ZA201702762B - Reducing viscosity of pharmaceutical formulations - Google Patents
Reducing viscosity of pharmaceutical formulationsInfo
- Publication number
- ZA201702762B ZA201702762B ZA2017/02762A ZA201702762A ZA201702762B ZA 201702762 B ZA201702762 B ZA 201702762B ZA 2017/02762 A ZA2017/02762 A ZA 2017/02762A ZA 201702762 A ZA201702762 A ZA 201702762A ZA 201702762 B ZA201702762 B ZA 201702762B
- Authority
- ZA
- South Africa
- Prior art keywords
- pharmaceutical formulations
- reducing viscosity
- viscosity
- reducing
- formulations
- Prior art date
Links
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
- 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
-
- 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
-
- 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 (1)
| Publication Number | Publication Date |
|---|---|
| ZA201702762B true ZA201702762B (en) | 2022-12-21 |
Family
ID=54427875
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ZA2017/02762A ZA201702762B (en) | 2014-10-23 | 2017-04-19 | Reducing viscosity of pharmaceutical formulations |
Country Status (17)
| Country | Link |
|---|---|
| US (3) | US11813328B2 (Direct) |
| EP (2) | EP3909611B1 (Direct) |
| JP (3) | JP2017531682A (Direct) |
| KR (1) | KR102534017B1 (Direct) |
| CN (2) | CN107206070B (Direct) |
| AU (2) | AU2015335743B2 (Direct) |
| BR (1) | BR112017008125B1 (Direct) |
| CA (1) | CA2964786C (Direct) |
| CL (2) | CL2017000984A1 (Direct) |
| EA (3) | EA033444B1 (Direct) |
| ES (1) | ES2964713T3 (Direct) |
| IL (2) | IL287947B2 (Direct) |
| MA (1) | MA54716A (Direct) |
| MX (2) | MX388858B (Direct) |
| SG (1) | SG11201703152RA (Direct) |
| WO (1) | WO2016065181A1 (Direct) |
| ZA (1) | ZA201702762B (Direct) |
Families Citing this family (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US11813328B2 (en) | 2014-10-23 | 2023-11-14 | Amgen Inc. | Methods for reducing the viscosity of liquid pharmaceutical formulations comprising therapeutic proteins |
| WO2018067987A1 (en) | 2016-10-06 | 2018-04-12 | 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 |
| 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 |
| SG11202003754YA (en) | 2017-05-16 | 2020-05-28 | Bhamis Research Laboratory Pvt Ltd | High concentration protein formulations with reduced viscosity |
| BR112019026711A2 (pt) | 2017-06-16 | 2020-06-30 | Zealand Pharma A/S | regimes de dosagem para a administração de análogos de peptídeo semelhante a glucagon- 2 (glp-2) |
| 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 |
| CA3105261A1 (en) | 2018-07-05 | 2020-01-09 | Bayer Aktiengesellschaft | Method for the production of freeze-dried pellets comprising an anti-coagulation factor xia (fxia) antibody |
| AU2019329686A1 (en) | 2018-08-27 | 2020-12-03 | Regeneron Pharmaceuticals, Inc. | Use of 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 |
| MX2021012782A (es) * | 2019-04-23 | 2021-11-25 | Amgen Inc | El uso de polivinilpirrolidona (pvp) de bajo peso molecular para reducir la viscosidad de formulaciones de proteinas de alta concentracion. |
| JOP20220183A1 (ar) * | 2020-02-13 | 2023-01-30 | Amgen Inc | صياغات أجسام مضادة ضد tslp بشرية وطرائق علاج مرض التهابي |
| KR102746418B1 (ko) * | 2020-12-03 | 2024-12-26 | 동국대학교 산학협력단 | N-아세틸-l-아르기닌을 포함하는 단백질 응집 억제용 조성물 |
| MX2023010457A (es) * | 2021-03-09 | 2023-09-14 | Gi Innovation Inc | Formulacion de proteina de fusion que incluye el dominio extracelular de la subunidad alfa del receptor fc de ige. |
| 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 |
| 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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| 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 |
