Antibiotic formulations for lower back pain

Abstract

The present invention relates to injectable compositions. More particularly, the present disclosure relates to injectable, thermogelling hydrogel formulations comprising at least one antibiotic for relieving and/or treating low back pain.

1 . An injectable pharmaceutical composition for relieving and/or treating low back pain comprising:
 (a) an effective amount of an antibiotic;   (b) a thermosensitive hydrogel;   (c) a radio-contrast agent; and   (d) at least one pharmaceutically acceptable excipient.   
     
     
         2 . The injectable pharmaceutical composition of  claim 1 , wherein the thermosensitive hydrogel is composed of biodegradable and biocompatible polymers. 
     
     
         3 . The injectable pharmaceutical composition of  claim 2 , wherein the polymer is poloxamer. 
     
     
         4 . The injectable pharmaceutical composition of  claim 3 , wherein the poloxamer is poloxamer 407 wherein said poloxamer 407 is present from about 2% to about 20% by weight or by volume of the composition. 
     
     
         5 . The injectable pharmaceutical composition of  claim 4  further comprising poloxamer 188, wherein said poloxamer 188 is present from about 5% to about 20% by weight of the composition. 
     
     
         6 . The injectable pharmaceutical composition of  claim 1 , wherein the composition is an aqueous solution at temperature from about 4° C. to about 25° C. 
     
     
         7 . The injectable pharmaceutical composition of  claim 6 , wherein the aqueous solution gels at a temperature from about 32° C. to about 38° C. 
     
     
         8 . The injectable pharmaceutical composition of  claim 6 , wherein the aqueous solution remains at least for 3 hours at room temperature. 
     
     
         9 . The injectable pharmaceutical composition of  claim 1 , wherein the antibiotic is selected from vancomycin and linezolid. 
     
     
         10 . The injectable pharmaceutical composition of  claim 9 , wherein the antibiotic is linezolid. 
     
     
         11 . The injectable pharmaceutical composition of  claim 9 , wherein the antibiotic is vancomycin. 
     
     
         12 . The injectable pharmaceutical composition of  claim 10 , wherein the composition further comprises a cyclodextrin at a concentration of 15% to 35% by weight or by volume of the composition. 
     
     
         13 . The injectable pharmaceutical composition of  claim 10 , wherein the concentration of linezolid is about 1% to about 20% by weight or by volume of the composition. 
     
     
         14 . The injectable pharmaceutical composition of  claim 11 , wherein the concentration of vancomycin is about 1% to about 30% by weight or by volume of the composition. 
     
     
         15 . The injectable pharmaceutical composition of  claim 10 , wherein the composition comprises a total dose of 1 mg to 200 mg of linezolid. 
     
     
         16 . The injectable pharmaceutical composition of  claim 11 , wherein the composition comprises a total dose of 1 mg to 600 mg of vancomycin. 
     
     
         17 . The injectable pharmaceutical composition of  claim 1 , wherein the contrast agent is selected from the group consisting of Iohexal, Iopamidol, Ioxilan, Iopromide, Iodixanol, Ioversol, Diatrizoate, Metrizoate, Ioxaglate, or the like. 
     
     
         18 . The injectable pharmaceutical composition of  claim 1 , wherein the injectable pharmaceutical composition is formulated for administering to a bone, joint, ligament, or tendon associated with the spine, and wherein the bone, joint, ligament, or tendon associated with the spine is associated with a cervical, thoracic, lumbar or sacral vertebra. 
     
     
         19 . (canceled) 
     
     
         20 . A method of treating or preventing pain in a subject comprising administration of an injectable pharmaceutical composition comprising
 (a) an effective amount of an antibiotic;   (b) a thermosensitive hydrogel;   (c) a radio-contrast agent; and   (d) at least one pharmaceutically acceptable excipient,   wherein the antibiotic is selected from vancomycin and linezolid.   
     
     
         21 . The method of  claim 20 , wherein the pain is acute pain, sub-acute pain, chronic pain, local pain, radicular pain, or referred pain. 
     
     
         22 . The method of  claim 21 , wherein the pain is lumbar or cervical pain and wherein the lumbar or cervical pain is associated with Modic changes or bone edema. 
     
     
         23 . (canceled) 
     
     
         24 . The method of  claim 22 , wherein the subject has a previous disc herniation. 
     
     
         25 . The method of  claim 20 , wherein the subject is suspected of, or has, a bacterial infection. 
     
     
         26 . The method of  claim 20 , wherein the injectable pharmaceutical composition is injected into an intervertebral disc, intervertebral space, intra-articular space, ligament, tendon, tendon and bone junction, or site adjacent to bone edema; or is injected adjacent to or into a site of Modic change or bone edema. 
     
     
         27 . (canceled) 
     
     
         28 . A method of simultaneously relieving or ameliorating pain in a subject and eliminating bacterial infection in a cervical, thoracic, lumbar or sacral vertebra of said subject comprising the administration of an injectable pharmaceutical composition by injection to an area in, near or around the infected vertebrae,
 wherein the injection pharmaceutical composition comprises an effective amount of an antibiotic formulated in a thermosensitive hydrogel comprising biodegradable and biocompatible polymers, a radio-contrast agent and at least one pharmaceutically acceptable excipient.