Granted Patent
B2
US 12,383,622 · App. 18/078,333 · Granted Aug 12, 2025
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:
CHIESI USA, INC.
A61K47/02A61K9/0019A61K31/4422A61K31/455A61K47/10A61K47/12A61K47/14A61K47/26A61K47/40A61K47/6951B82Y5/00C08B37/0015C08L5/16
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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 (16)
1. A method for making a pharmaceutical composition for intravenous administration comprising
preparing a pre-mixed aqueous solution with a pH from about 3.6 to about 4.4 comprising:
from about 0.1 to 0.4 mg/mL nicardipine or a pharmaceutically acceptable salt thereof; and
a tonicity agent;
and filling a pharmaceutically acceptable container with the aqueous solution such that the aqueous solution is in contact with non-polar polymers; 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)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Nov 6, 2024
From: EKR THERAPEUTICS, LLC
To: CHIESI USA, INC.
Reel/Frame 069156/0878 →
Continuity (9)
Provisional Application
60793074
· Apr 18, 2006
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