MX2017013995A - Stable pharmaceutical formulation of a fusion protein. - Google Patents
Stable pharmaceutical formulation of a fusion protein.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
Links
- 108020001507 fusion proteins Proteins 0.000 title 1
- 102000037865 fusion proteins Human genes 0.000 title 1
- 239000008194 pharmaceutical composition Substances 0.000 title 1
- 108010008165 Etanercept Proteins 0.000 abstract 3
- 238000009472 formulation Methods 0.000 abstract 3
- 239000000203 mixture Substances 0.000 abstract 3
- 229960000403 etanercept Drugs 0.000 abstract 2
- HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 abstract 1
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 abstract 1
- HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 abstract 1
- 229930195725 Mannitol Natural products 0.000 abstract 1
- 102000007056 Recombinant Fusion Proteins Human genes 0.000 abstract 1
- 108010008281 Recombinant Fusion Proteins Proteins 0.000 abstract 1
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 abstract 1
- 229930006000 Sucrose Natural products 0.000 abstract 1
- HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 abstract 1
- 108060008683 Tumor Necrosis Factor Receptor Proteins 0.000 abstract 1
- HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 abstract 1
- 239000007853 buffer solution Substances 0.000 abstract 1
- 229940073621 enbrel Drugs 0.000 abstract 1
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 abstract 1
- 239000012535 impurity Substances 0.000 abstract 1
- 239000007788 liquid Substances 0.000 abstract 1
- 239000012669 liquid formulation Substances 0.000 abstract 1
- 239000000594 mannitol Substances 0.000 abstract 1
- 235000010355 mannitol Nutrition 0.000 abstract 1
- 239000000546 pharmaceutical excipient Substances 0.000 abstract 1
- 229950008882 polysorbate Drugs 0.000 abstract 1
- 229920000136 polysorbate Polymers 0.000 abstract 1
- KDYFGRWQOYBRFD-UHFFFAOYSA-L succinate(2-) Chemical compound [O-]C(=O)CCC([O-])=O KDYFGRWQOYBRFD-UHFFFAOYSA-L 0.000 abstract 1
- 239000005720 sucrose Substances 0.000 abstract 1
- 239000012929 tonicity agent Substances 0.000 abstract 1
- 102000003298 tumor necrosis factor receptor Human genes 0.000 abstract 1
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 TNF? 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.
Priority Applications (6)
| 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 |
| PE2020000610A PE20201348A1 (en) | 2017-10-31 | 2018-10-31 | STABLE PHARMACEUTICAL FORMULATION OF A FUSION PROTEIN |
| CR20200240A CR20200240A (en) | 2017-10-31 | 2018-10-31 | Stable pharmaceutical formulation of a fusion protein |
| CL2020001122A CL2020001122A1 (en) | 2017-10-31 | 2020-04-28 | Stable pharmaceutical formulation of a fusion protein. |
| DO2020000079A DOP2020000079A (en) | 2017-10-31 | 2020-05-06 | STABLE PHARMACEUTICAL FORMULATION OF A FUSION PROTEIN |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| MX2017013995A MX2017013995A (en) | 2017-10-31 | 2017-10-31 | Stable pharmaceutical formulation of a fusion protein. |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| MX2017013995A true MX2017013995A (en) | 2019-05-01 |
Family
ID=66331521
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MX2017013995A MX2017013995A (en) | 2017-10-31 | 2017-10-31 | 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 |
|---|---|---|---|---|
| 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 |
| AU2012326171B2 (en) * | 2011-10-18 | 2017-03-09 | Coherus Biosciences, Inc. | Etanercept formulations stabilized with sodium chloride |
| WO2014011629A1 (en) * | 2012-07-09 | 2014-01-16 | Coherus Biosciences, Inc. | Stable aqueous formulations of etanercept |
-
2017
- 2017-10-31 MX MX2017013995A patent/MX2017013995A/en unknown
-
2018
- 2018-10-31 PE PE2020000610A patent/PE20201348A1/en unknown
- 2018-10-31 CR CR20200240A patent/CR20200240A/en unknown
- 2018-10-31 WO PCT/IB2018/058555 patent/WO2019087108A1/en active Application Filing
-
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 |
|---|---|
| CR20200240A (en) | 2020-09-15 |
| WO2019087108A1 (en) | 2019-05-09 |
| CL2020001122A1 (en) | 2020-10-02 |
| PE20201348A1 (en) | 2020-11-30 |
| DOP2020000079A (en) | 2020-09-15 |
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