Dual Formulation of Atropine-Scopolamine with Enhanced Stability

CMC Pharmaceuticals, Inc. (Cleveland, OH) has proposed developing a stable, combination product of two small molecule drug candidates as a countermeasure 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 combo product to meet FDA and ICH development guidelines. The specific aims of the SBIR-phase II submission include the development of stability indicating analytical methods, identification of promising prototype formulations, and determination of the stability-profiles of the proposed prototype formulations for up to 24 months. 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 a FDA regulatory pathway leading to commercialization.