EA033444B1 - Снижение вязкости фармацевтических составов - Google Patents
Снижение вязкости фармацевтических составовInfo
- Publication number
- EA033444B1 EA033444B1 EA201790787A EA201790787A EA033444B1 EA 033444 B1 EA033444 B1 EA 033444B1 EA 201790787 A EA201790787 A EA 201790787A EA 201790787 A EA201790787 A EA 201790787A EA 033444 B1 EA033444 B1 EA 033444B1
- Authority
- EA
- Eurasian Patent Office
- Prior art keywords
- pharmaceutical formulations
- reducing viscosity
- viscosity
- acetyl
- reducing
- Prior art date
Links
- 239000008194 pharmaceutical composition Substances 0.000 title abstract 3
- VEYYWZRYIYDQJM-ZETCQYMHSA-N N(2)-acetyl-L-lysine Chemical compound CC(=O)N[C@H](C([O-])=O)CCCC[NH3+] VEYYWZRYIYDQJM-ZETCQYMHSA-N 0.000 abstract 1
- 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 1
- GNMSLDIYJOSUSW-LURJTMIESA-N N-acetyl-L-proline Chemical compound CC(=O)N1CCC[C@H]1C(O)=O GNMSLDIYJOSUSW-LURJTMIESA-N 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
- 239000000203 mixture Substances 0.000 abstract 1
- 239000000546 pharmaceutical excipient Substances 0.000 abstract 1
- 102000004169 proteins and genes Human genes 0.000 abstract 1
- 108090000623 proteins and genes Proteins 0.000 abstract 1
Classifications
-
- 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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- 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
- 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
- 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
-
- 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
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Immunology (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Endocrinology (AREA)
- Dermatology (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201462067637P | 2014-10-23 | 2014-10-23 | |
| PCT/US2015/056972 WO2016065181A1 (en) | 2014-10-23 | 2015-10-22 | Reducing viscosity of pharmaceutical formulations |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| EA201790787A1 EA201790787A1 (ru) | 2017-08-31 |
| EA033444B1 true EA033444B1 (ru) | 2019-10-31 |
Family
ID=54427875
Family Applications (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EA201790787A EA033444B1 (ru) | 2014-10-23 | 2015-10-22 | Снижение вязкости фармацевтических составов |
| EA202191513A EA202191513A1 (ru) | 2014-10-23 | 2015-10-22 | Снижение вязкости фармацевтических составов |
| EA201991447A EA038462B1 (ru) | 2014-10-23 | 2015-10-22 | Снижение вязкости фармацевтических составов |
Family Applications After (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EA202191513A EA202191513A1 (ru) | 2014-10-23 | 2015-10-22 | Снижение вязкости фармацевтических составов |
| EA201991447A EA038462B1 (ru) | 2014-10-23 | 2015-10-22 | Снижение вязкости фармацевтических составов |
Country Status (17)
| Country | Link |
|---|---|
| US (3) | US11813328B2 (enExample) |
| EP (2) | EP3209332B1 (enExample) |
| JP (3) | JP2017531682A (enExample) |
| KR (1) | KR102534017B1 (enExample) |
| CN (2) | CN114569716A (enExample) |
| AU (2) | AU2015335743B2 (enExample) |
| BR (1) | BR112017008125B1 (enExample) |
| CA (1) | CA2964786C (enExample) |
| CL (2) | CL2017000984A1 (enExample) |
| EA (3) | EA033444B1 (enExample) |
| ES (1) | ES2964713T3 (enExample) |
| IL (2) | IL287947B2 (enExample) |
| MA (1) | MA54716A (enExample) |
| MX (2) | MX388858B (enExample) |
| SG (1) | SG11201703152RA (enExample) |
| WO (1) | WO2016065181A1 (enExample) |
| ZA (1) | ZA201702762B (enExample) |
Families Citing this family (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| MA54716A (fr) | 2014-10-23 | 2021-11-17 | Amgen Inc | Réduction de la viscosité de formulations pharmaceutiques |
| MA46466A (fr) | 2016-10-06 | 2019-08-14 | Amgen Inc | Formulations pharmaceutiques de protéines à viscosité réduite |
| 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 |
| US12257343B2 (en) | 2017-04-28 | 2025-03-25 | Amgen Inc. | Excipients to reduce the viscosity of antibody formulations and formulation compositions |
