BRPI0504445A - composição de trombina e processo para a sua preparação - Google Patents

composição de trombina e processo para a sua preparação

Info

Publication number
BRPI0504445A
BRPI0504445A BRPI0504445-6A BRPI0504445A BRPI0504445A BR PI0504445 A BRPI0504445 A BR PI0504445A BR PI0504445 A BRPI0504445 A BR PI0504445A BR PI0504445 A BRPI0504445 A BR PI0504445A
Authority
BR
Brazil
Prior art keywords
preparation
thrombin
thrombin composition
stable
composition
Prior art date
Application number
BRPI0504445-6A
Other languages
English (en)
Inventor
Juan Ignacio Jorquera Nieto
Pere Ristol Debart
Jesus Fernandez Rodriguez
Isabel Bravo Camison
Rafael Lopez Gomez
Original Assignee
Grifols Sa
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=34384852&utm_source=***_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BRPI0504445(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Grifols Sa filed Critical Grifols Sa
Publication of BRPI0504445A publication Critical patent/BRPI0504445A/pt

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
    • 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)
    • 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
    • A61K47/02—Inorganic compounds
    • 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

Landscapes

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

Abstract

"COMPOSIçãO DE TROMBINA E PROCESSO PARA A SUA PREPARAçãO". Uma composição de trombina estável compreende trombina purificada, albumina humana e um sal neutro, sendo o produto resultante estável quando armazenado como um liofilizado ou congelado e é ajustado para uma intensidade nominal de 500 IU de trombina, ou mais, por ml de solução, estando a albumina humana em uma concentração de mais que 0,05% (p/v) e, preferentemente, entre 0,1% (p/v) e 1% (p/v).
BRPI0504445-6A 2004-10-22 2005-10-21 composição de trombina e processo para a sua preparação BRPI0504445A (pt)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
ES200402523A ES2226587B1 (es) 2004-10-22 2004-10-22 Composicion de trombina estable.

Publications (1)

Publication Number Publication Date
BRPI0504445A true BRPI0504445A (pt) 2006-06-27

Family

ID=34384852

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0504445-6A BRPI0504445A (pt) 2004-10-22 2005-10-21 composição de trombina e processo para a sua preparação

Country Status (14)

Country Link
US (2) US20060088518A1 (pt)
EP (1) EP1649867B8 (pt)
JP (1) JP5105734B2 (pt)
AR (1) AR051396A1 (pt)
AU (1) AU2005225085B2 (pt)
BR (1) BRPI0504445A (pt)
CA (1) CA2523844C (pt)
ES (2) ES2226587B1 (pt)
HU (1) HUE052760T2 (pt)
MX (1) MXPA05011283A (pt)
NZ (1) NZ543084A (pt)
PL (1) PL1649867T3 (pt)
PT (1) PT1649867T (pt)
UY (1) UY29172A1 (pt)

Families Citing this family (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2775974T3 (es) * 2006-06-26 2020-07-28 Omrix Biopharmaceuticals Inc Eliminación de virus por nanofiltración
EP2259803B2 (en) 2008-02-29 2019-03-13 Ferrosan Medical Devices A/S Device for promotion of hemostasis and/or wound healing
EP2269594B1 (en) 2008-04-16 2016-03-02 The Chemo-Sero-Therapeutic Research Institute Method of producing thrombin-immobilized bioabsorbable sheet preparation
AU2011260274B2 (en) 2010-06-01 2015-07-02 Baxter Healthcare S.A. Process for making dry and stable hemostatic compositions
CN103037847B (zh) 2010-06-01 2016-01-20 巴克斯特国际公司 用于制备干燥、稳定的止血组合物的方法
MX345479B (es) 2010-06-01 2017-02-01 Baxter Int Inc * Proceso para elaborar composiciones hemostaticas secas y estables.
US11109849B2 (en) 2012-03-06 2021-09-07 Ferrosan Medical Devices A/S Pressurized container containing haemostatic paste
EP2977066A3 (en) 2012-06-12 2016-07-27 Ferrosan Medical Devices A/S Dry haemostatic composition
US9149529B2 (en) 2012-10-24 2015-10-06 Orthovita, Inc. Stable compositions containing thrombin and methods for preparation and use thereof
US9212357B2 (en) 2012-12-03 2015-12-15 Omrix Biopharmaceuticals Ltd. Thrombin solution and methods of use thereof
IL277033B2 (en) * 2012-12-03 2024-05-01 Omrix Biopharmaceuticals Ltd Thrombin solution and methods of using it
US9724078B2 (en) 2013-06-21 2017-08-08 Ferrosan Medical Devices A/S Vacuum expanded dry composition and syringe for retaining same
US10111980B2 (en) 2013-12-11 2018-10-30 Ferrosan Medical Devices A/S Dry composition comprising an extrusion enhancer
CN106999621B (zh) 2014-10-13 2020-07-03 弗罗桑医疗设备公司 用于止血和伤口愈合的干组合物
WO2016102446A1 (en) 2014-12-24 2016-06-30 Ferrosan Medical Devices A/S Syringe for retaining and mixing first and second substances
TW201702385A (zh) * 2015-03-13 2017-01-16 崇謹 孫 穩定凝血酶之方法及其組合物
US10918796B2 (en) 2015-07-03 2021-02-16 Ferrosan Medical Devices A/S Syringe for mixing two components and for retaining a vacuum in a storage condition
AU2019266529B2 (en) 2018-05-09 2024-05-23 Ethicon Inc. Method for preparing a haemostatic composition
WO2023115427A1 (en) 2021-12-23 2023-06-29 Guangzhou Bioseal Biotech Co., Ltd. Spray dried thrombin
US20230210958A1 (en) 2021-12-30 2023-07-06 Baxter International Inc. Fibrinogen and thrombin solutions for a fibrin sealant and fibrin sealant kit

