UTKHEDE, DEEPANK,SHIMIZU, ROBERT W,JAIN, RACHNA,BOYD, STEPHEN,GIFFORD, HANSON S,DE JUAN JR, EUGENE,REICH, CARY J
申请号：
ES12192860
公开号：
ES2538838T3
申请日:
2008.09.05
申请国别(地区):
ES
年份:
2015
代理人:
摘要：
A method for manufacturing a drug insert for an implant body adapted for disposition within or adjacent to a patient's eye, the insert comprising a drug core comprising a therapeutic agent and a matrix wherein the matrix comprises a matrix of silicone, wherein the therapeutic agent is uniformly and homogeneously dispersed through the matrix, or the therapeutic agent at least in part forms solid or liquid inclusions within the matrix wherein an amount of the therapeutic agent in a macroscopic volumetric portion of the nucleus of drug varies from an amount of the therapeutic agent in any other macroscopic volumetric portion equal to the drug core by no more than 30%, the sheath body being disposed on a portion of the drug core to inhibit the release of the agent from said portion and of such that it defines at least one exposed surface of the adapted drug core a to release the agent when the implant is inserted into the patient； the method comprising injecting into a body of precursor sheath, at a sub-ambient temperature of less than 20 ° C, a mixture comprising a therapeutic agent and a silicone matrix such that the precursor sheath is substantially filled therewith, being the precursor sheath body substantially impermeable to the agent, curing the mixture comprising the matrix with the sheath body to form the drug insert, the curing step comprising heating the mixture to a temperature of from 20 ° C to 100 ° C , at a relative humidity comprising a range from 40% to 100%, for a period of time ranging from 1 minute to 48 hours； and dividing the filled sheath with cured precursor to form a plurality of drug inserts.Un método para manufacturar un inserto de fármaco para un cuerpo de implante adaptado para disposición dentro de o adyacente a un ojo de un paciente, comprendiendo el inserto un núcleo de fármaco que comprende un agente terapéutico y una matriz en donde la matriz comprende una matriz de silicona, en donde el agente terapéutico es uniforme y homogéneamente di
