# US 12,005,220 B2 · Microneedle patch for immunostimulatory drug delivery

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- Number: US 12,005,220 B2
- Document ID: US12005220B2
- Status: Granted
- Kind: B2
- Application number: 17/100,722
- Filed: 2020-11-20
- Published: 2021-05-27
- Granted: 2024-06-11
- Earliest claimed: 2019-11-22
- Assignees: Veradermics Incorporated
- Applicants: Veradermics Incorporated
- Inventors: Reid Waldman; Madeline DeWane; Ming Hua Lee; Lauren Sweeney Durso
- Web page: https://patentgrep.com/patent/US12005220B2

## CPC

- A61M 37/0015: {by using microneedles}
- A61B 17/205: {Vaccinating by means of needles or other puncturing devices}
- A61K 39/0002: {Fungal antigens, e.g. Trichophyton, Aspergillus, Candida}
- A61K 39/12: Viral antigens
- A61K 39/35: Allergens
- A61K 2039/55555: {Liposomes; Vesicles, e.g. nanoparticles; Spheres, e.g. nanospheres; Polymers}
- A61M 2037/0023: {Drug applicators using microneedles}
- A61M 2037/0046: {Solid microneedles}
- A61M 2037/0061: {Methods for using microneedles}
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)

## Abstract

The application provides a dissolvable microneedle device to deliver immune stimulants to the skin. The application also provides a method of treating a skin condition comprising applying a dissolvable microneedle device to the skin.

## Claims

### Claim 1

A dissolvable microneedle patch for delivery of a therapeutically active ingredient to skin comprising:
a plurality of microneedles and a removable substrate;
wherein the plurality of microneedles are attached to the removable substrate;
wherein the plurality of microneedles comprise a tapered tip that extends away from the removable substrate;
wherein the plurality of microneedles comprise a biodegradable polymer and a therapeutically active ingredient dispersed in the biodegradable polymer; and
wherein the therapeutically active ingredient is an immunogenic stimulator selected from the group consisting of Candida antigen, trichophyton antigen, and tuberculin; and
wherein the immunogenic stimulator is substantially free of glycerin.

### Claim 2 (depends on 1)

The dissolvable microneedle patch of claim 1, wherein the plurality of microneedles can range from about 10 microns to about 1000 microns in length.

### Claim 3 (depends on 1)

The dissolvable microneedle patch of claim 1, wherein the plurality of microneedles each comprise about equal amounts of the therapeutically active ingredient.

### Claim 4 (depends on 1)

The dissolvable microneedle patch of claim 1, wherein the plurality of microneedles each comprise unequal amount of the therapeutically active ingredient.

### Claim 5 (depends on 1)

The dissolvable microneedle patch of claim 1, wherein the Candida antigen is lyophilized.

### Claim 6 (depends on 1)

The dissolvable microneedle patch of claim 1, wherein the dissolvable microneedle patch comprises at least about 1 to about 200 microneedles per square centimeter.

### Claim 7 (depends on 1)

The dissolvable microneedle patch of claim 1, wherein the dissolvable microneedle patch ranges from about 0.1 to about 1000 square centimeters and may be trimmed to fit any shape necessary to accommodate any surface of topology of human skin.

### Claim 8 (depends on 1)

The dissolvable microneedle patch of claim 1, wherein the plurality of microneedles are configured to have a sustained release of therapeutically active ingredient into the skin.

### Claim 9 (depends on 8)

The dissolvable microneedle patch of claim 8, is configured to release the therapeutically active ingredient from about 1 day to about 30 days after application of the dissolvable microneedle patch into the skin.

### Claim 10 (depends on 1)

The dissolvable microneedle patch of claim 1, wherein the plurality of microneedles are configured to have an immediate release of therapeutically active ingredient into the skin.

### Claim 11 (depends on 10)

The dissolvable microneedle patch of claim 10, wherein the plurality of microneedles are configured to release the therapeutically active ingredient from about 0 hours to about 24 hours after application of the dissolvable microneedle patch into the skin.

