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 . A punctal plug comprising a therapeutic agent dispersed in a matrix wherein the therapeutic agent is present as inclusions. 
     
     
         43 . The punctal plug of  claim 42 , wherein the matrix comprises a multiphase nonhomogeneous mixture. 
     
     
         44 . The punctal plug of  claim 42 , wherein the inclusions are encapsulated within the matrix. 
     
     
         45 . The punctal plug of  claim 44 , wherein the encapsulated therapeutic agent is present as microparticles. 
     
     
         46 . The punctal plug of  claim 42 , comprising a substantially cylindrical shape. 
     
     
         47 . The punctal plug of  claim 45 , wherein the microparticles have a dimension from 0.1 μm to 200 μm. 
     
     
         48 . The punctal plug of  claim 42 , wherein the therapeutic agent is a glaucoma medication, anti-inflammatory medication, anti-infective medication, anti-viral medication, dry eye medication, or a combination thereof. 
     
     
         49 . The punctal plug of  claim 42 , wherein the matrix is a biodegradable matrix. 
     
     
         50 . The punctal plug of  claim 42 , wherein the matrix is a non-biodegradable matrix. 
     
     
         51 . The punctal plug of  claim 42 , wherein the therapeutic agent in a volumetric portion of the matrix is similar to an amount of the therapeutic agent in another other equal volumetric portion of the matrix. 
     
     
         52 . The punctal plug of  claim 42 , wherein the matrix further comprises an inert filler material, a salt, a surfactant, a dispersant, a second polymer, an oligomer, or a combination thereof. 
     
     
         53 . A method for topical delivery of a therapeutic agent to an eye, comprising placing a punctal plug of  claim 42  through a punctum into a canaliculus of the eye.