Dexmedetomidine premix formulation
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.
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 μg/mL to about 50 μg/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 μg/mL to about 15 μg/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 μg/mL to about 10 μg/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 μg/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 μg/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.