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IL277033B2 - Thrombin solution and methods of use thereof - Google Patents

Thrombin solution and methods of use thereof

Info

Publication number
IL277033B2
IL277033B2 IL277033A IL27703320A IL277033B2 IL 277033 B2 IL277033 B2 IL 277033B2 IL 277033 A IL277033 A IL 277033A IL 27703320 A IL27703320 A IL 27703320A IL 277033 B2 IL277033 B2 IL 277033B2
Authority
IL
Israel
Prior art keywords
composition
total weight
concentration
solid
thrombin
Prior art date
Application number
IL277033A
Other languages
Hebrew (he)
Other versions
IL277033B1 (en
IL277033A (en
Original Assignee
Omrix Biopharmaceuticals Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Omrix Biopharmaceuticals Ltd filed Critical Omrix Biopharmaceuticals Ltd
Priority claimed from PCT/IL2013/000088 external-priority patent/WO2014087394A1/en
Publication of IL277033A publication Critical patent/IL277033A/en
Publication of IL277033B1 publication Critical patent/IL277033B1/en
Publication of IL277033B2 publication Critical patent/IL277033B2/en

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/96—Stabilising an enzyme by forming an adduct or a composition; Forming enzyme conjugates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/482—Serine endopeptidases (3.4.21)
    • A61K38/4833—Thrombin (3.4.21.5)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14—Hydrolases (3)
    • C12N9/48—Hydrolases (3) acting on peptide bonds (3.4)
    • C12N9/50—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25)
    • C12N9/64—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue
    • C12N9/6421—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue from mammals
    • C12N9/6424—Serine endopeptidases (3.4.21)
    • C12N9/6429—Thrombin (3.4.21.5)
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/21—Serine endopeptidases (3.4.21)
    • C12Y304/21005—Thrombin (3.4.21.5)

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Wood Science & Technology (AREA)
  • Genetics & Genomics (AREA)
  • Zoology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biochemistry (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • General Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Biotechnology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Microbiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Inorganic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Hematology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Diabetes (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Enzymes And Modification Thereof (AREA)

Claims (11)

29 277033/ CLAIMS:
1. A solid thrombin composition comprising: (i) thrombin; (ii) mannitol at a concentration of about 19.5% to about 78%, by total weight of the composition; (iii) sodium acetate at a concentration of about 1% to about 20%, by total weight of the composition; (iv) albumin at a concentration of about 2% to about 53%, by total weight of the total composition; (v) calcium chloride at a concentration of about 2.5% to about 31%, by total weight of the composition; and (vi) sodium chloride at a concentration of about 6% to about 45%, by total weight of the composition, wherein the solid composition has water content of less than 3%, by total weight of the composition, and wherein the solid composition is in a form of a sponge-like monolithic block having uniform porosity throughout the solid composition and comprising about 200 to about 2000 IU/cm thrombin.
2. The solid composition of claim, comprising about 22% to about 66% mannitol, by total weight of the composition.
3. The solid composition of claim or 2, comprising about 1.5% to about 10% sodium acetate, by total weight of the composition.
4. The solid composition of any one of claims 1 to 3, comprising about 2.5% to about 43% albumin, by total weight of the composition.
5. The solid composition of any one of claims 1 to 4, comprising about 4% to about 17% calcium chloride, by total weight of the composition.
6. The solid composition of any one of claims 1 to 5, comprising about 9.5% to about 25% sodium chloride, by total weight of the composition.
7. The solid composition of any one of claims 1 to 6, comprising mannitol at a concentration of about 22% to about 66%, by total weight of the composition, sodium acetate at a concentration of about 1.5% to about 10% by total weight of the composition; albumin at a concentration of about 2.5% to about 43%, by total weight of the composition; calcium chloride at a concentration of about 4% to about 17%, by total weight of the composition, and sodium chloride at a concentration of about 9.5% to about 25%, by total weight of the composition. 30 277033/
8. The solid composition of any one of claims 1 to 7, having thrombin activity recovery of at least 95%.
9. The solid thrombin composition of any one of claims 1 to 8, having a water content of not more than about 1.5% (w/w) and a thrombin activity recovery of at least 98%.
10. The solid composition of any one of claims 1 to 9, being stable for at least 2 years under non-freezing storage conditions.
11. The solid composition of any one of claims 1 to 10, being stable for at least years at room temperature.
IL277033A 2012-12-03 2013-11-28 Thrombin solution and methods of use thereof IL277033B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IL22339612 2012-12-03
US201361753542P 2013-01-17 2013-01-17
PCT/IL2013/000088 WO2014087394A1 (en) 2012-12-03 2013-11-28 Thrombin solution and methods of use thereof

Publications (3)

Publication Number Publication Date
IL277033A IL277033A (en) 2020-10-29
IL277033B1 IL277033B1 (en) 2024-01-01
IL277033B2 true IL277033B2 (en) 2024-05-01

Family

ID=67068240

Family Applications (1)

Application Number Title Priority Date Filing Date
IL277033A IL277033B2 (en) 2012-12-03 2013-11-28 Thrombin solution and methods of use thereof

Country Status (4)

Country Link
KR (1) KR102223275B1 (en)
ES (1) ES2828498T3 (en)
IL (1) IL277033B2 (en)
NZ (1) NZ708737A (en)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1927658A1 (en) * 2004-06-22 2008-06-04 Zymogenetics, Inc. Thrombin compositions
US20110045034A1 (en) * 2008-03-03 2011-02-24 Israel Nur Gelatin Sponge Comprising an Active Ingredient, Its Preparation and Use
WO2012020412A2 (en) * 2010-08-12 2012-02-16 Omrix Biopharmaceuticals Ltd, Fibrin based scaffold, preparation and use thereof

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2226587B1 (en) * 2004-10-22 2005-12-16 Probitas Pharma, S.A. STABLE THROMBINE COMPOSITION.

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1927658A1 (en) * 2004-06-22 2008-06-04 Zymogenetics, Inc. Thrombin compositions
US20110045034A1 (en) * 2008-03-03 2011-02-24 Israel Nur Gelatin Sponge Comprising an Active Ingredient, Its Preparation and Use
WO2012020412A2 (en) * 2010-08-12 2012-02-16 Omrix Biopharmaceuticals Ltd, Fibrin based scaffold, preparation and use thereof

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
JOHNSON, ROBERT E., CAROL F. KIRCHHOFF, AND HENRY T. GAUD., MANNITOL–SUCROSE MIXTURES—VERSATILE FORMULATIONS FOR PROTEIN LYOPHILIZATION., 27 February 2002 (2002-02-27) *

Also Published As

Publication number Publication date
ES2828498T3 (en) 2021-05-26
NZ708737A (en) 2019-06-28
KR102223275B1 (en) 2021-03-09
IL277033B1 (en) 2024-01-01
KR20200039831A (en) 2020-04-16
IL277033A (en) 2020-10-29

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