WO2006138099A3 - Bone morphogenetic protein formulations - Google Patents

Bone morphogenetic protein formulations Download PDF

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Publication number
WO2006138099A3
WO2006138099A3 PCT/US2006/021754 US2006021754W WO2006138099A3 WO 2006138099 A3 WO2006138099 A3 WO 2006138099A3 US 2006021754 W US2006021754 W US 2006021754W WO 2006138099 A3 WO2006138099 A3 WO 2006138099A3
Authority
WO
WIPO (PCT)
Prior art keywords
formulations
bone morphogenetic
protein formulations
morphogenetic protein
protein
Prior art date
Application number
PCT/US2006/021754
Other languages
French (fr)
Other versions
WO2006138099A2 (en
Inventor
Tianhong Zhou
Chunlin Yang
Jeffery Charles Geesin
Aruna Nathan
Joseph J Hammer
Original Assignee
Ethicon Inc
Tianhong Zhou
Chunlin Yang
Jeffery Charles Geesin
Aruna Nathan
Joseph J Hammer
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 Ethicon Inc, Tianhong Zhou, Chunlin Yang, Jeffery Charles Geesin, Aruna Nathan, Joseph J Hammer filed Critical Ethicon Inc
Priority to CA002612332A priority Critical patent/CA2612332A1/en
Priority to EP06772164A priority patent/EP1904090A4/en
Priority to AU2006259768A priority patent/AU2006259768A1/en
Publication of WO2006138099A2 publication Critical patent/WO2006138099A2/en
Publication of WO2006138099A3 publication Critical patent/WO2006138099A3/en

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
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • 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
    • A61K38/18—Growth factors; Growth regulators
    • A61K38/1841—Transforming growth factor [TGF]
    • 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
    • A61K38/18—Growth factors; Growth regulators
    • A61K38/1875—Bone morphogenic factor; Osteogenins; Osteogenic factor; Bone-inducing factor
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • 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
    • 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
    • A61L17/00—Materials for surgical sutures or for ligaturing blood vessels ; Materials for prostheses or catheters
    • A61L17/005—Materials for surgical sutures or for ligaturing blood vessels ; Materials for prostheses or catheters containing a biologically active substance, e.g. a medicament or a biocide
    • 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
    • A61L17/00—Materials for surgical sutures or for ligaturing blood vessels ; Materials for prostheses or catheters
    • A61L17/14—Post-treatment to improve physical properties
    • A61L17/145—Coating
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/22—Polypeptides or derivatives thereof, e.g. degradation products
    • A61L27/227—Other specific proteins or polypeptides not covered by A61L27/222, A61L27/225 or A61L27/24
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28—Materials for coating prostheses
    • A61L27/34—Macromolecular materials
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/54—Biologically active materials, e.g. therapeutic substances
    • 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
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04—Macromolecular materials
    • A61L31/043—Proteins; Polypeptides; Degradation products thereof
    • A61L31/047—Other specific proteins or polypeptides not covered by A61L31/044 - A61L31/046
    • 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
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/08—Materials for coatings
    • A61L31/10—Macromolecular materials
    • 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
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/16—Biologically active materials, e.g. therapeutic substances
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/412—Tissue-regenerating or healing or proliferative agents
    • A61L2300/414—Growth factors

Abstract

Protein formulations that can be lyophilized and are stable in organic solvents. The formulations contain bone morphogenetic proteins, lyoprotectants, and oxidation/reduction stabilizers. Optionally, the formulations may also contain solvent environment stabilizers. The protein formulations can be incorporated into a polymeric matrix to make medical devices for delivering the protein, and coatings for medical devices.
PCT/US2006/021754 2005-06-17 2006-06-05 Bone morphogenetic protein formulations WO2006138099A2 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
CA002612332A CA2612332A1 (en) 2005-06-17 2006-06-05 Bone morphogenetic protein formulations
EP06772164A EP1904090A4 (en) 2005-06-17 2006-06-05 Bone morphogenetic protein formulations
AU2006259768A AU2006259768A1 (en) 2005-06-17 2006-06-05 Bone morphogenetic protein formulations

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US11/156,153 US20060286171A1 (en) 2005-06-17 2005-06-17 Bone morphogenetic protein formulations
US11/156,153 2005-06-17

Publications (2)

Publication Number Publication Date
WO2006138099A2 WO2006138099A2 (en) 2006-12-28
WO2006138099A3 true WO2006138099A3 (en) 2007-10-04

Family

ID=37570961

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2006/021754 WO2006138099A2 (en) 2005-06-17 2006-06-05 Bone morphogenetic protein formulations

Country Status (7)

