CR20200240A - Stable pharmaceutical formulation of a fusion protein - Google Patents

Stable pharmaceutical formulation of a fusion protein

Info

Publication number
CR20200240A
CR20200240A CR20200240A CR20200240A CR20200240A CR 20200240 A CR20200240 A CR 20200240A CR 20200240 A CR20200240 A CR 20200240A CR 20200240 A CR20200240 A CR 20200240A CR 20200240 A CR20200240 A CR 20200240A
Authority
CR
Costa Rica
Prior art keywords
fusion protein
formulation
etanercept
pharmaceutical formulation
stable pharmaceutical
Prior art date
Application number
CR20200240A
Other languages
Spanish (es)
Inventor
Hernández Mariana Patricia Miranda
García Víctor Raúl Campos
Blanca Sánchez Lilia Tierra
Lara Nelly Piña
Flores Rodolfo Daniel Salazar
Ortíz Luis Francisco Flores
Ramírez Néstor Octavio Pérez
De La Garza Carlos Eduardo Espinoza
Alcántara María De Lourdes Muciño
Ceballos Rodolfo Alazar
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 CR20200240A publication Critical patent/CR20200240A/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 Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

The present invention describes a new liquid formulation of etanercept, a recombinant fusion protein TNFR:Fc targeted against TNFa in a high concentration (20 to 100 mg/mL), in the presence of a pH buffer solution of histidine or succinate, which maintain a pH between 5.8 and 6.8, with added polysorbate, sucrose or trehalose, and mannitol used as a tonicity agent. This formulation uses fewer excipients than the formulations described in the prior art and in a combination that has never been used before. In addition, the formulation has a reduced percentage of impurities and greater thermostability than the liquid formula of Enbrel®, while maintaining the physicochemical identity and biological potency of etanercept.
CR20200240A 2017-10-31 2018-10-31 Stable pharmaceutical formulation of a fusion protein CR20200240A (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
CR20200240A true CR20200240A (en) 2020-09-15

Family

ID=66331521

Family Applications (1)

Application Number Title Priority Date Filing Date
CR20200240A CR20200240A (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
US20110318349A1 (en) * 2010-06-24 2011-12-29 Abbott Laboratories Dual variable domain immunoglobulins and uses thereof
UY34105A (en) * 2011-06-03 2012-07-31 Lg Life Sciences Ltd STABLE LIQUID FORMULATION OF ETANERCEPT
TW201325606A (en) * 2011-10-18 2013-07-01 Coherus Biosciences Inc Etanercept formulations stabilized with sodium chloride
JP2015525762A (en) * 2012-07-09 2015-09-07 コヒラス・バイオサイエンシズ・インコーポレイテッド Stable aqueous formulation of etanercept

Also Published As

Publication number Publication date
DOP2020000079A (en) 2020-09-15
WO2019087108A1 (en) 2019-05-09
PE20201348A1 (en) 2020-11-30
MX2017013995A (en) 2019-05-01
CL2020001122A1 (en) 2020-10-02

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