# US 2025/0375481 A1 · Methods and processes for manufacture of a topically adherent selective bactericide

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- Number: US 2025/0375481 A1
- Document ID: US20250375481A1
- Status: Published application
- Kind: A1
- Application number: 18/865,540
- Filed: 2023-05-12
- Published: 2025-12-11
- Earliest claimed: 2022-05-13
- Assignees: Lintbells Limited
- Applicants: Lintbells Limited
- Inventors: Glenn Francis Vile; Ann Kimberly Haigh
- Web page: https://patentgrep.com/patent/US20250375481A1

## CPC

- A61K 9/0056: {Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals}
- A61K 35/20: Milk; Whey; Colostrum
- A61K 9/06: Ointments; Bases therefor; {Other semi-solid forms, e.g. creams, sticks, gels (composition of ointments, creams or gels A61K47/00)}
- A61K 38/018: {from milk}
- A61K 39/395: Antibodies (agglutinins A61K38/36 {; as drug carriers A61K47/50}); Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61P 31/04: Antibacterial agents
- C07K 16/00: Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- A61K 38/40: Transferrins, e.g. lactoferrins, ovotransferrins
- A61K 38/43: Enzymes; Proenzymes; Derivatives thereof
- 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
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)

## Abstract

Disclosed herein are processes for the manufacture of a new topically adherent selective bactericide and products resulting therefrom. More specifically a method for producing a complexed stable microbiome regulating protein configured for topical application and use of that product as a medicament, effective for therapeutic effect against pathogenic bacteria, but not commensal bacteria.

## Claims

### Claim 1

A complexed protein comprising:
a microbiome functional protein comprising lactoperoxidase, lactoferrin, lysomal alpha-mannosidase, immunoglobulin G, angiogenin, ribonuclease 4 or quiescin sulfhydryl oxidase and/or combinations thereof, complexed with a modified whey protein isolate (WPI) from milk, wherein the complexed microbiome functional protein is configured for topical application and, on application, to adhere to epithelial surfaces.

### Claim 2 (depends on 1)

The complexed protein as claimed in claim 1, wherein the complexed protein is a semi-solid aqueous gel with a viscosity of approximately 0.25 to 4.5 Poise.

### Claim 3 (depends on 1)

The complex protein as claimed in claim 1, wherein the microbiome functional protein is a blend of protein fractions that are selectively toxic to pathogenic bacteria, but which minimise any reduction in commensal bacteria population.

### Claim 4 (depends on 1)

The complexed protein of claim 1, wherein the modified WPI is derived from bovine species milk.

### Claim 5 (depends on 1)

The complexed protein of claim 1, wherein the ratio of microbiome regulating protein to modified WPI in the complexed protein is from 1:1 to 1:10.

### Claim 6 (depends on 1)

The complexed protein of claim 1, in therapeutically effect amount for use as a medicament.

### Claim 7

(canceled)

### Claim 8 (depends on 1)

Use of the complexed protein of claim 1, in the manufacture of a medicament for topical treatment of toxic pathogenic bacteria, or on an animal in need thereof, but minimising any reduction in commensal bacteria populations on epithelial surfaces of an animal.

### Claim 9 (depends on 1)

A method of selectively treating an animal for a toxic pathogenic bacteria, but minimising any reduction in commensal bacteria population, by the step of: topically administering a complexed protein as claimed in claim 1 and on application, the complexed protein adheres to the animal epithelial surfaces.

### Claim 10 (depends on 8)

The use or method as claimed in claim 8, wherein the animal is a non-human animal.

### Claim 11 (depends on 1)

A topical composition comprising the complexed protein of claim 1 and further comprising at least one pharmaceutically acceptable excipient.

### Claim 12

A method of producing a complexed stable microbiome regulating protein configured for topical application, the method comprising the steps of:
selecting a microbiome regulating protein wherein the protein comprises:
lactoperoxidase, lactoferrin, lysomal alpha-mannosidase, immunoglobulin G, angiogenin, ribonuclease 4, or quiescin sulfhydryl oxidase, and/or combinations thereof in a powder form;
selecting a modified whey protein isolate (WPI) from milk in a gel form;
solubilising the microbiome regulating protein in an aqueous salt solution, the aqueous salt solution having an ionic strength of 25-200 mM NaCl;
blending together the solubilised microbiome regulating protein and modified WPI;
adjusting the pH to 2.0-6.0;
adjusting the temperature to 18-37° C.; and
holding the blend at a pH of 2.0-6.0 and a temperature of 18-37° C. for at least 30 minutes.

### Claim 13 (depends on 12)

The method as claimed in claim 12, wherein the microbiome regulating protein is a blend of protein fractions that are selectively toxic to pathogenic bacteria, but which minimises any reduction in commensal bacteria population.

### Claim 14 (depends on 12)

The method as claimed in claim 12, wherein the complexed protein produced is a semi-solid gel with a viscosity of approximately 0.25 to 4.5 Poise.

### Claim 15 (depends on 12)

The method of claim 12 to, wherein the modified WPI selected is initially in the form of an aqueous gel.

### Claim 16 (depends on 12)

The method of any of claim 12, wherein the modified WPI selected is derived from bovine species milk.

### Claim 17 (depends on 12)

The method of claim 12, to 16, wherein the ratio of microbiome regulating protein to modified WPI used in the method and present in the complexed protein is from 1:1 to 1:10.

### Claim 18 (depends on 12)

The method of claim 12, wherein the salt solution comprises a mix of water and a chemical salt.

### Claim 19 (depends on 12)

The method of claim 12, wherein the ionic strength of the salt solution is approximately 75 mM NaCl.

### Claim 20 (depends on 12)

The method of claim 12, wherein the pH of the blend prior to pH adjustment is approximately 6.5 to 7.5.

### Claim 21 (depends on 12)

The method of claim 12, wherein the pH of the blend after pH adjustment is approximately 4.0.

### Claim 22 (depends on 12)

The method of claim 12, wherein the temperature of the blend after any adjustment is approximately 25° C.

### Claim 23 (depends on 12)

The method of claim 12, wherein the holding time is approximately 60 minutes.

### Claim 24 (depends on 12)

The method of claim 12, wherein the complexed protein is dried after holding to a water activity of less than 0.6.

### Claim 25 (depends on 12)

A complexed protein produced by the method as claimed in claim 12.