IP Library Granted Patent US 10,758,616
Granted Patent B2
US 10,758,616 · App. 16/010,898 · Granted Sep 1, 2020

Pre-mixed, ready-to-use pharmaceutical compositions

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, Inc.
A61K47/02A61K9/0019A61K31/4422A61K31/455A61K47/10A61K47/12A61K47/14A61K47/26A61K47/40A61K47/6951B82Y5/00C08B37/0015C08L5/16
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 10,758,616
App. No.
16/010,898
Granted
Sep 1, 2020
Kind
B2
Abstract

Provided herein are ready-to-use premixed pharmaceutical compositions of nicardipine or a pharmaceutically acceptable salt and methods for use in treating cardiovascular and cerebrovascular conditions.

Claims (14)

1. A pharmaceutical composition for parenteral administration 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 is buffered to 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 pharmaceutical composition for parenteral administration of claim 1 , the aqueous solution when stored in the container for at least one year 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%.

3. The composition of claim 1 , further comprising from about 1 mg/mL to about 4 mg/mL sorbitol.

4. The composition of claim 1 , wherein the non-polar polymers comprise copolyester, polyethylene or polyolefin.

5. The composition of claim 1 , comprising from about 0.1 to 0.2 mg/mL nicardipine or a pharmaceutically acceptable salt thereof.

6. The composition of claim 1 , further comprising from about 0 mg/mL to about 4 mg/mL sorbitol.

7. The composition of claim 1 , wherein the tonicity agent comprises dextrose.

8. The composition of claim 7 , comprising about 4.5% to about 5% w/v dextrose based on the composition.

9. The composition of claim 1 , wherein the tonicity agent comprises sodium chloride.

10. The composition of claim 9 , comprising about 0.8% to about 0.9% w/v sodium chloride based on the composition.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 6, 2024
From: EKR THERAPEUTICS, LLC
To: CHIESI USA, INC.
Reel/Frame 069156/0878 →
Continuity (7)
Continuation 15159495 · May 19, 2016
Continuation 12977965 · Dec 23, 2010
Continuation 12645169 · Dec 22, 2009
Continuation 12407557 · Mar 19, 2009
Division 11788076 · Apr 18, 2007
Provisional Application 60793074 · Apr 18, 2006
Related Publication 20190015511A1 · Jan 17, 2019