MX2017013995A - Formulacion farmaceutica estable de una proteina de fusion. - Google Patents

Formulacion farmaceutica estable de una proteina de fusion.

Info

Publication number
MX2017013995A
MX2017013995A MX2017013995A MX2017013995A MX2017013995A MX 2017013995 A MX2017013995 A MX 2017013995A MX 2017013995 A MX2017013995 A MX 2017013995A MX 2017013995 A MX2017013995 A MX 2017013995A MX 2017013995 A MX2017013995 A MX 2017013995A
Authority
MX
Mexico
Prior art keywords
fusion protein
formulation
etanercept
pharmaceutical formulation
stable pharmaceutical
Prior art date
Application number
MX2017013995A
Other languages
English (en)
Inventor
Eduardo Espinosa De La Garza Carlos
Raúl Campos García Víctor
De Lourdes Muciño Alcántara Maria
PIÑA LARA Nelly
Patricia Miranda Hernández Mariana
TIERRABLANCA SÁNCHEZ Lilia
Daniel Salazar Flores Rodolfo
SALAZAR CEBALLOS Rodolfo
Francisco Flores Ortiz Luis
Octavio Pérez Ramírez Néstor
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 MX2017013995A priority Critical patent/MX2017013995A/es
Priority to PCT/IB2018/058555 priority patent/WO2019087108A1/es
Priority to PE2020000610A priority patent/PE20201348A1/es
Priority to CR20200240A priority patent/CR20200240A/es
Publication of MX2017013995A publication Critical patent/MX2017013995A/es
Priority to CL2020001122A priority patent/CL2020001122A1/es
Priority to DO2020000079A priority patent/DOP2020000079A/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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/52—Cytokines; Lymphokines; Interferons
    • C07K14/525—Tumour necrosis factor [TNF]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies

Abstract

La presente invención describe una nueva formulación líquida para Etanercept, una proteína de fusión recombinante TNFR:Fc dirigida contra el TNFa en alta concentración (20 a 100 mg/mL), en presencia de una solución amortiguadora de pH de histidina o succinato, que mantienen un pH en el intervalo de 5.8 a 6.8, adicionadas con polisorbato, sacarosa o trehalosa, y manitol utilizado como agente tonificante. Esta formulación hace uso de un menor número de excipientes que las formulaciones descritas en el estado de la técnica y en una combinación nunca antes utilizada. Además, presenta un porcentaje de impurezas disminuido y una termoestabilidad incrementada a la formula líquida de Enbrel(r), mientras se mantiene la identidad fisicoquímica y potencia biológica de Etanercept. Por último, esta formulación es útil para contener Etanercept en su uso comercial como agente bioterapéutico de administración parenteral para tratar enfermedades autoinmunes en las cuales se presenta una elevación patológica del TNFa.
MX2017013995A 2017-10-31 2017-10-31 Formulacion farmaceutica estable de una proteina de fusion. MX2017013995A (es)

Priority Applications (6)

Application Number Priority Date Filing Date Title
MX2017013995A MX2017013995A (es) 2017-10-31 2017-10-31 Formulacion farmaceutica estable de una proteina de fusion.
PCT/IB2018/058555 WO2019087108A1 (es) 2017-10-31 2018-10-31 Formulación farmacéutica estable de una proteína de fusión
PE2020000610A PE20201348A1 (es) 2017-10-31 2018-10-31 Formulacion farmaceutica estable de una proteina de fusion
CR20200240A CR20200240A (es) 2017-10-31 2018-10-31 Formulación farmacéutica estable de una proteína de fusión
CL2020001122A CL2020001122A1 (es) 2017-10-31 2020-04-28 Formulación farmacéutica estable de una proteína de fusión.
DO2020000079A DOP2020000079A (es) 2017-10-31 2020-05-06 Formulación farmacéutica estable de una proteína de fusión

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
MX2017013995A MX2017013995A (es) 2017-10-31 2017-10-31 Formulacion farmaceutica estable de una proteina de fusion.

Publications (1)

Publication Number Publication Date
MX2017013995A true MX2017013995A (es) 2019-05-01

Family

ID=66331521

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2017013995A MX2017013995A (es) 2017-10-31 2017-10-31 Formulacion farmaceutica estable de una proteina de fusion.

Country Status (6)

Country Link
CL (1) CL2020001122A1 (es)
CR (1) CR20200240A (es)
DO (1) DOP2020000079A (es)
MX (1) MX2017013995A (es)
PE (1) PE20201348A1 (es)
WO (1) WO2019087108A1 (es)

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2011270848A1 (en) * 2010-06-24 2013-02-07 Abbvie Inc. Dual variable domain immunoglobulins and uses thereof
UY34105A (es) * 2011-06-03 2012-07-31 Lg Life Sciences Ltd Formulación líquida estable de etanercept
WO2013059406A1 (en) * 2011-10-18 2013-04-25 Coherus Biosciences, Inc. Etanercept formulations stabilized with metal ions
EP2869817A4 (en) * 2012-07-09 2016-04-06 Coherus Biosciences Inc STABLE AQUEOUS FORMULATIONS OF ETANERCEPT

Also Published As

Publication number Publication date
WO2019087108A1 (es) 2019-05-09
PE20201348A1 (es) 2020-11-30
DOP2020000079A (es) 2020-09-15
CL2020001122A1 (es) 2020-10-02
CR20200240A (es) 2020-09-15

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