Oral Solutions Comprising Lisdexamfetamine Salts
AssigneeAdalvo Limited
InventorsGeorgios LIOLIOS, Ioannis PSARRAKIS
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Abstract
Oral pharmaceutical solution comprising a pharmaceutically acceptable salt of lisdexamfetamine, and a pharmaceutically acceptable aqueous carrier comprising a buffer and a cosolvent selected from the group consisting of a glycol, a polyol, and a mixture thereof, wherein the pH of the solution is from 5.5 to 9.0. The oral pharmaceutical solution presents excellent physicochemical stability, even under alkaline conditions.
Claims21
-15. (canceled)
A method of treating binge eating disorder (BED) in a subject in need thereof, the method comprising administering to the subject an oral pharmaceutical solution comprising 10 mg/ml of lisdexamfetamine dimesylate and a pharmaceutically acceptable aqueous carrier comprising a buffer and a non-aqueous cosolvent selected from a glycol, a polyol and a mixture thereof, wherein the pH of the solution is from 6.0 to 9.0, and wherein the solution contains less than 1.0% total impurities after four weeks.
A method of treating binge eating disorder (BED) in a subject in need thereof, the method comprising administering to the subject an oral pharmaceutical solution comprising 10 mg/ml of lisdexamfetamine dimesylate and a pharmaceutically acceptable aqueous carrier comprising a buffer and a cosolvent, wherein the pH of the solution is from 6.0 to 9.0 and wherein the cosolvent comprises a glycol.
Dependencies are inferred from the claim text.