| AU2018258676B2 (en) * | 2017-04-28 | 2024-09-19 | Amgen Inc. | N-acetylated and non-acetylated dipeptides containing arginine to reduce the viscosity of viscous compositions of therapeutic polypeptides |
| EP3624846B1 (en) | 2017-05-16 | 2024-08-07 | Bhami's Research Laboratory, Pvt. Ltd. | High concentration protein formulations with reduced viscosity including a combination of nicotinic acid and tryoptophan |
| EP4424362A3 (en) | 2017-06-16 | 2024-11-27 | Zealand Pharma A/S | Dosage regimes for the administration of glucagon-like-peptide-2 (glp-2) analogues |
| JP6577683B2 (ja) * | 2017-09-22 | 2019-09-18 | 旭化成ファーマ株式会社 | 安定性に優れるテリパラチド含有液状医薬組成物 |
| WO2019106206A1 (en) | 2017-12-01 | 2019-06-06 | Fyb 202 Project Gmbh | Stable, low viscosity, high concentration liquid formulations of an anti-il-12/23p40 antibody |
| JP2021529800A (ja) | 2018-07-05 | 2021-11-04 | バイエル アクチェンゲゼルシャフトＢａｙｅｒ Ａｋｔｉｅｎｇｅｓｅｌｌｓｃｈａｆｔ | 抗ＦＸＩａ抗体のための新規な安定した高濃度製剤 |
| IL280880B2 (en) | 2018-08-27 | 2025-04-01 | Regeneron Pharma | Using Raman Spectroscopy in Downstream Purification |
| EP3628683A1 (en) * | 2018-09-28 | 2020-04-01 | Zealand Pharma A/S | Formulations of glucagon-like-peptide-2 (glp-2) analogues |
| WO2020219550A1 (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 |
| IL295042A (en) * | 2020-02-13 | 2022-09-01 | Amgen Inc | Formulations of human anti-tslp antibodies and methods of treating inflammatory disease |
| KR102746418B1 (ko) * | 2020-12-03 | 2024-12-26 | 동국대학교 산학협력단 | N-아세틸-l-아르기닌을 포함하는 단백질 응집 억제용 조성물 |
| KR20220126654A (ko) * | 2021-03-09 | 2022-09-16 | (주)지아이이노베이션 | IgE Fc 수용체의 알파 서브유닛의 세포외 도메인을 포함하는 융합단백질의 제형 |
| EP4319795A4 (en) * | 2021-04-09 | 2025-03-05 | Avantor Performance Materials, LLC | Performance-enhancing excipients and methods of reducing viscosity and increasing stability of biologic formulations |
| WO2025175164A1 (en) * | 2024-02-16 | 2025-08-21 | Regeneron Pharmaceuticals, Inc. | Methods of producing concentrated formulated drug substances comprising proteins, and concentrated formulated drug substance made by the methods |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6767892B1 (en) * | 1997-11-07 | 2004-07-27 | Chrion Corporation | Compositions providing for increased IGF-I solubility |
| EP1977763A1 (en) * | 2005-12-28 | 2008-10-08 | Chugai Seiyaku Kabushiki Kaisha | Antibody-containing stabilizing preparation |
| WO2011104381A2 (en) * | 2010-02-26 | 2011-09-01 | Novo Nordisk A/S | Stable antibody containing compositions |
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| 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 |
| AU1519399A (en) | 1997-11-07 | 1999-05-31 | Chiron Corporation | Compositions providing for increased igf-i solubility |
| US6660843B1 (en) | 1998-10-23 | 2003-12-09 | Amgen Inc. | Modified peptides as therapeutic agents |
| US6159485A (en) * | 1999-01-08 | 2000-12-12 | Yugenic Limited Partnership | N-acetyl aldosamines, n-acetylamino acids and related n-acetyl compounds and their topical use |
| CA2403962C (en) | 2000-03-31 | 2009-12-15 | Kirin Beer Kabushiki Kaisha | Powdery preparation for transmucosal administration comprising a medicine of high molecular weight and exhibiting an improved storage stability |
| PL209928B1 (pl) | 2000-11-07 | 2011-11-30 | Novartis Vaccines & Diagnostic | Kompozycja farmaceutyczna zawierająca biologicznie aktywny IFN-β i mannitol, wstępnie napełniona strzykawka zawierająca tę kompozycję oraz sposób wytwarzania preparatu IFN-β |
| IL160358A0 (en) | 2001-08-23 | 2004-07-25 | Genmab As | Human antibodies specific for interleukin 15 (il-15) |
| US20030180287A1 (en) | 2002-02-27 | 2003-09-25 | Immunex Corporation | Polypeptide formulation |
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| CA2512174A1 (en) | 2003-01-30 | 2004-08-12 | Christian B. Allan | Anti-integrin .alpha..nu..beta.3 antibody formulations and uses thereof |
