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Last Updated: November 19, 2019

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Claims for Patent: 10,016,396

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Summary for Patent: 10,016,396
Title:Dexmedetomidine premix formulation
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 within a sealed container as a premixture. The pharmaceutical compositions can be used, for example, in perioperative care of a patient or for sedation.
Inventor(s): Roychowdhury; Priyanka (Foster City, CA), Cedergren; Robert A. (Libertyville, IL)
Assignee: HOSPIRA, INC. (Lake Forest, IL)
Application Number:15/444,932
Patent Claims: 1. A liquid pharmaceutical composition for intravenous administration to a subject, comprising dexmedetomidine or a pharmaceutically acceptable salt thereof at a concentration of about 0.005 .mu.g/mL to about 50 .mu.g/mL disposed within a sealed glass container, wherein the liquid pharmaceutical composition is manufactured as a ready to use premixture that does not require reconstitution or dilution prior to administration to a patient.

2. The liquid pharmaceutical composition of claim 1, wherein the dexmedetomidine or pharmaceutically acceptable salt thereof is at a concentration of about 0.05 .mu.g/mL to about 15 .mu.g/mL.

3. The liquid pharmaceutical composition of claim 1, wherein the dexmedetomidine or pharmaceutically acceptable salt thereof is at a concentration of about 0.5 .mu.g/mL to about 10 .mu.g/mL.

4. The liquid pharmaceutical composition of claim 1, wherein the dexmedetomidine or pharmaceutically acceptable salt thereof is at a concentration of about 1 to about 7 .mu.g/mL.

5. The liquid pharmaceutical composition of claim 1, wherein the dexmedetomidine or pharmaceutically acceptable salt thereof is at a concentration of about 1 to about 4 .mu.g/mL.

6. The liquid pharmaceutical composition of claim 1, further comprising sodium chloride at a concentration of between about 0.01 and about 2.0 weight percent.

7. The liquid pharmaceutical composition of claim 5, wherein the sodium chloride is present at a concentration of about 0.9 weight percent.

8. The liquid pharmaceutical composition of claim 1, wherein the composition is formulated as a total volume selected from the group consisting of 20 mL, 50 mL and 100 mL.

9. The liquid pharmaceutical composition of claim 1, wherein the liquid pharmaceutical composition when stored in the glass container for at least five months exhibits no more than about 2% decrease in the concentration of dexmedetomidine.

10. The liquid pharmaceutical composition of claim 1, wherein the dexmedetomidine is formulated as a hydrochloride salt.

11. The liquid pharmaceutical composition of claim 1, wherein the liquid pharmaceutical composition has a pH of about 2 to about 10.

12. The liquid pharmaceutical composition of claim 11, wherein the liquid pharmaceutical composition has a pH of about 4 to about 8.

13. The liquid pharmaceutical composition of claim 11, wherein the liquid pharmaceutical composition has a pH of about 4.5 to about 8.

14. The liquid pharmaceutical composition of claim 11, wherein the liquid pharmaceutical composition has a pH of between about 4.5 and about 7.

15. The liquid pharmaceutical composition of claim 1, wherein the liquid pharmaceutical composition is terminally sterilized.

16. The liquid pharmaceutical composition of claim 15, wherein the liquid pharmaceutical composition is terminally sterilized by autoclave.

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