ES2964713T3 - Reducción de la viscosidad de formulaciones farmacéuticas - Google Patents
Reducción de la viscosidad de formulaciones farmacéuticas Download PDFInfo
- Publication number
- ES2964713T3 ES2964713T3 ES21175309T ES21175309T ES2964713T3 ES 2964713 T3 ES2964713 T3 ES 2964713T3 ES 21175309 T ES21175309 T ES 21175309T ES 21175309 T ES21175309 T ES 21175309T ES 2964713 T3 ES2964713 T3 ES 2964713T3
- Authority
- ES
- Spain
- Prior art keywords
- acetyl
- viscosity
- excipient
- antibody
- protein
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
Classifications
-
- 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
- A61K39/39591—Stabilisation, fragmentation
-
- 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 (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201462067637P | 2014-10-23 | 2014-10-23 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ES2964713T3 true ES2964713T3 (es) | 2024-04-09 |
Family
ID=54427875
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES21175309T Active ES2964713T3 (es) | 2014-10-23 | 2015-10-22 | Reducción de la viscosidad de formulaciones farmacéuticas |
Country Status (17)
| Country | Link |
|---|---|
| US (3) | US11813328B2 (enExample) |
| EP (2) | EP3909611B1 (enExample) |
| JP (3) | JP2017531682A (enExample) |
| KR (1) | KR102534017B1 (enExample) |
| CN (2) | CN107206070B (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 |
|---|---|---|---|---|
| ES2964713T3 (es) | 2014-10-23 | 2024-04-09 | Amgen Inc | Reducción de la viscosidad de formulaciones farmacéuticas |
| 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 |
| WO2018200533A1 (en) | 2017-04-28 | 2018-11-01 | 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 |
| SG11202003754YA (en) | 2017-05-16 | 2020-05-28 | Bhamis Research Laboratory Pvt Ltd | High concentration protein formulations with reduced viscosity |
| PE20200678A1 (es) | 2017-06-16 | 2020-06-11 | Zealand Pharma As | Posologias para la administracion de analogos de peptido de tipo glucagon-2 (glp-2) |
| US20200289621A1 (en) * | 2017-09-22 | 2020-09-17 | Asahi Kasei Pharma Corporation | Teriparatide-containing liquid pharmaceutical composition having excellent stability |
| 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 |
| BR112020026492A2 (pt) | 2018-07-05 | 2021-04-06 | Bayer Aktiengesellschaft | Método para a produção de péletes liofilizados compreendendo um anticorpo antifator de coagulação xia (fxia) |
| KR20210052389A (ko) | 2018-08-27 | 2021-05-10 | 리제너론 파마슈티칼스 인코포레이티드 | 다운스트림 정제에서의 라만 분광법의 사용 |
| 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 |
| WO2022191550A1 (ko) * | 2021-03-09 | 2022-09-15 | (주)지아이이노베이션 | ＩｇＥ Ｆｃ 수용체의 알파 서브유닛의 세포외 도메인을 포함하는 융합단백질의 제형 |
| CN117355321A (zh) * | 2021-04-09 | 2024-01-05 | 安万托特性材料股份有限公司 | 增强性能的赋形剂以及降低生物制剂的粘度和提高生物制剂的稳定性的方法 |
| 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 |
Family Cites Families (49)
| 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 |
| WO1999024063A1 (en) | 1997-11-07 | 1999-05-20 | Chiron Corporation | Compositions providing for increased igf-i solubility |
| US6767892B1 (en) * | 1997-11-07 | 2004-07-27 | Chrion 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 |
| AU4458401A (en) | 2000-03-31 | 2001-10-15 | Kirin Brewery | Powdery preparation for transmucosal administration containing a polymeric form of drug and exhibiting improved storage stability |
| US6994847B2 (en) | 2000-11-07 | 2006-02-07 | Chiron Corporation | Stabilized interferon compositions |
| AU2002332628B2 (en) | 2001-08-23 | 2007-07-26 | Genmab A/S | Human antibodies specific for interleukin 15 (IL-15) |
| MXPA04008215A (es) | 2002-02-27 | 2004-11-26 | Immunex Corp | Formulacion polipeptidica. |
| WO2004055164A2 (en) | 2002-12-13 | 2004-07-01 | Abgenix, Inc. | System and method for stabilizing antibodies with histidine |
| CA2512174A1 (en) | 2003-01-30 | 2004-08-12 | Christian B. Allan | Anti-integrin .alpha..nu..beta.3 antibody formulations and uses thereof |
| PT1610820E (pt) | 2003-04-04 | 2010-12-16 | Novartis Ag | Formulações de elevada concentração de anticorpos e proteínas |
| US8084032B2 (en) | 2004-01-21 | 2011-12-27 | Ajinomoto Co., Inc. | Purification method which prevents denaturation of an antibody |
| US20060051347A1 (en) | 2004-09-09 | 2006-03-09 | Winter Charles M | Process for concentration of antibodies and therapeutic products thereof |
