Mucoadhesive drug delivery devices and methods of making and using thereof

Abstract

The present invention relates to mucoadhesive drug delivery devices and their methods of preparation and use. More specifically the present invention relates to mucoadhesive drug delivery devices comprising one or more biocompatible purified proteins combined with one or more biocompatible solvents and one or more mucoadhesive agents. The mucoadhesive drug delivery devices may also include one or more pharmacologically active agents. The drug delivery devices of the present invention adhere to mucosal tissue, thereby providing a vehicle for delivery of the pharmacologically active agent(s) through such tissue.

1 . A mucoadhesive device, comprising:
 a solidified cohesive mass or cohesive body formed from at least one free-form protein, the solidified cohesive mass or cohesive body including at least one pharmacologically active agent and at least one mucoadhesion enhancement agent, wherein the solidified cohesive mass or cohesive body is formed into a delivery vehicle such that the at least one free-form protein and the at least one mucoadhesion enhancement agent is capable of adhering the delivery vehicle to mucosal tissue for delivering the at least one pharmacologically active agent to the patient.   
     
     
         2 . The mucoadhesive device of  claim 1 , wherein the cohesive body is compressed to form the delivery vehicle. 
     
     
         3 . The mucoadhesive device of  claim 1 , wherein the delivery vehicle comprises a plurality of mucoadhesive particles. 
     
     
         4 . The mucoadhesive device of  claim 3 , wherein the plurality of mucoadhesive particles are combined with one or more carriers to define a particle formulation, wherein the muchoadhesive particles attach to the mucosal tissue. 
     
     
         5 . The mucoadhesive device of  claim 1 , further comprising a migration-vulnerable drug delivery device including a secondary pharmacologically active agent, wherein the migration-vulnerable drug delivery device is maintained at a desired treatment site due to the adherence of the at least one mucoadhesion enhancement agent to the mucosal tissue. 
     
     
         6 . The mucoadhesive device of  claim 1 , wherein the delivery vehicle further comprises at least one biocompatible solvent, 
     
     
         7 . The mucoadhesive device of  claim 1 , wherein the at least one pharmacologically active agent is homogenously distributed through the delivery vehicle. 
     
     
         8 . The mucoadhesive device of  claim 1 , wherein the at least one free-form protein, the at least one pharmacologically active agent and the at least one mucoadhesion enhancement agent are homogenously distributed within the delivery vehicle. 
     
     
         9 . The mucoadhesive device of  claim 1 , wherein the at least one free-form protein has available binding sites. 
     
     
         10 . The mucoadhesive device of  claim 1 , wherein the at least one free-form protein is present in amount of about 15% to 85% by weight of the delivery vehicle. 
     
     
         11 . The mucoadhesive device of  claim 1 , wherein the at least one mucoadhesion enhancement agent is present in amount of about 0.15% to 35% by weight of the delivery vehicle. 
     
     
         12 . The mucoadhesive device of  claim 1 , wherein the at least one pharmacologically active agent is present in amount of about 0.00001% to 95% by weight of the delivery vehicle. 
     
     
         13 . The mucoadhesive device of  claim 1 , wherein the delivery vehicle further comprises at least one biocompatible solvent. 
     
     
         14 . The mucoadhesive device of  claim 13 , wherein the at least one biocompatible solvent is present in an amount of about 5% to 60% by weight of the delivery vehicle.