AR112443A2 - Un kit para reconstitución o dilución de un fármaco - Google Patents
Un kit para reconstitución o dilución de un fármacoInfo
- Publication number
- AR112443A2 AR112443A2 ARP180101902A AR112443A2 AR 112443 A2 AR112443 A2 AR 112443A2 AR P180101902 A ARP180101902 A AR P180101902A AR 112443 A2 AR112443 A2 AR 112443A2
- Authority
- AR
- Argentina
- Prior art keywords
- lyophilized cake
- sodium chloride
- formulation
- solution
- chloride solution
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/43—Enzymes; Proenzymes; Derivatives thereof
- A61K38/46—Hydrolases (3)
- A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
- A61K38/482—Serine endopeptidases (3.4.21)
- A61K38/4846—Factor VII (3.4.21.21); Factor IX (3.4.21.22); Factor Xa (3.4.21.6); Factor XI (3.4.21.27); Factor XII (3.4.21.38)
-
- 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
-
- 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
- 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
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
-
- 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
-
- 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
- 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
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Inorganic Chemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Gastroenterology & Hepatology (AREA)
- Immunology (AREA)
- Dermatology (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Diabetes (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Hematology (AREA)
- Organic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Reivindicación 1: Un método para la preparación de una formulación farmacéutica para inyección intravenosa, el método caracterizado porque comprende la adición de alrededor de 25 mM hasta alrededor de 150 mM de solución de cloruro de sodio a la formulación farmacéutica resultando de esa manera en una formulación preparada para inyección intravenosa, en donde la formulación preparada es casi isotónica con respecto al plasma o es ligeramente hipotónica o ligeramente hipertónica con respecto al plasma, y en donde la formulación preparada tiene una fuerza iónica suficiente para prevenir la aglutinación de eritrocitos. Reivindicación 22: El método de conformidad con cualesquiera de las reivindicaciones 1 a la 21, caracterizado porque antes de la adición de la solución de cloruro de sodio, la formulación farmacéutica comprende histidina, glicina, sacarosa, polisorbato, y Factor IX. Reivindicación 31: Un kit farmacéutico caracterizado porque comprende: (a) un frasco que contiene una torta liofilizada, en donde si la torta liofilizada se reconstituye en 5 mL de agua la solución comprendería: (i) desde alrededor de 5 mM hasta alrededor de 30 mM de histidina; (ii) desde alrededor de 0.1M hasta alrededor de 0.3M de glicina; (iii) desde alrededor de 0.5 hasta alrededor de 2 por ciento de sacarosa; (iv) desde alrededor de 0.001 hasta alrededor de 0.05 por ciento de polisorbato; y (v) desde alrededor de 50 IU/mL hasta alrededor de 2000 IU/mL de Factor IX; (b) una solución de cloruro de sodio de 25 mM hasta alrededor de 150 mM; y (c) instrucciones para la reconstitución de la torta liofilizada con la solución de cloruro de sodio, tal que después de reconstitución la solución resultante es casi