Microneedle Arrays and Methods of Use Thereof

• US 20080287858A1
• Filed: 11/16/2006
• Published: 11/20/2008
• Est. Priority Date: 11/30/2005
• Status: Active Grant

• Current Assignee: Kindeva Drug Delivery L.P.
• Original Assignee: 3M Innovative Properties Company (3M Company)
• Inventors: Duan, Daniel C.
• Granted Patent: US 8,554,317 B2
• Time in Patent Office: Days
• US Class Current: 604/21
• CPC Class Codes: A61M 2037/0046 Solid microneedles
• CPC Class Codes: A61M 2037/0061 Methods for using microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles

Abstract

A method of treating a patient with a microneedle array having an active agent disposed on at least a portion of one or more of the microneedles, wherein the array with active agent is characterized by a first optical response when probed with a selected incident light spectrum. The array with active agent is applied to a skin surface, optionally allowed to remain on the skin surface for a specified time, and removed. The used array is probed with the selected incident light spectrum, a second optical response is sensed, and the difference between the first optical response and the second optical response is determined and compared to a predetermined threshold value.

Claims

1. A method of treating a patient comprising:

providing a microneedle array with active agent comprising a plurality of microneedles arranged on a substrate and having an active agent formulation disposed on at least a portion of one or more of the microneedles, wherein the array with active agent is characterized by a first optical response when probed with a selected incident light spectrum;

applying the microneedle array with active agent to a skin surface;

optionally allowing the microneedle array to remain on the skin surface for a specified time;

removing the microneedle array;

probing the microneedle array with the selected incident light spectrum;

sensing a second optical response; and

determining if the difference between the first optical response and the second optical response exceeds a predetermined threshold value.

2. A method as claimed in claim 1 wherein the first optical response is selected from the group consisting of absorbance, reflection, scattering, fluorescence, image analysis, and phosphorescence.

3. A method as claimed in claim 1 wherein the first optical response is fluorescence.

4. A method as claimed in claim 1 wherein the first optical response is absorbance.

5. A method as claimed in claim 1 wherein the incident light spectrum comprises visible wavelengths.

6. A method as claimed in claim 1 wherein the incident light spectrum comprises ultraviolet wavelengths.

7. A method as claimed in claim 1 wherein the active agent formulation prevents a portion of the incident light spectrum from reaching one or more of the microneedles.

17. A method as claimed in claim 1 wherein a detection device is used to detect the second optical response.

18. A method as claimed in claim 17 wherein a measurement device probes the microneedle array with the selected incident light spectrum.

21. A method as claimed in claim 18 wherein an analysis device analyzes whether the difference between the first optical response and the second optical response exceeds a predetermined threshold value.

8-16. -16. (canceled)

19-20. -20. (canceled)

22. A drug delivery device comprising:

a plurality of microneedles arranged on a substrate, each microneedle having a base and a tip;

wherein the tip of one or more of the microneedles has a first optical response when probed with a selected incident light spectrum;

wherein the base of the microneedle has a second optical response when probed with the selected incident light spectrum, the second optical response differing from the first optical response;

an active agent formulation covering at least a portion of the tip of one or more of the microneedles; and

wherein the active agent formulation modulates the first optical response of the microneedles when probed with the selected incident light spectrum.

23. A drug delivery device as claimed in claim 22 wherein the first optical response is selected from the group consisting of absorbance, reflection, scattering, fluorescence, image analysis, and phosphorescence.

24. A drug delivery device as claimed in claim 22 wherein the first optical response is fluorescence.

25. A drug delivery device as claimed in claim 22 wherein the first optical response is absorbance.

26. A drug delivery device as claimed in claim 22 wherein the incident light spectrum comprises visible wavelengths.

27. A drug delivery device as claimed in claim 22 wherein the incident light spectrum comprises ultraviolet wavelengths.

28. A drug delivery device as claimed in claim 22 wherein the active agent formulation prevents a portion of the incident light spectrum from reaching one or more of the microneedles.

29-33. -33. (canceled)

34. A microneedle array comprising:

a plurality of tapered microneedles arranged on a substrate, wherein the microneedles have a fluorescence that is greater than that of the substrate.

35. A microneedle array as claimed in claim 34 and further comprising an active agent formulation at least partially disposed on the microneedles.

36. A microneedle array as claimed in claim 34 or 35 wherein the substrate provides a substantially negligible optical response to an incident light spectrum.

37-42. -42. (canceled)