CO5650230A2 - Composiciones estables de atorvastatina preparadas con granulacion en humedo - Google Patents

Composiciones estables de atorvastatina preparadas con granulacion en humedo

Info

Publication number
CO5650230A2
CO5650230A2 CO05124741A CO05124741A CO5650230A2 CO 5650230 A2 CO5650230 A2 CO 5650230A2 CO 05124741 A CO05124741 A CO 05124741A CO 05124741 A CO05124741 A CO 05124741A CO 5650230 A2 CO5650230 A2 CO 5650230A2
Authority
CO
Colombia
Prior art keywords
atorvastatin
dosage form
unit dosage
weight
pharmaceutical composition
Prior art date
Application number
CO05124741A
Other languages
English (en)
Inventor
Kenneth Craig Waterman
Michael Bruce Fergione
Barbara Alice Johnson
Original Assignee
Warner Lambert Co
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
Application filed by Warner Lambert Co filed Critical Warner Lambert Co
Publication of CO5650230A2 publication Critical patent/CO5650230A2/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
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • A61K9/1623Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • 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
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • 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
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/08Drugs for disorders of the urinary system of the prostate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/08Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/28Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/06Antihyperlipidemics

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Rheumatology (AREA)
  • Biomedical Technology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Diabetes (AREA)
  • Psychiatry (AREA)
  • Hospice & Palliative Care (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Urology & Nephrology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Pyrrole Compounds (AREA)

Abstract

1.- Una composición farmacéutica de atorvastatina granulada en húmedo con menos de aproximadamente 5 por ciento en peso de un aditivo constituido por una sal de metal alcalino- térreo, que comprende: (a) atorvastatina, en donde dicha atorvastatina es al menos algo desordenada o una mezcla de las formas desordenada y cristalina de atorvastatina o una de sus sales farmacéuticamente aceptables; y (b) un desintegrante o una combinación de desintegrantes, en donde dicha con posición farmacéutica de granulada en húmedo, contiene no más de aproximadamente 3% de lactona de atorvastatina basado en la relación del área del pico de lactona comparada con las áreas integradas de todos los picos relacionados con el fármaco empleando HPLC.2.- La composición farmacéutica granulada en húmedo de la reivindicación 1, en donde dicha composición incluye menos de aproximadamente 0,5% en peso de Tween 80.3.- Una forma de dosificación unitaria preparada a partir de la composición farmacéutica granulada en húmedo de la reivindicación 1.4.- La forma de dosificación unitaria de la reivindicación 4, en donde dicha forma de dosificación unitaria es un comprimido o una cápsula.5.- La forma de dosificación unitaria de la reivindicación 1, en donde dicho desintegrante o combinación de desintegrantes está presente en una proporción entre aproximadamente 1 y 10% (en peso/peso) de dicha composición.
CO05124741A 2003-06-12 2005-12-09 Composiciones estables de atorvastatina preparadas con granulacion en humedo CO5650230A2 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US47811903P 2003-06-12 2003-06-12

Publications (1)

Publication Number Publication Date
CO5650230A2 true CO5650230A2 (es) 2006-06-30

Family

ID=33551806

Family Applications (1)

Application Number Title Priority Date Filing Date
CO05124741A CO5650230A2 (es) 2003-06-12 2005-12-09 Composiciones estables de atorvastatina preparadas con granulacion en humedo

Country Status (15)

