MX2019009952A - Formulaciones de evolocumab de baja viscosidad y alta concentracion y metodos de elaboracion de las mismas. - Google Patents
Formulaciones de evolocumab de baja viscosidad y alta concentracion y metodos de elaboracion de las mismas.Info
- Publication number
- MX2019009952A MX2019009952A MX2019009952A MX2019009952A MX2019009952A MX 2019009952 A MX2019009952 A MX 2019009952A MX 2019009952 A MX2019009952 A MX 2019009952A MX 2019009952 A MX2019009952 A MX 2019009952A MX 2019009952 A MX2019009952 A MX 2019009952A
- Authority
- MX
- Mexico
- Prior art keywords
- formulations
- methods
- viscosity
- concentration
- making
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title abstract 5
- 238000009472 formulation Methods 0.000 title abstract 4
- 229960002027 evolocumab Drugs 0.000 title abstract 2
- 238000000034 method Methods 0.000 title abstract 2
- 101001098868 Homo sapiens Proprotein convertase subtilisin/kexin type 9 Proteins 0.000 abstract 3
- 102100038955 Proprotein convertase subtilisin/kexin type 9 Human genes 0.000 abstract 3
- SNEIUMQYRCDYCH-LURJTMIESA-N N(alpha)-acetyl-L-arginine Chemical compound CC(=O)N[C@H](C(O)=O)CCCNC(N)=N SNEIUMQYRCDYCH-LURJTMIESA-N 0.000 abstract 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 abstract 2
- 229920001184 polypeptide Polymers 0.000 abstract 2
- 102000004196 processed proteins & peptides Human genes 0.000 abstract 2
- 108090000765 processed proteins & peptides Proteins 0.000 abstract 2
- 201000010099 disease Diseases 0.000 abstract 1
Classifications
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- 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
- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
- A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
-
- 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
- A61K39/39591—Stabilisation, fragmentation
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/06—Antihyperlipidemics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/14—Extraction; Separation; Purification
- C07K1/16—Extraction; Separation; Purification by chromatography
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/14—Extraction; Separation; Purification
- C07K1/36—Extraction; Separation; Purification by a combination of two or more processes of different types
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/06—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
- C07K16/065—Purification, fragmentation
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/22—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/40—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against enzymes
-
- 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
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
- C07K2317/565—Complementarity determining region [CDR]
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
- C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
- C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance
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)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Immunology (AREA)
- Biochemistry (AREA)
- Engineering & Computer Science (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Analytical Chemistry (AREA)
- Dermatology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Endocrinology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Diabetes (AREA)
- Hematology (AREA)
- Obesity (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
Se proporcionan en el presente documento formulaciones de polipéptidos de unión a PCSK9, tales como las que comprenden evolocumab, que comprenden N-acetil arginina y tienen viscosidades reducidas en comparación con formulaciones que carecen de N-acetil arginina. También se proporcionan en el presente documento métodos para formular dichas composiciones que son ventajosas en cuanto conservan determinados componentes. Dichas formulaciones que comprenden polipéptidos de unión a PCSK9 se pueden administrar a pacientes para tratar y/o prevenir enfermedades, afecciones y trastornos relacionados con PCSK9.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201762462266P | 2017-02-22 | 2017-02-22 | |
