Microneedle arrays formed from polymer films

• US 10,377,062 B2
• Filed: 02/04/2013
• Issued: 08/13/2019
• Est. Priority Date: 08/06/2007
• Status: Active Grant

• Current Assignee: Transderm, Inc. (Abbvie Incorporated)
• Original Assignee: Transderm, Inc. (Abbvie Incorporated)
• Inventors: Kaspar, Roger L., Speaker, Tycho
• Primary Examiner(s): Schiffman, Benjamin A
• Application Number:
  US13/758,872
• Publication Number:
  US 20140046262A1
• Time in Patent Office: 2,381 Days
• CPC Class Codes: A61B 5/685 Microneedles
• CPC Class Codes: A61K 9/0021 Intradermal administration, e.g. through microneedle arrays, needleless injectors mechanical aspects A61M
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/003 having a lumen
• CPC Class Codes: A61M 2037/0053 Methods for producing microneedles
• CPC Class Codes: A61M 2037/0061 Methods for using microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: B29C 2059/023 Microembossing
• CPC Class Codes: B29C 39/38 Heating or cooling
• CPC Class Codes: B29C 39/42 Casting under special conditions, e.g. vacuum
• CPC Class Codes: B29C 41/02 for making articles of definite length, i.e. discrete articles
• CPC Class Codes: B29C 41/50 Shaping under special conditions, e.g. vacuum
• CPC Class Codes: B29L 2031/7544 Injection needles, syringes
• CPC Class Codes: B81B 2201/055 Microneedles
• CPC Class Codes: B81C 1/00111 Tips, pillars, i.e. raised structures microneedles A61M37/0015

Abstract

The present invention provides for transdermal delivery devices having microneedle arrays, as well as methods for their manufacture and use. In one embodiment, a transdermal delivery device is provided. The transdermal delivery device includes a polymer layer which has microneedles projecting from one of its surfaces. The microneedles are compositionally homogenous with the polymer base layer.

Claims

1. A method of manufacturing a transdermal drug delivery device having a microneedle array, comprising:

providing a substrate;

applying a polymer solution to the substrate to form a base layer;

disposing an exposed surface of the base layer with a textured surface having elevated points protruding therefrom such that the elevated points contact the exposed surface of the base layer;

distancing the textured surface from the exposed surface of the base layer such that the elevated points draw out tube-like projections from the exposed surface of the base layer, wherein the textured surface is distanced from the exposed surface of the base layer at a rate of about 0.1 mm/s to about 100 mm/s;

drying the base layer having the tube-like projections to form microneedles, wherein drying includes exposing the base layer to reduced pressure; and

trimming the microneedles to a predetermined length and tip-bevel to form the transdermal drug delivery device.

2. The method of claim 1, wherein the microneedles are hollow.

3. The method of claim 1, wherein the microneedles are regularly spaced on the exposed surface of the base layer.

4. The method of claim 1, wherein the step of drying is concurrent with the step of distancing.

5. The method of claim 1, wherein the step of drying can include one of blowing, baking, or combinations thereof.

6. The method of claim 1, wherein the substrate is not incorporated into the transdermal drug delivery device.

7. The method of claim 1, wherein the substrate is a backing layer.

8. The method of claim 1, wherein an active agent is included in the polymer solution.

9. The method of claim 8, wherein the composition containing the active agent includes a polymer which is different than the polymer in the base layer.

10. The method of claim 1, further comprising loading the microneedles with a composition containing an active agent.

11. The method of claim 10, wherein the polymer included in the active agent composition has solubility characteristics that differ from the polymer composing the micro needles.

12. The method of claim 1, wherein the microneedles are dried or baked subsequent to the loading thereof with an active agent composition.

13. The method of claim 1, further comprising cutting the base layer to form the transdermal drug delivery device.

14. The method of claim 1, wherein the microneedles are solid.