made, Giridhar said.
The Purdue scientists are searching for a partner to make the machines and sell them commercially. Giridhar guessed that might take six months to one year to pull together a partnership.
Assuming the technology makes it to market, Lutheran’s Bokhart sees potential for more effectively distributing drugs now in short supply. Some medications, including those for cancer treatment, have been difficult for pharmacies and hospitals to get in sufficient qualities.
Distributing lower doses by using Purdue’s new technology would help health care providers stretch supplies farther, he said.
Bokhart, who has been a pharmacist for 35 years, is eager to take the laser printer out for a test drive.
“This is cutting-edge technology,” he said. “That’s why I do research. It’s fun.”