COMPOSITIONS AND METHODS FOR TREATING POST-OPERATIVE PAIN USING BUPIVACAINE AND AN ANTI-ONFLAMMATORY AGENT

• US 20100203102A1
• Filed: 04/14/2009
• Published: 08/12/2010
• Est. Priority Date: 02/10/2009
• Status: Abandoned Application

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: Wohabrebbi, Amira
• Application Number:
  US12/423,201
• Publication Number:
  US 20100203102A1
• Time in Patent Office: Days
• US Class Current: 424/426
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/445 Non condensed piperidines, e.g. piperocaine
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Abstract

Effective treatments of pain that accompanies post-operative surgeries are provided. Through the administration of an effective amount of a combination of bupivacaine and an anti-inflammatory agent at or near a target site, one can alleviate or prevent pain while preventing undesirable levels of inflammation. This administration of bupivacaine and an anti-inflammatory agent is particularly useful following surgery.

Claims

1. An implantable drug depot useful for localized delivery to a site beneath the skin of a patient, the drug depot comprising:

a therapeutically effective amount of bupivacaine and an anti-inflammatory agent, wherein the drug depot is capable of releasing the bupivacaine and the anti-inflammatory agent over three days to fourteen days where the depot is capable of releasing a first percentage of bupivacaine relative to a total amount of bupivacaine over the first two days and a first percentage of anti-inflammatory agent relative to a total amount of anti-inflammatory agent over the first two days, wherein the first percentage of anti-inflammatory agent is less than the first percentage of bupivacaine.

2. An implantable drug depot of claim 1, wherein the bupivacaine is in the form of a base and the anti-inflammatory agent is an NSAID.

3. An implantable drug depot of claim 1, wherein the bupivacaine is in the form of a salt and the anti-inflammatory agent is an NSAID.

4. An implantable drug depot of claim 1, wherein the bupivacaine is in the form of a base and the anti-inflammatory agent is a COX-2 inhibitor.

5. An implantable drug depot of claim 1, wherein the bupivacaine is in the form of a salt and the anti-inflammatory agent is a COX-2 inhibitor.

6. A method of treating or preventing postoperative pain in a patient in need of such treatment, the method comprising administering one or more biodegradable drug depots comprising the drug depot of claim 1 to a target tissue site beneath the skin, wherein the drug depot releases an effective amount of said bupivacaine and said anti-inflammatory agent over a period of 3 to 14 days.

7. A method of treating or preventing postoperative pain according to claim 6, wherein one or more drug depots release an effective amount of bupivacaine and anti-inflammatory agent over a period of 5 to 12 days.

8. A method of treating or preventing postoperative pain or inflammation according to claim 6, wherein the drug depot releases 50%, 60%, 70%, 80%, 90%, 95%, or 99% of the bupivacaine relative to a total amount of bupivacaine over a period of 3 to 14 days after the drug depot is administered to the target tissue site.

9. A method of treating or preventing postoperative pain according to claim 6, wherein the drug depot releases 5 mg to 60 mg of bupivacaine and 1 μ

g to 4 μ

g of anti-inflammatory agent every 4 to 6 hours to treat postoperative pain.

10. A method of treating or preventing postoperative pain according to claim 6, wherein the target tissue site comprises at least one muscle, ligament, tendon, cartilage, spinal disc, spinal foraminal space near the spinal nerve root, facet or synovial joint, or spinal canal.

11. A method of treating or preventing postoperative pain according to claim 6, wherein the drug depot comprises at least one anabolic or an anti-catabolic growth factor or a combination thereof.

12. A method of treating or preventing postoperative pain according to claim 6, wherein the bupivacaine and anti-inflammatory agent is encapsulated in a plurality of depots comprising microparticles, microspheres, microcapsules, and/or microfibers suspended in a gel.

13. A method of treating or preventing postoperative pain according to claim 6, wherein the pain or inflammation is associated with orthopedic surgery, spine surgery, arthroscopic surgery, an excision of a mass, hernia repair, spinal fusion, thoracic, cervical, or lumbar surgery, pelvic surgery or a combination thereof.

14. A method of treating or preventing postoperative pain according to claim 6, wherein the drug depot comprises a radiographic marker adapted to assist in radiographic imaging.

15. A method of treating or preventing postoperative pain according to claim 14, wherein the radiographic marker comprises barium, calcium, and/or metal beads.

16. A method of inhibiting postoperative pain in a patient in need of such treatment, the method comprising delivering one or more biodegradable drug depots comprising the drug depot of claim 1 to a target tissue site beneath the skin before, during or after surgery, wherein the drug depot releases an effective amount of bupivacaine and anti-inflammatory agent over a period of 3 to 14 days.

17. A method of inhibiting postoperative pain according to claim 16, wherein one or more drug depots release an effective amount of bupivacaine and anti-inflammatory agent over a period of 5 to 12 days.

18. A method of inhibiting postoperative pain according to claim 17, wherein the drug depot releases 5%, 10%, 15%, 20%, 25%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 95%, or 99% of bupivacaine relative to a total amount of bupivacaine loaded in the drug depot over a period of 3 to 14 days after the drug depot is administered to the target tissue site.

19. A method of treating or preventing postoperative pain or inflammation in a patient in need of such treatment, the method comprising co-administering a first biodegradable drug depot and a second biodegradable drug depot to a target site, wherein said first biodegradable drug depot releases an effective amount of bupivacaine over a period of 3 to 14 days and wherein said second biodegradable drug depot releases an anti-inflammatory agent over a period of 3 to 14 days.

20. An implantable drug depot useful for localized delivery to a site beneath the skin of a patient, the drug depot comprising:

a therapeutically effective amount of bupivacaine and an anti-inflammatory agent, wherein the drug depot is capable of releasing the bupivacaine and the anti-inflammatory agent over five days to twelve days and wherein the drug depot is capable of releasing a first percentage of bupivacaine relative to a total amount of bupivacaine over the first two days and a first percentage of anti-inflammatory agent relative to a total amount of anti-inflammatory agent over the first two days, wherein the first percentage of bupivacaine is greater than the first percentage of the anti-inflammatory agent and wherein the anti-inflammatory agent is a COX-2 inhibitor.