Drug Delivery Devices and Methods of Making and Using Same

Abstract

The disclosure provides drug delivery devices and methods of making and using the drug delivery devices. The devices include single and multi-layer polymer films made by a breath figure technique having therapeutic agents associated therewith. For example, the devices may be a dual layer polymer film wherein the first layer includes a therapeutic agent incorporated into it by spin coating the first agent with a polymer solution and the second agent is incorporated into the second layer by loading the agent into pores of the second layer after it is spin coated onto the first layer. In some cases one layer provides a burst release and the second layer provides a slow release drug delivery profile. The devices may take on the form of a surgical mesh with a slow release therapeutic drug.

What is claimed is: 
     
         1 . A drug-delivery device for treatment of cancer, comprising: a multi-layer wafer comprising a therapeutic polymer film layer having a breath figure morphology, a sealing polymer layer on top of the therapeutic layer; and, an anticancer agent incorporated into the therapeutic layer. 
     
     
         2 . A drug-delivery device according to  claim 1 , wherein the sealing layer also has a breath figure morphology. 
     
     
         3 . A drug-delivery device according to  claim 1 , wherein the therapeutic polymer film layer comprises a first biodegradable polymer, the sealing layer comprises a second biodegradable polymer, and the first biodegradable polymer can be the same as the second biodegradable polymer. 
     
     
         4 . A drug-delivery device according to  claim 3 , wherein the wafer is made by solvent casting a solution comprising the first biodegradable polymer, the anticancer agent, and a solvent onto a substrate and slowly evaporating the solvent to produce the therapeutic layer with a breath figure morphology; and, spin coating a solution comprising the second biodegradable polymer onto the therapeutic layer to produce a sealing layer with breath figure morphology. 
     
     
         5 . A drug-delivery device according to  claim 4 , wherein the at least one anticancer agent is Fenofibrate. 
     
     
         6 . A drug-delivery device according to  claim 5 , wherein the first biodegradable polymer and the second biodegradable polymer comprise PGLA. 
     
     
         7 . A method of treating cancer, comprising implanting a drug-delivery device according to  claim 3  in a patient in need of cancer therapy. 
     
     
         8 . A method of treating cancer according to  claim 7 , wherein the therapeutic polymer film layer comprises PGLA, the anti-cancer agent comprises Fenofibrate and the sealing layer comprises PGLA. 
     
     
         9 . A method according to  claim 9 , wherein implanting comprises implanting the wafer at the site of a brain tumor. 
     
     
         10 . A drug delivery device in the form of a wafer, comprising one or more polymer film base layers having a breath figure pattern (“breath figure layer”), a sealing layer comprising a polymer on the one or more breath figure layers, and a first therapeutic agent. 
     
     
         11 . A wafer according to  claim 10 , wherein the sealing layer also has a breath figure pattern. 
     
     
         12 . A wafer according to  claim 11  wherein at least one of the one or more breath figure layers comprises a first polymer and the first therapeutic agent. 
     
     
         13 . A wafer according to  claim 12 , wherein the sealing layer comprises a second therapeutic agent. 
     
     
         14 . A wafer according to  claim 13 , wherein the one or more breath figure layers is one breath figure layer, and the first therapeutic agent is dispersed within the breath figure layer and the second therapeutic agent is loaded into pores of the sealing layer. 
     
     
         15 . A wafer according to  claim 14 , made by a process comprising spin coating a mixture of the first polymer and the first therapeutic agent onto a substrate to form a breath figure layer, spin coating the second polymer onto the breath figure layer to form the sealing layer, and loading the second therapeutic agent into the pores of the sealing layer. 
     
     
         16 . A wafer according to  claim 11 , wherein the one or more breath figure layers is one breath figure layer, and the wafer is made by forming the breath figure layer by solvent casting a mixture of the first polymer and the first therapeutic agent in a solvent onto a substrate and slowly evaporating the solvent, and forming the sealing layer by spin coating the second polymer onto the breath figure layer.