DRUG DEPOTS FOR TREATMENT OF PAIN AND INFLAMMATION IN SINUS AND NASAL CAVITIES OR CARDIAC TISSUE

• US 20100239632A1
• Filed: 03/23/2009
• Published: 09/23/2010
• Est. Priority Date: 03/23/2009
• Status: Abandoned Application

• Current Assignee: Companion Spine LLC
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: WALSH, Andrew J. Lowenthal
• Application Number:
  US12/409,058
• Publication Number:
  US 20100239632A1
• Time in Patent Office: Days
• US Class Current: 424/423
• CPC Class Codes: A61F 13/2005 specially adapted for the nose cavity
• CPC Class Codes: A61F 13/8405 Additives, e.g. for odour, disinfectant or pH control
• 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 31/4164 1,3-Diazoles
• CPC Class Codes: A61K 31/4168 having a nitrogen attached in position 2, e.g. clonidine
• CPC Class Codes: A61K 31/439 the ring forming part of a bridged ring system, e.g. quinuclidine 8-azabicyclo [3.2.1] octanes A61K31/46
• CPC Class Codes: A61K 31/44 Non condensed pyridines; Hydrogenated derivatives thereof
• CPC Class Codes: A61K 31/445 Non condensed piperidines, e.g. piperocaine
• CPC Class Codes: A61K 31/4468 having a nitrogen directly attached in position 4, e.g. clebopride, fentanyl
• CPC Class Codes: A61K 31/451 having a carbocyclic group directly attached to the heterocyclic ring, e.g. glutethimide, meperidine, loperamide, phencyclidine, piminodine
• CPC Class Codes: A61K 31/4523 containing further heterocyclic ring systems
• CPC Class Codes: A61K 31/4535 containing a heterocyclic ring having sulfur as a ring hetero atom, e.g. pizotifen
• CPC Class Codes: A61K 31/454 containing a five-membered ring with nitrogen as a ring hetero atom, e.g. pimozide, domperidone
• CPC Class Codes: A61K 31/485 Morphinan derivatives, e.g. morphine, codeine
• CPC Class Codes: A61K 31/56 Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
• 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 47/30 Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
• CPC Class Codes: A61K 47/36 : Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
• CPC Class Codes: A61K 51/1282 : Devices used in vivo and carrying the radioactive therapeutic or diagnostic agent, therapeutic or in vivo diagnostic kits, stents
• 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 9/0043 : Nose
• 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 a biodegradable drug depot film, patch, strip or sponge being implantable at or near a cardiac tissue or within a nasal or sinus cavity, one can reduce, prevent or treat pain and/or inflammation.

Claims

1. An implantable drug depot useful for reducing, preventing or treating pain and inflammation in a patient in need of such treatment, the implantable drug depot being in the form of a biodegradable film, patch, strip, sheet or sponge and comprising a therapeutically effective amount of an analgesic and/or an anti-inflammatory agent, the depot being implantable at or near a cardiac tissue or within a nasal or sinus cavity to reduce, prevent or treat pain and/or inflammation, wherein the drug depot is capable of releasing an effective amount of the analgesic and/or an anti-inflammatory agent over a period of at least one day.

2. An implantable drug depot according to claim 1, wherein the drug depot releases the analgesic and an anti-inflammatory over a period of at least 3 days.

3. An implantable drug depot according to claim 1, wherein the analgesic comprises alfentanil, butorphanol, codeine, fentanyl, hydromorphone, levorphanol, meperidine, morphine, sulfentanil, tramadol or a combination thereof.

4. An implantable drug depot according to claim 1, wherein the anti-inflammatory agent comprises clonidine, fluocinolone, dexamethasone, sulindac, sulfasalazine or a combination thereof.

5. An implantable drug depot according to claim 1, wherein the biodegradable sheet comprises a polymer and the polymer comprises 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.

6. An implantable drug depot according to claim 1, wherein the drug depot comprises a polymer and the polymer comprises about 60% to 99% of the total weight % of the drug depot.