### Claim 12 (depends on 1)

The dissolvable microneedle patch of claim 1, wherein the plurality of microneedles are configured to have both sustained release and an immediate release of therapeutically active ingredient into the skin.

### Claim 13 (depends on 1)

The dissolvable microneedle patch of claim 1, wherein the plurality of microneedles are spatially separated within the skin where one microneedle does not touch another microneedle.

### Claim 14 (depends on 1)

The dissolvable microneedle patch of claim 1, wherein the tapered tip constitutes about 5% to about 99% of a total volume of the plurality of microneedles.

### Claim 15 (depends on 1)

The dissolvable microneedle patch of claim 1, wherein the removable substrate comprises a therapeutically active ingredient dispersed in a polymer.

### Claim 16 (depends on 1)

The dissolvable microneedle patch of claim 1, wherein the removable substrate comprises an adhesive medical tape.

### Claim 17 (depends on 1)

The dissolvable microneedle patch of claim 1, wherein the dissolvable microneedle patch administers to a subject in need thereof a therapeutically effective amount of the immunogenic stimulator.

### Claim 18 (depends on 1)

The dissolvable microneedle patch of claim 1, wherein the therapeutically active ingredient stimulates a local immune response.

### Claim 19

A method of treating a skin condition comprising:
applying a dissolvable microneedle patch for delivery of a therapeutically active ingredient to skin comprising:
a plurality of microneedles and a removable substrate;
wherein the plurality of microneedles are attached to the removable substrate;
wherein the plurality of microneedles comprise a tapered tip that extends away from the removable substrate;
wherein the plurality of microneedles comprise a biodegradable polymer and a therapeutically active ingredient dispersed in the biodegradable polymer;
wherein the therapeutically active ingredient is an immunogenic stimulator selected from the group consisting of Candida antigen, trichophyton antigen, and tuberculin; and
wherein the immunogenic stimulator is substantially free of glycerin;
exerting sufficient force on the dissolvable microneedle patch to permit the plurality of microneedles to penetrate to a location selected from the group consisting of epidermis, dermis, and papillary dermis;
allowing the plurality of microneedles to remain in the skin until the biodegradable polymer degrades; and
removing an adhesive substrate from the dissolvable microneedle patch.

### Claim 20 (depends on 19)

The method of claim 19, wherein at least 90% of the plurality of microneedles detach from the removable substrate within about 20 minutes after application of the dissolvable microneedle patch.

### Claim 21 (depends on 19)

The method of claim 19, wherein at least 90% of the plurality of microneedles detach from the adhesive substrate of the removable substrate upon removal of the removable substrate within a period of 5 minutes.

### Claim 22 (depends on 19)

The method of claim 19, wherein the biodegradable polymer degrades and releases therapeutically active ingredient into the skin.

### Claim 23 (depends on 19)

The method of claim 19, wherein the biodegradable polymer degrades and releases therapeutically active ingredient into the skin over a period of about 1 day to about 30 days.

### Claim 24 (depends on 19)

The method of claim 19, wherein the biodegradable polymer degrades and releases therapeutically active ingredient into the skin over a period of about 2 days to about 21 days.

### Claim 25 (depends on 19)

The method of claim 19, wherein the sufficient force is applied to the skin by a finger.

### Claim 26 (depends on 25)

The method of claim 25, wherein the sufficient force applied to the skin ranges from 0N to about 1000N.

### Claim 27 (depends on 25)

The method of claim 25, wherein the sufficient force applied to the skin is 10N.

### Claim 28 (depends on 19)

The method of claim 19, wherein the sufficient force is applied by impact insertion using an applicator device.

### Claim 29 (depends on 28)

The method of claim 28, wherein the sufficient force applied to the skin ranges from 0N to about 1000N.

### Claim 30 (depends on 28)

The method of claim 28, wherein the sufficient force applied to the skin is 10N.