| ATE238807T1 (de) | 1997-11-07 | 2003-05-15 | Chiron Corp | Zusammensetzung um die löslichkeit von igf-i zu erhöhen |
| 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 |
| PT1343518E (pt) | 2000-11-07 | 2009-08-03 | Novartis Vaccines & Diagnostic | Composições de interferão estabilizadas |
| RS51829B (sr) | 2001-08-23 | 2012-02-29 | Genmab A/S. | Ljudska antitela specifična za interleukin 15 (il-15) |
| US20030180287A1 (en) | 2002-02-27 | 2003-09-25 | Immunex Corporation | Polypeptide formulation |
| 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 |
| SI2335725T1 (sl) * | 2003-04-04 | 2017-01-31 | Genentech, Inc. | Visokokoncentrirane formulacije protiteles in proteinov |
| 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 |
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| 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 |
| EP1977763A4 (en) * | 2005-12-28 | 2010-06-02 | Chugai Pharmaceutical Co Ltd | ANTIBODY-CONTAINING STABILIZING PREPARATION |
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| JP5059119B2 (ja) | 2006-12-14 | 2012-10-24 | シェーリング コーポレイション | 操作された抗ｔｓｌｐ抗体 |
| WO2008155365A1 (en) | 2007-06-20 | 2008-12-24 | 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) |
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| TR201903403T4 (tr) | 2010-02-04 | 2019-04-22 | Csl Behring Ag | İmmünoglobulin preparatı. |
| AU2011219715B2 (en) * | 2010-02-26 | 2014-12-11 | Novo Nordisk A/S | Stable antibody containing compositions |
| US20130171128A1 (en) * | 2010-03-02 | 2013-07-04 | 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 |
| CA2853823C (en) * | 2011-10-28 | 2016-12-20 | 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 |
| US11813328B2 (en) | 2014-10-23 | 2023-11-14 | Amgen Inc. | Methods for reducing the viscosity of liquid pharmaceutical formulations comprising therapeutic proteins |
| DK3763384T3 (da) | 2014-12-03 | 2024-09-23 | Csl Behring Ag | Farmaceuitisk produkt med øget stabilitet, omfattende immunoglobuliner |
| IL307684B2 (en) | 2016-09-29 | 2025-04-01 | Amgen Inc | Low viscosity antigen binding proteins and methods for preparing them |
| WO2018067987A1 (en) | 2016-10-06 | 2018-04-12 | 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 |
-
2015
- 2015-10-22 US US15/521,057 patent/US11813328B2/en active Active
- 2015-10-22 BR BR112017008125-3A patent/BR112017008125B1/pt active IP Right Grant
- 2015-10-22 ES ES21175309T patent/ES2964713T3/es active Active
- 2015-10-22 WO PCT/US2015/056972 patent/WO2016065181A1/en not_active Ceased
- 2015-10-22 EP EP21175309.0A patent/EP3909611B1/en active Active
- 2015-10-22 IL IL287947A patent/IL287947B2/en unknown
- 2015-10-22 EP EP15790759.3A patent/EP3209332B1/en active Active
- 2015-10-22 SG SG11201703152RA patent/SG11201703152RA/en unknown
- 2015-10-22 AU AU2015335743A patent/AU2015335743B2/en active Active
- 2015-10-22 EA EA201790787A patent/EA033444B1/ru not_active IP Right Cessation
- 2015-10-22 EA EA201991447A patent/EA038462B1/ru unknown
- 2015-10-22 MA MA054716A patent/MA54716A/fr unknown
- 2015-10-22 MX MX2017005243A patent/MX388858B/es unknown
- 2015-10-22 CN CN201580057461.5A patent/CN107206070B/zh active Active
- 2015-10-22 CA CA2964786A patent/CA2964786C/en active Active
- 2015-10-22 KR KR1020177011706A patent/KR102534017B1/ko active Active
- 2015-10-22 EA EA202191513A patent/EA202191513A1/ru unknown
- 2015-10-22 CN CN202210048275.7A patent/CN114569716A/zh active Pending
- 2015-10-22 JP JP2017522169A patent/JP2017531682A/ja active Pending
-
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
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