| PCT/US2018/019189 WO2018156741A1 (en) | 2017-02-22 | 2018-02-22 | Low-viscosity, high-concentration evolocumab formulations and methods of making the same |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| MX2019009952A true MX2019009952A (es) | 2019-10-14 |
Family
ID=61617101
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MX2019009952A MX2019009952A (es) | 2017-02-22 | 2018-02-22 | Formulaciones de evolocumab de baja viscosidad y alta concentracion y metodos de elaboracion de las mismas. |
Country Status (18)
| Country | Link |
|---|---|
| US (2) | US11464857B2 (es) |
| EP (1) | EP3585821A1 (es) |
| JP (1) | JP7377596B2 (es) |
| KR (2) | KR20190120257A (es) |
| CN (1) | CN110536906A (es) |
| AR (2) | AR110938A1 (es) |
| AU (1) | AU2018224095A1 (es) |
| BR (1) | BR112019017393A8 (es) |
| CA (1) | CA3053394A1 (es) |
| CL (1) | CL2019002362A1 (es) |
| EA (1) | EA201991951A1 (es) |
| IL (1) | IL268515B1 (es) |
| MA (1) | MA47601A (es) |
| MX (1) | MX2019009952A (es) |
| SG (1) | SG11201907505TA (es) |
| TW (1) | TWI833690B (es) |
| UY (1) | UY37611A (es) |
| WO (1) | WO2018156741A1 (es) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SG11201703152RA (en) | 2014-10-23 | 2017-05-30 | Amgen Inc | Reducing viscosity of pharmaceutical formulations |
| CN108239150A (zh) | 2016-12-24 | 2018-07-03 | 信达生物制药(苏州)有限公司 | 抗pcsk9抗体及其用途 |
| JP7377596B2 (ja) | 2017-02-22 | 2023-11-10 | アムジエン・インコーポレーテツド | 低粘度、高濃度エボロクマブ製剤及びそれらの製造方法 |
| CA3141857A1 (en) * | 2019-04-23 | 2020-10-29 | Amgen Inc. | The use of low molecular weight polyvinylpyrrolidone (pvp) to reduce viscosity of high concentration protein formulations |
| WO2022217021A1 (en) * | 2021-04-09 | 2022-10-13 | Avantor Performance Materials, Llc | Performance-enhancing excipients and methods of reducing viscosity and increasing stability of biologic formulations |
Family Cites Families (25)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5078997A (en) | 1988-07-13 | 1992-01-07 | Cetus Corporation | Pharmaceutical composition for interleukin-2 containing physiologically compatible stabilizers |
| US5955448A (en) | 1994-08-19 | 1999-09-21 | Quadrant Holdings Cambridge Limited | Method for stabilization of biological substances during drying and subsequent storage and compositions thereof |
| US6767892B1 (en) | 1997-11-07 | 2004-07-27 | Chrion Corporation | Compositions providing for increased IGF-I solubility |
| AU3070702A (en) | 2000-11-07 | 2002-05-21 | Chiron Corp | Stabilized inteferon compositions |
| SI1478394T1 (sl) | 2002-02-27 | 2008-12-31 | Immunex Corp | STABILIZIRAN TNFR-Fc SESTAVEK Z ARGININOM |
| US20040191243A1 (en) | 2002-12-13 | 2004-09-30 | Bei Chen | System and method for stabilizing antibodies with histidine |
| EP1589996A4 (en) | 2003-01-30 | 2009-01-21 | Medimmune Inc | ANTI-INTEGRIN ALPHA BETA 3 ANTIBODY FORMULATIONS AND ITS USES |
| ZA200507757B (en) | 2003-04-04 | 2007-01-31 | Genentech Inc | High concentration antibody and protein formulations |
| US20060051347A1 (en) | 2004-09-09 | 2006-03-09 | Winter Charles M | Process for concentration of antibodies and therapeutic products thereof |
| WO2007074880A1 (ja) | 2005-12-28 | 2007-07-05 | Chugai Seiyaku Kabushiki Kaisha | 抗体含有安定化製剤 |
| JOP20080381B1 (ar) | 2007-08-23 | 2023-03-28 | Amgen Inc | بروتينات مرتبطة بمولدات مضادات تتفاعل مع بروبروتين كونفيرتاز سيتيليزين ككسين من النوع 9 (pcsk9) |
| TWI516501B (zh) * | 2008-09-12 | 2016-01-11 | 禮納特神經系統科學公司 | Ｐｃｓｋ９拮抗劑類 |
| UA108994C2 (uk) | 2009-11-17 | 2015-07-10 | Ипсен Фарма С.А.С. | Фармацевтична композиція, що містить комбінацію hgh і rhigf-1, і процес її приготування (варіанти) |
