Solid ganaxolone compositions and methods for the making and use thereof

摘要

In certain embodiments, the invention is directed to composition comprising stable particles comprising ganaxolone, wherein the volume weighted median diameter (D50) of the particles is from about 50 nm to about 500 nm.

主权项

1. A pharmaceutical composition comprising solid stabilized particles comprising ganaxolone, a hydrophilic polymer, a wetting agent, and an effective amount of a complexing agent which is a small organic molecule having a molecular weight less than 550 and containing a moiety selected from the group consisting of a phenol moiety, an aromatic ester moiety and an aromatic acid moiety, wherein the solid stabilized particles have a volume weighted median diameter (D50) from about 50 nm to about 500 nm, the complexing agent being present in an amount from about 0.05% to about 5% w/w, based on the weight of the solid stabilized particles; the pharmaceutical composition further comprising one or more pharmaceutically acceptable additives selected from the group consisting of a diluent, a binder, a disintegrant, a plasticizer, a stabilizer, and mixtures of any of the foregoing, the pharmaceutical composition being an oral solid dosage form.