MX2020002429A - Compuestos para reducir la viscosidad de las formulaciones biologicas. - Google Patents

Compuestos para reducir la viscosidad de las formulaciones biologicas.

Info

Publication number
MX2020002429A
MX2020002429A MX2020002429A MX2020002429A MX2020002429A MX 2020002429 A MX2020002429 A MX 2020002429A MX 2020002429 A MX2020002429 A MX 2020002429A MX 2020002429 A MX2020002429 A MX 2020002429A MX 2020002429 A MX2020002429 A MX 2020002429A
Authority
MX
Mexico
Prior art keywords
sup
pharmaceutically acceptable
viscosity
relates
abi
Prior art date
Application number
MX2020002429A
Other languages
English (en)
Inventor
Ramesh S Kashi
Lin Chu
Nathalie Y Toussaint
Dong Xiao
Petr Vachal
Annette Bak
Original Assignee
Merck Sharp & Dohme
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 Merck Sharp & Dohme filed Critical Merck Sharp & Dohme
Publication of MX2020002429A publication Critical patent/MX2020002429A/es

Links

Classifications

    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D233/00—Heterocyclic compounds containing 1,3-diazole or hydrogenated 1,3-diazole rings, not condensed with other rings
    • C07D233/54—Heterocyclic compounds containing 1,3-diazole or hydrogenated 1,3-diazole rings, not condensed with other rings having two double bonds between ring members or between ring members and non-ring members
    • C07D233/64—Heterocyclic compounds containing 1,3-diazole or hydrogenated 1,3-diazole rings, not condensed with other rings having two double bonds between ring members or between ring members and non-ring members with substituted hydrocarbon radicals attached to ring carbon atoms, e.g. histidine
    • 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
    • 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
    • A61K9/0012—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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • 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
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C229/00—Compounds containing amino and carboxyl groups bound to the same carbon skeleton
    • C07C229/02—Compounds containing amino and carboxyl groups bound to the same carbon skeleton having amino and carboxyl groups bound to acyclic carbon atoms of the same carbon skeleton
    • C07C229/04—Compounds containing amino and carboxyl groups bound to the same carbon skeleton having amino and carboxyl groups bound to acyclic carbon atoms of the same carbon skeleton the carbon skeleton being acyclic and saturated
    • C07C229/06—Compounds containing amino and carboxyl groups bound to the same carbon skeleton having amino and carboxyl groups bound to acyclic carbon atoms of the same carbon skeleton the carbon skeleton being acyclic and saturated having only one amino and one carboxyl group bound to the carbon skeleton
    • C07C229/08—Compounds containing amino and carboxyl groups bound to the same carbon skeleton having amino and carboxyl groups bound to acyclic carbon atoms of the same carbon skeleton the carbon skeleton being acyclic and saturated having only one amino and one carboxyl group bound to the carbon skeleton the nitrogen atom of the amino group being further bound to hydrogen atoms
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C229/00—Compounds containing amino and carboxyl groups bound to the same carbon skeleton
    • C07C229/02—Compounds containing amino and carboxyl groups bound to the same carbon skeleton having amino and carboxyl groups bound to acyclic carbon atoms of the same carbon skeleton
    • C07C229/34—Compounds containing amino and carboxyl groups bound to the same carbon skeleton having amino and carboxyl groups bound to acyclic carbon atoms of the same carbon skeleton the carbon skeleton containing six-membered aromatic rings
    • C07C229/36—Compounds containing amino and carboxyl groups bound to the same carbon skeleton having amino and carboxyl groups bound to acyclic carbon atoms of the same carbon skeleton the carbon skeleton containing six-membered aromatic rings with at least one amino group and one carboxyl group bound to the same carbon atom of the carbon skeleton
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C235/00—Carboxylic acid amides, the carbon skeleton of the acid part being further substituted by oxygen atoms
    • C07C235/02—Carboxylic acid amides, the carbon skeleton of the acid part being further substituted by oxygen atoms having carbon atoms of carboxamide groups bound to acyclic carbon atoms and singly-bound oxygen atoms bound to the same carbon skeleton
    • C07C235/04—Carboxylic acid amides, the carbon skeleton of the acid part being further substituted by oxygen atoms having carbon atoms of carboxamide groups bound to acyclic carbon atoms and singly-bound oxygen atoms bound to the same carbon skeleton the carbon skeleton being acyclic and saturated
    • C07C235/12—Carboxylic acid amides, the carbon skeleton of the acid part being further substituted by oxygen atoms having carbon atoms of carboxamide groups bound to acyclic carbon atoms and singly-bound oxygen atoms bound to the same carbon skeleton the carbon skeleton being acyclic and saturated having the nitrogen atom of at least one of the carboxamide groups bound to an acyclic carbon atom of a hydrocarbon radical substituted by carboxyl groups
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C257/00—Compounds containing carboxyl groups, the doubly-bound oxygen atom of a carboxyl group being replaced by a doubly-bound nitrogen atom, this nitrogen atom not being further bound to an oxygen atom, e.g. imino-ethers, amidines
    • C07C257/10—Compounds containing carboxyl groups, the doubly-bound oxygen atom of a carboxyl group being replaced by a doubly-bound nitrogen atom, this nitrogen atom not being further bound to an oxygen atom, e.g. imino-ethers, amidines with replacement of the other oxygen atom of the carboxyl group by nitrogen atoms, e.g. amidines
    • C07C257/14—Compounds containing carboxyl groups, the doubly-bound oxygen atom of a carboxyl group being replaced by a doubly-bound nitrogen atom, this nitrogen atom not being further bound to an oxygen atom, e.g. imino-ethers, amidines with replacement of the other oxygen atom of the carboxyl group by nitrogen atoms, e.g. amidines having carbon atoms of amidino groups bound to acyclic carbon atoms
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C279/00—Derivatives of guanidine, i.e. compounds containing the group, the singly-bound nitrogen atoms not being part of nitro or nitroso groups
    • C07C279/04—Derivatives of guanidine, i.e. compounds containing the group, the singly-bound nitrogen atoms not being part of nitro or nitroso groups having nitrogen atoms of guanidine groups bound to acyclic carbon atoms of a carbon skeleton
    • C07C279/14—Derivatives of guanidine, i.e. compounds containing the group, the singly-bound nitrogen atoms not being part of nitro or nitroso groups having nitrogen atoms of guanidine groups bound to acyclic carbon atoms of a carbon skeleton being further substituted by carboxyl groups
    • 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
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/2818—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against CD28 or CD152
    • 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
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • 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

