Drug cores for sustained release of therapeutic agents

Abstract

A solid drug core insert can be manufactured by injecting a liquid mixture comprising a therapeutic agent and a matrix precursor into a sheath body. The injection can be conducted at subambient temperatures. The mixture is cured to form a solid drug-matrix core. The therapeutic agent can be a liquid at about room temperature that forms a dispersion of droplets in the matrix material. A surface of the solid drug core is exposed, for example by cutting the tube, and the exposed surface of the solid drug core releases therapeutic quantities of the therapeutic agent when implanted into the patient. In some embodiments, the insert body inhibits release of the therapeutic agent, for example with a material substantially impermeable to the therapeutic agent, such that the therapeutic quantities are released through the exposed surface, thereby avoiding release of the therapeutic agent to non-target tissues.

1 - 41 . (canceled) 
     
     
         42 . An ocular implant for topical delivery of at least one therapeutic agent to an eye for an extended period of time, comprising:
 a substantially cylindrical shaped body;   a therapeutic matrix comprising a therapeutic agent and a polymer, wherein at least a portion of the therapeutic matrix is exposed to tear fluid and the therapeutic agent is uniformly and homogenously dispersed throughout the matrix;   wherein the body is adapted to release the therapeutic agent at therapeutic levels into the tear fluid of the eye for at least one month and wherein the ocular implant is configured to be placed between conjunctiva tissue in a cul-de-sac of the eyelid and does not comprise a sheath body.   
     
     
         43 . The implant of  claim 42 , wherein the polymer comprises silicone or urethane. 
     
     
         44 . The implant of  claim 42 , wherein the therapeutic agent is an anti-glaucoma agent, a prostaglandin analog, a prostaglandin, an antimicrobial agent, an anti-inflammatory agent, or an allergy medication. 
     
     
         45 . The implant of  claim 42 , when placed in the cul-de-sac of the eyelid treats conditions selected from glaucoma, pre- and post-surgical treatments, dry eye, allergies, pain, conjunctivitis, infection, and inflammation. 
     
     
         46 . The implant of  claim 42 , wherein the therapeutic agent is latanoprost, bimatoprost, travoprost or Timolol. 
     
     
         47 . The implant of  claim 42 , wherein the body comprises a shape memory polymer. 
     
     
         48 . The implant of  claim 42 , wherein the body comprises acrylates, polyethylenes, polyurethane, hydrogel, polyester, polypropylene, polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), polyether ether ketone (PEEK), nylon, extruded collagen, polymer foam, silicone rubber, polyethylene terephthalate, ultra high molecular weight polyethylene, polycarbonate urethane, polyimides, stainless steel, nickel-titanium alloy, titanium, stainless steel, or cobalt-chrome alloy. 
     
     
         49 . The implant of  claim 42 , wherein the therapeutic agent is bimatoprost formulated for extended release of 3 to 6 months. 
     
     
         50 . The implant of  claim 42 , wherein the therapeutic agent is bimatoprost formulated for extended release of 6 to 12 months. 
     
     
         51 . The implant of  claim 42 , wherein the therapeutic matrix further comprises an additive to increase solubility of the therapeutic agent in the matrix. 
     
     
         52 . The implant of  claim 42 , wherein the body has a circular cross section. 
     
     
         53 . The implant of  claim 42 , wherein the matrix comprises a non-biodegradable polymer. 
     
     
         54 . A composition comprising a polymer matrix and a therapeutic agent, wherein the therapeutic agent is uniformly and homogenously dispersed in the matrix and wherein the composition is adapted to release the therapeutic agent at therapeutic levels to the eye for at least one month and wherein the composition is configured to be placed between conjunctiva tissue in a cul-de-sac of the eyelid and does not comprise a sheath body, and wherein the composition comprises a circular cross section. 
     
     
         55 . The composition of  claim 54 , wherein the composition is configured as a medical device. 
     
     
         56 . The composition of  claim 54 , wherein the composition is configured to be placed in contact with tear fluid. 
     
     
         57 . The composition of  claim 54 , wherein the polymer matrix comprises a non-biodegradable polymer. 
     
     
         58 . The composition of  claim 54 , wherein the therapeutic agent is an anti-glaucoma agent, a prostaglandin analog, a prostaglandin, an antimicrobial agent, an anti-inflammatory agent, or an allergy medication. 
     
     
         59 . The composition of  claim 54 , when placed in the cul-de-sac of the eyelid treats conditions selected from glaucoma, pre- and post-surgical treatments, dry eye, allergies, pain, conjunctivitis, infection, and inflammation. 
     
     
         60 . The composition of  claim 58 , wherein the anti-glaucoma agent is latanoprost, travoprost or Timolol. 
     
     
         61 . The composition of  claim 58 , wherein the anti-glaucoma agent is bimatoprost. 
     
     
         62 . The composition of  claim 54 , wherein the polymer comprises silicone or urethane. 
     
     
         63 . The composition of  claim 54 , wherein the polymer comprises acrylates, polyethylenes, polyurethane, hydrogel, polyester, polypropylene, polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), polyether ether ketone (PEEK), nylon, extruded collagen, polymer foam, silicone rubber, polyethylene terephthalate, ultra high molecular weight polyethylene, polycarbonate urethane, polyimides, stainless steel, nickel-titanium alloy, titanium, stainless steel, or cobalt-chrome alloy. 
     
     
         64 . The composition of  claim 54 , wherein the polymer matrix comprises hydrogel, polyglycolic acid (PGA), polylactic acid (PLA), poly(L-lactic acid) (PLLA), poly(L-glycolic acid) (PLGA), polyglycolide, poly-L-lactide, poly-D-lactide, poly(amino acids), polydioxanone, polycaprolactone, polygluconate, polylactic acid-polyethylene oxide copolymers, modified cellulose, collagen, polyorthoesters, polyhydroxybutyrate, polyanhydride, polyphosphoester, poly(alpha-hydroxy acid) or combinations thereof. 
     
     
         65 . The composition of  claim 54 , comprises a substantially cylindrical shape. 
     
     
         66 . An ocular implant for topical delivery of at least one therapeutic agent to an eye for an extended period of time, comprising:
 a substantially cylindrical shaped body;   a therapeutic matrix comprising an anti-glaucoma agent and a polymer, wherein at least a portion of the therapeutic matrix is exposed to tear fluid and the anti-glaucoma agent is uniformly and homogenously dispersed throughout the matrix;   wherein the body is adapted to release the anti-glaucoma agent at therapeutic levels into the tear fluid of the eye for at least one month and wherein the ocular implant is configured to be placed between conjunctiva tissue in a cul-de-sac of the eyelid and does not comprise a sheath body.   
     
     
         67 . The implant of  claim 66 , wherein the anti-glaucoma agent is latanoprost, travoprost or Timolol. 
     
     
         68 . The implant of  claim 66 , wherein the anti-glaucoma agent is bimatoprost.