MX2017013995A - Formulacion farmaceutica estable de una proteina de fusion. - Google Patents
Formulacion farmaceutica estable de una proteina de fusion.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 That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
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(r), 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.
Priority Applications (6)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| MX2017013995A MX2017013995A (es) | 2017-10-31 | 2017-10-31 | Formulacion farmaceutica estable de una proteina de fusion. |
| PE2020000610A PE20201348A1 (es) | 2017-10-31 | 2018-10-31 | Formulacion farmaceutica estable de una proteina de fusion |
| CR20200240A CR20200240A (es) | 2017-10-31 | 2018-10-31 | Formulación farmacéutica estable de una proteína de fusión |
| PCT/IB2018/058555 WO2019087108A1 (es) | 2017-10-31 | 2018-10-31 | Formulación farmacéutica estable de una proteína de fusión |
| CL2020001122A CL2020001122A1 (es) | 2017-10-31 | 2020-04-28 | Formulación farmacéutica estable de una proteína de fusión. |
| DO2020000079A DOP2020000079A (es) | 2017-10-31 | 2020-05-06 | Formulación farmacéutica estable de una proteína de fusión |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| MX2017013995A MX2017013995A (es) | 2017-10-31 | 2017-10-31 | Formulacion farmaceutica estable de una proteina de fusion. |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| MX2017013995A true MX2017013995A (es) | 2019-05-01 |
Family
ID=66331521
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MX2017013995A MX2017013995A (es) | 2017-10-31 | 2017-10-31 | Formulacion farmaceutica estable de una proteina de fusion. |
Country Status (6)
| Country | Link |
|---|---|
| CL (1) | CL2020001122A1 (es) |
| CR (1) | CR20200240A (es) |
| DO (1) | DOP2020000079A (es) |
| MX (1) | MX2017013995A (es) |
| PE (1) | PE20201348A1 (es) |
| WO (1) | WO2019087108A1 (es) |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| PE20130614A1 (es) * | 2010-06-24 | 2013-07-01 | Abbvie Inc | Inmunoglobulinas con dominio variable dual y su uso |
| UY34105A (es) * | 2011-06-03 | 2012-07-31 | Lg Life Sciences Ltd | Formulación líquida estable de etanercept |
| TWI595883B (zh) * | 2011-10-18 | 2017-08-21 | 柯赫勒斯生物科學有限公司 | 用木糖醇穩定化之依那西普調配物 |
| WO2014011672A1 (en) * | 2012-07-09 | 2014-01-16 | Coherus Biosciences, Inc. | Etanercept formulations exhibiting marked reduction in sub-visible particles |
-
2017
- 2017-10-31 MX MX2017013995A patent/MX2017013995A/es unknown
-
2018
- 2018-10-31 CR CR20200240A patent/CR20200240A/es unknown
- 2018-10-31 WO PCT/IB2018/058555 patent/WO2019087108A1/es not_active Ceased
- 2018-10-31 PE PE2020000610A patent/PE20201348A1/es unknown
-
2020
- 2020-04-28 CL CL2020001122A patent/CL2020001122A1/es unknown
- 2020-05-06 DO DO2020000079A patent/DOP2020000079A/es unknown
Also Published As
| Publication number | Publication date |
|---|---|
| PE20201348A1 (es) | 2020-11-30 |
| DOP2020000079A (es) | 2020-09-15 |
| WO2019087108A1 (es) | 2019-05-09 |
| CL2020001122A1 (es) | 2020-10-02 |
| CR20200240A (es) | 2020-09-15 |
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