Stable Antimicrobial Formulation of Scopolamine for Multi-dose Vial

Treatment for acute nerve agent poisoning would greatly benefit from the additional use of a scopolamine hydrobromide injectable. However, addition of a single-dose scopolamine injectable to the warfighter kit represents a substantial logistical burden in the field. A multi-dose vial formulation of scopolamine that is effectively antimicrobial and stable in the field would alleviate logistical burdens while significantly adding to medical capabilities and treatments in far forward operations. We propose to continue developing our effectively antimicrobial multi-dose vial scopolamine hydrobromide solution, demonstrating a real shelf-life at least 2 years, container-closure compatibility, a stable active use-life of no less than 28 days post needle punction, and manufacturing feasibility. The formulation will meet all USP and FDA requirements for a multi-dose vial, and will be developed under a 505(b)(2) ANDA drug approval pathway.