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| TWI661833B (zh) * | 2007-11-30 | 2019-06-11 | 百慕達商艾伯維生物技術有限責任公司 | 蛋白質調配物及製造其之方法 |
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| TWI516501B (zh) | 2008-09-12 | 2016-01-11 | 禮納特神經系統科學公司 | Ｐｃｓｋ９拮抗劑類 |
| JO3672B1 (ar) | 2008-12-15 | 2020-08-27 | Regeneron Pharma | أجسام مضادة بشرية عالية التفاعل الكيماوي بالنسبة لإنزيم سبتيليسين كنفرتيز بروبروتين / كيكسين نوع 9 (pcsk9). |
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| JP2013525484A (ja) * | 2010-05-03 | 2013-06-20 | ジェネンテック， インコーポレイテッド | タンパク質含有製剤の粘度を低減させるために有用な組成物及び方法 |
| AR083495A1 (es) | 2010-10-22 | 2013-02-27 | Esbatech Alcon Biomed Res Unit | Anticuerpos estables y solubles |
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| CA2951856A1 (en) * | 2011-10-28 | 2013-05-02 | Integritybio Inc. | Protein formulations containing amino acids |
| 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 |
| EP2863951A1 (en) | 2012-06-12 | 2015-04-29 | 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 |
| MA54716A (fr) | 2014-10-23 | 2021-11-17 | Amgen Inc | Réduction de la viscosité de formulations pharmaceutiques |
| CA2968915A1 (en) | 2014-12-03 | 2016-06-09 | Csl Behring Ag | Pharmaceutical product with increased stability comprising immunoglobulins |
| KR102551269B1 (ko) | 2016-09-29 | 2023-07-05 | 암젠 인크 | 저-점도 항원 결합 단백질 및 이의 제조 방법 |
| MA46466A (fr) | 2016-10-06 | 2019-08-14 | Amgen Inc | Formulations pharmaceutiques de protéines à viscosité réduite |
| 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 |
-
2015
- 2015-10-22 MA MA054716A patent/MA54716A/fr unknown
- 2015-10-22 SG SG11201703152RA patent/SG11201703152RA/en unknown
- 2015-10-22 EP EP15790759.3A patent/EP3209332B1/en active Active
- 2015-10-22 JP JP2017522169A patent/JP2017531682A/ja active Pending
- 2015-10-22 CA CA2964786A patent/CA2964786C/en active Active
- 2015-10-22 EP EP21175309.0A patent/EP3909611B1/en active Active
- 2015-10-22 US US15/521,057 patent/US11813328B2/en active Active
- 2015-10-22 CN CN202210048275.7A patent/CN114569716A/zh active Pending
- 2015-10-22 IL IL287947A patent/IL287947B2/en unknown
- 2015-10-22 MX MX2017005243A patent/MX388858B/es unknown
- 2015-10-22 KR KR1020177011706A patent/KR102534017B1/ko active Active
- 2015-10-22 EA EA201790787A patent/EA033444B1/ru not_active IP Right Cessation
- 2015-10-22 EA EA202191513A patent/EA202191513A1/ru unknown
- 2015-10-22 EA EA201991447A patent/EA038462B1/ru unknown
- 2015-10-22 WO PCT/US2015/056972 patent/WO2016065181A1/en not_active Ceased
- 2015-10-22 ES ES21175309T patent/ES2964713T3/es active Active
- 2015-10-22 CN CN201580057461.5A patent/CN107206070B/zh active Active
- 2015-10-22 BR BR112017008125-3A patent/BR112017008125B1/pt active IP Right Grant
- 2015-10-22 AU AU2015335743A patent/AU2015335743B2/en active Active
-
2017
- 2017-04-13 IL IL251726A patent/IL251726B/en unknown
- 2017-04-19 ZA ZA2017/02762A patent/ZA201702762B/en unknown
- 2017-04-20 CL CL2017000984A patent/CL2017000984A1/es unknown
- 2017-04-21 MX MX2021015789A patent/MX2021015789A/es unknown
-
2019
- 2019-08-02 CL CL2019002190A patent/CL2019002190A1/es unknown
- 2019-10-21 JP JP2019191701A patent/JP6965321B2/ja active Active
-
2021
- 2021-02-15 AU AU2021200990A patent/AU2021200990B2/en active Active
- 2021-10-19 JP JP2021170676A patent/JP7411615B2/ja active Active
-
2023
- 2023-10-24 US US18/383,121 patent/US12318447B2/en active Active
-
2025
- 2025-05-30 US US19/223,578 patent/US20250345421A1/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6767892B1 (en) * | 1997-11-07 | 2004-07-27 | Chrion Corporation | Compositions providing for increased IGF-I solubility |
| EP1977763A1 (en) * | 2005-12-28 | 2008-10-08 | Chugai Seiyaku Kabushiki Kaisha | Antibody-containing stabilizing preparation |
| WO2011104381A2 (en) * | 2010-02-26 | 2011-09-01 | Novo Nordisk A/S | Stable antibody containing compositions |
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