Therapeutic agent formulations for implanted devices

Abstract

An injectable formulation of therapeutic agent may comprise the therapeutic agent and a stabilizer such that a substantial portion of the stabilizer remains in the therapeutic device to stabilize the therapeutic agent when the therapeutic agent is released from the therapeutic device. The injectable formulation may comprise one or more of binding agent particles or erodible material particles, such that the formulation can be injected into the therapeutic device. The binding agent particles can bind reversibly to the therapeutic agent so as to modulate release of the therapeutic agent, and the erodible material particles can generate protons of an acid so as to increase stability of the therapeutic agent and may modulate release of the therapeutic agent. The therapeutic agent can be combined with one or more of the stabilizer, the binding agent particles or the erodible particles to increase stability of the therapeutic agent and may modulate release.

1 - 76 . (canceled) 
     
     
         77 . A device to treat an eye, the device comprising:
 a reservoir chamber having a volume sized to receive an injection of an amount of a formulation of a therapeutic agent;   a porous structure to release therapeutic amounts of the therapeutic agent for an extended time; and   a stabilizer to maintain stability of the therapeutic agent in the reservoir chamber, the stabilizer comprising a molecular weight of at least about 5 k Daltons such that a portion of the stabilizer remains in the reservoir chamber for the extended time.   
     
     
         78 . The device of  claim 77 , wherein the stabilizer comprises a molecular weight of at least about 10 k. 
     
     
         79 . The device of  claim 77 , wherein the stabilizer comprises a molecular weight of at least about 25% of a molecular weight of the therapeutic agent. 
     
     
         80 . The device of  claim 79 , wherein the therapeutic agent comprises a molecular weight of at least about 40 k. 
     
     
         81 . The device of  claim 80 , wherein the therapeutic agent comprises a Fab antibody fragment or a derivative thereof. 
     
     
         82 . The device of  claim 81 , wherein the therapeutic agent comprises ranibizumab. 
     
     
         83 . The device of  claim 77 , further comprising an amount of an erodible material to maintain the pH of the chamber at no more than about 6.5 for an extended time of at least about one month. 
     
     
         84 . The device of  claim 77 , further comprising an amount of an erodible material to maintain the pH of the chamber at no more than about 6.0 for an extended time of at least about one month. 
     
     
         85 . The device of  claim 77 , further comprising a plurality of particles to bind reversibly to the therapeutic agent, a majority of the plurality of particles having a size greater than channels of the porous structure such that the particles remain in the reservoir chamber for the extended time. 
     
     
         86 .- 107 . (canceled)