BR112014028443B1 - composição estéril esterilizada com radiação - Google Patents

composição estéril esterilizada com radiação Download PDF

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Publication number
BR112014028443B1
BR112014028443B1 BR112014028443-1A BR112014028443A BR112014028443B1 BR 112014028443 B1 BR112014028443 B1 BR 112014028443B1 BR 112014028443 A BR112014028443 A BR 112014028443A BR 112014028443 B1 BR112014028443 B1 BR 112014028443B1
Authority
BR
Brazil
Prior art keywords
protein
activity
thrombin
aliphatic polyester
sterile composition
Prior art date
Application number
BR112014028443-1A
Other languages
English (en)
Portuguese (pt)
Other versions
BR112014028443A8 (pt
BR112014028443A2 (pt
Inventor
Yukako Kageyama
Kentaro Fujinaga
Ayuko Yamaguchi
Susumu Honda
Makoto Satake
Hiroaki Kaneko
Ayumi Ishiwari
Original Assignee
Teijin Limited
Teijin Pharma Limited
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 Teijin Limited, Teijin Pharma Limited filed Critical Teijin Limited
Publication of BR112014028443A2 publication Critical patent/BR112014028443A2/pt
Publication of BR112014028443A8 publication Critical patent/BR112014028443A8/pt
Publication of BR112014028443B1 publication Critical patent/BR112014028443B1/pt

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    • 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)
    • 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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • 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
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36—Blood coagulation or fibrinolysis factors
    • A61K38/363—Fibrinogen
    • 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)
    • A61K38/465—Hydrolases (3) acting on ester bonds (3.1), e.g. lipases, ribonucleases
    • 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)
    • A61K38/47—Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0024—Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42—Use of materials characterised by their function or physical properties
    • A61L15/44—Medicaments
    • 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
    • C12Y—ENZYMES
    • C12Y302/00—Hydrolases acting on glycosyl compounds, i.e. glycosylases (3.2)
    • C12Y302/01—Glycosidases, i.e. enzymes hydrolysing O- and S-glycosyl compounds (3.2.1)
    • C12Y302/01021—Beta-glucosidase (3.2.1.21)
    • 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)
    • 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
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y301/00—Hydrolases acting on ester bonds (3.1)
    • C12Y301/01—Carboxylic ester hydrolases (3.1.1)
    • C12Y301/01003—Triacylglycerol lipase (3.1.1.3)

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Organic Chemistry (AREA)
  • Zoology (AREA)
  • Biochemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Genetics & Genomics (AREA)
  • Wood Science & Technology (AREA)
  • Hematology (AREA)
  • Dermatology (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Inorganic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Materials Engineering (AREA)
  • Diabetes (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Materials For Medical Uses (AREA)
  • Moulding By Coating Moulds (AREA)
  • Compositions Of Macromolecular Compounds (AREA)
  • Peptides Or Proteins (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)
BR112014028443-1A 2012-05-14 2013-05-13 composição estéril esterilizada com radiação BR112014028443B1 (pt)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
JP2012-110765 2012-05-14
JP2012110390 2012-05-14
JP2012110765 2012-05-14
JP2012-110390 2012-05-14
JP2013040593 2013-03-01
JP2013-040593 2013-03-01
PCT/JP2013/063868 WO2013172468A1 (ja) 2012-05-14 2013-05-13 滅菌組成物

Publications (3)

Publication Number Publication Date
BR112014028443A2 BR112014028443A2 (pt) 2017-06-27
BR112014028443A8 BR112014028443A8 (pt) 2018-02-06
BR112014028443B1 true BR112014028443B1 (pt) 2021-01-19

Family

ID=49583866

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112014028443-1A BR112014028443B1 (pt) 2012-05-14 2013-05-13 composição estéril esterilizada com radiação

Country Status (17)

