Grants Totaling a Potential $5M Awarded to SOP Researcher

Audra Stinchcomb, PhD, will use awards to advance transdermal and topical drug delivery research.

By Malissa Carroll
October 10, 2013

Audra Stinchcomb, PhD, professor in the Department of Pharmaceutical Sciences (PSC) at the University of Maryland School of Pharmacy, has received two significant grant awards from the Food and Drug Administration (FDA) to support her work in the field of transdermal and topical drug delivery. Combined, the grants total $1 million and have the potential to be renewed for up to five years.

“The recent grant awards presented to Dr. Stinchcomb by the FDA are a testament to the cutting-edge investigations being conducted in her transdermal drug delivery research program at the School of Pharmacy,” says Andrew Coop, PhD, professor and chair of PSC. “As a top research school, the School of Pharmacy applies an integrative approach to drug discovery and development. The studies that these grants will support will help to further advance our development of translational research models for future public-private partnerships.”

One groundbreaking project that Stinchcomb will undertake as part of these grant awards will test key regulatory-related hypotheses with which the FDA has grappled for years. Titled “Bioequivalence of Topical Drug Products: In Vitro-In Vivo Correlation,” the project aims to develop simple testing methods that can be used to determine how effective generic topical drug products, such as creams, ointments, or gels, are when compared to brand name products.

“Currently, the primary method available to evaluate the bioequivalence of many generic topical drug products is a large clinical trial, which involves a lot of patients and can cost several million dollars” says Stinchcomb. “The long-term goal of this project is to demonstrate that in vitro measurements related to the performance of topical drug products are correlated with in vivo outcomes. This will allow us to develop simpler experimental approaches that can be reliably and reproducibly used for the establishment of (in)equivalence between formulations containing the same active pharmaceutical ingredient for application to the skin.”

Stinchcomb will collaborate with Steve Hoag, PhD, professor in PSC and director of the Good Manufacturing Practice (GMP) Facility at the School, in the second year of the project. “I am excited for the opportunity to work with Dr. Stinchcomb on this project and look forward to bringing my expertise in drug manufacturing and the expertise of the School’s GMP Facility in analytical, preformulation, and formulation research to this investigation,” says Hoag.

Other researchers involved with this project include Richard H. Guy, PhD, professor of pharmaceutical sciences at the University of Bath in the United Kingdom and pioneer in the field of transdermal drug delivery; Annette L. Bunge, PhD, professor emerita of chemical and biological engineering at the Colorado School of Mines; and Thomas Franz, MD, inventor of the Franz diffusion cell that has been used in this type of research for many years. These individuals also presented at Stinchcomb’s CERSI-sponsored conference in May 2013, which spotlighted the most recent developments in topical drug bioequivalence and bioavailability.

If successful, the simplified experimental approaches developed through this project could significantly decrease the cost and improve the efficiency of the generic topical drug approval process.

Another project supported by these grants addresses a critical safety issue for individuals who use generic pain relief patches, which are often formulated differently than brand name patches. Titled “Heat Effect on Generic Transdermal Drug Delivery Systems,” this project seeks to simulate patients’ behavior when using a generic medicated patch for pain relief.

“Some patients who are coping with chronic pain and using a pain relief patch might also apply a heating pad to the affected area to help relieve their pain,” says Stinchcomb. “Our goal is to simulate what happens when an external heat source, like a heating pad, is applied to the same area as a pain relief patch. This will help us predict what might happen with other patch systems as well.”

In collaboration with Hazem Hassan, PhD, RPh, research assistant professor in PSC, Stinchcomb will conduct clinical trials and translate the results of those trials into an innovative approach that can be used to predict the clinical performance of generic products using a standard set of well-controlled laboratory tests. “I am thrilled to collaborate with Dr. Stinchcomb on this project which provides a unique opportunity to correlate results from transdermal laboratory experiments to that of clinical pharmacokinetic investigations. It is exciting that the FDA is supporting our goal to ensure the safety of patients who use transdermal patches,” says Hassan.

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