AR037965A1 - Formulacion oral de fludara purisimo con liberacion rapida del ingrediente activo - Google Patents
Formulacion oral de fludara purisimo con liberacion rapida del ingrediente activoInfo
- Publication number
- AR037965A1 AR037965A1 ARP020105054A ARP020105054A AR037965A1 AR 037965 A1 AR037965 A1 AR 037965A1 AR P020105054 A ARP020105054 A AR P020105054A AR P020105054 A ARP020105054 A AR P020105054A AR 037965 A1 AR037965 A1 AR 037965A1
- Authority
- AR
- Argentina
- Prior art keywords
- purin
- amine
- fluoro
- arabinofuranosyl
- fludara
- Prior art date
Links
- GIUYCYHIANZCFB-FJFJXFQQSA-N fludarabine phosphate Chemical compound C1=NC=2C(N)=NC(F)=NC=2N1[C@@H]1O[C@H](COP(O)(O)=O)[C@@H](O)[C@@H]1O GIUYCYHIANZCFB-FJFJXFQQSA-N 0.000 title abstract 5
- 229960005304 fludarabine phosphate Drugs 0.000 title abstract 5
- 239000000203 mixture Substances 0.000 title abstract 4
- 239000004480 active ingredient Substances 0.000 title abstract 3
- 238000009472 formulation Methods 0.000 title abstract 3
- 229960000643 adenine Drugs 0.000 abstract 4
- -1 6-amino-9H-purin-2-yl Chemical group 0.000 abstract 2
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 abstract 2
- 239000012535 impurity Substances 0.000 abstract 2
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 abstract 2
- WKMPTBDYDNUJLF-UHFFFAOYSA-N 2-fluoroadenine Chemical compound NC1=NC(F)=NC2=C1N=CN2 WKMPTBDYDNUJLF-UHFFFAOYSA-N 0.000 abstract 1
- WSVLPVUVIUVCRA-KPKNDVKVSA-N Alpha-lactose monohydrate Chemical compound O.O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O WSVLPVUVIUVCRA-KPKNDVKVSA-N 0.000 abstract 1
- 229920002785 Croscarmellose sodium Polymers 0.000 abstract 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 abstract 1
- 229910019142 PO4 Inorganic materials 0.000 abstract 1
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 abstract 1
- 229920003123 carboxymethyl cellulose sodium Polymers 0.000 abstract 1
- 229940063834 carboxymethylcellulose sodium Drugs 0.000 abstract 1
- 229940075614 colloidal silicon dioxide Drugs 0.000 abstract 1
- 229960001681 croscarmellose sodium Drugs 0.000 abstract 1
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 abstract 1
- 239000007948 fast release tablet Substances 0.000 abstract 1
- DRAVOWXCEBXPTN-UHFFFAOYSA-N isoguanine Chemical compound NC1=NC(=O)NC2=C1NC=N2 DRAVOWXCEBXPTN-UHFFFAOYSA-N 0.000 abstract 1
- 229960001021 lactose monohydrate Drugs 0.000 abstract 1
- 235000019359 magnesium stearate Nutrition 0.000 abstract 1
- 235000019813 microcrystalline cellulose Nutrition 0.000 abstract 1
- 239000008108 microcrystalline cellulose Substances 0.000 abstract 1
- 229940016286 microcrystalline cellulose Drugs 0.000 abstract 1
- 239000010452 phosphate Substances 0.000 abstract 1
- 239000003826 tablet Substances 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
- A61K9/20—Pills, tablets, discs, rods
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- 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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
- A61K31/706—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
- A61K31/7064—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines
- A61K31/7076—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines containing purines, e.g. adenosine, adenylic acid
