# US 9,517,205 B2 · Soluble needle arrays for delivery of influenza vaccines

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- Number: US 9,517,205 B2
- Document ID: US9517205B2
- Status: Granted
- Kind: B2
- Application number: 13/817,814
- Filed: 2011-08-19
- Published: 2013-10-31
- Granted: 2016-12-13
- Earliest claimed: 2010-08-20
- Assignees: Seqirus UK Limited
- Applicants: Derek O'Hagan; Manmohan Singh; Sung-Yun Kwon
- Inventors: Derek O'Hagan; Manmohan Singh; Sung-Yun Kwon
- Web page: https://patentgrep.com/patent/US9517205B2

## CPC

- A61K 39/145: Orthomyxoviridae, e.g. influenza virus
- A61B 17/205: {Vaccinating by means of needles or other puncturing devices}
- A61K 9/146: {with organic macromolecular compounds}
- A61K 39/12: Viral antigens
- A61M 37/0015: {by using microneedles}
- G01N 33/68: involving proteins, peptides or amino acids {(involving lipoproteins G01N33/92)}
- A61B 2017/00004: {(bio)absorbable, (bio)resorbable or resorptive}
- A61K 2039/5252: {inactivated (killed)}
- A61K 2039/54: {characterised by the route of administration}
- A61K 2039/70: {Multivalent vaccine}
- A61M 2037/0023: {Drug applicators using microneedles}
- A61M 2037/0046: {Solid microneedles}
- A61M 2202/30: Vaccines
- C12N 2760/16111: Influenzavirus A, i.e. influenza A virus
- C12N 2760/16134: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2760/16211: Influenzavirus B, i.e. influenza B virus
- C12N 2760/16234: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- G01N 2333/11: Orthomyxoviridae, e.g. influenza virus
- 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)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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)}
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

Influenza vaccines are administered using solid biodegradable microneedles. The microneedles are fabricated from the influenza vaccine in combination with solid excipient(s) and, after penetrating the skin, they dissolve in situ and release the vaccine to the immune system. The influenza vaccine is (i) a purified influenza virus surface antigen vaccine, rather than a live vaccine or a whole-virus or split inactivated vaccine (ii) an influenza vaccine prepared from viruses grown in cell culture, not eggs, (iii) a monovalent influenza vaccine e.g. for immunizing against a pandemic strain, (iv) a bivalent vaccine, (v) a tetravalent or >4-valent vaccine, (vi) a mercury-free vaccine, or (vii) a gelatin-free vaccine.

## Claims

### Claim 1

A skin patch comprising a plurality of solid biodegradable microneedles, wherein the microneedles comprise (i) a biosoluble and biodegradable matrix material mixed with (ii) a purified influenza virus surface antigen vaccine, wherein the vaccine comprises hemagglutinin and 5-30 μg of detergent per μg of hemagglutinin.

### Claim 2

A process for preparing a skin patch comprising a plurality of solid biodegradable microneedles, comprising steps of: (i) mixing a biosoluble and biodegradable matrix material with a purified influenza virus surface antigen vaccine, wherein the vaccine comprises hemagglutinin and 5-30 μg of detergent per μg of hemagglutinin; and (ii) adding the mixture from step (i) to a mold containing cavities for forming microneedles.

### Claim 3

A skin patch comprising a plurality of solid biodegradable microneedles, wherein the microneedles comprise (i) a biosoluble and biodegradable matrix material mixed with (ii) a split influenza virus vaccine, a purified influenza virus surface antigen vaccine, an influenza virosomes vaccine, or a recombinant influenza virus surface antigen vaccine comprising an influenza virus hemagglutinin, wherein the amount of influenza virus hemagglutinin per patch is <16 μg per strain, wherein the patch comprises 5-30 μg of detergent per μg of hemagglutinin.

### Claim 4 (depends on 3)

The patch of claim 3, wherein the patch comprises the purified influenza virus surface antigen vaccine.

### Claim 5 (depends on 1)

The patch of claim 1, wherein the influenza vaccine is an influenza vaccine prepared from viruses grown in cell culture.

### Claim 6 (depends on 5)

The patch of claim 5, wherein the viruses are grown in a MDCK cell line.

### Claim 7 (depends on 6)

The patch of claim 6, wherein the MDCK cell line is MDCK33016.

### Claim 8 (depends on 1)

The patch of claim 1, wherein the influenza vaccine is a monovalent influenza vaccine.

### Claim 9 (depends on 1)

The patch of claim 1, wherein the influenza vaccine is a bivalent influenza vaccine.

### Claim 10 (depends on 1)

The patch of claim 1, wherein the influenza vaccine is a tetravalent influenza vaccine.

### Claim 11 (depends on 1)

The patch of claim 1, wherein the influenza vaccine is a >4-valent influenza vaccine.

### Claim 12 (depends on 1)

The patch of claim 1, wherein the influenza vaccine is a mercury-free influenza vaccine.

### Claim 13 (depends on 1)

The patch of claim 1, wherein the influenza vaccine is a gelatin-free influenza vaccine.

### Claim 14 (depends on 1)

The patch of claim 1, wherein the matrix material comprises one or more carbohydrates.

### Claim 15 (depends on 14)

The patch of claim 14, wherein the matrix material comprises a cellulose and/or a dextrin and/or a disaccharide.

### Claim 16 (depends on 1)

The patch of claim 1, wherein the microneedles are 100-2500 μm long and are tapered with a skin-facing point.

### Claim 17 (depends on 1)

The patch of claim 1, wherein a single patch has >20 microneedles.

### Claim 18 (depends on 1)

The patch of claim 1, wherein the patch has an area of <2 cm2.

### Claim 19 (depends on 1)

The patch of claim 1, wherein a skin-facing area of the patch includes an adhesive to facilitate adherence to a subject's skin.

### Claim 20 (depends on 1)

The patch of claim 1, wherein the detergent is polysorbate 80.

### Claim 21 (depends on 1)

The patch of claim 1, containing 1-15 μg of hemagglutinin per influenza virus strain.