Claims for Patent: 11,850,222

Summary for Patent: 11,850,222

Title:	Sotalol compositions and uses of the same
Abstract:	The present invention provides oral solutions containing sotalol hydrochloride which advantageously avoid swallowing while providing with improved stability. The present invention also relates to methods of using the oral solutions for treatment of diseases and disorders, such as delay in reoccurrence of atrial fibrillation/atrial flutter and/or ventricular arrhythmias.
Inventor(s):	H. Greg Thomas, Jeffrey S. Kiel
Assignee:	Arbor Pharmaceuticals LLC
Application Number:	US17/036,790
Patent Claims:	1. A method of treating ventricular arrhythmia in a patient in need thereof comprising administering an oral solution comprising sotalol hydrochloride, wherein the oral solution is administered in a dose of about 80 mg sotalol hydrochloride once or twice daily; and wherein (i) the oral solution is administered in a dose of about 80 mg sotalol hydrochloride twice a day in a patient with a creatinine clearance greater than 60 mL/min or (ii) the oral solution is administered in a dose of about 80 mg sotalol hydrochloride once a day in a patient with a creatinine clearance between 40 and 60 mL/min. 2. The method of claim 1, wherein the ventricular arrhythmia is ventricular tachycardia. 3. The method of claim 1, wherein the ventricular arrhythmia is ventricular fibrillation. 4. The method of claim 1, wherein the dose is increased up to 320 mg sotalol hydrochloride once or twice a day. 5. The method of claim 1, wherein the dose is increased in increments of 80 mg sotalol hydrochloride per day for three days. 6. The method of claim 1, further comprising monitoring the QT interval corrected for heart rate (QTc) of the patient during dose escalation. 7. A method of delaying recurrence of atrial fibrillation/atria flutter in a patient in need thereof comprising administering an oral solution comprising sotalol hydrochloride, wherein the oral solution is administered in a dose of about 80 mg sotalol hydrochloride once or twice daily, and wherein (i) the oral solution is administered in a dose of about 80 mg sotalol hydrochloride twice a day in a patient with a creatinine clearance greater than 60 mL/min or (ii) the oral solution is administered in a dose of about 80 mg sotalol hydrochloride once a day in a patient with a creatinine clearance between 40 and 60 mL/min. 8. The method of claim 7, wherein the dose is increased up to 320 mg sotalol hydrochloride once or twice a day. 9. The method of claim 7, wherein the dose is increased in increments of 80 mg sotalol hydrochloride per day for three days. 10. The method of claim 7, further comprising monitoring the QT interval corrected for heart rate (QTc) of the patient during dose escalation. 11. A method of treating ventricular arrhythmia in a patient in need thereof comprising administering an oral solution comprising sotalol hydrochloride, wherein the oral solution is administered in a dose of about 80 mg sotalol hydrochloride once or twice daily, and wherein the method further comprises monitoring the QT interval corrected for heart rate (QTc) of the patient during dose escalation. 12. The method of claim 11, wherein the ventricular arrhythmia is ventricular tachycardia. 13. The method of claim 11, wherein the ventricular arrhythmia is ventricular fibrillation. 14. The method of claim 11, wherein the dose is increased up to 320 mg sotalol hydrochloride once or twice a day. 15. The method of claim 11, wherein the dose is increased in increments of 80 mg sotalol hydrochloride. 16. A method of delaying recurrence of atrial fibrillation/atria flutter in a patient in need thereof comprising administering an oral solution comprising sotalol hydrochloride, wherein the oral solution is administered in a dose of about 80 mg sotalol hydrochloride once or twice daily, and wherein the method further comprises monitoring the QT interval corrected for heart rate (QTc) of the patient during dose escalation. 17. The method of claim 16, wherein the dose is increased in increments of 80 mg sotalol hydrochloride.