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Molecular Biology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biophysics (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Saccharide Compounds (AREA)
Abstract
Formulación para comprimido de liberación rápida con Fludara en una pureza de > 99,19% (Fludara purísimo) como ingrediente activo de una composición definida de impurezas residuales. Reivindicación 1: Formulación para comprimido de liberación rápida, que comprende 1 a 100 mg del ingrediente activo Fludara en una pureza de >99,19%, junto con lactosa monohidrato, dióxido de silicio coloidal, celulosa microcristalina (Avicel), croscarmelosa sódica (carboximetilcelulosa sódica) y estearato de magnesio, caracterizada porque las impurezas en Fludara no superan los porcentajes indicados a continuación: 0,02% de 2-fluoro-9-(?-D-arabino-furanosil)-9H-purin-6-amina, 0,12% de 6-amino-9-(5-o-fosfono-?-D-arabino-furanosil)-9H-purin-2-ol, 0,02% de 2-fluoro-9H-purin-6-amina, 0,02% de 6-amino-9H-purin-2-ol, 0,05% de 2-fluoro-9-(5-O-fosfono-?-D-ribofuranosil)-9H-purin-6-amina, 0,1% de 9-(3,5-O-difosfono-?-D-arabinofuranosil)-2-fluoro-9H-purin-6-amina, H-purin-6-amina, 0,1% de 9-(2,5-O-difosfono-?-D-arabinofuranosil)-2-fluoro-9H-purin-6-amina, 0,02% de 2-fluoro-9-(5-O-fosfono-?-D-arabinofuranosil)-9H-purin-6-amina, 0,06% de 2-etoxi-9-(5-O-fosfono-?-D-arabinofuranosil)-9H-purin-6-amina, 0,02% de 2-(6-amino-9H-purin-2-il)-9-(5-O-fosfono-?-D-arabinofuranosil)-9H-purin-6-amina y O, O' -bis[2-(6-amino-2-fluoro-9H-purin-9-il)-5-desoxi-?-D-arabinofuranos-5-il]-fosfato de 9-(2-cloro-2-desoxi-5-fosfono-?-D-arabinofuranosil) -2 - fluoro-9H-purin-6-amina y 0,1% de 9-(2,5-anhidro-?-D-arabinofuranosil)-2-fluoro-9H-purin-6-amina.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE10164510A DE10164510A1 (de) | 2001-12-20 | 2001-12-20 | Orale Fludara reinst Formulierung mit schneller Freisetzung des Wirkstoffes |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AR037965A1 true AR037965A1 (es) | 2004-12-22 |
Family
ID=7711168
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP020105054A AR037965A1 (es) | 2001-12-20 | 2002-12-20 | Formulacion oral de fludara purisimo con liberacion rapida del ingrediente activo |
Country Status (29)
| Country | Link |
|---|---|
| US (1) | US7148207B2 (es) |
| EP (1) | EP1455760B1 (es) |
| JP (2) | JP2005519043A (es) |
| KR (1) | KR100884685B1 (es) |
| CN (1) | CN1306929C (es) |
| AR (1) | AR037965A1 (es) |
| AT (1) | ATE303797T1 (es) |
| AU (1) | AU2002349043B2 (es) |
| BR (1) | BR0215265A (es) |
| CA (1) | CA2471396A1 (es) |
| DE (2) | DE10164510A1 (es) |
| DK (1) | DK1455760T3 (es) |
| EC (1) | ECSP045185A (es) |
| ES (1) | ES2248624T3 (es) |
| HR (1) | HRP20040648B1 (es) |
| IL (2) | IL162555A0 (es) |
| JO (1) | JO2363B1 (es) |
| MX (1) | MXPA04006005A (es) |
| NO (1) | NO20043063L (es) |
| NZ (1) | NZ533701A (es) |
| PE (1) | PE20030639A1 (es) |
| RS (1) | RS50398B (es) |
| RU (1) | RU2318496C2 (es) |
| SA (1) | SA03240091B1 (es) |
| TW (1) | TWI255187B (es) |
| UA (1) | UA78741C2 (es) |
| UY (1) | UY27596A1 (es) |
| WO (1) | WO2003053418A1 (es) |
| ZA (1) | ZA200405735B (es) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2432457A1 (en) * | 2009-05-19 | 2012-03-28 | Grindeks, A Joint Stock Company | Stable pharmaceutical composition of fludarabine phosphate |
