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AR037965A1 - Formulacion oral de fludara purisimo con liberacion rapida del ingrediente activo - Google Patents

Formulacion oral de fludara purisimo con liberacion rapida del ingrediente activo

Info

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
Application number
ARP020105054A
Other languages
English (en)
Inventor
Wolfgang Heil
Ulf Tilstam
Ralph Lipp
Johannes Tack
Original Assignee
Schering Ag
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=7711168&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AR037965(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Schering Ag filed Critical Schering Ag
Publication of AR037965A1 publication Critical patent/AR037965A1/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • A61K31/706Compounds 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
    • A61K31/7064Compounds 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
    • A61K31/7076Compounds 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic 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.
ARP020105054A 2001-12-20 2002-12-20 Formulacion oral de fludara purisimo con liberacion rapida del ingrediente activo AR037965A1 (es)

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)

* Cited by examiner, † Cited by third party
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)

* Cited by examiner, † Cited by third party
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

Also Published As

Publication number Publication date
DE50204203D1 (de) 2005-10-13
HK1077741A1 (en) 2006-02-24
HRP20040648A2 (en) 2004-10-31
US7148207B2 (en) 2006-12-12
CA2471396A1 (en) 2003-07-03
HRP20040648B1 (en) 2012-11-30
ATE303797T1 (de) 2005-09-15
RS50398B (sr) 2009-12-31
KR100884685B1 (ko) 2009-02-18
JP2005519043A (ja) 2005-06-30
CN1617713A (zh) 2005-05-18
US20030176391A1 (en) 2003-09-18
UY27596A1 (es) 2003-07-31
NZ533701A (en) 2006-03-31
UA78741C2 (en) 2007-04-25
KR20040073501A (ko) 2004-08-19
RS53304A (sr) 2006-10-27
TW200305428A (en) 2003-11-01
AU2002349043A1 (en) 2003-07-09
BR0215265A (pt) 2004-12-07
TWI255187B (en) 2006-05-21
RU2004122479A (ru) 2005-05-20
CN1306929C (zh) 2007-03-28
NO20043063L (no) 2004-07-19
MXPA04006005A (es) 2004-09-27
PE20030639A1 (es) 2003-08-28
IL162555A0 (en) 2005-11-20
JP2006137771A (ja) 2006-06-01
JO2363B1 (en) 2006-12-12
AU2002349043B2 (en) 2007-08-16
DE10164510A1 (de) 2003-07-10
WO2003053418A1 (de) 2003-07-03
ZA200405735B (en) 2006-01-25
ECSP045185A (es) 2004-08-27
IL162555A (en) 2008-03-20
PL370792A1 (en) 2005-05-30
DK1455760T3 (da) 2006-01-02
ES2248624T3 (es) 2006-03-16
EP1455760A1 (de) 2004-09-15
EP1455760B1 (de) 2005-09-07
RU2318496C2 (ru) 2008-03-10
SA03240091B1 (ar) 2006-11-25

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Legal Events

Date Code Title Description
FA Abandonment or withdrawal
FC Refusal