CR20200240A - Stable pharmaceutical formulation of a fusion protein - Google Patents
Stable pharmaceutical formulation of a fusion proteinInfo
- 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
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
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.
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)
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 |
EA028520B1 (en) * | 2011-10-18 | 2017-11-30 | Кохерус Байосайенсис, Инк. | Etanercept formulations stabilized with meglumine |
AU2013290289B2 (en) * | 2012-07-09 | 2018-03-29 | Coherus Biosciences, Inc. | Etanercept formulations exhibiting marked reduction in sub-visible particles |
-
2017
- 2017-10-31 MX MX2017013995A patent/MX2017013995A/en unknown
-
2018
- 2018-10-31 PE PE2020000610A patent/PE20201348A1/en unknown
- 2018-10-31 WO PCT/IB2018/058555 patent/WO2019087108A1/en active Application Filing
- 2018-10-31 CR CR20200240A patent/CR20200240A/en unknown
-
2020
- 2020-04-28 CL CL2020001122A patent/CL2020001122A1/en unknown
- 2020-05-06 DO DO2020000079A patent/DOP2020000079A/en unknown
Also Published As
Publication number | Publication date |
---|---|
PE20201348A1 (en) | 2020-11-30 |
CL2020001122A1 (en) | 2020-10-02 |
DOP2020000079A (en) | 2020-09-15 |
MX2017013995A (en) | 2019-05-01 |
WO2019087108A1 (en) | 2019-05-09 |
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