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ES2180805T3 - Formulacion farmaceutica liofilizada, estable. - Google Patents

Formulacion farmaceutica liofilizada, estable.

Info

Publication number
ES2180805T3
ES2180805T3 ES96937367T ES96937367T ES2180805T3 ES 2180805 T3 ES2180805 T3 ES 2180805T3 ES 96937367 T ES96937367 T ES 96937367T ES 96937367 T ES96937367 T ES 96937367T ES 2180805 T3 ES2180805 T3 ES 2180805T3
Authority
ES
Spain
Prior art keywords
liofilized
stable
pharmaceutical formulation
alanina
manitol
Prior art date
Legal status (The legal status 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 status listed.)
Expired - Lifetime
Application number
ES96937367T
Other languages
English (en)
Inventor
Colette Bouloumie
Thierry Breul
Laurence Colliere
Philippe Faure
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sanofi Aventis France
Original Assignee
Sanofi Synthelabo SA
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=9484220&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=ES2180805(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Sanofi Synthelabo SA filed Critical Sanofi Synthelabo SA
Application granted granted Critical
Publication of ES2180805T3 publication Critical patent/ES2180805T3/es
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Diabetes (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Hematology (AREA)
  • Dermatology (AREA)
  • Rheumatology (AREA)
  • Endocrinology (AREA)
  • Obesity (AREA)
  • Pain & Pain Management (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

LA PRESENTE INVENCION CONSISTE EN UNA FORMULACION LIOFILIZADA FORMADA POR UNA FASE AMORFA Y UNA FASE CRISTALINA, FARMACEUTICAMENTE ACEPTABLE, QUE COMPRENDE POR LO MENOS UN PRINCIPIO ACTIVO NO PROTEICO. SE CARACTERIZA POR EL HECHO DE QUE CONTIENE MANITOL Y ALANINA SEGUN UNA RELACION R COMPRENDIDA ENTRE 0,1 Y 1, SIENDO R EL PESO DE MANITOL PARTIDO POR EL PESO DE ALANINA.
ES96937367T 1995-11-03 1996-10-30 Formulacion farmaceutica liofilizada, estable. Expired - Lifetime ES2180805T3 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
FR9513022A FR2740686B1 (fr) 1995-11-03 1995-11-03 Formulation pharmaceutique lyophilisee stable

Publications (1)

Publication Number Publication Date
ES2180805T3 true ES2180805T3 (es) 2003-02-16

Family

ID=9484220

Family Applications (1)

Application Number Title Priority Date Filing Date
ES96937367T Expired - Lifetime ES2180805T3 (es) 1995-11-03 1996-10-30 Formulacion farmaceutica liofilizada, estable.

Country Status (32)

Country Link
US (1) US6284277B1 (es)
EP (1) EP0858325B1 (es)
JP (1) JP3357376B2 (es)
KR (1) KR100367752B1 (es)
CN (1) CN1124844C (es)
AR (1) AR004255A1 (es)
AT (1) ATE221374T1 (es)
AU (1) AU713383B2 (es)
BR (1) BR9611367A (es)
CA (1) CA2234140C (es)
CZ (1) CZ287178B6 (es)
DE (1) DE69622735T2 (es)
DK (1) DK0858325T3 (es)
EE (1) EE04293B1 (es)
ES (1) ES2180805T3 (es)
FR (1) FR2740686B1 (es)
HK (1) HK1015697A1 (es)
IL (1) IL124214A (es)
IS (1) IS1967B (es)
MX (1) MX9803344A (es)
MY (1) MY116578A (es)
NO (1) NO322582B1 (es)
NZ (1) NZ321616A (es)
PL (1) PL186284B1 (es)
PT (1) PT858325E (es)
RU (1) RU2163801C2 (es)
SK (1) SK283031B6 (es)
TR (1) TR199800782T2 (es)
TW (1) TW442295B (es)
UA (1) UA60297C2 (es)
WO (1) WO1997017064A1 (es)
ZA (1) ZA969176B (es)

