# US 11,998,656 B2 · Hemostatic compositions and methods of making thereof

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- Number: US 11,998,656 B2
- Document ID: US11998656B2
- Status: Granted
- Kind: B2
- Application number: 17/549,131
- Filed: 2021-12-13
- Published: 2022-03-31
- Granted: 2024-06-04
- Earliest claimed: 2016-08-15
- Assignees: Guangzhou Bioseal Co., Ltd.
- Applicants: Guangzhou Bioseal Biotech Co. Ltd.
- Inventors: Shuang Chen; Yufu Li; Dengmin Feng; Xiang Wan
- Web page: https://patentgrep.com/patent/US11998656B2

## CPC

- A61L 24/108: {Specific proteins or polypeptides not covered by groups A61L24/102 - A61L24/106}
- A61K 9/16: Agglomerates; Granulates; Microbeadlets {; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction (A61K9/20 takes precedence if the final form is a tablet; microspheres with drug-free outer coating, microcapsules A61K9/50; mixture of different granules, microcapsules, (coated) microparticles A61K9/5084; nanoparticles A61K9/51)}
- A61K 9/1611: {Inorganic compounds}
- A61K 9/1682: {Processes}
- A61K 31/717: Celluloses
- A61K 38/363: {Fibrinogen}
- A61K 38/4833: {Thrombin (3.4.21.5)}
- A61K 47/18: Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61L 24/0042: {Materials resorbable by the body}
- A61L 24/02: containing inorganic materials
- A61L 24/08: Polysaccharides {(A61L24/043 takes precedence)}
- A61L 24/106: {Fibrin; Fibrinogen}
- C08J 3/12: Powdering or granulating
- C12Y 304/21005: Thrombin (3.4.21.5)
- A61L 2300/232: Monosaccharides, disaccharides, polysaccharides, lipopolysaccharides
- A61L 2300/252: Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
- A61L 2300/418: Agents promoting blood coagulation, blood-clotting agents, embolising agents
- A61L 2300/802: Additives, excipients, e.g. cyclodextrins, fatty acids, surfactants
- A61L 2400/04: Materials for stopping bleeding
- A61L 2430/36: for embolization or occlusion, e.g. vaso-occlusive compositions or devices
- C08J 2301/02: Cellulose; Modified cellulose
- C08J 2389/00: Characterised by the use of proteins; Derivatives thereof
- 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)
- 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)
- C08J: WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H (working, e.g. shaping, of plastics B29)
- C12Y: ENZYMES

## Abstract

The present invention is directed to hemostatic compositions comprising at least partially integrated agglomerated ORC fibers, fibrinogen, and thrombin and methods of forming a powdered hemostatic composition, comprising the steps of: forming a suspension of a mixture comprising particles of fibrinogen, thrombin, ORC fibers in a non-aqueous low boiling solvent; spraying the suspension through a nozzle onto a substrate, allowing the non-aqueous solvent to evaporate; separating from the substrate and sieving the composition.

## Claims

### Claim 1

A method of forming a powdered hemostatic composition, comprising the steps of:
a) forming a suspension of a mixture comprising particles of fibrinogen, thrombin, a calcium salt, a buffering agent, and oxidized regenerated cellulose (ORC) fibers in a non-aqueous low boiling solvent;
b) spraying the suspension through a nozzle onto a substrate,
c) allowing the non-aqueous solvent to evaporate;
d) separating the composition from the substrate and sieving the composition; and thus forming the powdered hemostatic composition comprising an agglomerate of said (i) ORC fibers, (ii) fibrinogen, (iii) thrombin; (iv) calcium salt, and (v) buffering agent, said components (i)-(v) being at least partially integrated, wherein the weight ratio of said fibrinogen, thrombin and calcium salt to the ORC fibers ranges from about 1:1 to about 10:1, and wherein said ORC fibers are not per se neutralized by said buffering agent until said buffering agent is dissolved.

### Claim 2 (depends on 1)

The method of claim 1, wherein said non-aqueous low boiling solvent comprises Hydrofluoroether.

### Claim 3 (depends on 1)

The method of claim 1, wherein said buffering agent comprises Tris.

### Claim 4 (depends on 1)

The method of claim 1, wherein said calcium salt comprises calcium chloride.

### Claim 5 (depends on 1)

The method of claim 1, wherein said powdered hemostatic composition comprises powder having a particle size in the range from about 250 to about 850 microns.

### Claim 6 (depends on 5)

The method of claim 5, wherein said powdered hemostatic composition comprises powder having a particle size in the range from about 355 to about 850 microns.