FDA Acetaminophen Proposal Spurs New Research Efforts

July 16, 2009

Researchers at the University of New Orleans are developing a method to produce large-scale batches of a new form of acetaminophen that may be safer than the current drug.

Researchers at the University of New Orleans (UNO) are developing a method to produce large-scale batches of a new form of acetaminophen that may be safer than the current drug.

Mark Trudell, PhD, a professor in the chemistry department at UNO, and his team of researchers report this development shortly after the recommendation from the US Food and Drug Administration (FDA) that certain pain killers containing acetaminophen be banned and that the standard dosages of Tylenol be lowered. Trudell and colleagues note that another recent discovery by scientists yielded a new formulation of the drug that has similar potency to the current form but less risk for liver toxicity, one of the main concerns behind the FDA’s proposal.

The newly developed form of acetaminophen had been difficult to produce “in quantities suitable for industrial scale-up.” Trudell and his team have developed a production process that involves “a few starting materials and a short series of chemical reactions.” In the course of their experiments, the team was able to produce multigram qualities of the new formulation with 99% purity. The researchers added that the process can be repeated on a “much larger production level” if such a need ever exists.

Production results were published in the online edition of the journal Organic Process Research and Development. Physicians without a subscription to the journal are only able to view a drawing of the new formula’s chemical structure, but subscription to the journal provides access to additional information about the new drug.

To read more on the FDA’s proposed acetaminophen restrictions, click here. Further information on the proposal and acetaminophen is also available from the FDA.