Dexmedetomidine premix formulation

• US 8,338,470 B1
• Filed: 07/03/2012
• Issued: 12/25/2012
• Est. Priority Date: 01/04/2012
• Status: Active Grant

• Current Assignee: Hospira Incorporated (Pfizer Inc.)
• Original Assignee: Hospira Incorporated (Pfizer Inc.)
• Inventors: Roychowdhury, Priyanka, Cedergren, Robert A.
• Primary Examiner(s): Lundgren, Jeffrey S.
• Assistant Examiner(s): Polansky, Gregg
• Application Number:
  US13/541,524
• Time in Patent Office: 175 Days
• Field of Search: None
• US Class Current: 514/396
• CPC Class Codes: A61K 31/4164 1,3-Diazoles
• CPC Class Codes: A61K 31/4174 Arylalkylimidazoles, e.g. oxymetazolin, naphazoline, miconazole
• CPC Class Codes: A61K 47/02 Inorganic compounds
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61K 9/08 Solutions composition of solutions A61K47/00
• CPC Class Codes: A61L 2/0023 Heat
• CPC Class Codes: A61P 23/02 Local anaesthetics
• CPC Class Codes: A61P 25/20 Hypnotics; Sedatives
• CPC Class Codes: A61P 25/22 Anxiolytics
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 9/12 Antihypertensives

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.

Claims

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 μ

g/mL disposed within a sealed glass container.

2. 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 ug/mL.

3. 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 ug/mL.

4. 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 ug/mL.

5. 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.

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

7. 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.