CL2017000984A1 - Reducción de la viscosidad de formulaciones farmacéuticas - Google Patents
Reducción de la viscosidad de formulaciones farmacéuticasInfo
- Publication number
- CL2017000984A1 CL2017000984A1 CL2017000984A CL2017000984A CL2017000984A1 CL 2017000984 A1 CL2017000984 A1 CL 2017000984A1 CL 2017000984 A CL2017000984 A CL 2017000984A CL 2017000984 A CL2017000984 A CL 2017000984A CL 2017000984 A1 CL2017000984 A1 CL 2017000984A1
- Authority
- CL
- Chile
- Prior art keywords
- viscosity
- reduction
- pharmaceutical formulations
- pharmaceutical formulation
- lylin
- Prior art date
Links
- 239000008194 pharmaceutical composition Substances 0.000 title 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 1
- 238000000034 method Methods 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
- 230000001225 therapeutic effect Effects 0.000 abstract 1
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
-
- 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
-
- 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)
Abstract
<p>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 DE 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.</p>
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201462067637P | 2014-10-23 | 2014-10-23 |
Publications (1)
Publication Number | Publication Date |
---|---|
CL2017000984A1 true CL2017000984A1 (es) | 2018-01-05 |
Family
ID=54427875
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CL2017000984A CL2017000984A1 (es) | 2014-10-23 | 2017-04-20 | Reducción de la viscosidad de formulaciones farmacéuticas |
CL2019002190A CL2019002190A1 (es) | 2014-10-23 | 2019-08-02 | Reducción de la viscosidad de formulaciones farmacéuticas que comprende una proteína terapéutica a una concentración de al menos 70 mg/ml, donde la proteína terapéutica no es un anticuerpo (divisional solicitud 201700984) |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CL2019002190A CL2019002190A1 (es) | 2014-10-23 | 2019-08-02 | Reducción de la viscosidad de formulaciones farmacéuticas que comprende una proteína terapéutica a una concentración de al menos 70 mg/ml, donde la proteína terapéutica no es un anticuerpo (divisional solicitud 201700984) |
Country Status (17)
Country | Link |
---|---|
US (2) | US11813328B2 (es) |
EP (2) | EP3209332B1 (es) |
JP (3) | JP2017531682A (es) |
KR (1) | KR102534017B1 (es) |
CN (2) | CN114569716A (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) | MX2017005243A (es) |
SG (1) | SG11201703152RA (es) |
WO (1) | WO2016065181A1 (es) |
ZA (1) | ZA201702762B (es) |
Families Citing this family (11)
Publication number | Priority date | Publication date | Assignee | Title |
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EA033444B1 (ru) | 2014-10-23 | 2019-10-31 | Amgen Inc | Снижение вязкости фармацевтических составов |
JP7275027B2 (ja) * | 2016-10-06 | 2023-05-17 | アムジェン インコーポレイテッド | 粘度低下タンパク質医薬製剤 |
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 |
MA48461A (fr) | 2017-04-28 | 2020-03-04 | Amgen Inc | Excipients pour réduire la viscosité de formulations d'anticorps et compositions de formulation |
US12103979B2 (en) * | 2017-04-28 | 2024-10-01 | Amgen Inc. | N-acetylated and non-acetylated dipeptides containing arginine to reduce the viscosity of viscous compositions of therapeutic polypeptides |
WO2018211517A1 (en) | 2017-05-16 | 2018-11-22 | Bhami's Research Laboratory, Pvt. Ltd. | High concentration protein formulations with reduced viscosity |
CN116898955A (zh) * | 2017-09-22 | 2023-10-20 | 旭化成制药株式会社 | 稳定性优异的含有特立帕肽的液态药物组合物 |
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 |
CA3105256A1 (en) | 2018-07-05 | 2020-01-09 | Bayer Aktiengesellschaft | Novel stable high-concentration formulation for anti-fxia antibodies |
EP3628683A1 (en) * | 2018-09-28 | 2020-04-01 | Zealand Pharma A/S | Formulations of glucagon-like-peptide-2 (glp-2) analogues |
EP3958840A1 (en) * | 2019-04-23 | 2022-03-02 | Amgen Inc. | The use of low molecular weight polyvinylpyrrolidone (pvp) to reduce viscosity of high concentration protein formulations |
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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 |
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 |
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JP2006516636A (ja) | 2003-01-30 | 2006-07-06 | メディミューン,インコーポレーテッド | 抗インテグリンαvβ3抗体製剤及びその用途 |
HUE030579T2 (en) | 2003-04-04 | 2017-05-29 | Genentech Inc | High Concentration Antibody And Protein Products |
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EA033444B1 (ru) | 2014-10-23 | 2019-10-31 | Amgen Inc | Снижение вязкости фармацевтических составов |
EP3226895B1 (en) | 2014-12-03 | 2020-07-22 | CSL Behring AG | Pharmaceutical product with increased stability comprising immunoglobulins |
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JP7275027B2 (ja) | 2016-10-06 | 2023-05-17 | アムジェン インコーポレイテッド | 粘度低下タンパク質医薬製剤 |
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 EA EA201790787A patent/EA033444B1/ru not_active IP Right Cessation
- 2015-10-22 AU AU2015335743A patent/AU2015335743B2/en active Active
- 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 MX MX2017005243A patent/MX2017005243A/es unknown
- 2015-10-22 EA EA202191513A patent/EA202191513A1/ru unknown
- 2015-10-22 EP EP21175309.0A patent/EP3909611B1/en active Active
- 2015-10-22 BR BR112017008125-3A patent/BR112017008125B1/pt active IP Right Grant
- 2015-10-22 IL IL287947A patent/IL287947B2/en unknown
- 2015-10-22 JP JP2017522169A patent/JP2017531682A/ja active Pending
- 2015-10-22 WO PCT/US2015/056972 patent/WO2016065181A1/en active Application Filing
- 2015-10-22 US US15/521,057 patent/US11813328B2/en active Active
- 2015-10-22 ES ES21175309T patent/ES2964713T3/es active Active
- 2015-10-22 KR KR1020177011706A patent/KR102534017B1/ko active IP Right Grant
- 2015-10-22 MA MA054716A patent/MA54716A/fr unknown
- 2015-10-22 EA EA201991447A patent/EA038462B1/ru unknown
- 2015-10-22 CN CN201580057461.5A patent/CN107206070B/zh active Active
- 2015-10-22 SG SG11201703152RA patent/SG11201703152RA/en unknown
- 2015-10-22 CA CA2964786A patent/CA2964786C/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
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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/US20240066124A1/en active Pending
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