| US20120010216A1 (en) * | 2010-07-06 | 2012-01-12 | Brown Arthur M | Pharmaceutical compositions containing vanoxerine |
| EP2428201A1 (en) | 2010-09-08 | 2012-03-14 | Merck Serono S.A. | Oral administration of nucleoside monophosphates |
| CN101947208B (zh) * | 2010-10-09 | 2012-05-23 | 江苏奥赛康药业股份有限公司 | 一种供注射用的磷酸氟达拉滨组合物及其制备方法 |
| CN102091046B (zh) * | 2011-02-12 | 2012-07-18 | 海南锦瑞制药股份有限公司 | 一种磷酸氟达拉滨冻干粉针剂及其制备方法 |
| WO2017036356A1 (zh) * | 2015-08-28 | 2017-03-09 | 浙江海正药业股份有限公司 | 磷酸氟达拉滨的晶型及其制备方法和用途 |
| CN111423458A (zh) * | 2020-04-29 | 2020-07-17 | 东南大学 | 磷酸氟达拉滨杂质h对照品的制备方法 |
Family Cites Families (19)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3903297A (en) * | 1973-11-01 | 1975-09-02 | Upjohn Co | Method of treatment and prophylaxis of gastric hypersecretion and gastric and duodenal ulcers using prostaglandin analogs |
| US4188378A (en) * | 1978-01-04 | 1980-02-12 | The United States Of America As Represented By The Department Of Health, Education And Welfare | Anticancer and antiviral activity of 9-β-D-arabinofuranosyl-2-fluoroadenine |
| US4210745A (en) * | 1978-01-04 | 1980-07-01 | The United States Of America As Represented By The Department Of Health, Education And Welfare | Procedure for the preparation of 9-β-D-arabinofuranosyl-2-fluoroadenine |
| US4357324A (en) * | 1981-02-24 | 1982-11-02 | The United States Of America As Represented By The Department Of Health And Human Services | Prodrug derivatives of 9β-D-arabinofuranosyl-2-fluoroadenine |
| DE3323621A1 (de) * | 1982-07-08 | 1984-03-01 | Yamasa Shoyu K.K., Choshi, Chiba | Pharmazeutisches praeparat mit die antitumor-wirkung verstaerkender wirkung, ein solches praeparat enthaltende chemotherapeutische zusammensetzung und verwendung des praeparates zur unterstuetzung der antitumor-behandlung beim menschen und tier |
| US5110919A (en) * | 1989-12-04 | 1992-05-05 | Ash Stevens, Inc. | Process for the preparation of 2-amino-9-(2,3,5-tri-o-benzyl-beta-d-arabinofuranosyl) adenine and novel intermediates |
| FR2701027B1 (fr) * | 1993-02-01 | 1997-07-18 | Warner Lambert Co | Procede de synthese ameliore du 9-(beta-d-arabinofuranosyl)adenine 5'-phosphate. |
| DE19543052A1 (de) | 1995-11-06 | 1997-05-07 | Schering Ag | Verfahren zur Herstellung und Reinigung von Fludarabin-Phosphat und die Verwendung von sauren Ionenaustauschern im Verfahren |
| ATE220543T1 (de) * | 1996-04-23 | 2002-08-15 | Janssen Pharmaceutica Nv | Rasch-freisetzende ph-unabhängige feste dosisformen enthaltend cisaprid |
| CA2210600A1 (en) * | 1996-07-17 | 1998-01-17 | Takashi Houkan | Inhibitor of tumor metastasis or recurrence |
| US6197785B1 (en) * | 1997-09-03 | 2001-03-06 | Guilford Pharmaceuticals Inc. | Alkoxy-substituted compounds, methods, and compositions for inhibiting PARP activity |
| DK1047704T4 (da) * | 1997-12-11 | 2008-03-25 | Bayer Schering Pharma Ag | Fremgangsmåde til fremstilling af lithium-, kalium-, calcium- og magnesiumsalte af fludarabin-phosphat og rensningsfremgangsmåde til fremstilling af fludarabin-phosphat og fludarabin-phosphat med en renhed på mindst 99,5% |
| DE69934582T2 (de) | 1998-06-11 | 2007-10-04 | Pharmacia & Upjohn Co. Llc, Kalamazoo | Delavirdin tablettenformulierung |
