MX2021015789A - Reduccion de la viscosidad de formulaciones farmaceuticas. - Google Patents
Reduccion de la viscosidad de formulaciones farmaceuticas.Info
- Publication number
- MX2021015789A MX2021015789A MX2021015789A MX2021015789A MX2021015789A MX 2021015789 A MX2021015789 A MX 2021015789A MX 2021015789 A MX2021015789 A MX 2021015789A MX 2021015789 A MX2021015789 A MX 2021015789A MX 2021015789 A MX2021015789 A MX 2021015789A
- Authority
- MX
- Mexico
- Prior art keywords
- pharmaceutical formulations
- reducing viscosity
- viscosity
- acetyl
- reducing
- Prior art date
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)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Mycology (AREA)
- Immunology (AREA)
- Microbiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Proteomics, Peptides & Aminoacids (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)
Abstract
Se proporciona un método para reducir la viscosidad de una formulación farmacéutica que utiliza una concentración de reducción de la viscosidad de un excipiente seleccionado del grupo que consiste en la n-acetil arginina, n-acetil lisina, n-acetil prolina y mezclas de los mismos en combinación con una proteína terapéutica. También se proporciona una formulación farmacéutica estable.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201462067637P | 2014-10-23 | 2014-10-23 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| MX2021015789A true MX2021015789A (es) | 2022-01-27 |
Family
ID=54427875
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MX2017005243A MX388858B (es) | 2014-10-23 | 2015-10-22 | Reducción de la viscosidad de formulaciones farmacéuticas |
| MX2021015789A MX2021015789A (es) | 2014-10-23 | 2017-04-21 | Reduccion de la viscosidad de formulaciones farmaceuticas. |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MX2017005243A MX388858B (es) | 2014-10-23 | 2015-10-22 | Reducción de la viscosidad de formulaciones farmacéuticas |
Country Status (17)
| Country | Link |
|---|---|
| US (3) | US11813328B2 (es) |
| EP (2) | EP3909611B1 (es) |
| JP (3) | JP2017531682A (es) |
| KR (1) | KR102534017B1 (es) |
| CN (2) | CN107206070B (es) |
| AU (2) | AU2015335743B2 (es) |
| BR (1) | BR112017008125B1 (es) |
| CA (1) | CA2964786C (es) |
| CL (2) | CL2017000984A1 (es) |
| EA (3) | EA033444B1 (es) |
| ES (1) | ES2964713T3 (es) |
| IL (2) | IL287947B2 (es) |
| MA (1) | MA54716A (es) |
| MX (2) | MX388858B (es) |
| SG (1) | SG11201703152RA (es) |
| WO (1) | WO2016065181A1 (es) |
| ZA (1) | ZA201702762B (es) |
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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| 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 |
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| 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 |
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| 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
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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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