BR112019006853B1 - Composição farmacêutica líquida, seu método de fabricação, seu uso, kit e dispositivo de liberação de fármaco que a compreendem e método de fabricação do dito dispositivo - Google Patents
Composição farmacêutica líquida, seu método de fabricação, seu uso, kit e dispositivo de liberação de fármaco que a compreendem e método de fabricação do dito dispositivo Download PDFInfo
- Publication number
- BR112019006853B1 BR112019006853B1 BR112019006853-8A BR112019006853A BR112019006853B1 BR 112019006853 B1 BR112019006853 B1 BR 112019006853B1 BR 112019006853 A BR112019006853 A BR 112019006853A BR 112019006853 B1 BR112019006853 B1 BR 112019006853B1
- Authority
- BR
- Brazil
- Prior art keywords
- pharmaceutical composition
- liquid pharmaceutical
- tocilizumab
- concentration
- lactic acid
- Prior art date
Links
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Classifications
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- A—HUMAN NECESSITIES
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- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39591—Stabilisation, fragmentation
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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
- A61K47/02—Inorganic compounds
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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
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
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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
- A61K47/16—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
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- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
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- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
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| PE20091174A1 (es) | 2007-12-27 | 2009-08-03 | Chugai Pharmaceutical Co Ltd | Formulacion liquida con contenido de alta concentracion de anticuerpo |
| CN110062620B (zh) * | 2016-10-31 | 2023-12-05 | 德国费森尤斯卡比有限公司 | 液体药物组合物 |
| EP4467565A3 (en) | 2016-12-21 | 2025-03-12 | Amgen Inc. | Anti-tnf alpha antibody formulations |
| US12433948B2 (en) * | 2018-10-31 | 2025-10-07 | Richter Gedeon Nyrt | Aqueous pharmaceutical formulations |
| WO2021119330A1 (en) * | 2019-12-10 | 2021-06-17 | Maxim Skulachev | Polymer matrixes for different compositions of mitochondrially targeted antioxidants |
| EP4117727A2 (en) * | 2020-03-10 | 2023-01-18 | Tiziana Life Sciences PLC | Compositions of il-6/il-6r antibodies and methods of use thereof |
| ES2987347T3 (es) * | 2020-03-13 | 2024-11-14 | Lek Pharmaceuticals | Estabilización de composiciones farmacéuticas que comprenden polisorbato |
| WO2022006051A1 (en) * | 2020-06-29 | 2022-01-06 | Anovent Pharmaceutical (U.S.), Llc | Formulation of tocilizumab and method for treating covid-19 by inhalation |
| KR20220028972A (ko) * | 2020-08-31 | 2022-03-08 | (주)셀트리온 | 안정한 약제학적 제제 |
| US20230090654A1 (en) * | 2021-08-24 | 2023-03-23 | Homology Medicines, Inc. | Adeno-associated virus formulations |
| WO2024043837A1 (en) * | 2022-08-26 | 2024-02-29 | Aslan Pharmaceuticals Pte Ltd | High concentration anti-il13r antibody formulation |
| KR102554775B1 (ko) | 2023-02-07 | 2023-07-12 | 한국코러스 주식회사 | 히알루로니다제의 안정화제 및 이를 포함하는 히알루로니다제 제형 |
| WO2024257040A1 (en) * | 2023-06-14 | 2024-12-19 | Enzene Biosciences Limited | Composition and stable liquid formulations comprising humanized anti-human interleukin 6 (il-6) receptor monoclonal antibodies |
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| TW205553B (enExample) | 1991-04-25 | 1993-05-11 | Chugai Pharmaceutical Co Ltd | |
| DK1314437T3 (da) | 2000-08-11 | 2014-07-14 | Chugai Pharmaceutical Co Ltd | Stabiliserede antistofindeholdende præparater |
| MXPA04007924A (es) | 2002-02-14 | 2005-05-17 | Chugai Pharmaceutical Co Ltd | Formulaciones en solucion que contienen anticuerpo. |
| GB0700523D0 (en) * | 2007-01-11 | 2007-02-21 | Insense Ltd | The Stabilisation Of Proteins |
| JP2009034095A (ja) * | 2007-07-06 | 2009-02-19 | Sanyo Chem Ind Ltd | タンパク質含有水溶液安定化剤、タンパク質含有水溶液の安定化方法及びタンパク質含有水溶液 |
| KR20100044261A (ko) * | 2007-08-27 | 2010-04-29 | 바이오제너릭스 에이지 | Ｇ-ｃｓｆ의 액상 조성물 |
| PE20091174A1 (es) | 2007-12-27 | 2009-08-03 | Chugai Pharmaceutical Co Ltd | Formulacion liquida con contenido de alta concentracion de anticuerpo |
| JO3417B1 (ar) | 2010-01-08 | 2019-10-20 | Regeneron Pharma | الصيغ المستقرة التي تحتوي على الأجسام المضادة لمضاد مستقبل( interleukin-6 (il-6r |
| KR20220070586A (ko) * | 2010-11-08 | 2022-05-31 | 제넨테크, 인크. | 피하 투여용 항―ｉｌ―6 수용체 항체 |
| AU2012328524B2 (en) | 2011-10-28 | 2017-05-18 | Excelse Bio, Inc. | Protein formulations containing amino acids |
| US20150150979A1 (en) * | 2012-06-21 | 2015-06-04 | Ucb Pharma, S.A. | Pharmaceutical formulation |
| CN102961745B (zh) * | 2012-09-27 | 2015-02-18 | 苏州康聚生物科技有限公司 | 抗体组合物制剂及其应用 |
| CN110062620B (zh) * | 2016-10-31 | 2023-12-05 | 德国费森尤斯卡比有限公司 | 液体药物组合物 |
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2019
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| ES2882181T3 (es) | 2021-12-01 |
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| RU2019116756A (ru) | 2020-11-30 |
| RU2019116756A3 (enExample) | 2021-02-26 |
| BR112019006853A2 (pt) | 2019-06-25 |
| CN110062620A (zh) | 2019-07-26 |
| EP3532029A1 (en) | 2019-09-04 |
| SG11201902531QA (en) | 2019-05-30 |
| JP2019536761A (ja) | 2019-12-19 |
| HUE054858T2 (hu) | 2021-10-28 |
| US20190262450A1 (en) | 2019-08-29 |
| KR20190078572A (ko) | 2019-07-04 |
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| US11291725B2 (en) | 2022-04-05 |
| CA3040342A1 (en) | 2018-05-03 |
| AU2017351805A1 (en) | 2019-04-11 |
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