DRUG DEPOTS HAVING DIFFREENT RELEASE PROFILES FOR REDUCING, PREVENTING OR TREATING PAIN AND INFLAMMATION

• US 20090263441A1
• Filed: 04/18/2008
• Published: 10/22/2009
• Est. Priority Date: 04/18/2008
• Status: Active Grant

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: McKay, William
• Granted Patent: US 8,470,360 B2
• Time in Patent Office: Days
• US Class Current: 424/422
• CPC Class Codes: A61K 31/135 having aromatic rings , e.g. ketamine, nortriptyline methadone A61K31/137
• CPC Class Codes: A61K 31/192 having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid cannabinoids A61K31/658
• CPC Class Codes: A61K 31/366 having six-membered rings, e.g. delta-lactones
• CPC Class Codes: A61K 31/4168 having a nitrogen attached in position 2, e.g. clonidine
• CPC Class Codes: A61K 31/485 Morphinan derivatives, e.g. morphine, codeine
• CPC Class Codes: A61K 31/573 substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
• CPC Class Codes: A61K 31/58 containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin digitoxin A61K31/7048
• CPC Class Codes: A61K 31/655 Azo (—N=N—), diazo (=N2), azoxy (>N—O—N< or N(=O)—N<), azido (—N3) or diazoamino (—N=N—N<) compounds
• CPC Class Codes: A61K 9/0002 Galenical forms characterised by the drug release technique; Application systems commanded by energy
• 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: A61K 9/7007 Drug-containing films, membranes or sheets A61K9/0041, A61K9/0043, A61K9/006, A61K9/0063 take precedence
• 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 and/or inflammation are provided. Through the administration of an effective amount of at least analgesic and/or at least one anti-inflammatory agent at or near a target site, one can reduce, prevent or treat inflammation and pain.

Claims

1. A plurality of implantable drug depots useful for reducing, preventing or treating pain and/or inflammation in a patient in need of such treatment, the plurality of drug depots comprising a first set of one or more drug depots capable of releasing a therapeutically effective bolus dose of an analgesic and/or an anti-inflammatory agent or pharmaceutically acceptable salts thereof at a site beneath the skin and a second set of one or more drug depots capable of releasing a therapeutically effective amount of the analgesic and/or the anti-inflammatory agent or pharmaceutically acceptable salts thereof over a period of at least three days.

2. A plurality of implantable drug depots according to claim 1, wherein at least one of the second set of drug depot releases the analgesic and/or an anti-inflammatory over a period of 3 days to 6 months.

3. A plurality of implantable drug depots according to claim 1, wherein at least one of the second set of drug depot releases the analgesic and/or an anti-inflammatory over a period of 3 days to 2 weeks.

4. A plurality of implantable drug depots according to claim 1, wherein the one or more drug depots of the first set releases a bolus dose of an analgesic and anti-inflammatory agent.

5. A plurality of implantable drug depots according to claim 1, wherein the first and second set of the drug depots comprise one or more polymer layers containing the analgesic and/or the anti-inflammatory agent.

6. A plurality of implantable drug depots according to claim 1, wherein the analgesic comprises alfentanil, butorphanol, codeine, fentanyl, hydromorphone, levorphanol, meperidine, morphine, sufentanil, tramadol or a combination thereof, and the anti-inflammatory agent comprises clonidine, fluocinolone, dexamethasone, sulindac, sulfasalazine or a combination thereof.

7. A plurality of implantable drug depots according to claim 1, wherein each drug depot of the first and second sets comprises at least one biodegradable polymer comprising one or more of poly(lactide-co-glycolide) (PLGA), polylactide (PLA), polyglycolide (PGA), D-lactide, D,L-lactide, L-lactide, D,L-lactide-ε

-caprolactone, D,L-lactide-glycolide-ε

-caprolactone, glycolide-caprolactone, poly(glycolide-,-caprolactone) or a combination thereof.

8. A plurality of implantable drug depots according to claim 1, wherein each drug depot of the first or second set comprises a polymer and the polymer comprises about 20 wt % to about 90 wt % of the drug depot.

9. A plurality of implantable drug depots according to claim 1, wherein at least one drug depot releases about 20% to about 99% of the analgesic and/or the anti-inflammatory agent or pharmaceutically acceptable salts thereof relative to a total amount of the analgesic and/or the anti-inflammatory agent or pharmaceutically acceptable salts thereof loaded in the drug depot over a period of 3 days to 6 months after the drug depot is administered to a target tissue site.

10. A plurality of implantable drug depots according to claim 1, wherein the analgesic and/or the anti-inflammatory agent or pharmaceutically acceptable salts thereof are encapsulated in each drug depot as microparticles, microspheres, microcapsules, and/or microfibers suspended in a gel.

11. A plurality of implantable drug depots according to claim 1, wherein each drug depot is in the form of one or more pellets.

20. A method of making an implantable drug depot of claim 1, the method comprising combining a biocompatible polymer and a therapeutically effective amount of the analgesic and/or the anti-inflammatory agent or pharmaceutically acceptable salts thereof and forming the implantable drug depot from the combination.

12. A kit comprising a plurality of implantable drug depots useful for reducing, preventing or treating pain and/or inflammation in a patient in need of such treatment, the kit comprising a first set of the plurality of drug depots capable of releasing a therapeutically effective bolus dose of an analgesic and/or an anti-inflammatory agent or pharmaceutically acceptable salts thereof at a site beneath the skin and a second set of the plurality of drug depots capable of releasing a therapeutically effective amount of the analgesic and/or the anti-inflammatory agent or pharmaceutically acceptable salts thereof over a period of at least three days.

13. A kit according to claim 12, wherein the second set of the plurality of drug depots releases the analgesic and/or an anti-inflammatory over a period of 3 days to 6 months.

14. A kit according to claim 12, wherein the second set of the plurality of drug depots releases the analgesic and/or an anti-inflammatory over a period of 3 days to 2 weeks.

15. A kit according to claim 12, wherein the first set of the plurality of drug depots releases a bolus amount of analgesic.

16. A kit according to claim 12, wherein the first set of the plurality of drug depots releases a bolus amount of anti-inflammatory agent.

17. A method of reducing, preventing or treating pain and/or inflammation in a patient in need of such treatment, the method comprising administering a plurality of implantable drug depots at or near a target tissue site beneath the skin of the patient, wherein a first set of the plurality of drug depots is capable of releasing a therapeutically effective bolus dose of an analgesic and/or an anti-inflammatory agent or pharmaceutically acceptable salts thereof and a second set of the plurality of drug depots is capable of releasing a therapeutically effective amount of the analgesic and/or the anti-inflammatory agent or pharmaceutically acceptable salts thereof over a period of at least three days.

18. A method according to claim 17, wherein the first and second set of the plurality of drug depots are administered to a plurality of target tissue sites that triangulate a pain generator.

19. A method according to claim 17, wherein the first and/or second set of the plurality of drug depots comprises at least one biodegradable polymer comprising one or more of poly(lactide-co-glycolide) (PLGA), polylactide (PLA), polyglycolide (PGA), D-lactide, D,L-lactide, L-lactide, D,L-lactide-ε

-caprolactone, D,L-lactide-glycolide-ε

-caprolactone or a combination thereof.