Country Link
US (1) US10071061B2 (cg-RX-API-DMAC7.html)
EP (1) EP2851085B1 (cg-RX-API-DMAC7.html)
JP (1) JP5746430B2 (cg-RX-API-DMAC7.html)
KR (1) KR102037555B1 (cg-RX-API-DMAC7.html)
CN (1) CN104284673B (cg-RX-API-DMAC7.html)
AU (1) AU2013261308B2 (cg-RX-API-DMAC7.html)
BR (1) BR112014028443B1 (cg-RX-API-DMAC7.html)
CA (1) CA2873602C (cg-RX-API-DMAC7.html)
DK (1) DK2851085T3 (cg-RX-API-DMAC7.html)
ES (1) ES2746300T3 (cg-RX-API-DMAC7.html)
IN (1) IN2014DN09621A (cg-RX-API-DMAC7.html)
MX (1) MX356545B (cg-RX-API-DMAC7.html)
PL (1) PL2851085T3 (cg-RX-API-DMAC7.html)
PT (1) PT2851085T (cg-RX-API-DMAC7.html)
RU (1) RU2695522C2 (cg-RX-API-DMAC7.html)
TW (1) TWI636799B (cg-RX-API-DMAC7.html)
WO (1) WO2013172468A1 (cg-RX-API-DMAC7.html)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP5844894B2 (ja) * 2012-05-14 2016-01-20 帝人株式会社 シート成形体および止血材
GB2540054B (en) 2014-04-30 2017-07-12 Matoke Holdings Ltd Antimicrobial compositions
WO2016124926A1 (en) * 2015-02-03 2016-08-11 Matoke Holdings Limited Antimicrobial fibers and compositions
FR3036707B1 (fr) * 2015-05-29 2019-05-17 Maco Pharma Procede de sterilisation d'un lysat plaquettaire
GB201716986D0 (en) 2017-10-16 2017-11-29 Matoke Holdings Ltd Antimicrobial compositions
EP3919022B1 (en) 2019-01-31 2025-06-11 Cell-Medicine, Inc. Inorganic salt-protein composite medical instrument

Family Cites Families (22)

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Publication number Priority date Publication date Assignee Title
GB2209937B (en) * 1987-09-21 1991-07-03 Depiopharm S A Water insoluble polypeptides
JPH0622570B2 (ja) * 1989-01-31 1994-03-30 多木化学株式会社 生体材料
US5225205A (en) 1989-07-28 1993-07-06 Debiopharm S.A. Pharmaceutical composition in the form of microparticles
CH679207A5 (cg-RX-API-DMAC7.html) * 1989-07-28 1992-01-15 Debiopharm Sa
US5439688A (en) 1989-07-28 1995-08-08 Debio Recherche Pharmaceutique S.A. Process for preparing a pharmaceutical composition
CA2033046C (en) 1990-01-12 1999-08-03 Lowell Saferstein Process for preparing a neutralized oxidized cellulose product and its method of use
CA2111199C (en) * 1991-06-21 2008-08-05 Eyal Ron Pharmaceutical formulations of osteogenic proteins
CH683149A5 (fr) 1991-07-22 1994-01-31 Debio Rech Pharma Sa Procédé pour la préparation de microsphères en matériau polymère biodégradable.
GB9206509D0 (en) 1992-03-25 1992-05-06 Jevco Ltd Heteromorphic sponges containing active agents
US5730933A (en) 1996-04-16 1998-03-24 Depuy Orthopaedics, Inc. Radiation sterilization of biologically active compounds
US5945128A (en) 1996-09-04 1999-08-31 Romano Deghenghi Process to manufacture implants containing bioactive peptides
GB2344519B (en) 1998-12-07 2004-05-19 Johnson & Johnson Medical Ltd Sterile therapeutic compositions
SI2079767T1 (sl) * 2006-10-11 2015-01-30 Tolmar Therapeutics, Inc. Priprava biorazgradljivih poliestrov, ki imajo lastnost majhnega izbruha, s superkritično tekočinsko ekstrakcijo
US8076448B2 (en) 2006-10-11 2011-12-13 Tolmar Therapeutics, Inc. Preparation of biodegradable polyesters with low-burst properties by supercritical fluid extraction
KR20100052499A (ko) * 2007-08-01 2010-05-19 에디컨인코포레이티드 콜라겐-관련 펩티드 및 이의 용도
AR074603A1 (es) 2008-12-15 2011-01-26 Novartis Ag Formulacion de deposito de octreotida con niveles de exposicion constantemente altos.uso. metodo. kit
KR20140090704A (ko) * 2009-03-10 2014-07-17 메드프린 리제너레이티브 메디컬 테크놀러지스 컴퍼니 리미티드 인공 경질막 및 인공 경질막의 제조방법
JP5555928B2 (ja) 2009-08-28 2014-07-23 日本バイリーン株式会社 酵素含有ナノファイバーの製造方法、酵素含有ナノファイバー、この酵素含有ナノファイバーを含む不織布及びこの不織布を用いた反応装置
WO2011138974A1 (ja) * 2010-05-07 2011-11-10 帝人株式会社 生体糊用補強材及びその製造方法
US8273369B2 (en) 2010-05-17 2012-09-25 Ethicon, Inc. Reinforced absorbable synthetic matrix for hemostatic applications
KR101967085B1 (ko) * 2010-06-01 2019-04-08 백스터 인터내셔널 인코포레이티드 건조 및 안정한 지혈 조성물의 제조 방법
JP5792442B2 (ja) * 2010-09-01 2015-10-14 帝人株式会社 細胞特異的ペプチドを含有する繊維構造体

