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 [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/32—Immunoglobulins [IG], 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 (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MX366337B (es) 2010-10-06 2019-07-05 Regeneron Pharma Formulaciones estabilizadas que contienen anticuerpos anti-receptor de interleucina-4 (il-4r).
BR112018014123A2 (pt) * 2016-01-12 2018-12-11 Dr. Reddy's Laboratories Limited formulação farmacêutica aquosa estável.
WO2021023267A1 (zh) * 2019-08-07 2021-02-11 信达生物制药(苏州)有限公司 包含抗pd-1/her2双特异性抗体的制剂及其制备方法和用途
KR20220131937A (ko) * 2020-01-23 2022-09-29 바이오아트라, 인코퍼레이티드 조건부 활성형 항-her2 항체, 항체 절편, 이의 면역접합체 및 이의 용도
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
EP4518837A1 (en) * 2022-05-02 2025-03-12 Regeneron Pharmaceuticals, Inc. Anti-interleukin-4 receptor (il-4r) antibody formulations
CN119775429B (zh) * 2024-12-26 2026-08-07 南开大学 一种抗人her2/ccr4的双特异性抗体及其应用

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Also Published As

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

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