Micro-needle array comprising a color change indicator

Abstract

The invention relates to a microneedle array and to the use thereof for intradermal delivery, comprising a plurality of microneedles on a carrier, wherein this microneedle array is suitable for penetrating the skin of humans or animals and includes at least one color change indicator.

1 - 16 . (canceled) 
     
     
         17 . A microneedle array for use with intradermal delivery, comprising a plurality of microneedles on a carrier, wherein the microneedles comprise at least one color change indicator, the microneedles comprising at least one active ingredient and the microneedles comprising at least one polymer made of biodegradable polymers, biocompatible polymers or water-soluble polymers, a color change or color shift indicating a sufficient penetration depth into the stratum corneum, wherein the color change indicator is an integral part of the microneedles, the at least one color change indicator being introduced or incorporated into the microneedles. 
     
     
         18 . The microneedle array for use according to  claim 17 , wherein the color change indicator is added during the production of the microneedles. 
     
     
         19 . The microneedle array for use according to  claim 17 , wherein the microneedles comprise at least one active ingredient. 
     
     
         20 . The microneedle array for use according to  claim 17 , wherein the color change indicator is at least one pH indicator. 
     
     
         21 . The microneedle array for use according to  claim 20 , wherein the color change indicator is at least one physiologically acceptable pH. 
     
     
         22 . The microneedle array according to  claim 17 , wherein the color change indicator is a compound selected from chromoionophores or fluoroionophores, the compound being composed of at least one ionophore covalently bound to at least one molecule, which is selected from chromophores and fluorophores. 
     
     
         23 . The microneedle array for use according to  claim 22 , wherein the chromophores or fluorophores are selected from the neutral, acidic or basic nitrated benzene dyes, neutral, acidic or basic azo dyes, quinone dyes. 
     
     
         24 . The microneedle array according to  claim 17 , wherein the color change indicator is ink. 
     
     
         25 . The microneedle array according to  claim 17 , wherein the color change indicator detects endogenous enzymes. 
     
     
         26 . The microneedle array for use according to  claim 17 , wherein the color change indicator is included in the tip of the microneedles. 
     
     
         27 . The microneedle array for use according to  claim 17 , wherein patterns are visible on the skin to the naked eye. 
     
     
         28 . The microneedle array for use according to  claim 17 , wherein microneedles made of biodegradable polymers, biocompatible polymers or water-soluble polymers. 
     
     
         29 . The microneedle array for use according to  claim 17 , wherein the microneedle array comprises fixation means. 
     
     
         30 . The microneedle array for use according to  claim 17 , wherein the microneedle array is accommodated in a microneedle system and comprises at least one reservoir and/or applicator. 
     
     
         31 . The microneedle array for use according to  claim 18 , wherein the microneedles comprise a medicinal drug. 
     
     
         32 . The microneedle array for use according to  claim 18 , wherein the color change indicator is at least one pH indicator, which is selected from the group consisting of nitrazine yellow, bromothymol blue, carminic acid, brazilin, Congo red, neutral red, phenolphthalein, phenolic red, tetrabromophenolphthalein and a mixture thereof. 
     
     
         33 . The microneedle array for use according to  claim 20 , wherein the color change indicator is nitrazine yellow or bromothymol blue. 
     
     
         34 . The microneedle array for use according to  claim 22 , wherein the chromophores or fluorophores are neutral, acidic or basic methines, azomethines, triarylmethane dyes, indoamine dyes, natural dyes, or direct dyes thereof. 
     
     
         35 . The microneedle array according to  claim 17 , wherein the color change indicator is biosensing ink. 
     
     
         36 . The microneedle array according to  claim 17 , wherein the color change indicator detects peroxidases, which do not form part of the epidermis, by means of benzidines or phthalazines.