Granted Patent B2

US 11,547,758 · App. 16/938,198 · Granted Jan 10, 2023

Inventors: Michelle Renee Duncan (Glenview, IL); Supriya Gupta (Waverly, IA); David Hartley Haas (Fremont, CA); Norma V. Nenonene (Skokie, IL); Camellia Zamiri (Fremont, CA)

Assignee: EKR Therapeutics, LLC

A61K47/02A61K9/0019A61K31/4422A61K31/455A61K47/10A61K47/12A61K47/14A61K47/26A61K47/40A61K47/6951B82Y5/00C08B37/0015C08L5/16

Abstract

Claims (16)

1. A method for preventing acute elevations of blood pressure in a human subject in need thereof, said method comprising parenterally administering a pharmaceutical composition comprising a pre-mixed aqueous solution comprising:

from about 0.1 to 0.4 mg/mL nicardipine or a pharmaceutically acceptable salt thereof; and

a tonicity agent;

the aqueous solution contained in a pharmaceutically acceptable container such that the solution is in contact with non-polar polymers;

wherein the composition requires no dilution before administration and has a pH from about 3.6 to about 4.4, the aqueous solution when stored in the container for at least three months at room temperature exhibiting (i) less than a 10% decrease in the concentration of nicardipine or pharmaceutically acceptable salt thereof and (ii) a total impurity formation of less than about 3%.

2. The method of claim 1 , wherein the pharmaceutically acceptable salt is nicardipine hydrochloride.

3. The method of claim 2 , wherein the quantity of nicardipine hydrochloride is in the range from about 0.1 to about 0.2 mg/ml.

4. The method of claim 1 , wherein the tonicity agent is selected from the group consisting of dextrose and sodium chloride.

5. The method of claim 4 , wherein the tonicity agent is dextrose.

6. The method of claim 4 , wherein the tonicity agent is sodium chloride.

7. The method of claim 1 , wherein the pharmaceutical composition further comprises a cosolvent.

8. The method of claim 7 , in which the cosolvent is sorbitol.

9. The method of claim 1 , wherein the pharmaceutical composition comprises sorbitol in a quantity in the range of from about 1.92 mg/ml to about 3.84 mg/ml.

10. The method of claim 1 , wherein the pharmaceutical composition further comprises a pH adjuster selected from the group consisting of an acid and a base.

11. The method of claim 1 , wherein the osmolality of the pharmaceutical composition is in the range from about 250 to 350 mOsm/kg.

12. The method of claim 1 , wherein the pharmaceutically acceptable container is selected from the group consisting of intravenous bags and bottles.

Assignments (1)

Continuity (8)