Claims for Patent: 10,758,616

Summary for Patent: 10,758,616

Title:	Pre-mixed, ready-to-use pharmaceutical compositions
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.
Inventor(s):	Duncan; Michelle Renee (Glenview, IL), Gupta; Supriya (Waverly, IA), Haas; David Hartley (Fremont, CA), Nenonene; Norma V. (Skokie, IL), Zamiri; Camellia (Fremont, CA)
Assignee:	EKR Therapeutics, Inc. (Cary, NC)
Application Number:	16/010,898
Patent Claims:	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.