Details for Patent: 9,549,994

Title:	Compositions of nicardipine and sulfoalkylated .beta.-cyclodextrin
Abstract:	Compositions of an inclusion complex of nicardipine or a pharmaceutically acceptable salt thereof and a sulfoalkylated .beta.-cyclodextrin. The compositions being formulated for parenteral bolus administration to a human subject. The compositions being useful in the treatment of cardiovascular and cerebrovascular disorders.
Inventor(s):	Gupta; Supriya (Sunnyvale, CA), Mi; Yanli (San Mateo, CA), Zamiri; Camellia (Fremont, CA)
Assignee:	EKR Therapeutics, Inc. (Cedar Knolls, NJ)
Filing Date:	Sep 18, 2013
Application Number:	14/030,692
Claims:	1. A pharmaceutical composition comprising an aqueous solution comprising an inclusion complex of nicardipine or a pharmaceutically acceptable salt thereof, a buffering agent and a sulfoalkylated .beta.-cyclodextrin, wherein the composition is premixed and is formulated for direct parenteral bolus administration for immediate use without dilution to a human subject, and wherein a pH of the composition is 4.5 to 5.5, wherein the composition is in unit dose format and the unit dose contains the formulation in a volume of from 0.5 to 20 ml, wherein the nicardipine concentration is 0.5 mg/ml, and wherein the sulfoalkylated .beta.-cyclodextrin in the pharmaceutical composition is from 2% to 5% (w/v) wherein the sulfoalkylated .beta.-cyclodextrin is a sulfobutylated .beta.-cyclodextrin having an average of 5 to 8 degrees of sulfobutylation. 2. The pharmaceutical composition of claim 1, wherein the sulfobutylated .beta.-cyclodextrin is sulfobutylether .beta.-cyclodextrin. 3. The pharmaceutical composition of claim 1, wherein the pharmaceutically acceptable salt of nicardipine is the nicardipine hydrochloride salt. 4. The pharmaceutical composition of claim 1, comprising the pharmaceutically acceptable salt of nicardipine in a parenterally injectable aqueous carrier, wherein the concentration of the buffering agent in the composition is 0.1 mM to 100 mM. 5. The pharmaceutical composition of claim 4, wherein the sulfoalkylated .beta.-cyclodextrin is a sulfobutylated .beta.-cyclodextrin having an average of 7 degrees of sulfobutylation. 6. The pharmaceutical composition of claim 4, wherein the buffering agent comprises at least one agent selected from a group consisting of acetate, citrate, succinate, and phosphate. 7. The pharmaceutical composition of claim 4, further comprising a tonicity adjusting agent. 8. The pharmaceutical composition of claim 4, wherein the composition further comprises at least one co-solvent in a concentration of 0.1 to 25% (w/v). 9. The pharmaceutical composition of claim 8, wherein concentration of at least one co-solvent is 0.1 to 10% (w/v). 10. The pharmaceutical composition of claim 4, wherein the pH is above a pH of 4.5 and equal to or less than a pH of 5.5.