Claims for Patent: 11,547,758

Summary for Patent: 11,547,758

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):	Michelle Renee Duncan, Supriya Gupta, David Hartley Haas, Norma V. Nenonene, Camellia Zamiri
Assignee:	Chiesi USA Inc
Application Number:	US16/938,198
Patent Claims:	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.