US2010239632A1PendingUtilityA1

Drug depots for treatment of pain and inflammation in sinus and nasal cavities or cardiac tissue

71
Assignee: WARSAW ORTHOPEDIC INCPriority: Mar 23, 2009Filed: Mar 23, 2009Published: Sep 23, 2010
Est. expiryMar 23, 2029(~2.7 yrs left)· nominal 20-yr term from priority
Inventors:Andrew J. Lowenthal Walsh
A61K 47/36A61K 31/4164A61K 31/44A61K 31/454A61K 31/56A61K 31/58A61K 31/573A61F 13/8405A61P 29/00A61K 31/485A61K 31/4168A61K 31/439A61K 9/0043A61K 9/0024A61K 31/4468A61K 31/4535A61K 31/655A61K 31/445A61K 31/451A61F 13/2005A61K 31/4523A61K 31/135A61K 51/1282A61K 9/7007A61K 47/30A61K 31/192
71
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Claims

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

exact text as granted — not AI-modified
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.

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