Systems and methods for delivery of a therapeutic agent

Abstract

The present disclosure relates to nozzles for removing a preservative from a fluid comprising a therapeutic agent to an eye. More particularly, the nozzles disclosed herein may minimize patient exposure to preservative by rapidly and selectively removing a preservative from a solution comprising a therapeutic agent. An example nozzle may comprise a flow diverter which directs a flow path from a fluid inlet to a fluid outlet over a length longer than the distance from the inlet to the outlet. In some cases, the nozzle may comprise a preservative removing agent.

What is claimed is: 
     
         1 . A device for removing a preservative from a formulation comprising a therapeutic agent, the device comprising:
 a nozzle comprising:   a fluid outlet;   an inlet cap comprising one or more apertures, the one or more apertures comprising a fluid inlet, wherein the inlet cap has a hydraulic permeability less than 10 Darcy; and   a matrix disposed within the nozzle, wherein the matrix comprises absorbed particles of the preservative and wherein the hydraulic permeability of the inlet cap is less than a hydraulic permeability of the matrix.   
     
     
         2 . The device of  claim 1 , further comprising an outlet cap comprising one or more apertures, the one or more apertures comprising the fluid outlet, wherein the outlet cap has a hydraulic permeability less than 10 Darcy. 
     
     
         3 . The device of  claim 2 , wherein either of the inlet cap or the outlet cap comprises a screen or a mesh. 
     
     
         4 . The device of  claim 2 , wherein either of the inlet cap or the outlet cap comprises a filter, wherein the filter comprise a pore size of about 0.2 microns. 
     
     
         5 . The device of  claim 2 , wherein either of the inlet cap or the outlet cap is prewetted with a preservative. 
     
     
         6 . The device of  claim 1 , wherein the nozzle further comprises a flow diverter to divert regions of the fluid flow path in a plurality of different directions, a total distance along the fluid flow path through the matrix from the fluid inlet to the fluid outlet being longer than a distance along an axis from the fluid inlet to the fluid outlet. 
     
     
         7 . The device of  claim 2 , wherein the hydraulic permeability of the inlet cap or the outlet cap is about 0.1 Darcy. 
     
     
         8 . The device of  claim 2 , wherein a pore size of the one or more apertures in the inlet cap or the outlet cap is less than a particle size of the matrix. 
     
     
         9 . The device of  claim 8 , wherein a pore size of the one or more apertures in the inlet cap or the outlet cap is about 0.2 microns. 
     
     
         10 . The device of  claim 1 , wherein a first drop of the formulation from the device and a tenth drop of the formulation from the device comprise equal concentrations of the preservative to within 10%. 
     
     
         11 . The device of  claim 1 , wherein a drop of the formulation from the device dispensed on a first day and a second drop dispensed on a seventh day comprise equal concentrations of the preservative to within 10% at a drop rate of at least one drop per day. 
     
     
         12 . The device of  claim 1 , wherein the formulation is forced through the nozzle from the fluid inlet to the fluid outlet and wherein forcing the fluid through the nozzle removes a preservative from the formulation. 
     
     
         13 . The device of  claim 12 , wherein at least 50 percent of the preservative is removed from the fluid and wherein at least 50 percent of the therapeutic agent is retained. 
     
     
         14 . The device of  claim 12 , wherein a squeeze pressure is exerted by a user to form a drop, wherein the device further comprises a reservoir containing the formulation, and wherein the reservoir has an internal pressure which increases with increasing squeeze pressure 
     
     
         15 . The device of  claim 14 , wherein the squeeze pressure is within a range from 0.01 Atm to 0.5 Atm. 
     
     
         16 . The device of  claim 14 , wherein the internal pressure comprises a pressure within a range from 1 Atm to 5 Atm. 
     
     
         17 . The device of  claim 14 , wherein the drop is formed within a time defined by a range between 0.1 seconds and 10 seconds. 
     
     
         18 . The device of  claim 14 , wherein the drop comprises a volume defined by a range between 1 μL and 100 μL. 
     
     
         19 . A nozzle for removing a preservative from a fluid comprising a therapeutic agent to treat an eye, the nozzle comprising:
 a fluid inlet configured to receive fluid from a container;   a fluid outlet coupled to the inlet, the outlet configured to deliver the fluid comprising the therapeutic agent to the eye;   a distance extending along an axis from the fluid inlet to the fluid outlet;   a fluid flow path extending from the fluid inlet to the fluid outlet, a porous material along the flow path to selectively remove the preservative; and   a flow diverter to divert regions of the fluid flow path in a plurality of different directions, a total distance along the fluid flow path through the porous material from the inlet to the outlet greater than the distance from the fluid inlet to the fluid outlet along the axis.   
     
     
         20 . A method of removing preservative from a therapeutic agent, the method comprising:
 receiving a solution comprising the therapeutic agent and a preservative;   squeezing a compressible bottle comprising a nozzle for removing a preservative from a fluid comprising the therapeutic agent to an eye, wherein the nozzle comprises a fluid inlet, a fluid outlet, and a flow path extending from the fluid inlet to the fluid outlet; and   wherein a flow diverter directs flow of the solution in a plurality of different directions, the flow path greater than the distance from the inlet to the outlet.