# US 10,869,912 B2 · Thrombin microcapsules, preparation and uses thereof

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- Number: US 10,869,912 B2
- Document ID: US10869912B2
- Status: Granted
- Kind: B2
- Application number: 16/184,321
- Filed: 2018-11-08
- Published: 2019-03-07
- Granted: 2020-12-22
- Earliest claimed: 2015-10-29
- Assignees: Omrix Biopharmaceuticals Ltd.
- Applicants: Omrix Biopharmaceuticals Ltd.
- Inventors: Erez Ilan; Assaf Gershonovitch; Rivka Kaufman
- Web page: https://patentgrep.com/patent/US10869912B2

## CPC

- A61K 38/4833: {Thrombin (3.4.21.5)}
- 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 9/1617: {Organic compounds, e.g. phospholipids, fats}
- A61K 9/1623: {Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules}
- A61K 9/1658: {Proteins, e.g. albumin, gelatin}
- A61K 9/1682: {Processes}
- A61K 9/1688: {resulting in pure drug agglomerate optionally containing up to 5% of excipient}
- A61K 9/1694: {resulting in granules or microspheres of the matrix type containing more than 5% of excipient}
- A61K 38/363: {Fibrinogen}
- C12Y 304/21005: Thrombin (3.4.21.5)
- 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)
- C12Y: ENZYMES

## Abstract

Provided are spray-dried thrombin powders comprising microcapsules, methods of preparation and uses thereof.

## Claims

### Claim 1

A method for preparing thrombin microcapsules, the method comprising the step of:
a) spray drying an aqueous solution comprising:
i) thrombin at a concentration ranging from 100 to 3000 IU/ml,
ii) a carrier protein at a concentration ranging from 0.6 to 60 mg/ml and
iii) a carbohydrate at a concentration ranging from 2 to 200 mg/ml,
wherein said spray drying comprises producing droplets from the solution, and evaporating water from the droplets, wherein said evaporating is carried out by a drying gas and comprises heating said gas to a temperature ranging from about 100 to 170° C., thereby obtaining the thrombin microcapsules; and
b) cooling the thrombin microcapsules by exposure to a cold gas flow.

### Claim 2 (depends on 1)

The method according to claim 1, wherein said drying gas is set to a flow rate of 0.1 to about 1.0 m3/min.

### Claim 3 (depends on 2)

The method according to claim 2, wherein said setting and said heating are carried out sequentially.

### Claim 4 (depends on 2)

The method according to claim 2, wherein said drying gas flow rate is set from about 0.3 to about 0.6 m3/min.