CU20180154A7 - Formulación farmacéutica líquida estable - Google Patents
Formulación farmacéutica líquida estableInfo
- Publication number
- CU20180154A7 CU20180154A7 CU2018000154A CU20180154A CU20180154A7 CU 20180154 A7 CU20180154 A7 CU 20180154A7 CU 2018000154 A CU2018000154 A CU 2018000154A CU 20180154 A CU20180154 A CU 20180154A CU 20180154 A7 CU20180154 A7 CU 20180154A7
- Authority
- CU
- Cuba
- Prior art keywords
- pharmaceutical formulation
- liquid pharmaceutical
- stable liquid
- antibody
- present
- Prior art date
Links
- 239000007788 liquid Substances 0.000 title abstract 3
- 239000008194 pharmaceutical composition Substances 0.000 title abstract 3
- 239000000427 antigen Substances 0.000 abstract 1
- 102000036639 antigens Human genes 0.000 abstract 1
- 108091007433 antigens Proteins 0.000 abstract 1
- 239000012634 fragment Substances 0.000 abstract 1
- 230000007774 longterm Effects 0.000 abstract 1
- 239000004094 surface-active agent 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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
-
- 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
-
- 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
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- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
-
- 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
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- 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
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- 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
-
- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/06—Antipsoriatics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/04—Immunostimulants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
- C07K16/241—Tumor Necrosis Factors
-
- 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
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/60—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
- C07K2317/62—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising only variable region components
- C07K2317/622—Single chain antibody (scFv)
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)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Immunology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Organic Chemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Dermatology (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Transplantation (AREA)
- Rheumatology (AREA)
- Endocrinology (AREA)
- Physical Education & Sports Medicine (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Pain & Pain Management (AREA)
- Oncology (AREA)
- Communicable Diseases (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Abstract
<p>La presente invención proporciona una formulación farmacéutica líquida estable que contiene: un anticuerpo o su fragmento de unión a antígeno; un tensioactivo; un azúcar o su derivado; y un tampón. La formulación farmacéutica líquida estable de acuerdo con Ia presente invención tiene baja viscosidad a Ia vez que contiene un contenido elevado del anticuerpo, tiene una estabilidad durante el almacenamiento a largo plazo excelente basándose en Ia estabilidad excelente en condiciones aceleradas y condiciones severas, y se puede administrar por vía subcutánea.</p>
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
KR20160083039 | 2016-06-30 | ||
PCT/KR2017/006855 WO2018004260A1 (ko) | 2016-06-30 | 2017-06-28 | 안정한 액체 약제학적 제제 |
Publications (2)
Publication Number | Publication Date |
---|---|
CU20180154A7 true CU20180154A7 (es) | 2019-08-06 |
CU24561B1 CU24561B1 (es) | 2022-01-13 |
Family
ID=60787364
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CU2018000154A CU24561B1 (es) | 2016-06-30 | 2017-06-28 | Formulación farmacéutica líquida estable |
Country Status (40)
Families Citing this family (16)
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US8883146B2 (en) | 2007-11-30 | 2014-11-11 | Abbvie Inc. | Protein formulations and methods of making same |
CN110167531A (zh) * | 2017-01-11 | 2019-08-23 | 赛特瑞恩股份有限公司 | 稳定的液体调配物 |