| US7906625B2 (en) | 2005-01-24 | 2011-03-15 | Amgen Inc. | Humanized anti-amyloid antibody |
| US8003108B2 (en) | 2005-05-03 | 2011-08-23 | Amgen Inc. | Sclerostin epitopes |
| US7592429B2 (en) | 2005-05-03 | 2009-09-22 | Ucb Sa | Sclerostin-binding antibody |
| JP5231810B2 (ja) * | 2005-12-28 | 2013-07-10 | 中外製薬株式会社 | 抗体含有安定化製剤 |
| CN101426527A (zh) * | 2006-02-03 | 2009-05-06 | 米迪缪尼有限公司 | 蛋白质制剂 |
| GB0603683D0 (en) | 2006-02-23 | 2006-04-05 | Novartis Ag | Organic compounds |
| CA2651453C (en) | 2006-05-11 | 2014-10-14 | Isis Pharmaceuticals, Inc. | 5'-modified bicyclic nucleic acid analogs |
| AR064333A1 (es) | 2006-12-14 | 2009-04-01 | Schering Corp | Anticuerpo anti-tslp de diseno |
| EP2170957A1 (en) | 2007-06-20 | 2010-04-07 | Irm, Llc | Methods and compositions for treating allergic diseases |
| JOP20080381B1 (ar) | 2007-08-23 | 2023-03-28 | Amgen Inc | بروتينات مرتبطة بمولدات مضادات تتفاعل مع بروبروتين كونفيرتاز سيتيليزين ككسين من النوع 9 (pcsk9) |
| US7982016B2 (en) | 2007-09-10 | 2011-07-19 | Amgen Inc. | Antigen binding proteins capable of binding thymic stromal lymphopoietin |
| JP5840364B2 (ja) * | 2007-11-30 | 2016-01-06 | アッヴィ バイオテクノロジー リミテッド | タンパク質製剤及びその製造方法 |
| CA2711984A1 (en) * | 2008-01-15 | 2009-07-23 | Abbott Gmbh & Co. Kg | Powdered protein compositions and methods of making same |
| 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). |
| JP2011067202A (ja) | 2009-08-31 | 2011-04-07 | Sanyo Chem Ind Ltd | タンパク質水溶液の安定化剤、この安定化剤を含有するタンパク質水溶液及びタンパク質の安定化方法 |
| BR112012011539A8 (pt) * | 2009-11-17 | 2017-12-26 | Ipsen Pharma Sas | formulação para a combinação de hgh e rhigf-1 |
| CA2788863C (en) * | 2010-02-04 | 2020-07-07 | Reinhard Franz Bolli | Immunoglobulin preparation |
| EP3409289B1 (en) * | 2010-02-26 | 2020-09-30 | Novo Nordisk A/S | Stable antibody containing compositions |
| WO2011109415A2 (en) | 2010-03-02 | 2011-09-09 | Amgen Inc. | Reducing viscosity of pharmaceutical formulations |
| MX2012012743A (es) | 2010-05-03 | 2012-11-23 | Genentech Inc | Composiciones y metodos utiles para reducir la viscosidad de formulaciones que contienen proteina. |
| UY33679A (es) | 2010-10-22 | 2012-03-30 | Esbatech | Anticuerpos estables y solubles |
| 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 |
| WO2013063510A1 (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 |
| US20150150982A1 (en) | 2012-06-12 | 2015-06-04 | 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 |
| ES2964713T3 (es) | 2014-10-23 | 2024-04-09 | Amgen Inc | Reducción de la viscosidad de formulaciones farmacéuticas |
| AU2015357068B2 (en) | 2014-12-03 | 2021-07-29 | Csl Behring Ag | Pharmaceutical product with increased stability comprising immunoglobulins |
| SG10201912565QA (en) | 2016-09-29 | 2020-02-27 | Amgen Inc | Low-viscosity antigen binding proteins and methods of making them |
| 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 ES ES21175309T patent/ES2964713T3/es active Active
- 2015-10-22 BR BR112017008125-3A patent/BR112017008125B1/pt active IP Right Grant
- 2015-10-22 JP JP2017522169A patent/JP2017531682A/ja active Pending
- 2015-10-22 EP EP21175309.0A patent/EP3909611B1/en active Active
- 2015-10-22 MX MX2017005243A patent/MX388858B/es unknown
- 2015-10-22 SG SG11201703152RA patent/SG11201703152RA/en unknown
- 2015-10-22 EA EA201790787A patent/EA033444B1/ru not_active IP Right Cessation
- 2015-10-22 CA CA2964786A patent/CA2964786C/en active Active
- 2015-10-22 AU AU2015335743A patent/AU2015335743B2/en active Active
- 2015-10-22 US US15/521,057 patent/US11813328B2/en active Active
- 2015-10-22 IL IL287947A patent/IL287947B2/en unknown
- 2015-10-22 CN CN201580057461.5A patent/CN107206070B/zh active Active
- 2015-10-22 EA EA201991447A patent/EA038462B1/ru unknown
- 2015-10-22 CN CN202210048275.7A patent/CN114569716A/zh active Pending
- 2015-10-22 EP EP15790759.3A patent/EP3209332B1/en active Active
- 2015-10-22 WO PCT/US2015/056972 patent/WO2016065181A1/en not_active Ceased
- 2015-10-22 KR KR1020177011706A patent/KR102534017B1/ko active Active
- 2015-10-22 MA MA054716A patent/MA54716A/fr unknown
- 2015-10-22 EA EA202191513A patent/EA202191513A1/ru unknown
-
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
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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
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