Country Link
US (1) US20060286171A1 (en)
EP (1) EP1904090A4 (en)
KR (1) KR20080034838A (en)
CN (1) CN101198348A (en)
AU (1) AU2006259768A1 (en)
CA (1) CA2612332A1 (en)
WO (1) WO2006138099A2 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7947649B2 (en) 2008-04-14 2011-05-24 Advanced Technologies And Regenerative Medicine, Llc Liquid buffered GDF-5 formulations

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2007234612B2 (en) 2006-12-14 2013-06-27 Johnson & Johnson Regenerative Therapeutics, Llc Protein stabilization formulations
US20080234727A1 (en) * 2007-03-22 2008-09-25 Venkat Garigapati Novel Carriers For Coating Growth Factors Onto Sutures
JP5362715B2 (en) * 2007-06-29 2013-12-11 アドバンスト・テクノロジーズ・アンド・リジェネレイティブ・メディスン・エルエルシー Liquid protein formulation containing GDF-5 for use at high temperatures
US7678764B2 (en) * 2007-06-29 2010-03-16 Johnson & Johnson Regenerative Therapeutics, Llc Protein formulations for use at elevated temperatures
CA2695697A1 (en) * 2007-08-07 2009-02-12 Advanced Technologies And Regenerative Medicine, Llc Protein formulations comprising gdf-5 in aqueous acidic solution
CN101785856B (en) * 2009-01-22 2012-06-06 齐鲁制药有限公司 Stably isoosmotic desmoteplase alpha1 or mutant preparation thereof
EP2386647A1 (en) * 2010-05-10 2011-11-16 Qiagen GmbH Method for transfecting a eukaryotic cell
AU2011284657B2 (en) * 2010-07-30 2013-11-14 Biopharm Gesellschaft Zur Biotechnologischen Entwicklung Von Pharmaka Mbh Drug delivery devices and growth factor formulations for accelerated wound healing
CN103768657A (en) * 2012-10-24 2014-05-07 上海交通大学医学院附属第九人民医院 Freeze-dried trehalose calcium phosphate BMP-2 sustained-release material, and preparation method thereof
CN109152744A (en) * 2016-03-25 2019-01-04 辉瑞公司 For the stabilization formulations of therapeutic particle to be lyophilized
CN106075400B (en) * 2016-08-16 2020-09-22 中国人民解放军总医院第四医学中心 BMP protein preparation and preparation method thereof
WO2019143578A1 (en) * 2018-01-17 2019-07-25 The Regents Of The University Of California Random heteropolymers preserve protein function in foreign environments
CN111647089A (en) * 2020-06-30 2020-09-11 安徽九川生物科技有限公司 Recombinant human elastin and composition thereof
CN114404664A (en) * 2022-02-17 2022-04-29 浙江瑞谷生物科技有限公司 Bone repair scaffold material with long-acting slow release function and preparation method and application thereof

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5658882A (en) * 1993-12-07 1997-08-19 Genetics Institute, Inc. Methods of inducting formation of tendon and/or ligament tissue comprising administering BMP-12, BMP-13, and/or MP-52
US6267958B1 (en) * 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation

Family Cites Families (7)

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ATE142460T1 (en) * 1991-06-21 1996-09-15 Genetics Inst MEDICINAL PRODUCTS CONTAINING OSTEOGENIC PROTEINS
CA2093836A1 (en) * 1992-04-24 1993-10-25 Wayne Gombotz Biodegradable tgf-.beta. delivery system for bone regeneration
US5385887A (en) * 1993-09-10 1995-01-31 Genetics Institute, Inc. Formulations for delivery of osteogenic proteins
AU2671599A (en) * 1998-02-10 1999-08-23 Oregon Health Sciences University Treatment of bony defects with osteoblast precursor cells
WO2003006052A1 (en) * 2001-07-09 2003-01-23 Yamanouchi Pharmaceutical Co., Ltd. Sustained-release compositions for injection and process for producing the same
CA2466947C (en) * 2001-11-19 2012-05-22 Scil Technology Gmbh A homogeneously coated device having osteoinductive and osteoconductive properties
KR101208291B1 (en) * 2003-04-04 2012-12-05 노파르티스 아게 High concentration antibody and protein formulations

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5658882A (en) * 1993-12-07 1997-08-19 Genetics Institute, Inc. Methods of inducting formation of tendon and/or ligament tissue comprising administering BMP-12, BMP-13, and/or MP-52
US6267958B1 (en) * 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7947649B2 (en) 2008-04-14 2011-05-24 Advanced Technologies And Regenerative Medicine, Llc Liquid buffered GDF-5 formulations

Also Published As

Publication number Publication date
CA2612332A1 (en) 2006-12-28
CN101198348A (en) 2008-06-11
WO2006138099A2 (en) 2006-12-28
EP1904090A2 (en) 2008-04-02
AU2006259768A1 (en) 2006-12-28
EP1904090A4 (en) 2010-10-13
US20060286171A1 (en) 2006-12-21
KR20080034838A (en) 2008-04-22

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