MX2019009952A - Formulaciones de evolocumab de baja viscosidad y alta concentracion y metodos de elaboracion de las mismas. - Google Patents

Formulaciones de evolocumab de baja viscosidad y alta concentracion y metodos de elaboracion de las mismas.

Info

Publication number
MX2019009952A
MX2019009952A MX2019009952A MX2019009952A MX2019009952A MX 2019009952 A MX2019009952 A MX 2019009952A MX 2019009952 A MX2019009952 A MX 2019009952A MX 2019009952 A MX2019009952 A MX 2019009952A MX 2019009952 A MX2019009952 A MX 2019009952A
Authority
MX
Mexico
Prior art keywords
formulations
methods
viscosity
concentration
making
Prior art date
Application number
MX2019009952A
Other languages
English (en)
Inventor
James Sloey Christopher
KANAPURAM Sekhar
Cui Huanchun
Mui Chan Chio
Binabaji Elaheh
Original Assignee
Amgen Inc
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 Amgen Inc filed Critical Amgen Inc
Publication of MX2019009952A publication Critical patent/MX2019009952A/es

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Classifications

    • 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
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • A61K47/16—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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/16—Extraction; Separation; Purification by chromatography
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/36—Extraction; Separation; Purification by a combination of two or more processes of different types
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/06—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065—Purification, fragmentation
    • 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
    • C07K16/22—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/40—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against enzymes
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

Abstract

Se proporcionan en el presente documento formulaciones de polipéptidos de unión a PCSK9, tales como las que comprenden evolocumab, que comprenden N-acetil arginina y tienen viscosidades reducidas en comparación con formulaciones que carecen de N-acetil arginina. También se proporcionan en el presente documento métodos para formular dichas composiciones que son ventajosas en cuanto conservan determinados componentes. Dichas formulaciones que comprenden polipéptidos de unión a PCSK9 se pueden administrar a pacientes para tratar y/o prevenir enfermedades, afecciones y trastornos relacionados con PCSK9.
MX2019009952A 2017-02-22 2018-02-22 Formulaciones de evolocumab de baja viscosidad y alta concentracion y metodos de elaboracion de las mismas. MX2019009952A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201762462266P 2017-02-22 2017-02-22
PCT/US2018/019189 WO2018156741A1 (en) 2017-02-22 2018-02-22 Low-viscosity, high-concentration evolocumab formulations and methods of making the same

Publications (1)

Publication Number Publication Date
MX2019009952A true MX2019009952A (es) 2019-10-14

Family

ID=61617101

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2019009952A MX2019009952A (es) 2017-02-22 2018-02-22 Formulaciones de evolocumab de baja viscosidad y alta concentracion y metodos de elaboracion de las mismas.

Country Status (17)

Country Link
US (2) US11464857B2 (es)
EP (1) EP3585821A1 (es)
JP (1) JP7377596B2 (es)
KR (1) KR20190120257A (es)
CN (1) CN110536906A (es)
AR (2) AR110938A1 (es)
AU (1) AU2018224095A1 (es)
BR (1) BR112019017393A8 (es)
CA (1) CA3053394A1 (es)
CL (1) CL2019002362A1 (es)
EA (1) EA201991951A1 (es)
IL (1) IL268515A (es)
MA (1) MA47601A (es)
MX (1) MX2019009952A (es)
SG (1) SG11201907505TA (es)
UY (1) UY37611A (es)
WO (1) WO2018156741A1 (es)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR102534017B1 (ko) 2014-10-23 2023-05-19 암젠 인크 약제학적 제형의 점도 감소
CN108239150A (zh) 2016-12-24 2018-07-03 信达生物制药(苏州)有限公司 抗pcsk9抗体及其用途
JP7377596B2 (ja) 2017-02-22 2023-11-10 アムジエン・インコーポレーテツド 低粘度、高濃度エボロクマブ製剤及びそれらの製造方法
MX2021012782A (es) * 2019-04-23 2021-11-25 Amgen Inc El uso de polivinilpirrolidona (pvp) de bajo peso molecular para reducir la viscosidad de formulaciones de proteinas de alta concentracion.
CN117355321A (zh) * 2021-04-09 2024-01-05 安万托特性材料股份有限公司 增强性能的赋形剂以及降低生物制剂的粘度和提高生物制剂的稳定性的方法

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Also Published As

Publication number Publication date
BR112019017393A2 (pt) 2020-04-14
IL268515A (en) 2019-09-26
AU2018224095A1 (en) 2019-08-22
SG11201907505TA (en) 2019-09-27
EP3585821A1 (en) 2020-01-01
JP7377596B2 (ja) 2023-11-10
CN110536906A (zh) 2019-12-03
KR20190120257A (ko) 2019-10-23
UY37611A (es) 2018-08-31
TW201841650A (zh) 2018-12-01
WO2018156741A1 (en) 2018-08-30
EA201991951A1 (ru) 2020-01-21
CL2019002362A1 (es) 2019-11-29
CA3053394A1 (en) 2018-08-30
AR110938A1 (es) 2019-05-15
MA47601A (fr) 2020-01-01
US20180237501A1 (en) 2018-08-23
AR125766A2 (es) 2023-08-09
US20230226177A1 (en) 2023-07-20
BR112019017393A8 (pt) 2022-03-03
JP2018154616A (ja) 2018-10-04
US11464857B2 (en) 2022-10-11

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