AU2013261308B2 - Sterilized composition - Google Patents

Sterilized composition Download PDF

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Publication number
AU2013261308B2
AU2013261308B2 AU2013261308A AU2013261308A AU2013261308B2 AU 2013261308 B2 AU2013261308 B2 AU 2013261308B2 AU 2013261308 A AU2013261308 A AU 2013261308A AU 2013261308 A AU2013261308 A AU 2013261308A AU 2013261308 B2 AU2013261308 B2 AU 2013261308B2
Authority
AU
Australia
Prior art keywords
protein
activity
thrombin
aliphatic polyester
particles
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
AU2013261308A
Other languages
English (en)
Other versions
AU2013261308A1 (en
Inventor
Kentaro Fujinaga
Susumu Honda
Ayumi ISHIWARI
Yukako Kageyama
Hiroaki Kaneko
Makoto Satake
Ayuko YAMAGUCHI
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Teijin Ltd
KM Biologics Co Ltd
Original Assignee
Teijin Ltd
KM Biologics Co 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 Teijin Ltd, KM Biologics Co Ltd filed Critical Teijin Ltd
Publication of AU2013261308A1 publication Critical patent/AU2013261308A1/en
Application granted granted Critical
Publication of AU2013261308B2 publication Critical patent/AU2013261308B2/en
Assigned to TEIJIN LIMITED, TEIJIN PHARMA LIMITED, KM BIOLOGICS CO., LTD. reassignment TEIJIN LIMITED Request for Assignment Assignors: TEIJIN LIMITED, TEIJIN PHARMA LIMITED, THE CHEMO-SERO-THERAPEUTIC RESEARCH INSTITUTE
Assigned to TEIJIN LIMITED, KM BIOLOGICS CO., LTD. reassignment TEIJIN LIMITED Request for Assignment Assignors: KM BIOLOGICS CO., LTD., TEIJIN LIMITED, TEIJIN PHARMA LIMITED
Ceased legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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)
  • Public Health (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (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)
  • Hematology (AREA)
  • Wood Science & Technology (AREA)
  • General Engineering & Computer Science (AREA)
  • Genetics & Genomics (AREA)
  • Neurosurgery (AREA)
  • Dermatology (AREA)
  • Biomedical Technology (AREA)
  • Inorganic Chemistry (AREA)
  • Diabetes (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Materials Engineering (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Materials For Medical Uses (AREA)
  • Moulding By Coating Moulds (AREA)
  • Peptides Or Proteins (AREA)
  • Compositions Of Macromolecular Compounds (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)
AU2013261308A 2012-05-14 2013-05-13 Sterilized composition Ceased AU2013261308B2 (en)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
JP2012110765 2012-05-14
JP2012-110765 2012-05-14
JP2012-110390 2012-05-14
JP2012110390 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 (2)

Publication Number Publication Date
AU2013261308A1 AU2013261308A1 (en) 2014-12-04
AU2013261308B2 true AU2013261308B2 (en) 2018-02-08

Family

ID=49583866

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2013261308A Ceased AU2013261308B2 (en) 2012-05-14 2013-05-13 Sterilized composition

Country Status (17)

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

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
GB2535666B (en) 2014-04-30 2017-03-29 Matoke Holdings Ltd Antimicrobial compositions
CA2975197A1 (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

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH05221855A (ja) * 1991-07-22 1993-08-31 Debio Rech Pharmaceut Sa 生分解性高分子物質の微小球の製造方法
US5730933A (en) * 1996-04-16 1998-03-24 Depuy Orthopaedics, Inc. Radiation sterilization of biologically active compounds
WO2000033893A1 (en) * 1998-12-07 2000-06-15 Johnson & Johnson Medical Limited Sterile complex of therapeutic peptide bond to a polysaccharide
JP2010506965A (ja) * 2006-10-11 2010-03-04 キューエルティー ユーエスエー，インコーポレイテッド． 超臨界流体抽出による低バースト特性の生分解性ポリエステルの調製
WO2010079047A2 (en) * 2008-12-15 2010-07-15 Novartis Ag Octreotide depot formulation with constantly high exposure levels
JP2011047089A (ja) * 2009-08-28 2011-03-10 Japan Vilene Co Ltd 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
WO2011146359A1 (en) * 2010-05-17 2011-11-24 Ethicon, Inc. Reinforced absorbable synthetic matrix for hemostatic applications

Family Cites Families (15)

