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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: 18.1
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
United States
DUNS: 057247750
HUBZone Owned: No
Woman Owned: Yes
Socially and Economically Disadvantaged: No
Principal Investigator
 Michael Radomsky
 President
 (415) 370-1139
 mike.radomsky@cmcpharm.com
Business Contact
 Lisa Losch
Phone: (216) 600-9430
Email: lisa.losch@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 a counter measure to chemical warfare nerve agents (NA). The combination product is expected to exploit complementary pharmacological profiles for optimal muscarinic receptor blockade and anticholinergic activity within the peripheral and central nervous system. It is expected that the development of this stable, combined formulation will increase the therapeutic efficacy over current NA treatment regimens. CMC Pharma proposes a pharmaceutical research and development program to develop preliminary specifications of this combination formulation to 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 be utilized. 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. *

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