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US6197787B1 (en) * 1997-03-03 2001-03-06 Sanofi-Synthelabo Pharmaceutical formulations containing poorly soluble drug substances
JP4939680B2 (ja) * 1997-05-27 2012-05-30 武田薬品工業株式会社 固形製剤
FR2764800B1 (fr) * 1997-06-23 1999-09-10 Sanofi Sa Composition pharmaceutique solide contenant des derives de benzofuranne
SE9702680D0 (sv) * 1997-07-11 1997-07-11 Astra Pharma Prod New formulation
DE19754324A1 (de) * 1997-12-08 1999-06-10 Byk Gulden Lomberg Chem Fab Neue Darreichungsform enthaltend einen säurelabilen Wirkstoff
ES2216351T3 (es) 1997-12-08 2004-10-16 Altana Pharma Ag Nueva forma de supositorio que comprende un compuesto activo labil o acidos.
GB9804013D0 (en) * 1998-02-25 1998-04-22 Sanofi Sa Formulations
FR2781227B1 (fr) 1998-07-20 2002-02-22 Sanofi Sa Procede pour la preparation du sel potassique du lintitript
FR2782455B3 (fr) * 1998-08-20 2000-09-15 Sanofi Sa Composition pharmaceutique injectable a base d'un sel pharmaceutiquement acceptable du clopidogrel ou de ticlopidine
US6898762B2 (en) 1998-08-21 2005-05-24 United Video Properties, Inc. Client-server electronic program guide
FR2787329B1 (fr) * 1998-12-17 2001-02-09 Aventis Pharma Sa Nouvelle application therapeutique des heparines de bas poids moleculaire
WO2000051564A1 (en) * 1999-03-03 2000-09-08 Eli Lilly And Company Echinocandin pharmaceutical formulations containing micelle-forming surfactants
IL145187A0 (en) * 1999-03-03 2002-06-30 Lilly Co Eli Echinocandin/carbohydrate complexes
FR2793685B1 (fr) * 1999-05-19 2001-08-24 Promindus Actions Promotionnel Compositions pharmaceutiques, destinees a l'administration par voie orale de phloroglucinol et leur preparation
FR2805539B1 (fr) * 2000-02-25 2005-06-10 Oreal Compositions de teinture des fibres keratiniques contenant des derives d'indolizine et procede de teinture
US6716884B1 (en) 2000-05-19 2004-04-06 Promindus (Actions Promotionnelles Dans L'industrie Et Le Commerce) Pharmaceutical compositions for oral administration of phloroglucinol and preparation thereof
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AU2002224063A1 (en) * 2000-11-24 2002-06-03 Yamanouchi Pharmaceutical Co..Ltd. Water-soluble liquid internal medicine
KR20050044450A (ko) * 2001-11-14 2005-05-12 테바 파마슈티컬 인더스트리즈 리미티드 로사르탄 칼륨의 무정형 및 결정형 형태 및 이의 제조 방법
EP1453826A1 (en) * 2001-12-10 2004-09-08 Dr. Reddy's Laboratories Ltd. Amorphous form of 2-n-butyl-3-[[2-(1h-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-1,3-diazaspiro[4,4'] non-1-en-4-one
DK1478339T3 (da) 2002-02-22 2008-08-25 Schering Corp Farmaceutiske formuleringer af antineoplastiske midler, specielt temozolomid, fremgangsmåder til fremstilling og anvendelse heraf
US20040022842A1 (en) * 2002-06-03 2004-02-05 Mebiopharm Co., Ltd. Liposome preparations containing oxaliplatin
US6991800B2 (en) * 2002-06-13 2006-01-31 Vicuron Pharmaceuticals Inc. Antifungal parenteral products
GB2393181A (en) * 2002-09-19 2004-03-24 Cipla Ltd Amorphous clopidogrel
DK1549638T3 (da) 2002-10-03 2008-01-21 Hoffmann La Roche Indol-3-carboxamider som glucokinase (GK) aktivatorer
ES2291722T3 (es) * 2002-12-03 2008-03-01 Hoffmann La Roche Aminoalcoxiindoles como ligandos 5-ht6-receptores para el tratamiento de transtornos del snc.
DE10305984A1 (de) * 2003-02-13 2004-09-02 Helm Ag Salze organischer Säuren mit Clopidogrel und deren Verwendung zur Herstellung phamazeutischer Formulierungen
GB0304636D0 (en) * 2003-02-28 2003-04-02 Britannia Pharmaceuticals Ltd Pharmaceutical composition for nasal delivery
CN100376251C (zh) * 2003-05-07 2008-03-26 卫材R&D管理有限公司 含有甲基维生素b12的冻干制剂及其制备方法
JP2007504177A (ja) * 2003-09-02 2007-03-01 プリヴァ−ラケマ,エー.エス. 医薬組成物、その製造方法及び治療上の使用
CA2550811C (en) * 2003-12-24 2012-05-01 Jane Hirsh Temperature-stable formulations, and methods of development thereof
US20050255161A1 (en) * 2004-05-10 2005-11-17 Servet Buyuktimkin Method for the long term stabilization of labile compounds at room temperature in pharmaceutical preparations containing water
AU2005249794A1 (en) 2004-06-04 2005-12-15 Teva Pharmaceutical Industries, Ltd. Pharmaceutical composition containing irbesartan
US20060275331A1 (en) * 2004-08-31 2006-12-07 Borek Zaludek Pharmaceutical composition, method of manufacturing and therapeutic use thereof
BRPI0517947A (pt) 2004-11-02 2008-10-21 Univ Northwestern composto de piridazina, composições e métodos
JP2006248978A (ja) 2005-03-10 2006-09-21 Mebiopharm Co Ltd 新規なリポソーム製剤
US20070026026A1 (en) * 2005-08-01 2007-02-01 David Delmarre Oral liquid losartan compositions
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US20080108664A1 (en) 2005-12-23 2008-05-08 Liu Belle B Solid-state form of AMG 706 and pharmaceutical compositions thereof
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CN103230371B (zh) * 2012-05-18 2014-07-23 湖北一半天制药有限公司 注射用奥沙利铂冻干制剂的制备方法
WO2018002673A1 (en) 2016-07-01 2018-01-04 N4 Pharma Uk Limited Novel formulations of angiotensin ii receptor antagonists
CN106706785B (zh) * 2016-12-23 2019-02-26 东药集团沈阳施德药业有限公司 一种采用高效液相色谱检测厄贝沙坦氢氯噻嗪片中有关物质的方法
US10149857B2 (en) 2017-03-09 2018-12-11 Ampac Fine Chemicals Llc Lyophilized cyclophosphamide composition and methods of preparation thereof
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CN114533683B (zh) * 2021-12-23 2023-08-01 李宏 一种注射用腺苷钴胺冻干制剂组合物及其制备方法
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Also Published As

