Methods and compositions for treating post-operative pain comprising a local anesthetic
The present invention is directed to an implantable drug depot useful for reducing, preventing or treating post-operative pain in a patient in need of such treatment, the implantable drug depot comprising a polymer and a therapeutically effective amount of a local anesthetic or pharmaceutically acceptable salt thereof, wherein the drug depot is implantable at a site beneath the skin to reduce, prevent or treat post-operative pain, and the drug depot is capable of releasing (i) a bolus dose of the local anesthetic or pharmaceutically acceptable salt thereof at a site beneath the skin and (ii) a sustained release dose of an effective amount of the local anesthetic or pharmaceutically acceptable salt thereof over a period of at least 4 days.
1. A method of treating or preventing post-operative pain in a patient in need of such treatment, the method comprising administering one or more biodegradable drug depots comprising a polymer comprising poly(D,L-lactide-co-caprolactone) in an amount of about 30 wt. % of the one or more drug depots, and a therapeutically effective amount of a local anesthetic or pharmaceutically acceptable salt thereof in an amount of about 60 wt. % of the one or more drug depots to a target tissue site beneath the skin before, during or after surgery, wherein the one or more drug depots is capable of releasing an initial bolus dose of the local anesthetic or pharmaceutically acceptable salt thereof at a site beneath the skin followed by a sustained release dose of an effective amount of the local anesthetic or pharmaceutically acceptable salt thereof over a period of at least 4 days, and the one or more drug depots further comprising an excipient comprising methoxy polyethylene glycol (mPEG) in an amount of about 10 wt. % of the one or more drug depots, and the one or more drug depots further comprises trehalose.
2. A method of treating or preventing post-operative pain according to claim 1 , wherein the local anesthetic is at least one of bupivacaine, ropivacaine, mepivacaine, etidocaine, levobupivacaine, trimecaine, carticaine or articaine.
3. A method of treating or preventing post-operative pain according to claim 1 , wherein the drug depot is capable of releasing about 40% to about 70% of the local anesthetic or pharmaceutically acceptable salt thereof relative to a total amount of the local anesthetic loaded in the drug depot over a period of 4 to 10 days after the drug depot is administered to the target tissue site.
4. A method of treating or preventing post-operative pain according to claim 1 , wherein the drug depot is capable of releasing between 50 and 800 mg/day of the local anesthetic or pharmaceutically acceptable salt thereof for a period of 4 to 10 days.
5. A method of treating or preventing post-operative pain according to claim 1 , wherein the polymer further comprises poly(lactide-co-glycolide), polylactide, polyglycolide, polyorthoester, D-lactide, D,L-lactide, poly(D,L-lactide), L-lactide, poly(D,L-lactide-co-glycolide-co-caprolactone), polycaprolactone or a combination thereof.
6. A method of treating or preventing post-operative pain according to claim 1 , wherein the poly(D,L-lactide-co-caprolactone) has a molar ratio of lactide to caprolactone (DL-CL) ranging from 10:90 to 90:10.
7. A method of treating or preventing post-operative pain according to claim 1 , wherein the one or more drug depots further comprises a pH adjusting agent comprising potassium bicarbonate, potassium carbonate or potassium hydroxide.
8. A method of treating or preventing post-operative pain according to claim 1 , wherein the one or more drug depots is a strip.