| US6174873B1 (en) * | 1998-11-04 | 2001-01-16 | Supergen, Inc. | Oral administration of adenosine analogs |
| AU6646700A (en) | 1999-08-20 | 2001-03-19 | Scripps Research Institute, The | Formation of heterocycles |
| DE60019741T2 (de) | 1999-12-08 | 2006-03-02 | Pharmacia Corp., Chicago | Nanopartikelzusammensetzungen enthaltend eplerenon |
| US20020131988A1 (en) | 1999-12-16 | 2002-09-19 | Foster Todd P. | Pharmaceutical implant containing immediate-release and sustained-release components and method of administration |
| MXPA02005912A (es) * | 1999-12-16 | 2002-10-23 | Upjohn Co | Composicion para implante que contiene acetato de melengestrol y acetato de trenbolona. |
| US6399591B1 (en) * | 2000-01-19 | 2002-06-04 | Yung-Shin Pharmaceutical Ind. Co., Ltd. | Chargeable pharmaceutical tablets |
-
2001
- 2001-12-20 DE DE10164510A patent/DE10164510A1/de not_active Ceased
-
2002
- 2002-11-25 DK DK02781328T patent/DK1455760T3/da active
- 2002-11-25 EP EP02781328A patent/EP1455760B1/de not_active Expired - Lifetime
- 2002-11-25 UA UA20040705884A patent/UA78741C2/uk unknown
- 2002-11-25 CN CNB028279034A patent/CN1306929C/zh not_active Expired - Fee Related
- 2002-11-25 BR BR0215265-7A patent/BR0215265A/pt not_active Application Discontinuation
- 2002-11-25 MX MXPA04006005A patent/MXPA04006005A/es active IP Right Grant
- 2002-11-25 CA CA002471396A patent/CA2471396A1/en not_active Abandoned
- 2002-11-25 DE DE50204203T patent/DE50204203D1/de not_active Expired - Lifetime
- 2002-11-25 RS YUP-533/04A patent/RS50398B/sr unknown
- 2002-11-25 AT AT02781328T patent/ATE303797T1/de active
- 2002-11-25 RU RU2004122479/15A patent/RU2318496C2/ru not_active IP Right Cessation
- 2002-11-25 IL IL16255502A patent/IL162555A0/xx active IP Right Grant
- 2002-11-25 NZ NZ533701A patent/NZ533701A/xx not_active IP Right Cessation
- 2002-11-25 ES ES02781328T patent/ES2248624T3/es not_active Expired - Lifetime
- 2002-11-25 WO PCT/EP2002/013252 patent/WO2003053418A1/de not_active Ceased
- 2002-11-25 AU AU2002349043A patent/AU2002349043B2/en not_active Ceased
- 2002-11-25 KR KR1020047009750A patent/KR100884685B1/ko not_active Expired - Fee Related
- 2002-11-25 HR HR20040648 patent/HRP20040648B1/xx not_active IP Right Cessation
- 2002-11-25 JP JP2003554177A patent/JP2005519043A/ja active Pending
- 2002-12-10 JO JO2002123A patent/JO2363B1/en active
- 2002-12-19 UY UY27596A patent/UY27596A1/es not_active Application Discontinuation
- 2002-12-20 AR ARP020105054A patent/AR037965A1/es not_active Application Discontinuation
- 2002-12-20 TW TW091136814A patent/TWI255187B/zh not_active IP Right Cessation
- 2002-12-20 US US10/324,141 patent/US7148207B2/en not_active Expired - Fee Related
-
2003
- 2003-01-06 PE PE2003000017A patent/PE20030639A1/es not_active Application Discontinuation
- 2003-04-27 SA SA03240091A patent/SA03240091B1/ar unknown
-
2004
- 2004-06-16 IL IL162555A patent/IL162555A/en not_active IP Right Cessation
- 2004-07-12 EC EC2004005185A patent/ECSP045185A/es unknown
- 2004-07-19 NO NO20043063A patent/NO20043063L/no not_active Application Discontinuation
- 2004-07-19 ZA ZA2004/05735A patent/ZA200405735B/en unknown
-
2005
- 2005-12-28 JP JP2005379628A patent/JP2006137771A/ja active Pending
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FA | Abandonment or withdrawal | ||
| FC | Refusal |