Publication number Publication date
NO322582B1 (no) 2006-10-30
UA60297C2 (uk) 2003-10-15
EP0858325A1 (fr) 1998-08-19
HK1015697A1 (en) 1999-10-22
ZA969176B (en) 1998-04-30
BR9611367A (pt) 1999-02-23
IS4729A (is) 1998-04-29
IL124214A (en) 2001-01-28
KR19990067325A (ko) 1999-08-16
RU2163801C2 (ru) 2001-03-10
PL186284B1 (pl) 2003-12-31
ATE221374T1 (de) 2002-08-15
JPH11507945A (ja) 1999-07-13
KR100367752B1 (ko) 2003-03-15
DK0858325T3 (da) 2002-11-25
WO1997017064A1 (fr) 1997-05-15
EE04293B1 (et) 2004-06-15
NZ321616A (en) 1999-04-29
CZ287178B6 (en) 2000-10-11
CA2234140A1 (fr) 1997-05-15
JP3357376B2 (ja) 2002-12-16
DE69622735T2 (de) 2003-04-03
PL326451A1 (en) 1998-09-28
EP0858325B1 (fr) 2002-07-31
CN1203527A (zh) 1998-12-30
PT858325E (pt) 2002-12-31
EE9800123A (et) 1998-10-15
DE69622735D1 (de) 2002-09-05
CZ123198A3 (cs) 1998-07-15
MX9803344A (es) 1998-09-30
AR004255A1 (es) 1998-11-04
CA2234140C (fr) 2004-10-26
US6284277B1 (en) 2001-09-04
FR2740686A1 (fr) 1997-05-09
NO981967D0 (no) 1998-04-30
TR199800782T2 (xx) 1998-09-21
CN1124844C (zh) 2003-10-22
SK283031B6 (sk) 2003-02-04
AU7499096A (en) 1997-05-29
SK52598A3 (en) 1998-10-07
TW442295B (en) 2001-06-23
MY116578A (en) 2004-02-28
FR2740686B1 (fr) 1998-01-16
NO981967L (no) 1998-06-30
IS1967B (is) 2004-12-15
AU713383B2 (en) 1999-12-02

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