Also Published As

Publication number Publication date
WO2013172468A1 (ja) 2013-11-21
PL2851085T3 (pl) 2019-12-31
US10071061B2 (en) 2018-09-11
TW201350147A (zh) 2013-12-16
KR20150023253A (ko) 2015-03-05
MX2014013818A (es) 2015-05-11
RU2695522C2 (ru) 2019-07-23
AU2013261308B2 (en) 2018-02-08
CA2873602A1 (en) 2013-11-21
EP2851085B1 (en) 2019-06-26
JP5746430B2 (ja) 2015-07-08
MX356545B (es) 2018-06-01
BR112014028443A8 (pt) 2018-02-06
HK1204947A1 (en) 2015-12-11
JPWO2013172468A1 (ja) 2016-01-12
EP2851085A1 (en) 2015-03-25
AU2013261308A1 (en) 2014-12-04
EP2851085A4 (en) 2015-04-15
BR112014028443A2 (pt) 2017-06-27
IN2014DN09621A (cg-RX-API-DMAC7.html) 2015-07-31
CA2873602C (en) 2022-08-16
ES2746300T3 (es) 2020-03-05
RU2014150498A (ru) 2016-07-10
KR102037555B1 (ko) 2019-10-28
CN104284673B (zh) 2018-02-13
PT2851085T (pt) 2019-10-11
TWI636799B (zh) 2018-10-01
DK2851085T3 (da) 2019-09-09
US20150125511A1 (en) 2015-05-07
CN104284673A (zh) 2015-01-14

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Legal Events

Date Code Title Description
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B25A Requested transfer of rights approved

Owner name: TEIJIN LIMITED (JP) , TEIJIN PHARMA LIMITED (JP)

B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B06I Publication of requirement cancelled [chapter 6.9 patent gazette]

Free format text: ANULADA A PUBLICACAO CODIGO 6.6.1 NA RPI NO 2462 DE 13/03/2018 POR TER SIDO INDEVIDA.

B07G Grant request does not fulfill article 229-c lpi (prior consent of anvisa) [chapter 7.7 patent gazette]

Free format text: NOTIFICACAO DE DEVOLUCAO DO PEDIDO POR NAO SE ENQUADRAR NO ART. 229-C DA LPI.

B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 13/05/2013, OBSERVADAS AS CONDICOES LEGAIS.

B25G Requested change of headquarter approved

Owner name: TEIJIN PHARMA LIMITED (JP) ; TEIJIN LIMITED (JP)

B25A Requested transfer of rights approved

Owner name: TEIJIN LIMITED (JP)

B21F Lapse acc. art. 78, item iv - on non-payment of the annual fees in time

Free format text: REFERENTE A 12A ANUIDADE.

B24J Lapse because of non-payment of annual fees (definitively: art 78 iv lpi, resolution 113/2013 art. 12)

Free format text: EM VIRTUDE DA EXTINCAO PUBLICADA NA RPI 2827 DE 11-03-2025 E CONSIDERANDO AUSENCIA DE MANIFESTACAO DENTRO DOS PRAZOS LEGAIS, INFORMO QUE CABE SER MANTIDA A EXTINCAO DA PATENTE E SEUS CERTIFICADOS, CONFORME O DISPOSTO NO ARTIGO 12, DA RESOLUCAO 113/2013.