RU2720412C2 - Композиции доставки с замедленным высвобождением и способ стабилизации белков в процессе изготовления - Google Patents

Композиции доставки с замедленным высвобождением и способ стабилизации белков в процессе изготовления Download PDF

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RU2720412C2
RU2720412C2 RU2015135147A RU2015135147A RU2720412C2 RU 2720412 C2 RU2720412 C2 RU 2720412C2 RU 2015135147 A RU2015135147 A RU 2015135147A RU 2015135147 A RU2015135147 A RU 2015135147A RU 2720412 C2 RU2720412 C2 RU 2720412C2
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anticalin
composition
microspheres
protein
weight
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RU2015135147A
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Russian (ru)
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RU2015135147A (ru
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Саймон Х. ТРАН
Синди ВУ
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Аллерган, Инк.
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    • 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
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/02—Peptides of undefined number of amino acids; Derivatives thereof
    • 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
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40—Cyclodextrins; Derivatives thereof
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/56—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poly(lactide-co-glycolide)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Ophthalmology & Optometry (AREA)
RU2015135147A 2013-03-14 2014-03-13 Композиции доставки с замедленным высвобождением и способ стабилизации белков в процессе изготовления RU2720412C2 (ru)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201361786035P 2013-03-14 2013-03-14
US61/786,035 2013-03-14
PCT/US2014/026320 WO2014151725A1 (en) 2013-03-14 2014-03-13 Composition of a sustained-release delivery and method of stabilizing proteins during fabrication process

Publications (2)

Publication Number Publication Date
RU2015135147A RU2015135147A (ru) 2017-04-18
RU2720412C2 true RU2720412C2 (ru) 2020-04-29

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RU2015135147A RU2720412C2 (ru) 2013-03-14 2014-03-13 Композиции доставки с замедленным высвобождением и способ стабилизации белков в процессе изготовления

Country Status (10)

Country Link
US (1) US20140274873A1 (https=)
EP (2) EP2968574A1 (https=)
JP (2) JP6649246B2 (https=)
KR (1) KR20150128857A (https=)
CN (1) CN105188759A (https=)
AU (2) AU2014236938B2 (https=)
BR (1) BR112015021000A2 (https=)
CA (1) CA2902547A1 (https=)
RU (1) RU2720412C2 (https=)
WO (1) WO2014151725A1 (https=)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106076214B (zh) * 2016-07-15 2019-12-17 沈阳化工大学 一种具有核壳结构的海藻酸钙微球制备方法
GB201906835D0 (en) * 2019-05-15 2019-06-26 Ucb Biopharma Sprl Dry microparticles
WO2022163966A1 (ko) * 2021-01-29 2022-08-04 주식회사 티온랩테라퓨틱스 초기 방출 제어된 데포 조성물 및 이의 제조방법

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4777043A (en) * 1985-12-17 1988-10-11 Genentech, Inc. Stabilized human tissue plasminogen activator compositions
US5730969A (en) * 1988-10-05 1998-03-24 Chiron Corporation Method and compositions for solubilization and stabilization of polypeptides, especially proteins
US6346274B1 (en) * 1995-03-10 2002-02-12 Roche Diagnostics Gmbh Polypeptide-containing pharmaceutical forms of administration in the form of microparticles and method for the preparation thereof
US20070224246A1 (en) * 2004-04-30 2007-09-27 Hughes Patrick M Oil-in-oil emulsified polymeric implants containing a hypotensive lipid and related methods
US20110034448A1 (en) * 2004-04-30 2011-02-10 Allergan, Inc. Carbonic anhydrase inhibitor sustained release intraocular drug delivery systems
RU2010108162A (ru) * 2007-09-05 2011-09-10 Пфайзер Лимитед (GB) Ксинафоатная соль n4-[(2,2-дифтор-4н-бензо[1,4]оксазин-3-он)-6-ил]-5-фтор-n2-[3-(метиламинокарбонилметиленокси)фенил]-2,4-пиримидиндиамина
AU2012201364A1 (en) * 2011-03-08 2012-09-20 Alexion Pharmaceuticals, Inc. High concentration antibody formulations

