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