MX384635B - Formulaciones de proteína estables que comprenden un exceso molar de sorbitol. - Google Patents

Formulaciones de proteína estables que comprenden un exceso molar de sorbitol.

Info

Publication number
MX384635B
MX384635B MX2016013559A MX2016013559A MX384635B MX 384635 B MX384635 B MX 384635B MX 2016013559 A MX2016013559 A MX 2016013559A MX 2016013559 A MX2016013559 A MX 2016013559A MX 384635 B MX384635 B MX 384635B
Authority
MX
Mexico
Prior art keywords
sorbitol
protein
molar excess
protein formulations
stable protein
Prior art date
Application number
MX2016013559A
Other languages
English (en)
Other versions
MX2016013559A (es
Inventor
Kala Chandramouli
Rohan Pai
Original Assignee
Biosimilars Newco Ltd
Biocon 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 Biosimilars Newco Ltd, Biocon Ltd filed Critical Biosimilars Newco Ltd
Publication of MX2016013559A publication Critical patent/MX2016013559A/es
Publication of MX384635B publication Critical patent/MX384635B/es

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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/06—Ampoules or carpules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1412—Containers with closing means, e.g. caps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • 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
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic 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
    • A61K47/06—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
    • 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
    • A61P35/00—Antineoplastic agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/32—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Genetics & Genomics (AREA)
  • Oncology (AREA)
  • Biophysics (AREA)
  • Fluid Mechanics (AREA)
  • Hematology (AREA)
  • Physics & Mathematics (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)

Abstract

La presente invención se refiere a una formulación farmacéutica estable caracterizada porque comprende un anticuerpo anti-HER2; sorbitol, de 1.0 mM a 3.0 mM de L-histidina y de 1.5 mM a 3.0 m M de clorhidrato de L-histidina y polietilenglicol (PEG), en donde el sorbitol y el anticuerpo anti-HER2 están presentes en una relación molar de 550 a 700 moles de sorbitol: 1 mol del anticuerpo anti-HER2, en donde la relación molar de PEG al anticuerpo anti-HER2 está en un intervalo de 2:1 a 50:1, y en donde el peso molecular del PEG es de 2,000 g/mol a 5,000 g/mol, donde la concentración molar del anticuerpo anti-HER2 es de 0.10 mM a 0.25 mM y en donde la formulación tiene un p H de 5.0 a 7.5.
MX2016013559A 2014-04-16 2015-04-16 Formulaciones de proteína estables que comprenden un exceso molar de sorbitol. MX384635B (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN1989CH2014 2014-04-16
PCT/IB2015/052789 WO2015159254A1 (en) 2014-04-16 2015-04-16 Stable protein formulations comprising a molar excess of sorbitol

Publications (2)

Publication Number Publication Date
MX2016013559A MX2016013559A (es) 2017-04-27
MX384635B true MX384635B (es) 2025-03-14

Family

ID=53055071

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2016013559A MX384635B (es) 2014-04-16 2015-04-16 Formulaciones de proteína estables que comprenden un exceso molar de sorbitol.

Country Status (7)

Country Link
US (1) US11058768B2 (es)
EP (1) EP3131584B1 (es)
CN (1) CN106456784A (es)
ES (1) ES2910443T3 (es)
MX (1) MX384635B (es)
RU (1) RU2689145C2 (es)
WO (1) WO2015159254A1 (es)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017122121A1 (en) * 2016-01-12 2017-07-20 Dr. Reddy's Laboratories Limited Stable pharmaceutical composition
KR20220044286A (ko) * 2019-08-07 2022-04-07 이노벤트 바이오로직스 (쑤저우) 컴퍼니, 리미티드 항 pd-1/her2 이중특이성 항체를 포함하는 제제, 이의 제조 방법 및 용도
CA3165662A1 (en) * 2020-01-23 2021-07-29 Jay M. Short Conditionally active anti-her2 antibodies, antibody fragments, their immunoconjugates and uses thereof
CN113521018B (zh) * 2021-07-20 2022-11-18 浙江新码生物医药有限公司 一种含有抗her2-药物偶联物的冻干组合物、冻干制剂及其制备方法和用途
CN113651893B (zh) * 2021-08-12 2023-08-01 上海生物制品研究所有限责任公司 联合her2和meso双靶点car-t载体及其构建方法和在癌症中的应用
TW202406572A (zh) * 2022-05-02 2024-02-16 美商再生元醫藥公司 抗介白素－４受體（ｉｌ－４ｒ）抗體調配物

