MX2016012870A - Formulaciones de factor viii estables con bajo tenor de azucar - glicina. - Google Patents
Formulaciones de factor viii estables con bajo tenor de azucar - glicina.Info
- Publication number
- MX2016012870A MX2016012870A MX2016012870A MX2016012870A MX2016012870A MX 2016012870 A MX2016012870 A MX 2016012870A MX 2016012870 A MX2016012870 A MX 2016012870A MX 2016012870 A MX2016012870 A MX 2016012870A MX 2016012870 A MX2016012870 A MX 2016012870A
- Authority
- MX
- Mexico
- Prior art keywords
- glycine
- factor viii
- salt
- sugar
- amorphous matrix
- Prior art date
Links
- 239000004471 Glycine Substances 0.000 title abstract 6
- 229960000301 factor viii Drugs 0.000 title abstract 5
- 238000009472 formulation Methods 0.000 title abstract 2
- 239000000203 mixture Substances 0.000 title abstract 2
- 108010023321 Factor VII Proteins 0.000 title 1
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 abstract 10
- 150000003839 salts Chemical class 0.000 abstract 6
- 108010054218 Factor VIII Proteins 0.000 abstract 4
- 102000001690 Factor VIII Human genes 0.000 abstract 4
- 239000011159 matrix material Substances 0.000 abstract 4
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 abstract 3
- 229930006000 Sucrose Natural products 0.000 abstract 3
- 239000005720 sucrose Substances 0.000 abstract 3
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 abstract 2
- HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 abstract 1
- 108010089996 B-domain-deleted factor VIII Proteins 0.000 abstract 1
- HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 abstract 1
- HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 abstract 1
- 150000001413 amino acids Chemical class 0.000 abstract 1
- 238000002425 crystallisation Methods 0.000 abstract 1
- 230000008025 crystallization Effects 0.000 abstract 1
- 238000004108 freeze drying Methods 0.000 abstract 1
- 238000002360 preparation method Methods 0.000 abstract 1
- 239000011780 sodium chloride Substances 0.000 abstract 1
- 230000006641 stabilisation Effects 0.000 abstract 1
- 238000011105 stabilization Methods 0.000 abstract 1
- 239000003381 stabilizer Substances 0.000 abstract 1
- 230000000087 stabilizing effect Effects 0.000 abstract 1
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
- A61K9/14—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
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/36—Blood coagulation or fibrinolysis factors
- A61K38/37—Factors VIII
-
- 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
- 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
-
- 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)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Hematology (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Zoology (AREA)
- Gastroenterology & Hepatology (AREA)
- Immunology (AREA)
- Inorganic Chemistry (AREA)
- Diabetes (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
Abstract
La presente invención proporciona una nueva preparación sin albúmina de factor VIII, que tiene elevada cantidad de sal y una baja concentración de azúcar y de glicina. La alta concentración salina proporciona estabilidad y una estructura de torta elegante como el principal componente cristalino. Las pequeñas cantidades de azúcar y glicina proporcionan una matriz amorfa compleja conjuntamente con sal no cristalizada amorfa para estabilizar el factor VIII. Esta formulación es particularmente adecuada para el factor VIII sin el dominio B, que requiere de un ambiente de alta fuerza iónica para la estabilidad. La adición de una pequeña cantidad de glicina con relación a la sacarosa impide la cristalización de la sal. Esto resulta en una matriz amorfa comprendiendo glicina, sacarosa y sal. Esta matriz amorfa proporciona un ambiente de estabilización, donde el factor VIII es protegido por tres estabilizadores; aminoácido (glicina), azúcar (sacarosa o trehalosa) y sal (NaCl). Tal matriz amorfa puede estabilizar el factor VIII a lo largo de la liofilización y durante el almacenamiento como un liófilo.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201461973281P | 2014-04-01 | 2014-04-01 | |
| PCT/BR2015/000044 WO2015149143A2 (en) | 2014-04-01 | 2015-03-30 | Stable factor viii formulations with low sugar-glycine |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| MX2016012870A true MX2016012870A (es) | 2017-05-12 |
Family
ID=54241375
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MX2016012870A MX2016012870A (es) | 2014-04-01 | 2015-03-30 | Formulaciones de factor viii estables con bajo tenor de azucar - glicina. |
Country Status (10)
| Country | Link |
|---|---|
| US (1) | US9907835B2 (es) |
| EP (1) | EP3126003A4 (es) |
| JP (1) | JP2017509659A (es) |