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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 (enExample) * 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
MX9203083A (es) 1991-06-21 1994-08-31 Genetics Inst Formulaciones farmaceuticas de proteinas osteogenicas.
GB9206509D0 (en) 1992-03-25 1992-05-06 Jevco Ltd Heteromorphic sponges containing active agents
US5945128A (en) 1996-09-04 1999-08-31 Romano Deghenghi Process to manufacture implants containing bioactive peptides
US8076448B2 (en) 2006-10-11 2011-12-13 Tolmar Therapeutics, Inc. Preparation of biodegradable polyesters with low-burst properties by supercritical fluid extraction
CA2695288A1 (en) * 2007-08-01 2009-02-05 Ethicon, Inc. Collagen-related peptides and uses thereof
KR20140090704A (ko) * 2009-03-10 2014-07-17 메드프린 리제너레이티브 메디컬 테크놀러지스 컴퍼니 리미티드 인공 경질막 및 인공 경질막의 제조방법
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
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Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH05221855A (ja) * 1991-07-22 1993-08-31 Debio Rech Pharmaceut Sa 生分解性高分子物質の微小球の製造方法
US5730933A (en) * 1996-04-16 1998-03-24 Depuy Orthopaedics, Inc. Radiation sterilization of biologically active compounds
WO2000033893A1 (en) * 1998-12-07 2000-06-15 Johnson & Johnson Medical Limited Sterile complex of therapeutic peptide bond to a polysaccharide
JP2010506965A (ja) * 2006-10-11 2010-03-04 キューエルティー ユーエスエー，インコーポレイテッド． 超臨界流体抽出による低バースト特性の生分解性ポリエステルの調製
WO2010079047A2 (en) * 2008-12-15 2010-07-15 Novartis Ag Octreotide depot formulation with constantly high exposure levels
JP2011047089A (ja) * 2009-08-28 2011-03-10 Japan Vilene Co Ltd 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
WO2011146359A1 (en) * 2010-05-17 2011-11-24 Ethicon, Inc. Reinforced absorbable synthetic matrix for hemostatic applications

Non-Patent Citations (3)

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Title
GAMBOA-MARTINEZ et al. "Fibrin coating on poly (L-lactide) scaffolds for tissue engineering", Journal of Bioactive and Compatible Polymers, 2011, 0(0): 1-14 *
HO, S.T. et al., "The Evaluation of a Biphasic Osteochondral Implant Coupled with an Electrospun Membrane in a Large Animal Model", Tissue Engineering: Part A, 2010, Volume 16, Number 4, pages 1123-1141 *
JAIN, S. et al: "A two-stage strategy for sterilization of poly(lactide-coglycolide) particles by irradiation does not impair their potency for vaccine delivery", J. Pharmaceutical Sciences, vol. 100, no. 2, February 2011, pages 646-654 *

Also Published As

Publication number Publication date
CN104284673B (zh) 2018-02-13
BR112014028443A8 (pt) 2018-02-06
EP2851085B1 (en) 2019-06-26
AU2013261308A1 (en) 2014-12-04
US20150125511A1 (en) 2015-05-07
HK1204947A1 (en) 2015-12-11
TW201350147A (zh) 2013-12-16
CA2873602A1 (en) 2013-11-21
RU2695522C2 (ru) 2019-07-23
JPWO2013172468A1 (ja) 2016-01-12
EP2851085A1 (en) 2015-03-25
KR102037555B1 (ko) 2019-10-28
ES2746300T3 (es) 2020-03-05
IN2014DN09621A (enExample) 2015-07-31
EP2851085A4 (en) 2015-04-15
MX356545B (es) 2018-06-01
KR20150023253A (ko) 2015-03-05
PT2851085T (pt) 2019-10-11
DK2851085T3 (da) 2019-09-09
MX2014013818A (es) 2015-05-11
TWI636799B (zh) 2018-10-01
BR112014028443B1 (pt) 2021-01-19
JP5746430B2 (ja) 2015-07-08
CN104284673A (zh) 2015-01-14
PL2851085T3 (pl) 2019-12-31
CA2873602C (en) 2022-08-16
WO2013172468A1 (ja) 2013-11-21
RU2014150498A (ru) 2016-07-10
BR112014028443A2 (pt) 2017-06-27
US10071061B2 (en) 2018-09-11

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FGA Letters patent sealed or granted (standard patent)
PC Assignment registered

Owner name: TEIJIN LIMITED

Free format text: FORMER OWNER(S): TEIJIN PHARMA LIMITED; THE CHEMO-SERO-THERAPEUTIC RESEARCH INSTITUTE; TEIJIN LIMITED

Owner name: KM BIOLOGICS CO., LTD.

Free format text: FORMER OWNER(S): TEIJIN PHARMA LIMITED; THE CHEMO-SERO-THERAPEUTIC RESEARCH INSTITUTE; TEIJIN LIMITED

Owner name: TEIJIN PHARMA LIMITED

Free format text: FORMER OWNER(S): TEIJIN PHARMA LIMITED; THE CHEMO-SERO-THERAPEUTIC RESEARCH INSTITUTE; TEIJIN LIMITED

PC Assignment registered

Owner name: KM BIOLOGICS CO., LTD.

Free format text: FORMER OWNER(S): TEIJIN LIMITED; KM BIOLOGICS CO., LTD.; TEIJIN PHARMA LIMITED

Owner name: TEIJIN LIMITED

Free format text: FORMER OWNER(S): TEIJIN LIMITED; KM BIOLOGICS CO., LTD.; TEIJIN PHARMA LIMITED

MK14 Patent ceased section 143(a) (annual fees not paid) or expired