Family Cites Families (42)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4474893A (en) 1981-07-01 1984-10-02 The University of Texas System Cancer Center Recombinant monoclonal antibodies
US4714681A (en) 1981-07-01 1987-12-22 The Board Of Reagents, The University Of Texas System Cancer Center Quadroma cells and trioma cells and methods for the production of same
JPS60500673A (ja) 1983-03-08 1985-05-09 コモンウエルス　セラム　ラボラトリ−ズ　コミツシヨン 抗原活性を有するアミノ酸配列
US4816567A (en) 1983-04-08 1989-03-28 Genentech, Inc. Recombinant immunoglobin preparations
US6054561A (en) 1984-02-08 2000-04-25 Chiron Corporation Antigen-binding sites of antibody molecules specific for cancer antigens
US5225539A (en) 1986-03-27 1993-07-06 Medical Research Council Recombinant altered antibodies and methods of making altered antibodies
US5260203A (en) 1986-09-02 1993-11-09 Enzon, Inc. Single polypeptide chain binding molecules
US4946778A (en) 1987-09-21 1990-08-07 Genex Corporation Single polypeptide chain binding molecules
JP3040121B2 (ja) 1988-01-12 2000-05-08 ジェネンテク，インコーポレイテッド 増殖因子レセプターの機能を阻害することにより腫瘍細胞を処置する方法
US4925648A (en) 1988-07-29 1990-05-15 Immunomedics, Inc. Detection and treatment of infectious and inflammatory lesions
US5601819A (en) 1988-08-11 1997-02-11 The General Hospital Corporation Bispecific antibodies for selective immune regulation and for selective immune cell binding
US5530101A (en) 1988-12-28 1996-06-25 Protein Design Labs, Inc. Humanized immunoglobulins
WO1991000360A1 (en) 1989-06-29 1991-01-10 Medarex, Inc. Bispecific reagents for aids therapy
US5859205A (en) 1989-12-21 1999-01-12 Celltech Limited Humanised antibodies
ATE139258T1 (de) 1990-01-12 1996-06-15 Cell Genesys Inc Erzeugung xenogener antikörper
CA2093022C (en) 1990-10-05 2005-02-22 Michael W. Fanger Targeted immunostimulation with bispecific reagents
AU8727291A (en) 1990-10-29 1992-06-11 Cetus Oncology Corporation Bispecific antibodies, method of production, and uses thereof
EP0582595A1 (en) 1991-04-26 1994-02-16 Surface Active Limited Novel antibodies, and methods for their use
DE122004000008I1 (de) 1991-06-14 2005-06-09 Genentech Inc Humanisierter Heregulin Antikörper.
WO1994000136A1 (en) 1992-06-30 1994-01-06 Oncologix, Inc. A COMBINATION OF ANTI-erbB-2 MONOCLONAL ANTIBODIES AND METHOD OF USING
US6004554A (en) 1992-03-05 1999-12-21 Board Of Regents, The University Of Texas System Methods for targeting the vasculature of solid tumors
WO1994012520A1 (en) 1992-11-20 1994-06-09 Enzon, Inc. Linker for linked fusion polypeptides
CA2115811A1 (en) 1993-02-17 1994-08-18 Claus Krebber A method for in vivo selection of ligand-binding proteins
US5731168A (en) 1995-03-01 1998-03-24 Genentech, Inc. Method for making heteromultimeric polypeptides
US6267958B1 (en) 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
PT1516628E (pt) 1995-07-27 2013-09-24 Genentech Inc Formulação de proteína liofilizada isotónica estável
US6685940B2 (en) 1995-07-27 2004-02-03 Genentech, Inc. Protein formulation
US5783186A (en) 1995-12-05 1998-07-21 Amgen Inc. Antibody-induced apoptosis
US6897044B1 (en) 1999-01-28 2005-05-24 Biogen Idec, Inc. Production of tetravalent antibodies
US6849425B1 (en) 1999-10-14 2005-02-01 Ixsys, Inc. Methods of optimizing antibody variable region binding affinity
US7319139B2 (en) 2001-01-29 2008-01-15 Biogen Idec, Inc. TAG-72 specific CH2 domain deleted antibodies
US20030020733A1 (en) 2001-07-24 2003-01-30 Yin Memphis Zhihong Computer display having selective area magnification
AU2005259221B2 (en) * 2004-07-01 2011-02-10 Innate Pharma Antibodies binding to receptors KIR2DL1, -2, 3 but not KIR2DS4 and their therapeutic use
JO3000B1 (ar) 2004-10-20 2016-09-05 Genentech Inc مركبات أجسام مضادة .
CA2634547C (en) * 2005-12-20 2016-10-11 Bristol-Myers Squibb Company Stable ctla4 formulation for subcutaneous administration
WO2008031531A1 (en) * 2006-09-15 2008-03-20 F. Hoffmann-La Roche Ag Tumor therapy with a combination of anti-her2 antibodies
KR20090110349A (ko) * 2007-02-16 2009-10-21 와이어쓰 소르비톨을 함유하는 단백질 제제
WO2009015345A1 (en) 2007-07-25 2009-01-29 Amgen Inc. Pharmaceutical compositions comprising fc fusion proteins
RU2584232C2 (ru) * 2010-03-22 2016-05-20 Дженентек, Инк. Композиции и способы, используемые для стабилизации белоксодержащих готовых форм
JOP20190250A1 (ar) * 2010-07-14 2017-06-16 Regeneron Pharma صيغ مستقرة تحتوي على الأجسام المضادة لمضاد عامل نمو الأعصاب
AU2011344652B2 (en) * 2010-12-14 2015-11-19 Immatics Biotechnologies Gmbh HLA-binding peptides derived from prostate-associated antigenic molecules and methods of use thereof
UA116189C2 (uk) * 2011-05-02 2018-02-26 Мілленніум Фармасьютікалз, Інк. КОМПОЗИЦІЯ АНТИ-α4β7 АНТИТІЛА