| WO2011104381A2 (en) | 2010-02-26 | 2011-09-01 | Novo Nordisk A/S | Stable antibody containing compositions |
| JOP20200043A1 (ar) * | 2011-05-10 | 2017-06-16 | Amgen Inc | طرق معالجة أو منع الاضطرابات المختصة بالكوليسترول |
| EP2735315B1 (en) | 2011-07-19 | 2019-10-02 | Chugai Seiyaku Kabushiki Kaisha | Stable protein-containing preparation containing argininamide or valinamide |
| EA039663B1 (ru) | 2012-05-03 | 2022-02-24 | Амген Инк. | Применение антитела против pcsk9 для снижения сывороточного холестерина лпнп и лечения связанных с холестерином расстройств |
| WO2013186230A1 (en) | 2012-06-12 | 2013-12-19 | Boehringer Ingelheim International Gmbh | Pharmaceutical formulation for a therapeutic antibody |
| US20150004174A1 (en) * | 2013-06-28 | 2015-01-01 | Amgen Inc. | Methods for treating homozygous familial hypercholesterolemia |
| TWI694836B (zh) | 2014-05-16 | 2020-06-01 | 英商葛蘭素史克智慧財產管理有限公司 | 抗體調配物 |
| SG11201703152RA (en) | 2014-10-23 | 2017-05-30 | Amgen Inc | Reducing viscosity of pharmaceutical formulations |
| JP6726666B2 (ja) | 2014-12-03 | 2020-07-22 | ツェー・エス・エル・ベーリング・アクチエンゲゼルシャフト | 免疫グロブリンを含む安定性が高められた医薬製品 |
| MX2019003727A (es) | 2016-09-29 | 2019-08-05 | Amgen Inc | Proteinas de union a antigeno de baja viscosidad y metodos de prepararlas. |
| US11459401B2 (en) * | 2016-10-06 | 2022-10-04 | Amgen Inc. | Reduced viscosity protein pharmaceutical formulations |
| JP7377596B2 (ja) | 2017-02-22 | 2023-11-10 | アムジエン・インコーポレーテツド | 低粘度、高濃度エボロクマブ製剤及びそれらの製造方法 |
-
2018
- 2018-02-14 JP JP2018023742A patent/JP7377596B2/ja active Active
- 2018-02-20 UY UY0001037611A patent/UY37611A/es unknown
- 2018-02-20 AR ARP180100397A patent/AR110938A1/es unknown
- 2018-02-22 US US15/902,775 patent/US11464857B2/en active Active
- 2018-02-22 EA EA201991951A patent/EA201991951A1/ru unknown
- 2018-02-22 KR KR1020197026969A patent/KR20190120257A/ko not_active IP Right Cessation
- 2018-02-22 MX MX2019009952A patent/MX2019009952A/es unknown
- 2018-02-22 CN CN201880025966.7A patent/CN110536906A/zh active Pending
- 2018-02-22 EP EP18710193.6A patent/EP3585821A1/en active Pending
- 2018-02-22 MA MA047601A patent/MA47601A/fr unknown
- 2018-02-22 CA CA3053394A patent/CA3053394A1/en active Pending
- 2018-02-22 AU AU2018224095A patent/AU2018224095A1/en active Pending
- 2018-02-22 WO PCT/US2018/019189 patent/WO2018156741A1/en unknown
- 2018-02-22 SG SG11201907505TA patent/SG11201907505TA/en unknown
- 2018-02-22 KR KR1020247014122A patent/KR20240060732A/ko active Search and Examination
- 2018-02-22 IL IL268515A patent/IL268515B1/en unknown
- 2018-02-22 TW TW107105962A patent/TWI833690B/zh active
- 2018-02-22 BR BR112019017393A patent/BR112019017393A8/pt unknown
-
2019
- 2019-08-21 CL CL2019002362A patent/CL2019002362A1/es unknown
-
2022
- 2022-05-04 AR ARP220101176A patent/AR125766A2/es unknown
- 2022-08-23 US US17/893,515 patent/US20230226177A1/en active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| KR20190120257A (ko) | 2019-10-23 |
| UY37611A (es) | 2018-08-31 |
| AR110938A1 (es) | 2019-05-15 |
| US11464857B2 (en) | 2022-10-11 |
| CL2019002362A1 (es) | 2019-11-29 |
| EP3585821A1 (en) | 2020-01-01 |
| US20230226177A1 (en) | 2023-07-20 |
| CA3053394A1 (en) | 2018-08-30 |
| JP2018154616A (ja) | 2018-10-04 |
| MA47601A (fr) | 2020-01-01 |
| WO2018156741A1 (en) | 2018-08-30 |
| TWI833690B (zh) | 2024-03-01 |
| CN110536906A (zh) | 2019-12-03 |
| SG11201907505TA (en) | 2019-09-27 |
| US20180237501A1 (en) | 2018-08-23 |
| TW201841650A (zh) | 2018-12-01 |
| BR112019017393A8 (pt) | 2022-03-03 |
| JP7377596B2 (ja) | 2023-11-10 |
| BR112019017393A2 (pt) | 2020-04-14 |
| EA201991951A1 (ru) | 2020-01-21 |
| AR125766A2 (es) | 2023-08-09 |
| AU2018224095A1 (en) | 2019-08-22 |
| KR20240060732A (ko) | 2024-05-08 |
| IL268515B1 (en) | 2024-06-01 |
| IL268515A (en) | 2019-09-26 |
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