Transdermal patch containing microneedles

• US 8,696,637 B2
• Filed: 02/28/2011
• Issued: 04/15/2014
• Est. Priority Date: 02/28/2011
• Status: Active Grant

• Current Assignee: Sorrento Therapeutics Inc.
• Original Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Inventors: Ross, Russell F.
• Primary Examiner(s): Sirmons, Kevin C.
• Assistant Examiner(s): PATEL, SHEFALI DILIP
• Application Number:
  US13/036,096
• Publication Number:
  US 20120220980A1
• Time in Patent Office: 1,142 Days
• Field of Search: 604/46, 604/47, 604/73, 604/80, 604/173, 604/191, 604/244, 604/272, 604/22, 604/48, 604/93.01, 604/264, 606/185, 606/186
• US Class Current: 604/173
• 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 2037/0038 having a channel at the side surface
• CPC Class Codes: A61M 2037/0061 Methods for using microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: A61M 5/14248 of the skin patch type

Abstract

A transdermal patch that can easily deliver a controlled volume of a fluidic drug compound to skin is provided. More particularly, the patch contains a microneedle assembly that is configured to be placed in fluid communication with a drug delivery assembly. The microneedle assembly contains a support and a plurality of microneedles that extend outwardly from the support. The microneedles are formed with one or more channels of a certain dimension such that passive capillary flow drives a flow of the drug compound. The drug delivery assembly contains a reservoir for the drug compound that is in fluid communication with a rate control membrane that helps control a flow rate of the drug compound by modulating a pressure of the drug compound, downstream from the reservoir. A release member is also positioned adjacent to the microneedle and drug delivery assemblies. Prior to use, the release member acts as a barrier to the flow of the drug compound and thus inhibits premature leakage. In this manner, the patch can initially be provided in an “inactive” configuration in which the drug compound is securely retained. When it is desired to release the drug compound, the patch can simply be activated by at least partially separating the release member from the drug delivery and microneedle assemblies.

Claims

1. A transdermal patch comprising:

a drug delivery assembly that comprises a reservoir for holding a drug compound and a rate control membrane that is in fluid communication with the reservoir;

a microneedle assembly that comprises a support having a first surface and a second surface, wherein an aperture extends between the first surface of the support and the second surface of the support, and wherein the microneedle assembly further comprises a plurality of microneedles that extend outwardly from the second surface of the support, wherein at least one of the microneedles contains a channel that is in fluid communication with the aperture and has a cross-sectional dimension ranging from about 1 micrometer to about 100 micrometers; and

a release member that is generally impermeable to the drug compound and positioned adjacent to the rate control membrane of the drug delivery assembly and the first surface of the support of the microneedle assembly, wherein the release member is configured to be at least partially separated from the rate control membrane of the drug delivery assembly and the support of the microneedle assembly when the patch is an active configuration, wherein the release member is positioned between the rate control membrane and the support.

2. The transdermal patch of claim 1, wherein the drug compound has a molecular weight of from about 20 kDa to about 250 kDa.

3. The transdermal patch of claim 1, wherein the drug compound is a rheumatoid arthritis drug compound.

4. The transdermal patch of claim 3, wherein the drug compound is a TNF-α

blacker.

5. The transdermal patch of claim 1, wherein the drug delivery assembly further comprises an adhesive layer, the reservoir being positioned between the adhesive layer and the rate control membrane.

6. The transdermal patch of claim 1, wherein the cross-sectional dimension of the channel is from about 5 micrometers to about 50 micrometers.

7. The transdermal patch of claim 1, wherein an aspect ratio of the channel is from about 5 to about 40.

8. The transdermal patch of claim 1, wherein a length of the channel is from about 50 micrometers to about 500 micrometers.

9. The transdermal patch of claim 1, wherein a cross-sectional area of the channel is from about 100 square micrometers to about 500 square micrometers.

10. The transdermal patch of claim 1, wherein the microneedles contain a base that extends from the second surface of the support and a tip that extends from the base.

11. The transdermal patch of claim 10, wherein the channel is disposed on an exterior surface of the base.

12. The transdermal patch of claim 10, wherein the channel is in alignment with at least a portion of the aperture to form a junction through which the drug compound is able to pass, the junction being formed in a plane of the second surface at the base of the microneedle.

13. The transdermal patch of claim 10, wherein the channel forms a substantially linear path from the base to the tip.

14. The transdermal patch of claim 1, wherein the support defines a plurality of apertures, wherein at least a portion of one of the apertures is in alignment with the channel.

15. The transdermal patch of claim 1, wherein the release member contains a tab portion that extends at least partially beyond a perimeter of the patch.

16. The transdermal patch of claim 1, wherein the release member is configured to be detached from the patch to place the drug delivery assembly in fluid communication with the microneedle assembly.

17. The transdermal patch of claim 1, wherein a microreservoir is formed between the rate control membrane and the support upon separation of the release member.