Methods of treatment using a dexmedetomidine premix formulation

• US 8,455,527 B1
• Filed: 11/15/2012
• Issued: 06/04/2013
• 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:
  US13/678,148
• Time in Patent Office: 201 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 method of providing sedation to a patient in need thereof, the method comprising administering to the patient an effective amount of a composition, wherein the composition comprises dexmedetomidine or a pharmaceutically acceptable salt thereof at a concentration of about 0.005 to about 50 μ

g/mL, wherein the composition is a ready to use liquid pharmaceutical composition for parenteral administration to the patient disposed within a sealed glass container.

2. The method of claim 1, wherein the dexmedetomidine or pharmaceutically acceptable salt thereof is at a concentration of about 0.05 to about 15 μ

g/mL.

3. The method of claim 1, wherein the dexmedetomidine or pharmaceutically acceptable salt thereof is at a concentration of about 0.5 to about 10 μ

g/mL.

4. The method of claim 1, wherein the dexmedetomidine or pharmaceutically acceptable salt thereof is at a concentration of about 1 to about 7 μ

g/mL.

5. The method of claim 1, wherein the dexmedetomidine or pharmaceutically acceptable salt thereof is at a concentration of about 4 μ

g/mL.

6. The method of claim 1, wherein the composition is administered perioperatively.

7. The method of claim 6, wherein the composition is administered before or after surgery.

8. The method of claim 1, wherein the composition is administered to the patient in an intensive care unit.

9. The method of claim 1, wherein the patient is non-ventilated or intubated.

10. The method of claim 1, wherein the patient is critically ill.

11. The method of claim 1, wherein the composition is administered by an intravenous infusion.

12. The method of claim 1, wherein the composition is administered as an anxiolytic.

13. The method of claim 1, wherein the composition is administered as an adjunct to an anesthetic.

14. The method of claim 1, wherein the composition is administered as an analgesic.

15. The method of claim 1, wherein the composition is administered as an anti-hypertensive agent.