Claims for Patent: 9,717,796

Summary for Patent: 9,717,796

Title:	Heat sterilizeable, premixed, ready to use dexmedetomidine solution packaged in a flexible plastic container
Abstract:	The presently disclosed subject matter relates to pharmaceutical compositions comprising dexmedetomidine or a pharmaceutically acceptable salt thereof wherein the composition is formulated as a liquid for parenteral administration to a subject, and wherein the composition is disposed in a flexible plastic container as a ready to use premixed solution.
Inventor(s):	Pizza; Joseph M. (Paramus, NJ)
Assignee:	SLYPHARMA, LLC (Palm Beach, FL)
Application Number:	15/133,922
Patent Claims:	1. A premixed, ready to use sterile dexmedetomidine solution comprising dexmedetomidine and a sugar packaged in a plastic container substantially free of DEHP. 2. The dexmedetomidine solution of claim 1 wherein the dexmedetomidine concentration is from about 0.5 to about 20 .mu.g/ml. 3. The dexmedetomidine solution of claim 2 wherein the dexmedetomidine concentration is between about 4 to 6 .mu.g/ml. 4. The dexmedetomidine solution of claim 2 wherein the solution consists essentially of dexmedetomidine, dextrose and water. 5. The dexmedetomidine solution of claim 4 wherein the plastic container is flexible. 6. The dexmedetomidine solution of claim 5 wherein the plastic container comprises an inner layer comprising a copolymer of ethylene and vinyl acetate. 7. The dexmedetomidine solution of claim 5 wherein the solution has been sterilized in moist steam. 8. The dexmedetomidine solution of claim 1 wherein the sugar is selected from the group consisting of dextrose, mannitol, glycerol, and sucrose. 9. The dexmedetomidine solution of claim 1 wherein the solution has been aseptically sterilized. 10. The dexmedetomidine solution of claim 3 wherein the dexmedetomidine concentration is about 4.0 .mu.g/ml. 11. The dexmedetomidine solution of claim 9 wherein the sugar is dextrose, and the dextrose concentration is about 50 mg/ml. 12. The dexmedetomidine solution of claim 1 wherein the plastic container is an ampule, vial or syringe. 13. The dexmedetomidine solution of claim 12 wherein the plastic container comprises an inner layer comprising a copolymer of an ethylene-propylene and a Styrene-ethylene-butylene-styrene (SEBS). 14. The dexmedetomidine solution of claim 1 wherein the solution is isotonic, and the dexmedetomidine concentration is between about 4 to 7 .mu.g/ml. 15. The dexmedetomidine solution of claim 14 wherein the sugar is dextrose. 16. The dexmedetomidine solution of claim 1 wherein the dexmedetomidine is dexmedetomidine hydrochloride and the amount of dexmedetomidine hydrochloride is about 4.7 .mu.g/ml.