DOP2020000079A - STABLE PHARMACEUTICAL FORMULATION OF A FUSION PROTEIN - Google Patents

STABLE PHARMACEUTICAL FORMULATION OF A FUSION PROTEIN

Info

Publication number
DOP2020000079A
DOP2020000079A DO2020000079A DO2020000079A DOP2020000079A DO P2020000079 A DOP2020000079 A DO P2020000079A DO 2020000079 A DO2020000079 A DO 2020000079A DO 2020000079 A DO2020000079 A DO 2020000079A DO P2020000079 A DOP2020000079 A DO P2020000079A
Authority
DO
Dominican Republic
Prior art keywords
etanercept
formulation
fusion protein
tnfa
pharmaceutical formulation
Prior art date
Application number
DO2020000079A
Other languages
Spanish (es)
Inventor
Eduardo Espinosa De La Garza Carlos
Raul Campos Garcia Victor
PIÑA LARA Nelly
Patricia Miranda Hernandez Mariana
Tierrablanca Sanchez Lilia
Daniel Salazar Flores Rodolfo
SALAZAR CEBALLOS Rodolfo
Francisco Flores Ortiz Luis
Octavio Perez Ramirez Nestor
De Lourdes Muciño Alcantara Maria
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
Publication of DOP2020000079A publication Critical patent/DOP2020000079A/en

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®, 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.The present invention describes a new liquid formulation for Etanercept, a recombinant TNFR: Fc fusion protein directed against TNFa in high concentration (20 to 100 mg / mL), in the presence of a histidine or succinate pH buffer, which maintains a pH in the range of 5.8 to 6.8, added with polysorbate, sucrose or trehalose, and mannitol used as a toning agent. This formulation makes use of a smaller number of excipients than the formulations described in the state of the art and in a combination never used before. In addition, it presents a decreased percentage of impurities and increased thermostability to the liquid Enbrel® formula, while maintaining the physicochemical identity and biological potency of Etanercept. Finally, this formulation is useful to contain Etanercept in its commercial use as a biotherapeutic agent for parenteral administration to treat autoimmune diseases in which there is a pathological elevation of TNFa.

DO2020000079A 2017-10-31 2020-05-06 STABLE PHARMACEUTICAL FORMULATION OF A FUSION PROTEIN DOP2020000079A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
MX2017013995A MX2017013995A (en) 2017-10-31 2017-10-31 Stable pharmaceutical formulation of a fusion protein.
PCT/IB2018/058555 WO2019087108A1 (en) 2017-10-31 2018-10-31 Stable pharmaceutical formulation of a fusion protein

Publications (1)

Publication Number Publication Date
DOP2020000079A true DOP2020000079A (en) 2020-09-15

Family

ID=66331521

Family Applications (1)

Application Number Title Priority Date Filing Date
DO2020000079A DOP2020000079A (en) 2017-10-31 2020-05-06 STABLE PHARMACEUTICAL FORMULATION OF A FUSION PROTEIN

Country Status (6)

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

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BR112012032778A2 (en) * 2010-06-24 2019-09-24 Abbvie Inc "multispecific and multivalent proteins"
UY34105A (en) * 2011-06-03 2012-07-31 Lg Life Sciences Ltd STABLE LIQUID FORMULATION OF ETANERCEPT
MX2014004725A (en) * 2011-10-18 2015-02-05 Coherus Biosciences Inc Etanercept formulations stabilized with amino acids.
EP2869817A4 (en) * 2012-07-09 2016-04-06 Coherus Biosciences Inc Stable aqueous formulations of etanercept

Also Published As

Publication number Publication date
CR20200240A (en) 2020-09-15
WO2019087108A1 (en) 2019-05-09
MX2017013995A (en) 2019-05-01
CL2020001122A1 (en) 2020-10-02
PE20201348A1 (en) 2020-11-30

Similar Documents

Publication Publication Date Title
PE20170780A1 (en) STABLE FORMULATION OF PROTEIN IN SOLUTION CONTAINING A HIGH CONCENTRATION OF AN ANTI-VEGF ANTIBODY
PE20200513A1 (en) STABLE FORMULATIONS OF ANTIBODIES AGAINST PROGRAMMED DEATH RECEIVER 1 (PD-1) AND METHODS FOR THEIR USE
KR20190053214A (en) Stabilized non-protein clostridial toxin composition
AR109494A1 (en) FORMULATIONS OF INHIBITING ANTIBODIES OF LOW VISCOSITY MASP-2 AND HIGHLY CONCENTRATED, KITS, AND METHODS
Mühl et al. IL-18/IL-18BP and IL-22/IL-22BP: two interrelated couples with therapeutic potential
EP4233892A3 (en) Stable anti-ifnar1 formulation
PE20190448A1 (en) STABLE LIQUID PHARMACEUTICAL FORMULATION
BRPI0717441B8 (en) compound, drug, and use of the metastin derivative
BR112014028600A8 (en) Suspension formulations comprising high concentration monoclonal antibody, its method of preparation, its use and device for its subcutaneous administration, and method for producing an article of manufacture
AR071852A1 (en) PHARMACEUTICAL FORMULATION OF AN ANTIBODY AGAINST OX40L
WO2012141978A2 (en) Formulations with reduced viscosity
JP2019529506A (en) New formulation
RU2017146657A (en) PROCEDURES CONTAINING HYALURONIC ACID CONJUGATE, LIQUEURER AND DOUBLE AGONIST GLP-1GLUCAGON
EP2694100A1 (en) Formulations with reduced viscosity
Evers et al. Peptide optimization at the drug discovery-development interface: tailoring of physicochemical properties toward specific formulation requirements
EA201892493A1 (en) Neurotoxin liquid formulation stabilized by tryptophane or tyrosine
PE20230819A1 (en) COMPOSITIONS AND USES OF GLP-1
AR111229A1 (en) WATER FORMULATION OF ANTIBODY
BR112021015751A2 (en) Gene therapy vectors for the treatment of danon's disease
BR112022003169A2 (en) Anti-IL-23p19 Antibody Formulations
DOP2020000079A (en) STABLE PHARMACEUTICAL FORMULATION OF A FUSION PROTEIN
Blanchard et al. Respiratory infections associated with anti-TNFα agents
ECSP21043639A (en) PROTEIN SOLUTION FORMULATION CONTAINING A HIGH CONCENTRATION OF AN ANTI-VEGF ANTIBODY
WO2015150968A2 (en) Lyophilized pharmaceutical composition of fc-peptide fusion protein
ES2922481T3 (en) Lyophilized pharmaceutical formulation and its use