Therapeutics dispensing device and methods of making same

Abstract

A therapeutics delivery system, and methods of making and using same, are disclosed for environments that rapidly clear any injected therapeutics, such as a patient's eye. The therapeutics delivery system releases the drug in a therapeutically effective concentration for a desired duration of time with a predefined drug kinetics. In one embodiment, the embodiments of the present disclosure release a therapeutically effective concentration for a longer time period than other delivery systems, for instance from a day to a week. Certain embodiments comprise a therapeutics dispensing device comprising a biodissolvable hydrogel matrix for long term drug release that allows the device to be placed directly at the injured site, e.g., onto the surface at or near the injury, and retained there rather than through injection, whether locally or systematically.

What is claimed is: 
     
         1 . A device for delivering a therapeutic substance to an eye, the device comprising:
 a hydrogel matrix comprising at least one biocompatible material; and   at least one reservoir disposed in the hydrogel matrix, wherein the therapeutic substance is disposed within the at least one reservoir;   wherein at least a portion of the hydrogel matrix containing an open end of the at least one reservoir is configured to contact an exterior surface of the eye and dissolve at a predetermined rate upon contact, thereby delivering at least a portion of the therapeutic substance to the eye.   
     
     
         2 . The device of  claim 1 , wherein the at least one biocompatible material comprises at least one of: dextran, polyvinyl alcohol, carboxy methyl cellulose, hydroxypropyl cellulose, polyvinylpyrrolidone, PLGA, PolyHEMA, polyhydroxy ethylacrylate, gelatin, collagen, and any combination thereof. 
     
     
         3 . The device of  claim 1 , wherein the therapeutic substance is delivered over a period of at least 24 hours. 
     
     
         4 . The device of  claim 1 , wherein the therapeutic substance is selected from the group consisting of chemical compounds, drugs, including anti-inflammatory agents, as well as drug matrices, other small molecule drugs, antibodies, antibiotics, siRNAs, peptides, steroids, including corticosteroids, biologic antifungal agents, amino acids, mRNAs, nutrient supplements,
 or any combination thereof.   
     
     
         5 . The device of  claim 1 , wherein the therapeutic substance is cysteamine. 
     
     
         6 . The device of  claim 1 , wherein the at least one reservoir has a depth of about 500 nm. 
     
     
         7 . The device of  claim 1 , wherein the hydrogel matrix has a surface area of between about 1 square mm to about 150 square mm. 
     
     
         8 . A wafer for delivering cysteamine to an eye of a patient in need thereof, the wafer comprising:
 a hydrogel matrix comprising at least one biocompatible material and cysteamine, wherein the wafer is configured to contact an exterior surface of the eye and dissolve upon contact at a predetermined rate, thereby delivering a therapeutically effective amount of cysteamine to the eye.   
     
     
         9 . The wafer of  claim 8 , wherein the at least one biocompatible material comprises at least one of: dextran, polyvinyl alcohol, carboxy methyl cellulose, hydroxypropyl cellulose, polyvinylpyrrolidone, PLGA, PolyHEMA, polyhydroxy ethylacrylate, gelatin, collagen, and any combination thereof. 
     
     
         10 . The wafer of  claim 8 , wherein the at least one biocompatible material comprises polyvinyl alcohol. 
     
     
         11 . A method for treating corneal cystinosis in an eye of an individual in need thereof, comprising:
 applying the wafer of  claim 8  to an exterior surface of the eye, wherein the predetermined rate of dissolution provides extended release of cysteamine over a period ranging from hours to days.   
     
     
         12 . The method of  claim 11 , wherein the predetermined rate of dissolution provides extended release of cysteamine over a period of at least 24 hours.