MX2017016884A - Formulacion farmaceutica estable de una proteina anti-tnfa. - Google Patents

Formulacion farmaceutica estable de una proteina anti-tnfa.

Info

Publication number
MX2017016884A
MX2017016884A MX2017016884A MX2017016884A MX2017016884A MX 2017016884 A MX2017016884 A MX 2017016884A MX 2017016884 A MX2017016884 A MX 2017016884A MX 2017016884 A MX2017016884 A MX 2017016884A MX 2017016884 A MX2017016884 A MX 2017016884A
Authority
MX
Mexico
Prior art keywords
formulation
tnf
adalimumab
protein
pharmaceutical formulation
Prior art date
Application number
MX2017016884A
Other languages
English (en)
Inventor
Raúl Campos García Víctor
PIÑA LARA Nelly
Patricia Miranda Hernández Mariana
SALAZAR CEBALLOS Rodolfo
Octavio Pérez Ramírez Néstor
Eduardo Epinosa De La Garza Carlos
De Lourdes MUCIÑO ALCÁNTARA María
GONZÁLEZ SANTOYO Germán
Bolivar Vichido Mariana
Germán Hernández García Antonio
Jardón Castillo Maribel
Pérez Medina Martínez Victor
Original Assignee
Probiomed S A De C V
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 Probiomed S A De C V filed Critical Probiomed S A De C V
Priority to MX2017016884A priority Critical patent/MX2017016884A/es
Priority to PCT/IB2018/060293 priority patent/WO2019123283A1/es
Publication of MX2017016884A publication Critical patent/MX2017016884A/es

Links

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
    • 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
    • A61K47/12—Carboxylic acids; Salts or anhydrides 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
    • A61K47/26—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
    • 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
    • C07K16/24—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons

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)
  • Immunology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Mycology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Microbiology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Abstract

La presente invención describe una nueva formulación líquida para Adalimumab, un anticuerpo monoclonal recombinante dirigido contra el TNFa en alta concentración (20 a 100 mg/mL), en presencia de una solución amortiguadora de pH de citratos, que mantiene un pH de 5.2, adicionada con polisorbato, manitol y cloruro de sodio utilizado como agente tonificante. Esta formulación hace uso de un menor número de excipientes que la formulación descrita en el estado de la técnica, mientras que mantiene las propiedades fisicoquímicas, biológicas, farmacológicas y de seguridad de Adalimumab. Por último, esta formulación es útil para contener Adalimumab en su uso comercial como agente bioterapéutico de administración parenteral para tratar enfermedades autoinmunes en las cuales se presenta una elevación patológica del TNFa.
MX2017016884A 2017-12-19 2017-12-19 Formulacion farmaceutica estable de una proteina anti-tnfa. MX2017016884A (es)

Priority Applications (2)

Application Number Priority Date Filing Date Title
MX2017016884A MX2017016884A (es) 2017-12-19 2017-12-19 Formulacion farmaceutica estable de una proteina anti-tnfa.
PCT/IB2018/060293 WO2019123283A1 (es) 2017-12-19 2018-12-19 Formulación farmacéutica estable de una proteína anti-tnfα

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
MX2017016884A MX2017016884A (es) 2017-12-19 2017-12-19 Formulacion farmaceutica estable de una proteina anti-tnfa.

Publications (1)

Publication Number Publication Date
MX2017016884A true MX2017016884A (es) 2019-06-20

Family

ID=66993169

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2017016884A MX2017016884A (es) 2017-12-19 2017-12-19 Formulacion farmaceutica estable de una proteina anti-tnfa.

Country Status (2)

Country Link
MX (1) MX2017016884A (es)
WO (1) WO2019123283A1 (es)

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040033228A1 (en) * 2002-08-16 2004-02-19 Hans-Juergen Krause Formulation of human antibodies for treating TNF-alpha associated disorders
PE20142275A1 (es) * 2012-03-07 2015-01-08 Lilly Co Eli Formulacion de anticuerpo il-17
ES2607489T3 (es) * 2014-05-23 2017-03-31 Ares Trading S.A. Composición farmacéutica líquida
EP3250598A1 (en) * 2015-01-28 2017-12-06 Mabxience S.A. Pharmaceutical formulations for anti-tnf-alpha antibodies

Also Published As

Publication number Publication date
WO2019123283A1 (es) 2019-06-27

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