MX351706B - Estabilizacion de inmunoglobulinas a traves de una formulacion acuosa con histidina a ph acido debil a neutro. - Google Patents
Estabilizacion de inmunoglobulinas a traves de una formulacion acuosa con histidina a ph acido debil a neutro.Info
- Publication number
- MX351706B MX351706B MX2013003018A MX2013003018A MX351706B MX 351706 B MX351706 B MX 351706B MX 2013003018 A MX2013003018 A MX 2013003018A MX 2013003018 A MX2013003018 A MX 2013003018A MX 351706 B MX351706 B MX 351706B
- Authority
- MX
- Mexico
- Prior art keywords
- neutral
- immunoglobulins
- histidine
- stabilization
- aqueous formulation
- 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
- A61K9/08—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
- 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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/14—Alkali metal chlorides; Alkaline earth metal chlorides
-
- 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
- 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
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Inorganic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Dermatology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Immunology (AREA)
- Diabetes (AREA)
- Hematology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
La presente invención se refiere a una composición acuosa de inmunoglobulina estable durante el almacenamiento, caracterizada porque comprende: (a) una inmunoglobulina; (b) de 100 mM a 500 mM de histidina; (c) de 0 mM a 10 mM de un catión de metal alcalino; y (d) un pH de 5.5 a 7.0, en donde la composición es estable durante al menos 6 meses cuando se almacena a partir de 28°C a 32°C, y en donde la composición se considera estable siempre y cuando el porcentaje de inmunoglobulina en el estado agregado se mantenga por debajo del 2%, y en donde la composición no contiene un tensioactivo o azúcar.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US38420910P | 2010-09-17 | 2010-09-17 | |
PCT/US2011/052053 WO2012037534A1 (en) | 2010-09-17 | 2011-09-16 | Stabilization of immunoglobulins through aqueous formulation with histidine at weak acidic to neutral ph |
Publications (2)
Publication Number | Publication Date |
---|---|
MX2013003018A MX2013003018A (es) | 2013-06-28 |
MX351706B true MX351706B (es) | 2017-10-25 |
Family
ID=44721088
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
MX2013003018A MX351706B (es) | 2010-09-17 | 2011-09-16 | Estabilizacion de inmunoglobulinas a traves de una formulacion acuosa con histidina a ph acido debil a neutro. |
Country Status (23)
Country | Link |
---|---|
US (4) | US8795658B2 (es) |
EP (3) | EP2616091A1 (es) |
JP (4) | JP6055412B2 (es) |
KR (1) | KR101879885B1 (es) |
CN (2) | CN103282042B (es) |
AR (3) | AR083035A1 (es) |
AU (2) | AU2011301807C1 (es) |
BR (1) | BR112013006308B1 (es) |
CA (2) | CA2810734A1 (es) |
CL (1) | CL2013000724A1 (es) |
CO (1) | CO6660498A2 (es) |
DK (1) | DK2616090T3 (es) |
EA (2) | EA027353B1 (es) |
ES (1) | ES2959479T3 (es) |
FI (1) | FI2616090T3 (es) |
IL (1) | IL225093B (es) |
MX (1) | MX351706B (es) |
MY (1) | MY188828A (es) |
PL (1) | PL2616090T3 (es) |
PT (1) | PT2616090T (es) |
SG (1) | SG188487A1 (es) |
TW (2) | TWI621625B (es) |
WO (2) | WO2012037530A1 (es) |
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TWI532498B (zh) | 2008-03-17 | 2016-05-11 | 巴克斯特保健公司 | 供免疫球蛋白及玻尿酸酶之皮下投藥之用的組合及方法 |
MX2012003282A (es) * | 2009-09-17 | 2012-04-30 | Baxter Healthcare Sa | Co-formulacion estable de hialuronidasa e inmunoglobulina, y metodos de su uso. |
JP6055412B2 (ja) * | 2010-09-17 | 2016-12-27 | バクスアルタ ゲーエムベーハー | 弱酸性〜中性のpHにおける、ヒスチジンを有する水性製剤を介した免疫グロブリンの安定化 |
BR112015004984A2 (pt) | 2012-09-07 | 2017-07-04 | Coherus Biosciences Inc | formulações aquosas estáveis de adalimumab |
PT2994160T (pt) * | 2013-05-06 | 2019-08-07 | Baxalta Inc | Tratamento de sub-populações com doença de alzheimer com imunoglobulina g combinada |
DK3177317T3 (en) | 2014-08-04 | 2020-06-15 | Csl Ltd | Factor viii formulation |
EP3233111B1 (en) * | 2014-12-19 | 2024-08-07 | Kedrion Biopharma Inc. | Pharmaceutical composition comprising plasminogen and uses thereof |
CN104826117B (zh) * | 2015-05-05 | 2017-11-14 | 广东卫伦生物制药有限公司 | 用于人体血清免疫球蛋白溶液制剂的储存稳定剂 |
US11229702B1 (en) | 2015-10-28 | 2022-01-25 | Coherus Biosciences, Inc. | High concentration formulations of adalimumab |
WO2017121867A1 (en) * | 2016-01-13 | 2017-07-20 | Genmab A/S | Formulation for antibody and drug conjugate thereof |
WO2017184880A1 (en) | 2016-04-20 | 2017-10-26 | Coherus Biosciences, Inc. | A method of filling a container with no headspace |
US20190282569A1 (en) * | 2016-10-26 | 2019-09-19 | Astellas Pharma Inc. | Stable pharmaceutical composition |
WO2018181876A1 (ja) * | 2017-03-31 | 2018-10-04 | Meiji Seikaファルマ株式会社 | 水性製剤及び注射器入り水性製剤、並びに、抗体タンパク脱凝集剤及び抗体タンパク脱凝集方法 |
JP7465215B2 (ja) * | 2018-04-12 | 2024-04-10 | アムジェン インコーポレイテッド | 安定なタンパク質組成物を製造する方法 |
WO2021001522A1 (en) | 2019-07-04 | 2021-01-07 | CSL Behring Lengnau AG | A truncated von willebrand factor (vwf) for increasing the in vitro stability of coagulation factor viii |
IL301681A (en) * | 2020-09-27 | 2023-05-01 | Emergent Biosolutions Canada Inc | Hyperimmune globulin preparations |
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2011
- 2011-09-16 JP JP2013529386A patent/JP6055412B2/ja active Active
- 2011-09-16 EA EA201390400A patent/EA027353B1/ru not_active IP Right Cessation
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