# US 11,992,508 B2 · Micronized eggshell membrane particles and the use thereof to promote the healing of wounds

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- Number: US 11,992,508 B2
- Document ID: US11992508B2
- Status: Granted
- Kind: B2
- Application number: 15/522,441
- Filed: 2015-10-28
- Published: 2017-11-09
- Granted: 2024-05-28
- Earliest claimed: 2014-10-28
- Assignees: Biovotec AS
- Applicants: Biovotec AS
- Inventors: Ralf Schmidt; Henri-Pierre Suso; Enda Kenny
- Web page: https://patentgrep.com/patent/US11992508B2

## CPC

- A61K 35/57: Birds; Materials from birds, e.g. eggs, feathers, egg white, egg yolk or endothelium corneum gigeriae galli
- A61K 9/14: Particulate form, e.g. powders, {Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles (microspheres A61K9/16; microcapsules A61K9/50; nanocapsules, nanoparticles of the matrix type A61K9/51)}
- A61L 15/40: containing ingredients of undetermined constitution or reaction products thereof {, e.g. plant or animal extracts}
- A61L 15/60: Liquid-swellable gel-forming materials, e.g. super-absorbents
- A61L 26/0023: {Polysaccharides}
- A61L 26/0057: {Ingredients of undetermined constitution or reaction products thereof}
- A61L 26/008: {Hydrogels or hydrocolloids}
- A61L 27/3604: {characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel}
- A61L 31/005: {Ingredients of undetermined constitution or reaction products thereof}
- A61L 31/08: Materials for coatings
- A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like
- A61L 2300/30: Compounds of undetermined constitution extracted from natural sources, e.g. Aloe Vera
- A61L 2300/404: Biocides, antimicrobial agents, antiseptic agents
- A61L 2300/41: Anti-inflammatory agents, e.g. NSAIDs
- A61L 2300/412: Tissue-regenerating or healing or proliferative agents
- Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
- 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)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

The invention provides a particle consisting essentially of micronized ESM and having a mean particle diameter of less than 100 μm for use in promoting the healing of a chronic wound at risk of, or in which there is, (i) an inappropriate level of matrix-metalloproteinase (MMP) activity against extracellular matrix (ECM) proteins and/or peptide growth or differentiation factors, and/or (ii) an excessive inflammatory response. The invention further provides pharmaceutical compositions, wound dressings and implantable medical devices comprising the micronized ESM-containing particles for use in said treatments. The invention still further provides methods for manufacturing the micronized ESM-containing particles and the compositions, dressings and implantable medical devices comprising the same.

## Claims

### Claim 1

A method of promoting the healing of a non-healing chronic wound, wherein the non-healing chronic wound healing,
(i) has not healed in 30 days after wound formation, and
(ii) is stalled in the inflammatory stage of wound healing,
wherein said method consists of applying directly to the surface or interior of the non-healing chronic wound a particle consisting of micronized egg shell membrane (ESM) having a mean particle diameter of equal to or less than 80 μm and being essentially insoluble in water at a neutral pH, and
wherein the application of the particle to the non-healing chronic wound causes the non-healing chronic wounds to progress through the healing stages.

### Claim 2 (depends on 1)

The method of claim 1, wherein said particle has a mean particle diameter of equal to or greater than 1 μm.

### Claim 3 (depends on 1)

The method of claim 1, wherein said ESM is chicken, duck, goose, turkey, guineafowl, ostrich, pigeon, pheasant, partridge, grouse or gull ESM.

### Claim 4 (depends on 1)

The method of claim 1, wherein said ESM is chemically non-degraded, non-digested and/or non-denatured as compared to naturally occurring ESM from a corresponding avian source.

### Claim 5 (depends on 1)

The method of claim 1, wherein said ESM is non-hydrolysed.

### Claim 6 (depends on 1)

The method of claim 1, wherein inflammation in the wound is reduced or limited following application of the particle to the wound.

### Claim 7 (depends on 1)

The method of claim 1, wherein the viability and/or growth of a microorganism present in the wound is inhibited following application of the particle to the wound.

### Claim 8 (depends on 7)

The method of claim 7, wherein said microorganism is selected from the genera Citrobacter, Enterobacter, Escherichia, Hafnia, Serratia, Yersinia, Peptostreptococcus, Bacteroides, Pseudomonas, Legionella, Staphylococcus, Enterococcus, Streptococcus, Klebsiella, Candida, Proteus, Burkholderia, Fusobacterium or Mycobacterium.

### Claim 9 (depends on 1)

The method of claim 1, wherein the viability and/or growth of the cells of the wound tissue is promoted following application of the particle to the wound.

### Claim 10 (depends on 1)

The method of claim 1, wherein the migration of the cells of the wound tissue into the wound is promoted following application of the particle to the wound.

### Claim 11 (depends on 1)

The method of claim 1, wherein the wound is a skin wound and/or a wound containing an implantable medical device.

### Claim 12 (depends on 3)

The method of claim 3, wherein said ESM is Gallus domesticus ESM.

### Claim 13 (depends on 8)

The method of claim 8, wherein said microorganism is Escherichia coli, Enterococcus faecalis Staphylococcus aureus, Staphylococcus epidermidis, Legionella pneumophila, Candida albicans, Pseudomonas aeruginosa, Burkholderia cepacia or Streptococcus pyogenes.