| KR (1) | KR20160146762A (es) |
| CN (1) | CN106413741A (es) |
| AU (1) | AU2015240353A1 (es) |
| CA (1) | CA2944349A1 (es) |
| CL (1) | CL2016002492A1 (es) |
| MX (1) | MX2016012870A (es) |
| WO (1) | WO2015149143A2 (es) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA2944183A1 (en) | 2014-04-01 | 2015-10-08 | Advantech Bioscience Farmaceutica Ltda. | Stabilization of factor viii without calcium as an excipient |
| EP3167877A1 (en) * | 2015-11-12 | 2017-05-17 | Bayer Pharma Aktiengesellschaft | Method for the production of freeze-dried pellets comprising factor viii |
Family Cites Families (20)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CZ290342B6 (cs) * | 1992-10-02 | 2002-07-17 | Genetics Institute Inc. | Kompozice stabilní při skladování, obsahující koagulační faktor VIII a neiontovou povrchově aktivní látku a způsob její výroby |
| US5763401A (en) * | 1996-07-12 | 1998-06-09 | Bayer Corporation | Stabilized albumin-free recombinant factor VIII preparation having a low sugar content |
| US5804420A (en) | 1997-04-18 | 1998-09-08 | Bayer Corporation | Preparation of recombinant Factor VIII in a protein free medium |
| US6200560B1 (en) | 1998-10-20 | 2001-03-13 | Avigen, Inc. | Adeno-associated virus vectors for expression of factor VIII by target cells |
| PT2193809E (pt) * | 1999-02-22 | 2015-08-24 | Baxter Int | Formulações de fator viii livres de albumina |
| JP4674021B2 (ja) * | 1999-07-13 | 2011-04-20 | ビオヴィトルム・アクチボラゲット（プブリクト） | 安定第ｖｉｉｉ因子組成物 |
| US20040185535A1 (en) | 2003-03-21 | 2004-09-23 | Giles Wilson | Industrial-scale serum-free production of recombinant FVII in mammalian cells |
| EP1233064A1 (en) | 2001-02-09 | 2002-08-21 | Aventis Behring Gesellschaft mit beschränkter Haftung | Modified factor VIII cDNA and its use for the production of factor VIII |
| US20040229335A1 (en) | 2003-05-15 | 2004-11-18 | Introgen Therapeutics, Inc. | Methods and compositions for the production of adenoviral vectors |
| KR100624013B1 (ko) * | 2004-06-25 | 2006-09-19 | 주식회사 녹십자홀딩스 | 동결건조된 알부민 비함유 재조합 사람 혈액응고 제 8인자 제제 |
| US20080070251A1 (en) | 2006-06-30 | 2008-03-20 | Kaufman Randal J | Method of Producing Factor VIII Proteins by Recombinant Methods |
| WO2009018307A2 (en) | 2007-07-31 | 2009-02-05 | Wyeth | Analysis of polypeptide production |
| US8580554B2 (en) | 2009-07-31 | 2013-11-12 | Baxter International Inc. | Method of producing a polypeptide or virus of interest in a continuous cell culture |
| SMT201700529T1 (it) | 2009-11-17 | 2018-01-11 | Squibb & Sons Llc | Metodi per un'aumentata produzione di proteine |
| WO2012122611A1 (en) | 2011-03-11 | 2012-09-20 | Universidade De São Paulo - Usp | Method for the production of recombinant human factor viii |
| US8668886B2 (en) | 2011-04-24 | 2014-03-11 | Therapeutic Proteins International, LLC | Separative bioreactor |
| AU2012318292B2 (en) * | 2011-10-18 | 2015-08-20 | Csl Limited | Method for improving the stability of purified Factor VIII after reconstitution |
| US20170009269A1 (en) | 2014-02-17 | 2017-01-12 | Advantech Bioscience Farmacêutica Ltda | Enhancement of recombinant protein expression using a membrane-based cell retention system |
| AU2015234611A1 (en) | 2014-03-23 | 2016-11-10 | Advantech Bioscience Farmaceutica Ltda. | Enhancement of recombinant protein expression with copper |
| CA2944183A1 (en) | 2014-04-01 | 2015-10-08 | Advantech Bioscience Farmaceutica Ltda. | Stabilization of factor viii without calcium as an excipient |
-
2015
- 2015-03-30 MX MX2016012870A patent/MX2016012870A/es unknown
- 2015-03-30 CA CA2944349A patent/CA2944349A1/en not_active Abandoned
- 2015-03-30 WO PCT/BR2015/000044 patent/WO2015149143A2/en not_active Ceased
- 2015-03-30 CN CN201580027155.7A patent/CN106413741A/zh active Pending
- 2015-03-30 JP JP2016559443A patent/JP2017509659A/ja not_active Withdrawn
- 2015-03-30 EP EP15772253.9A patent/EP3126003A4/en not_active Withdrawn
- 2015-03-30 KR KR1020167030251A patent/KR20160146762A/ko not_active Withdrawn
- 2015-03-30 US US15/120,264 patent/US9907835B2/en active Active
- 2015-03-30 AU AU2015240353A patent/AU2015240353A1/en not_active Abandoned
-
2016
- 2016-09-30 CL CL2016002492A patent/CL2016002492A1/es unknown
Also Published As
| Publication number | Publication date |
|---|---|
| EP3126003A4 (en) | 2017-11-29 |
| US9907835B2 (en) | 2018-03-06 |
| KR20160146762A (ko) | 2016-12-21 |
| CA2944349A1 (en) | 2015-10-08 |
| US20170065683A1 (en) | 2017-03-09 |
| AU2015240353A1 (en) | 2016-11-17 |
| CL2016002492A1 (es) | 2017-07-07 |
| EP3126003A2 (en) | 2017-02-08 |
| WO2015149143A2 (en) | 2015-10-08 |
| JP2017509659A (ja) | 2017-04-06 |
| WO2015149143A3 (en) | 2015-12-10 |
| CN106413741A (zh) | 2017-02-15 |
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