Abstract

La presente invención se refiere a compuestos de aminoácidos pegilados de fórmula I: (ver Fórmula) y sales farmacéuticamente aceptables del mismo, en donde X, R1, R2, R3A, R3B y n son como se define en la presente. La presente invención se refiere también a composiciones que comprenden un compuesto de aminoácidos pegilados de la invención o una sal farmacéuticamente aceptable del mismo y un vehículo farmacéuticamente aceptable, en combinación con una alta concentración de un ingrediente biológico activo (ABI). En modalidades de la invención, el ABI es un anticuerpo anti-PD-1 o un fragmento de unión a antígeno del mismo que se une específicamente al receptor de muerte programada 1 humano (PD-1). La invención se refiere además a métodos para disminuir la viscosidad de una solución acuosa de una composición farmacéutica que comprende agregar un compuesto de la invención a la solución. La invención proporciona también métodos para tratar una enfermedad o afección patológica, tal como cáncer, mediante la administración a un sujeto que necesita dicho tratamiento de una cantidad terapéuticamente eficaz de una composición farmacéutica de la invención.
MX2020002429A 2017-09-05 2018-08-31 Compuestos para reducir la viscosidad de las formulaciones biologicas. MX2020002429A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201762554134P 2017-09-05 2017-09-05
PCT/US2018/048995 WO2019050780A1 (en) 2017-09-05 2018-08-31 COMPOUNDS FOR REDUCING THE VISCOSITY OF BIOLOGICAL FORMULATIONS

Publications (1)

Publication Number Publication Date
MX2020002429A true MX2020002429A (es) 2020-07-13

Family

ID=65634495

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2020002429A MX2020002429A (es) 2017-09-05 2018-08-31 Compuestos para reducir la viscosidad de las formulaciones biologicas.

