Granted Patent B2

US 12,740,947 · App. 18/322,111 · Granted Sep 22, 2026

Inventors: John Charin Somberg (Chicago, IL); Brandon Ira Kashfian (Chicago, IL); Janos Molnar (Chicago, IL)

Assignee: AltaThera Pharmaceuticals LLC

A61K31/136A61K9/0019A61K9/0053

Abstract

Claims (16)

1 . A method of administering sotalol hydrochloride therapy comprising:

administering to a subject a single intravenous (IV) dosage of sotalol hydrochloride:

in an amount in the range of 99 mg to 128 mg;

over a period of 1 hour; and

at a rate in the range of about 1.65 mg/min to about 2.13 mg/min; wherein in response to the administering of the IV dosage, the subject is capable of achieving a peak serum, plasma or blood concentration of the sotalol hydrochloride in the range of 90-110% of a C max at steady-state expected for that subject from oral dosing; and

administering to the subject at least one 160 mg oral dose of sotalol hydrochloride and wherein the 160 mg oral dose starts at about 2-12 hours after completion of the administering of the IV dosage.

2 . The method of claim 1 , wherein the subject is administered a number of oral doses timed, from each other and/or the IV dose, such that the subject is capable of achieving a peak serum, plasma or blood concentration of sotalol hydrochloride at least three times within 24 hours that is in the range of 90-110% of the expected C max at steady-state for that subject from 160 mg oral dosing.

3 . The method of claim 1 , wherein the subject is naïve to sotalol prior to administering the sotalol hydrochloride therapy.

4 . The method of claim 1 , wherein the administering of the at least one 160 mg oral dose starts at about 4-12 hours after completion of the administering of the IV dosage.

5 . The method of claim 4 , wherein one or more of the at least one 160 mg oral dose is administered at a 12- to 48-hour interval from administration of a previous oral dose.

6 . The method of claim 1 , wherein the administering of the IV dosage begins at a time when the subject has a serum, plasma or blood concentration of sotalol hydrochloride at a steady state C min .

7 . The method of claim 4 , wherein the subject is one who had been administered a 120 mg oral dose of sotalol hydrochloride prior to the administering of the IV dosage.

8 . The method of claim 1 , wherein one or more of the at least 160 mg one oral dose is administered at a 12- to 48-hour interval from administration of a previous oral dose.

9 . The method of claim 1 , wherein the subject has atrial fibrillation or atrial flutter.

10 . The method of claim 2 , wherein the subject has atrial fibrillation or atrial flutter.

11 . The method of claim 1 , wherein the subject is in sinus rhythm prior to initiation of the administering of the IV dosage.

Assignments (1)

Continuity (3)

References Cited (400)