Family Cites Families (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR0166088B1 (ko) * 1990-01-23 1999-01-15 . 수용해도가 증가된 시클로덱스트린 유도체 및 이의 용도
US6448077B1 (en) 1994-02-10 2002-09-10 Imclone Systems, Inc. Chimeric and humanized monoclonal antibodies specific to VEGF receptors
GB9514285D0 (en) * 1995-07-13 1995-09-13 Univ Nottingham Polymeric lamellar substrate particles for drug delivery
US5665428A (en) * 1995-10-25 1997-09-09 Macromed, Inc. Preparation of peptide containing biodegradable microspheres by melt process
US6884879B1 (en) 1997-04-07 2005-04-26 Genentech, Inc. Anti-VEGF antibodies
JP4360758B2 (ja) * 1999-04-08 2009-11-11 ジェネンテック・インコーポレーテッド 逆の電荷のポリペプチド類をベースにした組成物
DE60127175T2 (de) * 2000-12-21 2007-11-08 Nektar Therapeutics, San Carlos Lagerstabile pulverzusammensetzungen mit interleukin-4 rezeptor
EP1436329A4 (en) 2001-09-20 2005-04-27 Alexion Pharma Inc ANTI-PDGF ANTIBODIES AND METHODS FOR PRODUCING FOCUSED ANTIBODIES
US7265084B2 (en) * 2001-10-10 2007-09-04 Neose Technologies, Inc. Glycopegylation methods and proteins/peptides produced by the methods
KR100466637B1 (ko) * 2003-06-26 2005-01-13 주식회사 펩트론 서방성 미립구의 혼합 제형을 연속한 단일 공정으로제조하는 방법
US20060182783A1 (en) * 2004-04-30 2006-08-17 Allergan, Inc. Sustained release intraocular drug delivery systems
WO2005110374A1 (en) * 2004-04-30 2005-11-24 Allergan, Inc. Intraocular drug delivery systems containing a therapeutic component, a cyclodextrin, and a polymeric component
CA2593112A1 (en) * 2005-01-21 2006-07-27 Alza Corporation Therapeutic peptide formulations for coating microneedles with improved stability containing at least one counterion
MX2007013213A (es) * 2005-04-25 2007-12-12 Amgen Inc Composiciones de liberacion prolongada de peptidos biodegradables que contienen porogenos.
JP5074750B2 (ja) * 2005-12-07 2012-11-14 一般財団法人化学及血清療法研究所 シクロデキストリン類を含有する液状フィブリノゲン製剤
US8642067B2 (en) * 2007-04-02 2014-02-04 Allergen, Inc. Methods and compositions for intraocular administration to treat ocular conditions
WO2009099132A1 (ja) * 2008-02-05 2009-08-13 Kyowa Hakko Bio Co., Ltd. グルタチオンの保存安定性向上方法
EP3785735A1 (en) * 2008-11-03 2021-03-03 Molecular Partners AG Binding proteins inhibiting the vegf-a receptor interaction
CA2776472A1 (en) 2009-10-01 2011-04-07 Evonik Degussa Corporation Microparticle compositions and methods for treating age-related macular degeneration
US9668915B2 (en) * 2010-11-24 2017-06-06 Dose Medical Corporation Drug eluting ocular implant

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4777043A (en) * 1985-12-17 1988-10-11 Genentech, Inc. Stabilized human tissue plasminogen activator compositions
US5730969A (en) * 1988-10-05 1998-03-24 Chiron Corporation Method and compositions for solubilization and stabilization of polypeptides, especially proteins
US6346274B1 (en) * 1995-03-10 2002-02-12 Roche Diagnostics Gmbh Polypeptide-containing pharmaceutical forms of administration in the form of microparticles and method for the preparation thereof
US20070224246A1 (en) * 2004-04-30 2007-09-27 Hughes Patrick M Oil-in-oil emulsified polymeric implants containing a hypotensive lipid and related methods
US20110034448A1 (en) * 2004-04-30 2011-02-10 Allergan, Inc. Carbonic anhydrase inhibitor sustained release intraocular drug delivery systems
RU2010108162A (ru) * 2007-09-05 2011-09-10 Пфайзер Лимитед (GB) Ксинафоатная соль n4-[(2,2-дифтор-4н-бензо[1,4]оксазин-3-он)-6-ил]-5-фтор-n2-[3-(метиламинокарбонилметиленокси)фенил]-2,4-пиримидиндиамина
AU2012201364A1 (en) * 2011-03-08 2012-09-20 Alexion Pharmaceuticals, Inc. High concentration antibody formulations