KR20190024572A (ko) * | 2017-08-30 | 2019-03-08 | (주)셀트리온 | TNFα 관련 질환을 치료하기 위한 피하 투여 요법 |
WO2020060192A1 (ko) * | 2018-09-18 | 2020-03-26 | 삼성바이오에피스 주식회사 | 고농도의 계면활성제를 포함하는 트라스투주맙 안정화 액체 제제 |
JP7374544B2 (ja) * | 2018-10-10 | 2023-11-07 | アステラス製薬株式会社 | 標識部-抗ヒト抗体Fabフラグメント複合体を含む医薬組成物 |
US11634485B2 (en) | 2019-02-18 | 2023-04-25 | Eli Lilly And Company | Therapeutic antibody formulation |
CN111686247B (zh) * | 2019-03-13 | 2022-07-29 | 苏州康乃德生物医药有限公司 | 包含人白介素-4受体α的抗体的液体组合物 |
EP3941521A1 (en) * | 2019-03-18 | 2022-01-26 | Alvotech HF | Aqueous formulations of tnf-alpha antibodies in high concentrations |
CN110095615A (zh) * | 2019-05-27 | 2019-08-06 | 山东艾科达生物科技有限公司 | 一种测定超敏c反应蛋白含量的试剂盒 |
CN110585430B (zh) * | 2019-09-29 | 2023-09-08 | 华博生物医药技术(上海)有限公司 | 一种人源化抗人il-17a单克隆抗体的药物组合物 |
KR20220152540A (ko) * | 2020-03-13 | 2022-11-16 | 삼성바이오에피스 주식회사 | 안정성이 증진된 액상 약제학적 조성물 |
CN115361971A (zh) * | 2020-04-06 | 2022-11-18 | 里兰斯坦福初级大学理事会 | 抗体制剂 |
KR20240073051A (ko) * | 2021-09-16 | 2024-05-24 | 주식회사 에이프로젠 | 항-TNFα 항체를 포함하는 약제학적 조성물 |
CN113940997B (zh) * | 2021-12-21 | 2022-04-08 | 迈威(上海)生物科技股份有限公司 | 一种双特异性抗体的稳定制剂 |
TW202333788A (zh) * | 2021-12-28 | 2023-09-01 | 大陸商江蘇先聲藥業有限公司 | 一種抗tnfr2抗體藥物組合物 |
WO2024124177A2 (en) * | 2022-12-09 | 2024-06-13 | Xentria, Inc. | Methods of treating sarcoidosis with a tnf-α antibody and associated compositions and methods |
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WO1994011041A1 (en) | 1992-11-19 | 1994-05-26 | R G S.A.S. Di Rosaria Galli & C. | Disposable auto-injector for prefilled syringes |
DE4438360C2 (de) | 1994-10-27 | 1999-05-20 | Schott Glas | Vorfüllbare partikelarme, sterile Einmalspritze für die Injektion von Präparaten und Verfahren zu ihrer Herstellung |
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2017
- 2017-06-28 KR KR1020170081814A patent/KR20180003452A/ko not_active Application Discontinuation
- 2017-06-28 EP EP24152383.6A patent/EP4338752A3/en active Pending
- 2017-06-28 GE GEAP201714966A patent/GEP20217249B/en unknown
- 2017-06-28 RS RS20240425A patent/RS65395B1/sr unknown
- 2017-06-28 TW TW106121657A patent/TWI736643B/zh active
- 2017-06-28 PT PT178205365T patent/PT3479819T/pt unknown
- 2017-06-28 ES ES17820536T patent/ES2975782T3/es active Active
- 2017-06-28 PL PL17820536.5T patent/PL3479819T3/pl unknown
- 2017-06-28 CR CR20180599A patent/CR20180599A/es unknown
- 2017-06-28 EP EP17820536.5A patent/EP3479819B1/en active Active
- 2017-06-28 CA CA3028238A patent/CA3028238C/en active Active
- 2017-06-28 SI SI201731501T patent/SI3479819T1/sl unknown
- 2017-06-28 JP JP2018565705A patent/JP7082070B2/ja active Active
- 2017-06-28 HU HUE17820536A patent/HUE066142T2/hu unknown
- 2017-06-28 LT LTEPPCT/KR2017/006855T patent/LT3479819T/lt unknown
- 2017-06-28 TN TNP/2018/000443A patent/TN2018000443A1/en unknown
- 2017-06-28 SG SG11201811320YA patent/SG11201811320YA/en unknown
- 2017-06-28 JO JOP/2018/0125A patent/JOP20180125B1/ar active
- 2017-06-28 MX MX2018015960A patent/MX2018015960A/es unknown
- 2017-06-28 AU AU2017287743A patent/AU2017287743C1/en active Active
- 2017-06-28 DK DK17820536.5T patent/DK3479819T5/da active
- 2017-06-28 BR BR112018076377-2A patent/BR112018076377A2/pt active Search and Examination
- 2017-06-28 CU CU2018000154A patent/CU24561B1/es unknown
- 2017-06-28 MD MDE20190562T patent/MD3479819T2/ro unknown
- 2017-06-28 FI FIEP17820536.5T patent/FI3479819T3/fi active
- 2017-06-28 PE PE2018003247A patent/PE20190448A1/es unknown
- 2017-06-28 US US16/310,585 patent/US11951207B2/en active Active
- 2017-06-28 CN CN201780036776.0A patent/CN109310628A/zh active Pending
- 2017-06-28 WO PCT/KR2017/006855 patent/WO2018004260A1/ko active Application Filing
- 2017-06-28 UA UAA201812485A patent/UA122610C2/uk unknown
- 2017-06-28 HR HRP20240426TT patent/HRP20240426T1/hr unknown
- 2017-06-28 MA MA45562A patent/MA45562B1/fr unknown
- 2017-06-28 EA EA201892653A patent/EA201892653A1/ru unknown
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2018
- 2018-07-25 KR KR1020180086393A patent/KR102229274B1/ko active IP Right Grant
- 2018-12-10 IL IL263630A patent/IL263630B2/en unknown
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