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Case Study

Formulating a solution to mass radiation exposure

In the event of a radiation leak or nuclear accident, oral medication options are needed for quick-turnaround, effective, large-scale treatment

Innovative Science Overcomes Formulation Challenges

The chemical compound zinc diethylenetriaminepentaacetate (Zn-DTPA) is a known antidote to radionuclide exposure. However, to be effectively deployed in mass-exposure emergency situations, Zn-DTPA needed to be adapted from an intravenous formulation – which is highly impractical in mass-casualty situations – to an orally bioavailable formulation. Previous attempts to reformulate the drug have failed, due primarily to poor biologic absorption and the requirement for a room-temperature stable product.

Novel, Oral Formulation of Zn-DTPA That Has Proven Efficacy

Backed by funding from the U.S. National Institutes of Health (NIH), SRI International researchers set out to develop an effective oral formulation of Zn-DTPA. Utilizing the organization’s proprietary “IVtoPO” platform technology, which comprises novel, advanced screening tools, SRI researchers identified potent permeation enhancers that could improve Zn-DTPA oral bioavailability.  Additionally, they designed a plan to quickly evaluate the safety and efficacy of various formulations. This work resulted in an oral Zn-DTPA tablet with proven efficacy in vivo.

Formulating a solution to mass radiation exposure

The combination of advanced formulation tools and staff with extensive expertise developing formulations for numerous administration routes enabled SRI International to solve the two primary challenges associated with Zn-DTPA reformulation.

The organization’s novel “IVtoPO” Platform Technology, which includes a robotically controlled, automatic screening system to complete both high-throughput solubility screening and intra-intestinal permeation through live tissue, efficiently screened hundreds of permeation enhancer combinations. This resulted in the identification of a proprietary formulation of Zn-DTPA that sufficiently enhances oral bioavailability of the drug – allowing for effective oral administration instead of intravenous administration.

SRI is now working toward submission of a New Drug Application (NDA) with the US Food and Drug Administration following completion of trials in healthy, human subjects.

 


This project has been funded in whole or in part with Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272201000029C.

The views expressed in written conference materials or publications and by speakers and moderators at HHS-sponsored conferences, do not necessarily reflect the official policies of the Department of Health and Human Services; nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government.

November 2019

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