# US 2008/0187553 A1 · Immunstimulating lipid formulation

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- Number: US 2008/0187553 A1
- Document ID: US20080187553A1
- Status: Published application
- Kind: A1
- Application number: 12/076,981
- Filed: 2008-03-26
- Published: 2008-08-07
- Earliest claimed: 1996-06-10
- Assignees: Eurocine AB
- Inventors: Ulf Schroder
- Web page: https://patentgrep.com/patent/US20080187553A1

## CPC

- C12N 7/00: Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof (preparing medicinal viral antigen or antibody compositions, e.g. virus vaccines, A61K39/00)
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 9/1274: Non-vesicle bilayer structures, e.g. liquid crystals, tubules, cubic phases or cochleates; Sponge phases
- A61K 39/05: {Actinobacteria, e.g. Actinomyces, Streptomyces, Nocardia, Bifidobacterium, Gardnerella}, Corynebacterium; Propionibacterium {(Mycobacterium A61K39/04)}
- A61K 39/12: Viral antigens
- A61K 39/145: Orthomyxoviridae, e.g. influenza virus
- A61K 39/15: Reoviridae, e.g. calf diarrhea virus
- A61K 39/39: characterised by the immunostimulating additives, e.g. chemical adjuvants
- A61P 31/04: Antibacterial agents
- A61P 31/14: for RNA viruses
- A61P 31/16: for influenza or rhinoviruses
- A61P 37/04: Immunostimulants
- A61K 47/12: Carboxylic acids; Salts or anhydrides thereof
- A61K 47/14: Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
- A61K 2039/5252: {inactivated (killed)}
- A61K 2039/543: {intranasal}
- A61K 2039/55505: {Inorganic adjuvants}
- A61K 2039/55511: {Organic adjuvants}
- A61K 2039/55555: {Liposomes; Vesicles, e.g. nanoparticles; Spheres, e.g. nanospheres; Polymers}
- C12N 2720/12334: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2760/16134: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2760/16151: Methods of production or purification of viral material
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

A pharmaceutical formulation for parenteral or mucosal administration of antigens and/or vaccines to humans and animals, comprising monglyceride preparations having at least 80% monoglyceride content and where the acyl group contains from 6 to 24 carbon atoms, together with fatty acids where the number of carbon atoms may be varied between 4 and 22.

## Claims

### Claim 1

A pharmaceutical formulation for parenteral or mucosal administration of antigens and/or vaccines to an animal, characterized by comprising one or more substances selected from
a) monoglyceride preparations having at least 80% monoglyceride content and having the general formula
wherein R1 and R2 is H and R3 is one acyl group containing from 6 to 24 carbon atoms, and where the acyl chains may contain one or more unsaturated bonds
and
b) fatty acids of the general formula
CH3—(CH2)n—COOH
where “n” may be varied between 4 and 22, and where the acyl chain may contain one or more unsaturated bonds.

### Claim 2 (depends on 1)

A pharmaceutical formulation according to claim 1, characterized by having a monoglyceride preparation content of at least 90%, preferably at least 95%.

### Claim 3 (depends on 1)

A pharmaceutical formulation according to claim 1, wherein the acyl chains of the monoglyceride preparations contains 8 to 20 carbon atom, preferably 14 to 20 carbon atoms and where the acyl chains may contain one or more unsaturated bonds.

### Claim 4 (depends on 1)

A pharmaceutical formulation according to claim 1, wherein the acyl chains of the fatty acid contains 8 to 20 carbon atom, preferably 14 to 20 carbon atoms and where the acyl chains may contain one or more unsaturated bonds.

### Claim 5 (depends on 1)

A pharmaceutical formulation according to claim 1, wherein the antigen comprises an antigen and/or vaccine that is selected among the antigen and/or vaccines relevant to humans or animals, including marine animals.

### Claim 6 (depends on 1)

A pharmaceutical formulation according to claim 1, wherein the formulation comprises additional pharmaceutical excipients selected from the one or several of the following groups; preservatives and osmotic pressure controlling agents, pH-controlling agents, organic solvents, hydrophobic agents, enzyme inhibitors, water absorbing polymers, surfactants and absorption promoters, anti-oxidative agents, and the like.

### Claim 7 (depends on 1)

A pharmaceutical formulation according to claim 1, wherein the formulation comprises additional adjuvants.

### Claim 8 (depends on 1)

A pharmaceutical formulation according to claim 1, wherein the formulation is in a form suitable for parenteral or mucosal administration.

### Claim 9 (depends on 8)

A pharmaceutical formulation according to claim 8, wherein the formulation is in a form suitable for administration to the mucosa of the nose, mouth, vagina, rectum or the intestine.

### Claim 10 (depends on 8)

A pharmaceutical formulation according to claim 8, wherein the formulation is in a form suitable for administration to the mucosa of the nose.

### Claim 11

A vaccine or antigen formulation, characterized by that 100 g of the final formulation contains:
from 0.01 to 90 g of the antigen/vaccine component
from 0.1 to 90 g of the monoglyceride
from 0.1 to 90 g of the fatty acid
from 0.01 to 99 g of the water
from 0.01 to 99 g of PBS/saline
and optionally one or more adjuvant and/or excipient.

### Claim 12

The use of compounds selected from
a) monoglyceride preparations having at least 80% monoglyceride content and having the general formula
wherein R1 and R2 is H and R3 is one acyl group containing from 6 to 24 carbon atoms, and where the acyl chains may contain one or more unsaturated bonds
and
b) fatty acids of the general formula
CH3—(CH2)n—COOH
where “n” may be varied between 4 and 22, and where the acyl chain may contain one or more unsaturated bonds in an amount of 0.01 to 15 g/100 ml of total volume of the formulation as adjuvants/vehicles in pharmaceutical formulations for parenteral or mucosal administration of antigens and/or vaccines to humans or animals, including marine animals.

### Claim 13 (depends on 12)

The use of compounds according to claim 12, characterized by having a monoglyceride preparation content of at least 90%, preferably at least 95%.

### Claim 14 (depends on 12)

The use of compounds according to claim 12, wherein the acyl chains of the monoglyceride preparations contains 8 to 20 carbon atom, preferably 14 to 20 carbon atoms and where the acyl chains may contain one or more unsaturated bonds.

### Claim 15 (depends on 12)

The use of compounds according to claim 12, wherein the acyl chains of the fatty acid contains 8 to 20 carbon atom, preferably 14 to 20 carbon atoms and where the acyl chains may contain one or more unsaturated bonds.