isotónica y tiene una fuerza iónica suficiente para prevenir la agregación de eritrocitos en la inyección intravenosa. Reivindicación 33: Una torta liofilizada, caracterizada porque si la torta liofilizada se reconstituye en 5 ml de agua, la solución comprendería: (i) desde alrededor de 5 mM hasta alrededor de 30 mM de histidina; (ii) desde alrededor de 0.1M hasta alrededor de 0.3M de glicina; (iii) desde alrededor de 0.5 hasta alrededor de 2 por ciento de sacarosa; (iv) desde alrededor de 0.001 hasta alrededor de 0.05 por ciento de polisorbato; y (v) desde alrededor de 50 IU/mL hasta alrededor de 2000 IU/mL de Factor IX.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US73222105P | 2005-11-01 | 2005-11-01 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AR112443A2 true AR112443A2 (es) | 2019-10-30 |
Family
ID=37801586
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP060104769A AR056748A1 (es) | 2005-11-01 | 2006-10-31 | Solucion de cloruro de sodio para reconstitucion o dilucion de farmaco |
| ARP180101902 AR112443A2 (es) | 2005-11-01 | 2018-07-06 | Un kit para reconstitución o dilución de un fármaco |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP060104769A AR056748A1 (es) | 2005-11-01 | 2006-10-31 | Solucion de cloruro de sodio para reconstitucion o dilucion de farmaco |
Country Status (31)
| Country | Link |
|---|---|
| US (4) | US20070135343A1 (es) |
| EP (3) | EP3593790A1 (es) |
| JP (1) | JP5555425B2 (es) |
| KR (2) | KR20110128957A (es) |
| CN (1) | CN101351190B (es) |
| AR (2) | AR056748A1 (es) |
| AU (1) | AU2006308921C1 (es) |
| BR (1) | BRPI0618133A2 (es) |
| CA (1) | CA2626531C (es) |
| CR (1) | CR9958A (es) |
| DK (2) | DK3225233T3 (es) |
| EC (1) | ECSP088485A (es) |
| ES (2) | ES2627684T5 (es) |
| FI (1) | FI1942868T4 (es) |
| FR (1) | FR20C1005I1 (es) |
| GT (1) | GT200800037A (es) |
| HK (1) | HK1245090B (es) |
| HU (4) | HUE033949T2 (es) |
| IL (1) | IL190843A (es) |
| LU (1) | LUC00035I2 (es) |
| MY (1) | MY184364A (es) |
| NO (1) | NO347263B1 (es) |
| NZ (1) | NZ567685A (es) |
| PE (3) | PE20110803A1 (es) |
| PL (2) | PL3225233T3 (es) |
| PT (2) | PT1942868T (es) |
| RU (1) | RU2432157C2 (es) |
| SI (2) | SI1942868T2 (es) |
| TW (1) | TWI480063B (es) |
| UA (1) | UA97234C2 (es) |
| WO (1) | WO2007053533A2 (es) |
Families Citing this family (25)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR20110128957A (ko) | 2005-11-01 | 2011-11-30 | 와이어쓰 엘엘씨 | 약물 재구성 또는 희석을 위한 염화나트륨 용액 |
| US7767206B2 (en) | 2006-10-02 | 2010-08-03 | Amgen Inc. | Neutralizing determinants of IL-17 Receptor A and antibodies that bind thereto |
| US8431011B2 (en) * | 2008-01-31 | 2013-04-30 | Abbott Diabetes Care Inc. | Method for automatically and rapidly distinguishing between control and sample solutions in a biosensor strip |
| CA2780554C (en) * | 2009-11-17 | 2017-08-15 | Ipsen Pharma S.A.S. | Formulation for hgh and rhigf-1 combination |
| US9427186B2 (en) | 2009-12-04 | 2016-08-30 | Endomagnetics Ltd. | Magnetic probe apparatus |
| US10634741B2 (en) | 2009-12-04 | 2020-04-28 | Endomagnetics Ltd. | Magnetic probe apparatus |
| SG182468A1 (en) | 2010-01-15 | 2012-08-30 | Kirin Amgen Inc | Antibody formulation and therapeutic regimens |
| JP5937523B2 (ja) | 2010-03-01 | 2016-06-22 | サイトダイン インコーポレイテッドＣｙｔｏＤｙｎ， Ｉｎｃ． | 濃縮されたタンパク質製剤およびその使用 |
