Dual Formulation of Atropine/Scopolamine with Enhanced Stability

Award Information
Agency: Department of Defense
Branch: Office for Chemical and Biological Defense
Contract: W911QY-18-C-0198
Agency Tracking Number: C181-005-0066
Amount: $149,268.80
Phase: Phase I
Program: SBIR
Solicitation Topic Code: CBD181-005
Solicitation Number: 2018.0
Timeline
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2018-10-01
Award End Date (Contract End Date): 2019-03-31
Small Business Information
7100 Euclid Ave, Suite 152, Cleveland, OH, 44103
DUNS: 057247750
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 Michael Radomsky
 (415) 370-1139
 mike.radomsky@cmcpharm.com
Business Contact
 Michael Radomsky
Phone: (415) 370-1139
Email: mike.radomsky@cmcpharm.com
Research Institution
N/A
Abstract
CMC Pharmaceuticals, Inc. (Cleveland, OH) is proposing developing a stable, combination product of two small molecule drug candidates as acounter measure to chemical warfare nerve agents (NA). The combination product is expected to exploit complementary pharmacologicalprofiles for optimal muscarinic receptor blockade and anticholinergic activity within the peripheral and central nervous system. It is expectedthat the development of this stable, combined formulation will increase the therapeutic efficacy over current NA treatment regimens. CMCPharma proposes a pharmaceutical research and development program to develop preliminary specifications of this combination formulationto meet FDA and ICH development guidelines. The specific aims include the development of a stability indicating analytical method,identification of promising prototype formulations, and determination of the initial stability-profiles of the proposed prototype formulations.Previous research at CMC Pharma that identified methods and formulation approaches for similar small molecule drug candidates will beutilized. This early stage research and development effort is expected to proceed to bridge the gap between laboratory-scale innovation (i.e.This effort) and entry into an FDA regulatory pathway leading to commercialization.

* Information listed above is at the time of submission. *

Agency Micro-sites

SBA logo
Department of Agriculture logo
Department of Commerce logo
Department of Defense logo
Department of Education logo
Department of Energy logo
Department of Health and Human Services logo
Department of Homeland Security logo
Department of Transportation logo
Environmental Protection Agency logo
National Aeronautics and Space Administration logo
National Science Foundation logo
US Flag An Official Website of the United States Government