Claims for Patent: 11,576,878

Summary for Patent: 11,576,878

Title:	Oral solutions comprising lisdexamfetamine salts
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.
Inventor(s):	Georgios LIOLIOS, Ioannis Psarrakis
Assignee:	Adalvo Ltd
Application Number:	US16/961,784
Patent Claims:	1. Oral pharmaceutical solution comprising from 1 mg/ml to 40 mg/ml of 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. 2. Oral pharmaceutical solution according to claim 1, wherein the solution is free of any antioxidant. 3. Oral pharmaceutical solution according to claim 1, wherein the solution is free of an antioxidant selected from the group consisting of sodium metabisulfite, butylated hydroxy anisole, butylated hydroxytoluene, ethylenediamine tetraacetic acid, ascorbic acid, α-tocopherol, and propyl gallate. 4. Oral pharmaceutical solution according to claim 1, wherein the cosolvent is selected from the group consisting of maltitol, glycerol, mannitol, sorbitol, xylitol, propylene glycol, low molecular weight polyethylene glycol and a mixture thereof. 5. Oral pharmaceutical solution according to claim 1, wherein the cosolvent is selected from the group consisting of maltitol and low molecular weight polyethylene glycol. 6. Oral pharmaceutical solution according to claim 1, wherein the cosolvent is maltitol. 7. Oral pharmaceutical solution according to claim 1, wherein the total concentration of the cosolvent is from 5 mg/ml to 300 mg/ml. 8. Oral pharmaceutical solution according to claim 1, wherein the total concentration of the cosolvent is from 50 mg/ml to 250 mg/ml. 9. Oral pharmaceutical solution according to claim 1, wherein the total concentration of the cosolvent is from 100 mg/ml to 200 mg/ml. 10. Oral pharmaceutical solution according to claim 1, wherein the pH of the solution is from 6.0 to 8.5. 11. Oral pharmaceutical solution according to claim 1, wherein the pH of the solution is from 6.5 to 8.0. 12. Oral pharmaceutical solution according to claim 1, wherein the concentration of the pharmaceutically acceptable salt of lisdexamfetamine is from 5 mg/ml to 30 mg/ml. 13. Oral pharmaceutical solution according to claim 1, wherein the concentration of the pharmaceutically acceptable salt of lisdexamfetamine is from 10 mg/ml to 20 mg/ml. 14. Oral pharmaceutical solution according to claim 1, wherein the pharmaceutically acceptable salt of lisdexamfetamine is selected from the group consisting of lisdexamfetamine dimesylate and lisdexamfetamine hydrochloride. 15. Oral pharmaceutical solution according to claim 1, wherein the pharmaceutically acceptable salt of lisdexamfetamine is lisdexamfetamine dimesylate.