Country Link
EP (1) EP1635814A1 (es)
JP (1) JP2006527260A (es)
KR (1) KR100814218B1 (es)
CN (1) CN100434069C (es)
AR (1) AR044774A1 (es)
AU (1) AU2004246868B2 (es)
BR (1) BRPI0411344A (es)
CA (1) CA2465565A1 (es)
CO (1) CO5650230A2 (es)
MX (1) MXPA05013281A (es)
NO (1) NO20060022L (es)
NZ (1) NZ543337A (es)
RU (1) RU2332211C2 (es)
TW (1) TW200503690A (es)
WO (1) WO2004110431A1 (es)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FI94339C (fi) 1989-07-21 1995-08-25 Warner Lambert Co Menetelmä farmaseuttisesti käyttökelpoisen /R-(R*,R*)/-2-(4-fluorifenyyli)- , -dihydroksi-5-(1-metyylietyyli)-3-fenyyli-4-/(fenyyliamino)karbonyyli/-1H-pyrroli-1-heptaanihapon ja sen farmaseuttisesti hyväksyttävien suolojen valmistamiseksi
GB0613925D0 (en) * 2006-07-13 2006-08-23 Unilever Plc Improvements relating to nanodispersions
CA2691956A1 (en) * 2007-06-25 2008-12-31 Pharmathen S.A. Improved pharmaceutical formulation containing an hmg-coa reductase inhibitor and method for the preparation thereof
CA2716671A1 (en) * 2008-02-27 2009-09-03 Thommen Medical Ag Implant and method for the manufacture thereof
JP5714492B2 (ja) * 2008-09-17 2015-05-07 マイラン インコーポレイテッド 粒状体、それらの調製方法、およびそれらを含む医薬品
HUP1000299A2 (hu) 2010-06-08 2012-02-28 Nanoform Cardiovascular Therapeutics Ltd Nanostrukturált Atorvastatint, gyógyszerészetileg elfogadott sóit és kokristályait tartalmazó készítmény és eljárás elõállításukra
RU2014124118A (ru) 2011-11-15 2015-12-27 Др. Редди'С Лабораторис Лтд. Фармацевтические препараты, включающие аторвастатин и глимепирид
CN104069078B (zh) * 2014-05-22 2019-06-11 西藏九瑞健康股份有限公司 阿托伐他汀钙药物组合物及其制备方法
US10085993B2 (en) 2014-07-25 2018-10-02 Novartis Ag Tablet formulation of 2-fluoro-N-methyl-4-[ 7-( quinolin-6-ylmethyl) imidazo [1,2-B] [1,2,4] triazin-2-yl] benzamide
KR101658350B1 (ko) * 2015-02-06 2016-09-30 경성대학교 산학협력단 고지혈증 치료에 유용한 약학 조성물
WO2016145132A1 (en) * 2015-03-12 2016-09-15 Fmc Corporation Solid dispersions
CN109152787A (zh) 2016-03-31 2019-01-04 英特塞普特医药品公司 具有优越的溶出性的口服制剂

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1994016693A1 (en) * 1993-01-19 1994-08-04 Warner-Lambert Company Stable oral ci-981 formulation and process of preparing same
JPH06242003A (ja) * 1993-02-12 1994-09-02 Nkk Corp 鉄鋼中のアルミナの粒度測定方法
JP3014040B2 (ja) * 1996-10-30 2000-02-28 信久 川野 食物繊維パン及びその製造法
ATE524163T1 (de) * 2000-04-10 2011-09-15 Teva Pharma Stabile pharmazeutische zusammensetzungen enthaltend 7-substituierte-3,5- dihydroxyheptansäuren oder 7-substituierte-3,5- dihydroxyheptensäuren
US6242003B1 (en) * 2000-04-13 2001-06-05 Novartis Ag Organic compounds
EP1226818A1 (en) * 2001-01-26 2002-07-31 Pfizer Products Inc. Pharmaceutical dosage forms with enhanced cohesive and compressibility properties
SI20848A (sl) * 2001-03-14 2002-10-31 Lek, Tovarna Farmacevtskih In Kemijskih Izdelkov, D.D. Farmacevtska formulacija, ki vsebuje atorvastatin kalcij

Also Published As

Publication number Publication date
KR20060020666A (ko) 2006-03-06
TW200503690A (en) 2005-02-01
AR044774A1 (es) 2005-10-05
RU2332211C2 (ru) 2008-08-27
NO20060022L (no) 2006-01-03
CN100434069C (zh) 2008-11-19
KR100814218B1 (ko) 2008-03-17
AU2004246868A1 (en) 2004-12-23
WO2004110431A1 (en) 2004-12-23
NZ543337A (en) 2008-03-28
CN1805741A (zh) 2006-07-19
CA2465565A1 (en) 2004-12-12
BRPI0411344A (pt) 2006-07-11
MXPA05013281A (es) 2006-03-09
JP2006527260A (ja) 2006-11-30
RU2005136745A (ru) 2006-07-27
AU2004246868B2 (en) 2008-01-17
EP1635814A1 (en) 2006-03-22

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