Neuroactive steroid formulations and methods of treating CNS disorders
Formulations of comprising a neuroactive steroid, e.g., allopregnanolone; and optionally a cyclodextrin, e.g., a β-cyclodextrin, e.g., a sulfo butyl ether β-cyclodextrin, e.g., a β-cyclodextrin, e.g., a sulfo butyl ether β-cyclodextrin, e.g., CAPTISOL®; and methods of use in treating CNS disorders.
1. A method of treating a traumatic brain injury in a subject in need thereof, comprising administering to the subject an effective amount of an aqueous pharmaceutical composition formulated for parenteral administration comprising allopregnanolone at a concentration of 5 mg/mL, sulfo butyl ether β-cyclodextrin at a concentration of about 250 mg/mL, and a citrate buffer, wherein the pH of the composition is from 5 to 9.
2. The method of claim 1 , wherein the composition is formulated for intravenous administration.
3. The method of claim 1 , wherein the composition further comprises an antioxidant.
4. The method of claim 1 , wherein the composition has a pH of about 6.
5. The method of claim 1 , wherein the composition is formulated for subcutaneous administration.
6. The method of claim 1 , wherein the composition is contained within a glass vial.