| KR20230156435A (ko) | 2010-07-09 | 2023-11-14 | 바이오버라티브 테라퓨틱스 인크. | 인자 iｘ 폴리펩티드 및 이들의 사용 방법 |
| WO2014052490A1 (en) * | 2012-09-25 | 2014-04-03 | Biogen Idec Ma Inc. | Methods of using fix polypeptides |
| CN105283202B (zh) | 2013-03-11 | 2019-04-23 | 安都磁学有限公司 | 用于淋巴结检测的低渗溶液 |
| US9239314B2 (en) | 2013-03-13 | 2016-01-19 | Endomagnetics Ltd. | Magnetic detector |
| US9234877B2 (en) | 2013-03-13 | 2016-01-12 | Endomagnetics Ltd. | Magnetic detector |
| EP2968498A4 (en) * | 2013-03-15 | 2016-09-07 | Biogen Ma Inc | PREPARATIONS CONTAINING FACTOR IX POLYPEPTIDE |
| FR3005420B1 (fr) | 2013-05-07 | 2015-09-18 | Erytech Pharma | Procede de stabilisation de suspensions d'erythrocytes encapsulant un principe actif, suspensions obtenues. |
| KR102385372B1 (ko) * | 2014-03-24 | 2022-04-11 | 바이오버라티브 테라퓨틱스 인크. | 동결건조된 ix 인자 제형 |
| US9351945B1 (en) * | 2015-02-27 | 2016-05-31 | John Daniel Dobak, III | Reduction of adipose tissue |
| GB2536703B (en) * | 2015-03-27 | 2020-12-02 | Ge Healthcare Bio Sciences Ab | Method for baseline correction in a chromatogram |
| EP3081942A1 (en) * | 2015-04-17 | 2016-10-19 | Roche Diagniostics GmbH | Pressure transmission liquid for cellular analyzer, cellular analyzer and method for analyzing a liquid cellular sample |
| EP4085866A3 (en) | 2015-06-04 | 2023-01-18 | Endomagnetics Ltd. | Marker materials and forms for magnetic marker localization |
| US10124021B2 (en) * | 2016-12-23 | 2018-11-13 | Andrew L. Gostine | Intravenous fluid |
| US10793327B2 (en) | 2017-10-09 | 2020-10-06 | Terumo Bct Biotechnologies, Llc | Lyophilization container and method of using same |
| CA3130700A1 (en) | 2019-03-14 | 2020-09-17 | Terumo Bct Biotechnologies, Llc | Lyophilization container fill fixture, system and method of use |
| US20200345658A1 (en) * | 2019-05-01 | 2020-11-05 | Southwest Research Institute | Compositions Of Dimethyl Trisulfide (DMTS) As A Cyanide Antidote |
| IL272145A (en) * | 2020-01-20 | 2021-07-29 | Stem Cell Medicine Ltd | Cosmetic preparations with protein concentrate from a conditioned growth medium of stem cells from adipose tissue |
Family Cites Families (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3717708A (en) * | 1968-10-24 | 1973-02-20 | Cutter Lab | Blood coagulation complex |
| US4364861A (en) | 1980-05-27 | 1982-12-21 | Cutter Laboratories, Inc. | Blood-coagulation-promoting products and methods of preparing them |
| US6372716B1 (en) | 1994-04-26 | 2002-04-16 | Genetics Institute, Inc. | Formulations for factor IX |
| JP5149470B2 (ja) | 1999-02-22 | 2013-02-20 | バクスター・インターナショナル・インコーポレイテッド | 新規のアルブミンを含有していない第ｖｉｉｉ因子処方物 |
| US20010031721A1 (en) * | 1999-05-05 | 2001-10-18 | Chandra Webb | Highly concentrated, lyophilized, and liquid factor IX formulations |
| ES2332402T5 (es) * | 2000-10-12 | 2018-05-14 | Genentech, Inc. | Formulaciones de proteína concentradas de viscosidad reducida |
| EP2311437A1 (en) | 2003-12-19 | 2011-04-20 | Novo Nordisk Health Care AG | Stabilised compositions of factor VII polypeptides |
| AU2005225000A1 (en) * | 2004-03-04 | 2005-09-29 | Wyeth | Lyophilization method to improve excipient crystallization |
| KR20110128957A (ko) | 2005-11-01 | 2011-11-30 | 와이어쓰 엘엘씨 | 약물 재구성 또는 희석을 위한 염화나트륨 용액 |
-
2006
- 2006-10-27 KR KR1020117027131A patent/KR20110128957A/ko not_active Application Discontinuation