Non-Patent Citations (7)

* Cited by examiner, † Cited by third party
Title
CASTELLANOS J. I. et al. Effect of cyclodextrins on [alfa]-chymotrypsin stability and loading in PLGA microspheres upon S/O/W encapsulation // JOURNAL OF PHARMACEUTICAL SCIENCES, 2006, V.95, pp.849-858. *
CLELAND J. L. ET AL.: "A Specific Molar Ratio of Stabilizer to Protein is Required for Storage Stability of a Lyophilized Monoclonal Antibody", JOURNAL OF PHARMACEUTICAL SCIENCES,, vol. 90, 2001, pages 310 - 321, XP002397269, DOI: 10.1002/1520-6017(200103)90:3<310::AID-JPS6>3.0.CO;2-R *
DE ROSA G. et al. How cyclodextrin incorporation affects the properties of protein-loaded PLGA-based microspheres: the case of insulin/hydroxypropyl-beta-cyclodextrin system // JOURNAL OF CONTROLLED RELEASE, 2005, V.102, pp.71-83. LYUTOVA E. M. et al. Effects of Arginine on Kinetics of Protein Aggregation Studied by Dinamic Laser Light Scattering and Tubidimetry Techniques // BIOTECHNOLOGY PROGRESS, 2007, V.23, pp.1411-1416. SERNO T. et al. Protein stabilization by cyclodextrins in the liquid and dried state // ADVANCED DRUG DELIVERY REVIEWS, 2011, V.63, pp.1086-1106. TOKIHIRO K. et al. Varying Effects of Cyclodextrin Derivatives on Aggregation and Thermal Behavior of Insulin in Aqueous Solution // Chem. Pharm. Bull., 1997, V.45, pp.525-531. CLELAND J. L. et al. A Specific Molar Ratio of Stabilizer to Protein is Required for Storage Stability of a Lyophilized Monoclonal Antibody // Journal of Pharmaceutical Sciences, 2001, V.90, pp.310-321. *
DE ROSA G. ET AL.: "How cyclodextrin incorporation affects the properties of protein-loaded PLGA-based microspheres: the case of insulin/hydroxypropyl-beta-cyclodextrin system", JOURNAL OF CONTROLLED RELEASE, vol. 102, 2005, pages 71 - 83 *
LYUTOVA E. M. ET AL.: "Effects of Arginine on Kinetics of Protein Aggregation Studied by Dinamic Laser Light Scattering and Tubidimetry Techniques", BIOTECHNOLOGY PROGRESS,, vol. 23, 2007, pages 1411 - 1416, XP055118357, DOI: 10.1021/bp070209h *
SERNO T. ET AL.: "Protein stabilization by cyclodextrins in the liquid and dried state", ADVANCED DRUG DELIVERY REVIEWS, vol. 63, 2011, pages 1086 - 1106, XP028320146, DOI: 10.1016/j.addr.2011.08.003 *
TOKIHIRO K. ET AL.: "Varying Effects of Cyclodextrin Derivatives on Aggregation and Thermal Behavior of Insulin in Aqueous Solution", CHEM. PHARM. BULL.,, vol. 45, 1997, pages 525 - 531 *

Also Published As

Publication number Publication date
AU2014236938B2 (en) 2018-12-20
JP6649246B2 (ja) 2020-02-19
KR20150128857A (ko) 2015-11-18
AU2019201884A1 (en) 2019-04-11
EP3693021A1 (en) 2020-08-12
JP2016517418A (ja) 2016-06-16
US20140274873A1 (en) 2014-09-18
CA2902547A1 (en) 2014-09-25
RU2015135147A (ru) 2017-04-18
JP2020029466A (ja) 2020-02-27
EP2968574A1 (en) 2016-01-20
AU2019201884B2 (en) 2020-08-27
BR112015021000A2 (pt) 2017-07-18
CN105188759A (zh) 2015-12-23
AU2014236938A1 (en) 2015-09-03
WO2014151725A1 (en) 2014-09-25

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