Microneedle patches and methods

Abstract

Microneedle patches and systems, and methods for use of such patches and systems. In one aspect, a microneedle patch is provided including a tab portion for handling the microneedle patch. In another aspect, a system is provided including a microneedle patch and a tray for housing the microneedle patch. In still another aspect, various indicators providing for providing feedback prior to, during, and after administration of the microneedle patch are provided. Advantageously, the described microneedle patches and systems provide improved handling and ease of application of the microneedle patches to skin for the delivery of therapeutic agents.

We claim: 
     
         1 . A microneedle patch comprising:
 a base substrate having a microneedle side and an opposing back side;   an array of dissolvable microneedles extending from the microneedle side of the base substrate, wherein the microneedles are molded of a composition which comprises (i) a substance of interest selected from active pharmaceutical ingredients, allergens, vitamins, cosmetic agents, cosmeceuticals, and markers, and (ii) a water-soluble matrix material in which the substance of interest is dispersed, wherein the water soluble matrix material comprises carboxymethylcellulose sodium, polyvinyl alcohol, and/or a sugar; and   an indicator connected to the opposing back side of the base substrate, wherein the indicator is configured to provide audible, tactile, and visual signals when a force applied to the patch by a user, in the course of manually applying the patch to a person's skin to insert the microneedles into the skin, meets or exceeds a predetermined threshold.   
     
     
         2 . The patch of  claim 1 , further comprising:
 a handle layer affixed to the base substrate and including an elongated tab portion extending laterally away from a side of the microneedles, the tab portion being configured for manual manipulation of the patch; and   an adhesive layer disposed between and securing together the base substrate and the handle layer.   
     
     
         3 . The patch of  claim 1 , further comprising:
 a handle layer affixed to the base substrate and including an elongated tab portion extending laterally away from the microneedles, the tab portion being configured for manual manipulation of the patch; and   an adhesive layer which comprises (i) a first adhesive composition disposed between and securing together the base substrate and the handle layer, and (ii) a second adhesive composition disposed on the handle layer beyond the base substrate and configured to releasably secure the patch to the skin.   
     
     
         4 . The patch of  claim 3 , wherein the first adhesive composition has a coefficient of adhesion between the base substrate and the handle layer that is greater than the coefficient of adhesion of the second adhesive composition between the handle layer and a patient's skin. 
     
     
         5 . The patch of  claim 1 , wherein the indicator comprises a mechanical force indicator which comprises a button that is displaced during application of the force to the patch meets or exceeds the predetermined threshold. 
     
     
         6 . The patch of  claim 5 , wherein the mechanical force indicator comprises a snap dome disposed inside a housing. 
     
     
         7 . The patch of  claim 6 , wherein the mechanical force indicator is integrated with another component such that the displacement is irreversible when the force applied to the patch meets or exceeds the predetermined threshold. 
     
     
         8 . The patch of  claim 7 , wherein the another component comprises a snap-in-place mechanism or latch. 
     
     
         9 . The patch of  claim 1 , wherein the substance of interest comprises a vaccine or other active pharmaceutical ingredient. 
     
     
         10 . The patch of  claim 1 , wherein the microneedles have a height between 100 μm to and 2000 μm. 
     
     
         11 . A microneedle patch comprising:
 a base substrate having a microneedle side and an opposing back side;   an array of microneedles extending from the microneedle side of the base substrate, the microneedles being formed by molding a composition which comprises a substance of interest selected from active pharmaceutical ingredients, allergens, vitamins, cosmetic agents, cosmeceuticals, and markers;   a handle layer affixed to the base substrate and comprising a tab portion which extends laterally away from the microneedles and permits a person to manually hold the tab portion to manipulate the patch without contacting the microneedles; and   an adhesive layer disposed between and securing together the base substrate and the handle layer,   wherein the adhesive layer comprises a differential adhesive.   
     
     
         12 . The patch of  claim 11 , wherein the adhesive layer has a coefficient of adhesion between the base substrate and the handle layer that is greater than the coefficient of adhesion between the handle layer a patient's skin. 
     
     
         13 . The patch of  claim 11 , wherein the substance of interest comprises a vaccine or other active pharmaceutical ingredient. 
     
     
         14 . The patch of  claim 11 , further comprising an indicator connected to the opposing back side of the base substrate, wherein the indicator is configured to provide audible, tactile, and visual signals when a force applied to the patch by a user, in the course of manually applying the patch to a person's skin to insert the microneedles into the skin, meets or exceeds a predetermined threshold. 
     
     
         15 . The patch of  claim 11 , wherein the microneedles are dissolvable microneedles and the composition further comprises a water-soluble matrix material in which the substance of interest is dispersed. 
     
     
         16 . The patch of  claim 15 , wherein the water soluble matrix material comprises carboxymethylcellulose sodium, polyvinyl alcohol, and/or a sugar. 
     
     
         17 . A microneedle patch comprising:
 a base substrate having a microneedle side and an opposing back side;   an array of dissolvable microneedles extending from the microneedle side of the base substrate, the microneedles being formed molding and comprising a composition which comprises a substance of interest selected from active pharmaceutical ingredients, allergens, vitamins, cosmetic agents, cosmeceuticals, and markers;   a handle layer affixed to the base substrate and comprising a tab portion which extends laterally away from the microneedles and permits a person to manually hold the tab portion to manipulate the patch without contacting the microneedles;   an adhesive layer disposed between and securing together the base substrate and the handle layer; and   an indicator connected to the opposing back side of the base substrate, wherein the indicator is configured to provide a visual signal indicative of (i) at least substantially complete insertion of the microneedles into the biological tissue, or (ii) completion of delivery of the substance of interest to the biological tissue,   wherein the indicator comprises (a) a dye that is configured to be transferred from the patch to the biological tissue, or (b) a reactant that undergoes a chemical reaction producing a color change.   
     
     
         18 . The patch of  claim 17 , wherein the indicator comprises the dye and the dye is disposed on the microneedle side of the base substrate or is disposed in or coated onto at least part of the microneedles. 
     
     
         19 . The patch of  claim 17 , wherein the indicator comprises the reactant and the chemical reaction is configured to be triggered (i) upon removal of the microneedle patch from its packaging and exposure, resulting from said removal, of the reactant to oxygen in air, (ii) upon insertion of the microneedles into skin and exposure, resulting from said insertion, of the reactant to water from the skin, or (iii) upon removal of a release liner or other component of the patch before or after application of the patch to the skin and exposure, resulting from said removal, of the reactant to air or light. 
     
     
         20 . The patch of  claim 19 , wherein the chemical reaction has a reaction time that is equal to or longer than a predetermined patch wear time. 
     
     
         21 . The patch of  claim 17 , wherein the substance of interest comprises a vaccine or other active pharmaceutical ingredient.