Method of treatment using nanoparticulate ganaxolone formulations
AssigneeMarinus Pharmaceuticals
InventorsKenneth Shaw, Mingbao Zhang
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Abstract
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.
Claims28
A method of treatment for depression, comprising administering to a human patient in need thereof an oral dosage form of stabilized ganaxolone particles comprising a therapeutically effective amount of ganaxolone, a hydrophilic polymer, a wetting agent, and an effective amount of a complexing agent selected from the group of small organic molecules 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, the stabilized particles having a volume weighted median diameter (D50) of the particles from about 50 nm to about 500 nm, wherein the therapeutically effective amount of ganaxolone is sufficient to provide treatment to the human patient suffering from depression.
A method of treatment for depression, comprising administering to a human patient in need thereof a therapeutically effective amount of an oral dosage form comprising stabilized ganaxolone particles comprising ganaxolone, a hydrophilic polymer in an amount from about 3% to about 50%, w/w, a wetting agent in an amount from about 0.05% to about 2%, w/w, based on the weight of the composition, and a complexing agent selected from the group of small organic molecules 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, the complexing agent being included in an amount from about 0.05% to about 5%, w/w, based on the weight of the solid particles, wherein the stabilized particles have a volume weighted median diameter (D50) of the particles from about 50 nm to about 500 nm and the concentration of ganaxolone in the solid stabilized particles is at least 50% by weight, wherein the therapeutically effective amount of ganaxolone is sufficient to provide treatment to the human patient suffering from depression.
Dependencies are inferred from the claim text.