PE20201348A1 - STABLE PHARMACEUTICAL FORMULATION OF A FUSION PROTEIN - Google Patents

STABLE PHARMACEUTICAL FORMULATION OF A FUSION PROTEIN

Info

Publication number
PE20201348A1
PE20201348A1 PE2020000610A PE2020000610A PE20201348A1 PE 20201348 A1 PE20201348 A1 PE 20201348A1 PE 2020000610 A PE2020000610 A PE 2020000610A PE 2020000610 A PE2020000610 A PE 2020000610A PE 20201348 A1 PE20201348 A1 PE 20201348A1
Authority
PE
Peru
Prior art keywords
etanercept
formulation
fusion protein
tnfalpha
pharmaceutical formulation
Prior art date
Application number
PE2020000610A
Other languages
Spanish (es)
Inventor
De La Garza Carlos Eduardo Espinosa
Alcantara Maria De Lourdes Mucino
Garcia Victor Raul Campos
Lara Nelly Pina
Hernandez Mariana Patricia Miranda
Sanchez Lilia Tierrablanca
Flores Rodolfo Daniel Salazar
Ceballos Rodolfo Salazar
Ortiz Luis Francisco Flores
Ramirez Nestor Octavio Perez
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 PE20201348A1 publication Critical patent/PE20201348A1/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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Immunology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Zoology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Toxicology (AREA)
  • Rheumatology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Abstract

La presente invencion describe una nueva formulacion liquida para Etanercept, una proteina de fusion recombinante TNFR:Fc dirigida contra el TNFalfa en alta concentracion (20 a 100 mg/mL), en presencia de una solucion 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 formulacion hace uso de un menor numero de excipientes que las formulaciones descritas en el estado de la tecnica y en una combinacion nunca antes utilizada. Ademas, presenta un porcentaje de impurezas disminuido y una termoestabilidad incrementada a la formula liquida de Enbrel®, mientras se mantiene la identidad fisicoquimica y potencia biologica de Etanercept. Por ultimo, esta formulacion es util para contener Etanercept en su uso comercial como agente bioterapeutico de administracion parenteral para tratar enfermedades autoinmunes en las cuales se presenta una elevacion patologica del TNFalfaThe present invention describes a new liquid formulation for Etanercept, a recombinant fusion protein TNFR: Fc directed against TNFalpha 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 an 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 a pathological elevation of TNFalpha occurs.

PE2020000610A 2017-10-31 2018-10-31 STABLE PHARMACEUTICAL FORMULATION OF A FUSION PROTEIN PE20201348A1 (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
PE20201348A1 true PE20201348A1 (en) 2020-11-30

Family

ID=66331521

Family Applications (1)

Application Number Title Priority Date Filing Date
PE2020000610A PE20201348A1 (en) 2017-10-31 2018-10-31 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
KR20130043168A (en) * 2010-06-24 2013-04-29 아비에 인코포레이티드 Dual variable domain immunoglobulins and uses thereof
UY34105A (en) * 2011-06-03 2012-07-31 Lg Life Sciences Ltd STABLE LIQUID FORMULATION OF ETANERCEPT
WO2013059410A1 (en) * 2011-10-18 2013-04-25 Coherus Biosciences, Inc. Etanercept formulations stabilized with xylitol
EA029193B1 (en) * 2012-07-09 2018-02-28 Кохерус Байосайенсис, Инк. Etanercept formulations exhibiting marked reduction in sub-visible particles

Also Published As

Publication number Publication date
DOP2020000079A (en) 2020-09-15
CL2020001122A1 (en) 2020-10-02
WO2019087108A1 (en) 2019-05-09
CR20200240A (en) 2020-09-15
MX2017013995A (en) 2019-05-01

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