Country Status (11)

Country Link
US (2) US20200206350A1 (es)
EP (1) EP3678700A4 (es)
JP (1) JP2020532562A (es)
KR (1) KR20200051687A (es)
CN (1) CN111107873A (es)
AU (1) AU2018328015A1 (es)
BR (1) BR112020004325A2 (es)
CA (1) CA3074565A1 (es)
MX (1) MX2020002429A (es)
RU (1) RU2020112302A (es)
WO (1) WO2019050780A1 (es)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JOP20190260A1 (ar) 2017-05-02 2019-10-31 Merck Sharp & Dohme صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها
CA3060581A1 (en) 2017-05-02 2018-11-08 Merck Sharp & Dohme Corp. Formulations of anti-lag3 antibodies and co-formulations of anti-lag3 antibodies and anti-pd-1 antibodies
MA55033A (fr) 2019-02-18 2021-12-29 Lilly Co Eli Formulation d'anticorps thérapeutique
CN114507227A (zh) * 2020-11-17 2022-05-17 中国医学科学院药物研究所 苯并异噻唑类化合物、及其制法和药物组合物与用途

Family Cites Families (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0144290A3 (de) * 1983-12-01 1987-05-27 Ciba-Geigy Ag Substituierte Aethylendiaminderivate
PT1441589E (pt) 2001-11-08 2012-08-13 Abbott Biotherapeutics Corp Formulação farmacêutica líquida estável de anticorpos igg
CN1252130C (zh) * 2002-04-01 2006-04-19 北京键凯科技有限公司 亲水性聚合物与丹参酮类药物的结合物以及包含该结合物的药物组合物
BRPI0403964B8 (pt) 2003-04-04 2021-05-25 Genentech Inc formulações líquidas estáveis, artigo manufaturado e uso dessas formulações para o tratamento de disfunção mediada por ige
CN100543063C (zh) * 2006-04-03 2009-09-23 中国科学院过程工程研究所 氨基酸端基聚乙二醇及其制备方法
EP2230312A1 (en) * 2009-03-19 2010-09-22 Helmholtz-Zentrum für Infektionsforschung GmbH Probe compound for detecting and isolating enzymes and means and methods using the same
CN102740888B (zh) * 2009-11-24 2016-10-12 奥尔德生物制药公司 Il-6抗体及其用途
EP2566510A1 (en) 2010-05-03 2013-03-13 F. Hoffmann-La Roche AG Compositions and methods useful for reducing the viscosity of protein-containing formulations
CN103402516B (zh) * 2010-06-17 2018-01-30 富津世生物技术有限公司 用作抗病毒药物的化合物、组合物及使用方法
CN103429264A (zh) * 2011-03-31 2013-12-04 默沙东公司 针对人程序性死亡受体pd-1的抗体的稳定制剂和有关的治疗
CN102532319A (zh) * 2011-12-28 2012-07-04 暨南大学 二硫键稳定的抗bFGF人源双链抗体及其制备方法与应用
FR2994390B1 (fr) 2012-08-10 2014-08-15 Adocia Procede d'abaissement de la viscosite de solutions de proteines a concentration elevee
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TN2017000440A1 (en) * 2015-04-17 2019-04-12 Bristol Myers Squibb Co Compositions comprising a combination of an anti-pd-1 antibody and another antibody

Also Published As

Publication number Publication date
EP3678700A4 (en) 2021-04-28
US20220378916A1 (en) 2022-12-01
KR20200051687A (ko) 2020-05-13
RU2020112302A3 (es) 2021-10-20
CA3074565A1 (en) 2019-03-14
JP2020532562A (ja) 2020-11-12
US20200206350A1 (en) 2020-07-02
EP3678700A1 (en) 2020-07-15
CN111107873A (zh) 2020-05-05
RU2020112302A (ru) 2021-10-06
AU2018328015A1 (en) 2020-03-05
WO2019050780A1 (en) 2019-03-14
BR112020004325A2 (pt) 2020-10-06

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