Dissolvable microneedles for skin treatment

Patent metadata

Field	Value
Publication number	US-10603477-B2
Application number	US-201815903262-A
Country	US
Kind code	B2
Filing date	Feb 23, 2018
Priority date	Mar 28, 2014
Publication date	Mar 31, 2020
Grant date	Mar 31, 2020

Abstract

A skin treatment device is provided including bioerodible polymeric microneedles which are designed to more effectively deliver beneficial agents to the skin. The device includes a flexible substrate and an arrangement, for example, an array, of microneedles projecting from the substrate.

First claim

What is claimed is:

1. A method for manufacturing a microneedle device comprising the steps of:
providing a precursor composition comprising a hyaluronic acid (HA) gel hydrate;
casting the precursor composition onto a negative microneedle mold, the mold defining a microneedle array;
partially dehydrating the precursor composition to provide a pre-concentrated composition;
compressing the pre-concentrated composition;
drying the pre-concentrated composition thereby forming a solid microneedle array; and
removing the solid microneedle array from the negative microneedle mold.

2. The method of claim 1 , wherein the step of providing a precursor composition comprises mixing a HA in an aqueous medium to form a mixture and allowing the mixture to equilibrate, thereby forming a uniform hydrogel.

3. The method of claim 2 , wherein the HA is a low molecular weight HA having a molecular weight in the range of about 340,000 Da to about 840,000 Da.

4. The method of claim 2 , wherein the aqueous medium is selected from deionized water and phosphate buffered saline (PBS).

5. The method of claim 2 , wherein the HA is selected from the group consisting of a fully protonated hyaluronic acid; a deprotonated hyaluronic acid; a salt of hyaluronic acid; and combinations thereof.

6. The method of claim 1 , wherein the step of partially dehydrating the precursor composition comprises evaporation of water at room temperature.

7. The method of claim 1 , wherein the step of partially dehydrating the precursor composition comprises incubating the HA gel hydrate and negative microneedle mold in an oven.

8. The method of claim 7 , wherein the oven has been preheated.

9. The method of claim 7 , wherein the incubating is performed at a temperature of 40° C.

10. The method of claim 7 , wherein the incubating is performed for a period of about 1.5 hours.

11. The method of claim 1 , wherein the negative microneedle mold is a silicone mold.

12. The method of claim 1 , wherein the negative microneedle mold is configured to produce a microneedle array comprising microneedles having a length of about 25 μm to about 2000 μm.

13. The method of claim 1 , wherein the negative microneedle mold is configured to produce a microneedle array comprising first microneedles having a first length and second microneedles having a second length different from the first length, wherein in a side view, the first microneedles are arranged with the second microneedles along a substrate in a set pattern, the first microneedles having a length of between 200 μm and 2000 μm.

14. The method of claim 13 , wherein the set pattern consists of the first and second microneedles arranged in an alternating fashion.

15. The method of claim 1 , wherein the step of compressing the pre-concentrated composition comprises applying a film on top of the pre-concentrated composition prior to compressing the pre-concentrated composition.

16. The method of claim 15 , wherein the step of compressing the pre-concentrated composition comprises applying an initial compression pressure, incrementally increasing the compression pressure at a constant rate until a predetermined maximum compression pressure is achieved, and maintaining the compression pressure at the predetermined maximum pressure for a period of time.

17. The method of claim 16 , wherein the initial compression pressure is 20 psi, the predetermined maximum compression pressure is 50 psi, and the period of time is about 30 seconds.

18. The method of claim 1 , wherein the step of drying the pre-concentrated composition comprises incubating at 40° C. for about 2.5 hours.

19. The method of claim 1 , wherein the precursor composition further comprises an active agent beneficial to skin.

20. The method of claim 19 , wherein the active agent is selected from the group consisting of vitamins, antioxidants, skin-whitening agents, peptides, and growth factors.

Assignees

• Allergan Inc

Inventors

• Schwab Justin J
• Augarten Michael
• Dominguez Zachary
• Franklin Ethan
• Kayda Edwin J
• Metzner Jason

Classifications

• A61L31/148

  Materials at least partially resorbable by the body · CPC title

• A61L2300/414

  Growth factors · CPC title

• A61L31/16

  Biologically active materials, e.g. therapeutic substances {(A61L31/047 takes precedence)} · CPC title

• A61M37/0015 Primary

  by using microneedles · CPC title

• A61M2037/0061

  Methods for using microneedles · CPC title