Methods and compositions for treating postoperative pain comprosing ketorolac

Patent metadata

Field	Value
Publication number	US-8956636-B2
Application number	US-38863509-A
Country	US
Kind code	B2
Filing date	Feb 19, 2009
Priority date	Apr 18, 2008
Publication date	Feb 17, 2015
Grant date	Feb 17, 2015

Abstract

Methods and compositions are provided for reducing, treating or preventing postoperative pain or inflammation in a patient in need of such treatment, the methods and compositions comprising administering one or more biodegradable drug depots comprising a therapeutically effective amount of ketorolac or pharmaceutically acceptable salt thereof to a target tissue site, wherein the drug depot releases an effective amount of ketorolac or pharmaceutically acceptable salt thereof over a period of 3 to 10 days.

First claim

What is claimed is:

1. An implantable drug depot useful for reducing or treating postoperative pain or inflammation in a patient in need of such treatment, the implantable drug depot comprising a therapeutically effective amount of ketorolac or pharmaceutically acceptable salt thereof, the depot being implantable at a site beneath the skin to reduce or treat postoperative pain, wherein the drug depot releases 0.5 mg to 60 mg of ketorolac or pharmaceutically acceptable salt thereof over 24 hours and wherein the drug depot comprises a biodegradable polymer having an inherent viscosity of about 0.05 to about 0.15 dL/g and the drug depot releases 25%, 30%, 40%, 50%, 60, 70%, 80%, 90%, 95%, or 99% of the ketorolac or pharmaceutically acceptable salt thereof relative to a total amount of ketorolac loaded in the drug depot over a period of 3 to 10 days after the drug depot is administered to the target tissue site and the drug depot comprises from about 5% to about 30% by weight of mPEG, and the biodegradable polymer comprises poly(lactide-co-glycolide) (PLGA) or polylactide (PLA).

2. A method of treating postoperative pain or inflammation in a patient in need of such treatment, the method comprising administering one or more biodegradable drug depots comprising a therapeutically effective amount of ketorolac or pharmaceutically acceptable salt thereof to a target tissue site beneath the skin, wherein the drug depot releases 0.5 mg to 60 mg of ketorolac or pharmaceutically acceptable salt thereof over 24 hours and wherein the drug depot comprises a biodegradable polymer having an inherent viscosity of about 0.05 to about 0.15 dL/g and the drug depot releases 25%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 95%, or 99% of the ketorolac or pharmaceutically acceptable salt thereof relative to a total amount of ketorolac loaded in the drug depot over a period of 3 to 10 days after the drug depot is administered to the target tissue site and the drug depot comprises from about 5% to about 30% by weight of mPEG, and the biodegradable polymer comprises poly (lactide-co-glycolide) (PLGA) or polylactide (PLA).

3. A method of treating postoperative pain or inflammation according to claim 2 , wherein one or more drug depots release an effective amount of ketorolac or pharmaceutically acceptable salt thereof over a period of 5 to 7 days.

4. A method of treating postoperative pain or inflammation according to claim 2 , wherein the ketorolac comprises ketorolac tromethamine.

5. A method of treating postoperative pain or inflammation according to claim 2 , 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.

6. A method of treating postoperative pain or inflammation according to claim 2 , wherein the drug depot comprises at least one additional anti-inflammatory or analgesic agent, at least one anabolic or an anti-catabolic growth factor or a combination thereof.

7. A method of treating postoperative pain or inflammation according to claim 2 , wherein the ketorolac or pharmaceutically acceptable salt thereof is encapsulated in a plurality of depots comprising microparticles, microspheres, microcapsules, and/or micro fibers.

8. A method of treating postoperative pain or inflammation according to claim 2 , wherein the pain or inflammation is associated with hernia repair, orthopedic or spine surgery or a combination thereof.

9. A method of treating postoperative pain or inflammation according to claim 8 , wherein the surgery is arthroscopic surgery, an excision of a mass, spinal fusion, thoracic, cervical, or lumbar surgery, pelvic surgery or a combination thereof.

10. A method of treating postoperative pain or inflammation according to claim 2 , wherein the drug depot comprises a radiographic marker adapted to assist in radiographic imaging.

11. A method of treating postoperative pain or inflammation according to claim 10 , wherein the radiographic marker comprises barium, calcium, or a combination thereof.

12. A method of reducing postoperative pain or inflammation in a patient in need of such treatment, the method comprising delivering one or more biodegradable drug depots comprising a therapeutically effective amount of ketorolac or pharmaceutically acceptable salt thereof to a target tissue site beneath the skin before, during or after surgery, wherein the drug depot releases 0.5 mg to 60 mg of ketorolac or pharmaceutically acceptable salt thereof over 24 hours and wherein the drug depot comprises a biodegradable polymer having an inherent viscosity of about 0.05 to about 0.15 dL/g and the drug depot releases 25%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 95%, or 99% of the ketorolac or pharmaceutically acceptable salt thereof relative to a total amount of ketorolac loaded in the drug depot over a period of 3 to 10 days after the drug depot is administered to the target tissue site and the drug depot comprises from about 5% to about 30% by weight of mPEG and the biodegradable polymer comprises poly (lactide-co-glycolide) (PLGA) or polylactide (PLA).

13. A method of reducing postoperative pain or inflammation according to claim 12 , wherein one or more drug depots release an effective amount of ketorolac or pharmaceutically acceptable salt thereof over a period of 5 to 7 days.

14. A method of reducing postoperative pain or inflammation according to claim 12 , wherein the ketorolac comprises ketorolac tromethamine.

15. A method of reducing postoperative pain or inflammation according to claim 12 , wherein the drug depot comprises at least one additional anti-inflammatory or analgesic agent, at least one anabolic or an anti-catabolic growth factor or combination thereof.

Assignees

• Wohabrebbi Amira
• Mckay William F
• Hobot Christopher M
• Hildebrand Keith R
• Mcdonald Edward Phillip
• Warsaw Orthopedic Inc

Inventors

• Wohabrebbi Amira
• Mckay William F
• Hobot Christopher M
• Hildebrand Keith R
• Mcdonald Edward Phillip

Classifications

• A61K49/0419

  Microparticles, microbeads, microcapsules, microspheres, i.e. having a size or diameter higher or equal to 1 micrometer · CPC title

• A61K9/1647

  Polyesters, e.g. poly(lactide-co-glycolide) · CPC title

• A61K49/0404

  containing barium sulfate · CPC title

• A61K31/407 Primary

  condensed with other heterocyclic ring systems, e.g. ketorolac, physostigmine · CPC title

• A61K9/0024

  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 title