CL2019002190A1 - 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) - Google Patents
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)Info
- Publication number
- CL2019002190A1 CL2019002190A1 CL2019002190A CL2019002190A CL2019002190A1 CL 2019002190 A1 CL2019002190 A1 CL 2019002190A1 CL 2019002190 A CL2019002190 A CL 2019002190A CL 2019002190 A CL2019002190 A CL 2019002190A CL 2019002190 A1 CL2019002190 A1 CL 2019002190A1
- Authority
- CL
- Chile
- Prior art keywords
- therapeutic protein
- viscosity
- concentration
- antibody
- reduction
- Prior art date
Links
- 239000008194 pharmaceutical composition Substances 0.000 title abstract 3
- 102000004169 proteins and genes Human genes 0.000 title abstract 3
- 108090000623 proteins and genes Proteins 0.000 title abstract 3
- 230000001225 therapeutic effect Effects 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
Classifications
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- 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
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 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.
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201462067637P | 2014-10-23 | 2014-10-23 |
Publications (1)
Publication Number | Publication Date |
---|---|
CL2019002190A1 true CL2019002190A1 (es) | 2019-11-22 |
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 Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CL2017000984A CL2017000984A1 (es) | 2014-10-23 | 2017-04-20 | Reducción de la viscosidad de formulaciones farmacéuticas |
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) | EA202191513A1 (es) |
ES (1) | ES2964713T3 (es) |
IL (2) | IL287947B1 (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)
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EA202191513A1 (ru) | 2014-10-23 | 2021-11-30 | Эмджен Инк. | 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 |
EP3615065A1 (en) | 2017-04-28 | 2020-03-04 | Amgen Inc. | Excipients to reduce the viscosity of antibody formulations and formulation compositions |
AU2018258676A1 (en) | 2017-04-28 | 2019-10-31 | Amgen Inc. | N-acetylated and non-acetylated dipeptides containing arginine to reduce the viscosity of viscous compositions of therapeutic polypeptides |
EP3624846A1 (en) | 2017-05-16 | 2020-03-25 | Bhami's Research Laboratory, Pvt. Ltd. | High concentration protein formulations with reduced viscosity |
CN110996988A (zh) * | 2017-09-22 | 2020-04-10 | 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 |
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) |
EP3628683A1 (en) * | 2018-09-28 | 2020-04-01 | Zealand Pharma A/S | Formulations of glucagon-like-peptide-2 (glp-2) analogues |
CA3141857A1 (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 |
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US6767892B1 (en) * | 1997-11-07 | 2004-07-27 | Chrion Corporation | Compositions providing for increased IGF-I solubility |
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2015
- 2015-10-22 EA EA202191513A patent/EA202191513A1/ru unknown
- 2015-10-22 EA EA201790787A patent/EA033444B1/ru not_active IP Right Cessation
- 2015-10-22 EP EP15790759.3A patent/EP3209332B1/en 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
- 2015-10-22 SG SG11201703152RA patent/SG11201703152RA/en unknown
- 2015-10-22 CA CA2964786A patent/CA2964786C/en active Active
- 2015-10-22 ES ES21175309T patent/ES2964713T3/es active Active
- 2015-10-22 EA EA201991447A patent/EA038462B1/ru unknown
- 2015-10-22 EP EP21175309.0A patent/EP3909611B1/en active Active
- 2015-10-22 CN CN202210048275.7A patent/CN114569716A/zh active Pending
- 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 CN CN201580057461.5A patent/CN107206070B/zh active Active
- 2015-10-22 KR KR1020177011706A patent/KR102534017B1/ko active IP Right Grant
- 2015-10-22 IL IL287947A patent/IL287947B1/en unknown
- 2015-10-22 MA MA054716A patent/MA54716A/fr unknown
- 2015-10-22 US US15/521,057 patent/US11813328B2/en active Active
- 2015-10-22 MX MX2017005243A patent/MX2017005243A/es unknown
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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
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2019
- 2019-08-02 CL CL2019002190A patent/CL2019002190A1/es unknown
- 2019-10-21 JP JP2019191701A patent/JP6965321B2/ja active Active
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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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