Multi-component bio-active drug delivery and controlled release to the skin by microneedle array devices

Abstract

A method of forming a microneedle array can include forming a microneedle array that has one or more bioactive component. The microneedle array can include a base portion and plurality of microneedles extending from the base portion, and the one or more bioactive components can be combined with other components to exhibit specific release kinetics when the microneedle array is inserted into the skin of a patient.

We claim: 
     
         1 . A dissolvable microneedle array for transdermal insertion into a patient comprising:
 a base portion; and   a plurality of microneedles extending from the base portion, the plurality of microneedles including a first controlled release component, the first controlled release component comprising a first bioactive component and a first biocompatible polymer that interacts with the first bioactive component to provide a first controlled release profile of the first bioactive component,   wherein the first bioactive component is complexed with, integrated to, or otherwise encapsulated by the first biocompatible to form the first controlled release component, and   wherein the first controlled release profile of the first bioactive component is triggered by a temperature sensitive phase transition.   
     
     
         2 . The microneedle array of  claim 1 , further comprising a second bioactive component that is different from the first bioactive component. 
     
     
         3 . The microneedle array of  claim 2 , wherein the second bioactive component is complexed with, integrated to, or otherwise encapsulated by a second biocompatible polymer to form a second controlled release component. 
     
     
         4 . The microneedle array of  claim 3 , wherein the first and second biocompatible polymers are different, and the first controlled release profile is different from a second controlled release profile of the second controlled release component. 
     
     
         5 . The microneedle array of  claim 3 , wherein the first and second biocompatible polymers are the same. 
     
     
         6 . The microneedle array of  claim 1 , wherein the first biocompatible polymer is selected from the group consisting of PLGA, P(L)LA, P(D,L)LA, PCL, PLCL. 
     
     
         7 . The microneedle array of  claim 3 , wherein the second biocompatible polymer is selected from the group consisting of PLGA, P(L)LA, P(D,L)LA, PCL, PLCL. 
     
     
         8 . The microneedle array of  claim 1 , further comprising a second bioactive component and, in use, the second bioactive component is configured to be released from the microneedle array with an initial burst release kinetic activity and the first bioactive component is configured to have a delayed release relative to the second bioactive component. 
     
     
         9 . The microneedle array of  claim 1 , wherein the first controlled release profile of the first bioactive component is also triggered by a second trigger signal, the second trigger signal being selected from the group consisting of trigger signals based on electric-field triggers, light triggers, and ultrasound triggers. 
     
     
         10 . The microneedle array of  claim 4 , wherein the second controlled release profile of the second bioactive component is triggered by a second trigger signal, the second trigger signal being selected from the group consisting of trigger signals based on electric-field triggers, light triggers, and ultrasound triggers. 
     
     
         11 . A method of forming a microneedle array, comprising:
 forming a sheet of material having a plurality of layers, at least one of the plurality of layers comprising one or more bioactive component, the one or more bioactive components including a first bioactive component; and   combining the first bioactive component with a first biocompatible polymer to form a first controlled release component that provides a first controlled release profile of the first bioactive component when the microneedle array is inserted into the skin of a patient,   wherein the first controlled release profile of the first bioactive component is triggered by a temperature sensitive phase transition.   
     
     
         12 . The method of  claim 11 , wherein the bioactive component is complexed with the first biocompatible polymer to form the first controlled release component. 
     
     
         13 . The method of  claim 11 , wherein the bioactive component is integrated with the first biocompatible polymer to form the first controlled release component. 
     
     
         14 . The method of  claim 11 , wherein the bioactive component is encapsulated by the first biocompatible polymer to form the first controlled release component. 
     
     
         15 . The method of  claim 11 , wherein at least some of the one or more bioactive components are released more quickly than the first controlled release component when the microneedle array is inserted into the skin of a patient. 
     
     
         16 . The method of  claim 11 , wherein the one or more bioactive components comprises a second bioactive component and the method further comprises:
 combining the second bioactive component with the second biocompatible polymer to form a second controlled release component that provides a second controlled release profile of the second bioactive component when the microneedle array is inserted into the skin of the patient.   
     
     
         17 . The method of  claim 16 , wherein the second bioactive component is combined with a second biocompatible polymer that is different from the first biocompatible polymer, and the first and second biocompatible polymers provide different kinetic activities when the microneedle array is inserted into the skin of a patient. 
     
     
         18 . The method of  claim 11 , wherein the first biocompatible polymer is selected from the group consisting of PLGA, P(L)LA, P(D,L)LA, PCL, PLCL. 
     
     
         19 . The method of  claim 17 , wherein the second biocompatible polymer is selected from the group consisting of PLGA, P(L)LA, P(D,L)LA, PCL, PLCL. 
     
     
         20 . The method of  claim 16 , wherein the second controlled release component comprises one or more trigger signals selected from the group consisting of trigger signals based on a temperature sensitive phase transition, electric-field triggers, light triggers, and ultrasound triggers.