7. An implantable drug depot according to claim 1, wherein the drug depot releases (i) a bolus dose of the analgesic or pharmaceutically acceptable salt thereof at or near cardiac tissue or within the nasal or sinus cavity over a period of up to 3 days and (ii) an effective amount of the anti-inflammatory agent or pharmaceutically acceptable salt thereof over a period of at least 7 days.

8. An implantable drug depot according to claim 1, wherein the drug depot releases about 20% to about 99% of the analgesic and the anti-inflammatory relative to a total amount of the analgesic and the anti-inflammatory agent loaded in the drug depot over a period of 3 days to 2 weeks after the drug depot is administered at or near a cardiac tissue or within the nasal or sinus cavity.

9. An implantable drug depot according to claim 1, wherein the analgesic and the anti-inflammatory agent are encapsulated in a plurality of depots comprising microparticles, microspheres, microcapsules, and/or microfibers suspended in a film, strip or sponge.

10. An implantable drug depot according to claim 1, wherein the drug depot is in the form of a nasal or cardiac packing film or cardiac patch.

11. 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 the anti-inflammatory agent or pharmaceutically acceptable salts thereof and forming the implantable drug depot from the combination.

12. A method of treating or preventing pain and 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 an analgesic and/or an anti-inflammatory agent at or near a cardiac tissue or within a nasal or sinus cavity to reduce, prevent or treat pain and/or inflammation, wherein the drug depot is in the form of a biodegradable film, strip or patch that releases an effective amount of the analgesic and/or the anti-inflammatory agent or pharmaceutically acceptable salts thereof over a period of at least 1 day.

13. A method according to claim 12, wherein the analgesic comprises alfentanil, butorphanol, codeine, fentanyl, hydromorphone, levorphanol, meperidine, morphine, sulfentanil, tramadol or a combination thereof, and the anti-inflammatory agent comprises clonidine, fluocinolone, dexamethasone, sulindac, sulfasalazine or a combination thereof.

14. A method according to claim 12, wherein the drug depot releases 0.1 mg to 100 mg of the analgesic and the anti-inflammatory agent or pharmaceutically acceptable salts thereof every 24 to 48 hours to reduce, treat or prevent pain and inflammation over a period of 3 days to 2 weeks after the drug depot is administered at or near the cardiac tissue or within the nasal or sinus cavity target tissue site.

15. A method according to claim 12, wherein the drug depot comprises a polymer comprising poly(lactide-co-glycolide) (PLGA), polylactide (PLA), polyglycolide (PGA), D-lactide, D,L-lactide, L-lactide, D,L-lactide-ε

-caprolactone, poly(orthoester) (POE), D,L-lactide-glycolide-ε

-caprolactone or a combination thereof.

16. A method according to claim 12, wherein the drug depot comprises a polymer and the polymer comprises about 70% to about 90% of the total weight % of the drug depot.

17. A method according to claim 12, wherein the drug depot releases (i) a bolus dose of the analgesic or pharmaceutically acceptable salt thereof at or near cardiac tissue or within the nasal or sinus cavity over a period up to 3 days and (ii) an effective amount of the anti-inflammatory agent or pharmaceutically acceptable salts thereof over a period of up to 2 weeks.

18. A method of reducing pain and inflammation in a patient in need of such treatment, the method comprising delivering one or more biodegradable drug depots in the form of a biodegradable film or patch comprising a therapeutically effective amount of an analgesic and/or an anti-inflammatory agent or pharmaceutically acceptable salts thereof at or near a cardiac tissue or within a nasal or sinus cavity of the patient, wherein the drug depot releases an effective amount of the analgesic and the anti-inflammatory agent or pharmaceutically acceptable salts thereof over a period of at least 1 day.

19. A method according to claim 18, wherein the drug depot is in the form of a nasal packing film.

20. A method according to claim 18, wherein the drug depot is in the form of a cardiac packing film or patch.