| abstract |
According to the present disclosure, an injectable formulation of nanoparticles of a neurosteroid is provided comprising nanoparticles having a D50 of less than 2000 nm, the nanoparticles comprising a neurosteroid according to formula I, wherein the variables R1-R9 and X are defined herein, and at least one surface stabilizer. The surface stabilizer can be a polymeric surface stabilizer such as hydroxyethyl starch, dextran, or povidone. The injectable formulation of neurosteroid nanoparticles can be an intravenous formulation. The present disclosure also provides a lyophilized powder of an injectable neurosteroid nanoparticle formulation that can be reconstituted in an aqueous solution prior to administration. The present disclosure provides injectable formulations of neurosteroid nanoparticles and dry powders of such formulations that have been sterilized by electron beam irradiation. According to the present disclosure, there is provided a method for treating a patient having a seizure disorder, stroke or traumatic brain injury, comprising administering an effective amount of an injectable formulation of neurosteroid nanoparticles. Also contemplated by the present disclosure are combined methods wherein the injectable nanoparticle neurosteroid formulation is a first active agent that is administered in combination with at least one additional active agent. |