Also Published As

Publication number Publication date
EP3131584B1 (en) 2022-01-12
CN106456784A (zh) 2017-02-22
US20170028063A1 (en) 2017-02-02
ES2910443T3 (es) 2022-05-12
RU2016144190A3 (es) 2018-11-12
BR112016024088A2 (pt) 2018-06-19
RU2016144190A (ru) 2018-05-16
WO2015159254A1 (en) 2015-10-22
EP3131584A1 (en) 2017-02-22
RU2689145C2 (ru) 2019-05-24
MX2016013559A (es) 2017-04-27
US11058768B2 (en) 2021-07-13

Similar Documents

Publication Publication Date Title
MX384635B (es) Formulaciones de proteína estables que comprenden un exceso molar de sorbitol.
PH12017500281A1 (en) Pyrrolopyrimidine compounds used as tlr7 agonist
MX2021006035A (es) Formulaciones cannabinoides estables.
PH12017501321A1 (en) Oral care compositions and methods of use
MD20170070A2 (ro) Derivaţi de chinazolină utilizaţi în tratamentul HIV
PH12017501539A1 (en) Disacetoxytubulysin h and analogs thereof
MX363347B (es) Sal de omecamtiv mecarbilo y proceso para preparar la sal.
EP4371616A3 (en) Compositions of obeticholic acid and methods of use
MX2018002301A (es) Composiciones de glucano y usos de las mismas.
MX372756B (es) Composiciones para el cuidado bucal y métodos de uso.
NZ709958A (en) Enhanced stability of novel liquid compositions
MY201832A (en) Sulfonamide compounds and use thereof
MY179756A (en) Stabilized efinaconazole formulations
WO2015160843A8 (en) Ion channel activators and methods of use
MX351584B (es) Formulacion farmaceutica acuosa de tapentadol para administracion oral.
MX2013001677A (es) Formulaciones estables de linaclotida.
BR112016020181A8 (pt) composições de ácido lipoico éster colina e métodos de uso.
BR112015000229A2 (pt) formulações aquosas estáveis de etanercept
EA201590491A1 (ru) Иммуногенная композиция
WO2015171460A3 (en) Formulations of cyclophosphamide liquid concentrate
NI201300034A (es) Conjugado de naloxol - peg cristalino
MX2019004580A (es) Formulaciones farmaceuticas y metodos para prepararlas.
MX2021005910A (es) Formulacion de proteina de alta concentracion.
PH12016500832B1 (en) Crystalline forms of s-acetyl glutathione, their preparations and uses in pharmaceutical and nutraceutical formulations
MX2023000348A (es) Composicion que contiene ciclodextrina y busulfan.