- 2006-10-27 DK DK17166616.7T patent/DK3225233T3/da active
- 2006-10-27 ES ES06827036T patent/ES2627684T5/es active Active
- 2006-10-27 PT PT68270362T patent/PT1942868T/pt unknown
- 2006-10-27 KR KR1020087013252A patent/KR101126670B1/ko active IP Right Grant
- 2006-10-27 EP EP19189599.4A patent/EP3593790A1/en not_active Withdrawn
- 2006-10-27 NZ NZ567685A patent/NZ567685A/en unknown
- 2006-10-27 SI SI200632172T patent/SI1942868T2/sl unknown
- 2006-10-27 JP JP2008538945A patent/JP5555425B2/ja active Active
- 2006-10-27 RU RU2008119514/15A patent/RU2432157C2/ru active
- 2006-10-27 PE PE2011000653A patent/PE20110803A1/es not_active Application Discontinuation
- 2006-10-27 US US11/589,002 patent/US20070135343A1/en not_active Abandoned
- 2006-10-27 PE PE2015001729A patent/PE20151284A1/es not_active Application Discontinuation
- 2006-10-27 HU HUE06827036A patent/HUE033949T2/hu unknown
- 2006-10-27 AU AU2006308921A patent/AU2006308921C1/en active Active
- 2006-10-27 PL PL17166616T patent/PL3225233T3/pl unknown
- 2006-10-27 PE PE2006001318A patent/PE20070714A1/es not_active Application Discontinuation
- 2006-10-27 MY MYPI20081347A patent/MY184364A/en unknown
- 2006-10-27 HU HUE17166616A patent/HUE045421T2/hu unknown
- 2006-10-27 EP EP06827036.2A patent/EP1942868B2/en active Active
- 2006-10-27 ES ES17166616T patent/ES2749574T3/es active Active
- 2006-10-27 BR BRPI0618133-3A patent/BRPI0618133A2/pt not_active Application Discontinuation
- 2006-10-27 EP EP17166616.7A patent/EP3225233B1/en not_active Revoked
- 2006-10-27 TW TW095139724A patent/TWI480063B/zh active
- 2006-10-27 DK DK06827036.2T patent/DK1942868T5/da active
- 2006-10-27 PT PT171666167T patent/PT3225233T/pt unknown
- 2006-10-27 SI SI200632348T patent/SI3225233T1/sl unknown
- 2006-10-27 WO PCT/US2006/042258 patent/WO2007053533A2/en active Application Filing
- 2006-10-27 UA UAA200807432A patent/UA97234C2/ru unknown
- 2006-10-27 CA CA2626531A patent/CA2626531C/en active Active
- 2006-10-27 PL PL06827036.2T patent/PL1942868T5/pl unknown
- 2006-10-27 NO NO20082180A patent/NO347263B1/no unknown
- 2006-10-27 CN CN2006800400807A patent/CN101351190B/zh active Active
- 2006-10-31 AR ARP060104769A patent/AR056748A1/es not_active Application Discontinuation
-
2008
- 2008-04-14 IL IL190843A patent/IL190843A/en active IP Right Grant
- 2008-04-17 GT GT200800037A patent/GT200800037A/es unknown
- 2008-05-07 CR CR9958A patent/CR9958A/es not_active Application Discontinuation
- 2008-05-30 EC EC2008008485A patent/ECSP088485A/es unknown
-
2016
- 2016-10-07 US US15/288,860 patent/US20170021022A1/en not_active Abandoned
-
2017
- 2017-09-25 LU LU00035C patent/LUC00035I2/fr unknown
- 2017-09-27 HU HUS1700035C patent/HUS1700035I1/hu unknown
-
2018
- 2018-04-04 HK HK18104477.4A patent/HK1245090B/zh unknown
- 2018-07-06 AR ARP180101902 patent/AR112443A2/es not_active Application Discontinuation
-
2019
- 2019-12-20 US US16/723,563 patent/US20200138952A1/en not_active Abandoned
-
2020
- 2020-01-31 HU HUS2000003C patent/HUS2000003I1/hu unknown
- 2020-02-10 FR FR20C1005C patent/FR20C1005I1/fr active Active
- 2020-07-14 US US16/946,998 patent/US20200338199A1/en not_active Abandoned
-
2023
- 2023-03-17 FI FIEP06827036.2T patent/FI1942868T4/fi active
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