Mitch Emmons (emmonmb@mail.auburn.edu)

ALABAMA PHARMACEUTICAL MANUFACTURERS GET HELP FROM AU

AUBURN -- Alabama's pharmaceutical manufacturers -- who boost the state's economy by some $50 million annually -- are turning to Auburn University's School of Pharmacy for research expertise in formulating medications.

Auburn's role involves analysis and formula development, says Guru Betageri, an associate professor in the Department of Pharmacal Science.

"These companies do not have research facilities in their plants, so Auburn is providing these services," he said. "We are helping in the development of dosage forms -- such as capsules and tablets."

Auburn's research involves work with newly developed as well as existing drugs, Betageri said.

"When a new drug is discovered, you have to develop a dosage form, depending on the properties of the drug . . . you have to make a stable dosage form that works pharmacologically," he said. "The right additives have to be determined and the drug has to react to deliver the desired benefit to the patient."

Some of the drug manufacturers simply are developing alternative forms of already available generic or over-the-counter drugs. In these cases, Betageri said Auburn is helping to determine the product composition from scratch.

"To transfer these technologies, you need formulations," he said. "And even though the drug may already exist in some form with approval from the Food and Drug Administration, and the company may only be remanufacturing it into a different form, these new forms have to get FDA approval.

"Any time you change the formulation, or even the (manufacturing) process, the FDA has to give its approval before the drug can be put on the market."

And winning FDA approval may be a one-to-three-year process, says Betageri.

Alabama is home to about nine different pharmaceutical firms, and Auburn has been working with some as long as one year.

AU's involvement currently deals with drugs in capsule or tablet form, Betageri said, adding, "In the future, we will be working with these companies to develop drugs in other dosage forms," he said.

june96:AU-pharmacy

CONTACT: Betageri, 844-8327.