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5639782A (en) * 1979-09-04 1981-04-15 Dai Ichi Pure Chem Co Ltd Stabilization of thrombin
US4696812A (en) * 1985-10-28 1987-09-29 Warner-Lambert Company Thrombin preparations
JPS63243032A (ja) * 1987-03-27 1988-10-07 Green Cross Corp:The トロンビンの加熱処理方法
JPH0813750B2 (ja) * 1990-03-01 1996-02-14 持田製薬株式会社 経口用トロンビン製剤
FR2679251B1 (fr) * 1991-07-18 1993-11-12 Nord Assoc Essor Transfusion San Procede de preparation d'un concentre de thrombine humaine destine a un usage therapeutique.
JP3404038B2 (ja) * 1991-12-31 2003-05-06 ザイモジェネティクス，インコーポレイティド トロンビンの製造方法
US5506127A (en) * 1994-09-21 1996-04-09 Proba; Zbigniew Therapeutic grade thrombin produced by chromatography
GB9503750D0 (en) * 1995-02-24 1995-04-12 Common Services Agency Thrombin preparation
JPH10215875A (ja) * 1997-02-06 1998-08-18 Mitsubishi Chem Corp 蛋白質の精製方法
US5981254A (en) * 1997-10-30 1999-11-09 Haemacure Corporation Process for producing thrombin from plasma
WO2001023536A1 (fr) * 1999-09-27 2001-04-05 International Reagents Corporation Stabilisation de la thrombine et compositions
DE10022092A1 (de) * 2000-05-08 2001-11-15 Aventis Behring Gmbh Stabilisiertes Protein-Präparat und Verfahren zu seiner Herstellung

Also Published As

Publication number Publication date
EP1649867A1 (en) 2006-04-26
JP2006117678A (ja) 2006-05-11
AR051396A1 (es) 2007-01-10
AU2005225085B2 (en) 2007-05-31
CA2523844A1 (en) 2006-04-22
EP1649867B1 (en) 2020-11-25
PT1649867T (pt) 2021-02-03
CA2523844C (en) 2012-06-19
AU2005225085A1 (en) 2006-05-11
EP1649867B8 (en) 2021-09-08
HUE052760T2 (hu) 2021-05-28
ES2226587B1 (es) 2005-12-16
US20060088518A1 (en) 2006-04-27
MXPA05011283A (es) 2006-05-25
US9376674B2 (en) 2016-06-28
NZ543084A (en) 2007-03-30
JP5105734B2 (ja) 2012-12-26
UY29172A1 (es) 2006-04-28
PL1649867T3 (pl) 2021-06-14
ES2845143T3 (es) 2021-07-26
ES2226587A1 (es) 2005-03-16
ES2845143T8 (es) 2021-11-17
US20140322791A1 (en) 2014-10-30

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Legal Events

Date Code Title Description
B25G Requested change of headquarter approved

Owner name: GRIFOLS, S.A. (ES)

B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B07A Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]
B09B Patent application refused [chapter 9.2 patent gazette]
B12B Appeal against refusal [chapter 12.2 patent gazette]
B15W Others matters related to applications: legal action concerning application

Free format text: INPI NO 52402.009734/2020-87 ORIGEM: JUIZO FEDERAL DA 9A VF DO RIO DE JANEIRO (TRF2) PROCESSO NO: 00408.055151/2020-74 (REF. 5046129-08.2020.4.02.5101) NULIDADE DO ATO ADMINISTRATIVO QUE MANTEVE O INDEFERIMENTO DO PEDIDO DE PATENTE AUTOR: GRIFOLS S.A. REU(S): INSTITUTO NACIONAL DA PROPRIEDADE INDUSTRIAL ? INPI