Stable Antimicrobial Formulation of Scopolamine for Multi-dose Vial

Recent efforts to improve treatment for nerve agent poisoning include the development of a scopolamine hydrobromide injectable as an anticholinergic. A scopolamine injectable would add an extremely beneficial capability to the warfighter kit, however, incorporation of single-use vials represents a substantial logistical burden in the field. Co-formulation of the scopolamine injectable with a suitable and stable preservative would render the therapeutic safe for packaging and use in a multi-dose vial format, substantially reducing the burden on the warfighter while enhancing the medical capabilities in the field. However, such a formulation has not been demonstrated. We propose to develop a stable and antimicrobial formulation of scopolamine hydrobromide that is compatible with multi-dose vial requirements. The formulation will meet USP and FDA requirements for antimicrobial activity while maintaining therapeutic efficacy, resulting in a product that has a shelf-life of at least 2 years and a use life once punctured of at least 28 days.