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 ready to use liquid pharmaceutical composition for parenteral administration to a subject, comprising dexmedetomidine or a pharmaceutically acceptable salt thereof at a concentration of about 0.005 to about 50 μg/mL disposed within a sealed glass container, wherein the liquid pharmaceutical composition has a pH of about 2 to about 10.
2. The ready to use liquid pharmaceutical composition of claim 1 , wherein the liquid pharmaceutical composition has a pH of about 4 to about 8.
3. The ready to use liquid pharmaceutical composition of claim 1 , wherein the liquid pharmaceutical composition has a pH of about 4.5 to about 8.
4. The ready to use liquid pharmaceutical composition of claim 1 , wherein the liquid pharmaceutical composition has a pH of between about 4.5 and about 7.
5. The ready to use liquid pharmaceutical composition of claim 1 , wherein the dexmedetomidine or pharmaceutically acceptable salt thereof is at a concentration of about 0.05 to about 15 μg/mL.
6. The ready to use liquid pharmaceutical composition of claim 1 , wherein the dexmedetomidine or pharmaceutically acceptable salt thereof is at a concentration of about 0.5 to about 10 μg/mL.
7. The ready to use 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.
8. The ready to use liquid pharmaceutical composition of claim 1 , wherein the dexmedetomidine or pharmaceutically acceptable salt thereof is at a concentration of about 4 μg/mL.
9. The ready to use liquid pharmaceutical composition of claim 1 , further comprising sodium chloride at a concentration of between about 0.01 and about 2.0 weight percent.
10. The ready to use liquid pharmaceutical composition of claim 9 , wherein the sodium chloride is present at a concentration of about 0.9 weight percent.
11. The ready to use 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.
12. The ready to use liquid pharmaceutical composition of claim 1 , wherein the dexmedetomidine is formulated as a hydrochloride salt.
13. The ready to use liquid pharmaceutical composition of claim 1 , wherein the liquid pharmaceutical composition is terminally sterilized.
14. The ready to use liquid pharmaceutical composition of claim 13 , wherein the liquid pharmaceutical composition is terminally sterilized by autoclave.