CO5640071A2 - Composiciones farmaceuticas de atorvastatina - Google Patents

Composiciones farmaceuticas de atorvastatina

Info

Publication number
CO5640071A2
CO5640071A2 CO05124314A CO05124314A CO5640071A2 CO 5640071 A2 CO5640071 A2 CO 5640071A2 CO 05124314 A CO05124314 A CO 05124314A CO 05124314 A CO05124314 A CO 05124314A CO 5640071 A2 CO5640071 A2 CO 5640071A2
Authority
CO
Colombia
Prior art keywords
pharmaceutical composition
composition according
atorvastatin
pharmaceutically acceptable
unit dosage
Prior art date
Application number
CO05124314A
Other languages
English (en)
Inventor
Kenneth Craig Waterman
Paul Evan Luner
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 CO5640071A2 publication Critical patent/CO5640071A2/es

Links

Classifications

    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40—Heterocyclic 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
    • A61K31/401—Proline; Derivatives thereof, e.g. captopril
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40—Heterocyclic 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
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A61K9/1688—Processes resulting in pure drug agglomerate optionally containing up to 5% of excipient
    • 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
    • A61K9/2004—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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/08—Drugs for disorders of the urinary system of the prostate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1611—Inorganic compounds
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin

Landscapes

  • Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (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)
  • 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)
  • Hematology (AREA)
  • Psychiatry (AREA)
  • Urology & Nephrology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Hospice & Palliative Care (AREA)
  • Obesity (AREA)
  • Diabetes (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Pyrrole Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

1.- Una composición farmacéutica granulada en seco que comprende atorvastatina o una sal farmacéuticamente aceptable de la misma. 2.- La composición farmacéutica de acuerdo con la reivindicación 1 en la que la composición contiene menos de aproximadamente el 5% (p:p) de un aditivo de sal de metal alcalinotérreo.3.- La composición farmacéutica de acuerdo con la reivindicación 1 en la que la composición granulada en seco, después de almacenarla a 40°C y al 75% de humedad relativa durante 4 semanas, no contiene más de aproximadamente el 2% de impurezas totales y/o productos de degradación basándose en el área porcentual de los picos de HPLC relacionados con el fármaco.4.- La composición farmacéutica de acuerdo con la reivindicación 1 en la que la composición se usa en la formación de una forma de dosificación unitaria sólida.5.- La composición farmacéutica de acuerdo con la reivindicación 4 en la que la forma de dosificación unitaria se selecciona entre el grupo compuesto por un comprimido y una cápsula.6.- La composición farmacéutica de acuerdo con la reivindicación 1 en la que la atorvastatina contiene al menos una forma de atorvastatina parcial o completamente desordenada o una sal farmacéuticamente aceptable de la misma.
CO05124314A 2003-06-12 2005-12-07 Composiciones farmaceuticas de atorvastatina CO5640071A2 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US47791703P 2003-06-12 2003-06-12

Publications (1)

Publication Number Publication Date
CO5640071A2 true CO5640071A2 (es) 2006-05-31

Family

ID=33551780

Family Applications (1)

Application Number Title Priority Date Filing Date
CO05124314A CO5640071A2 (es) 2003-06-12 2005-12-07 Composiciones farmaceuticas de atorvastatina

Country Status (15)

Country Link
EP (1) EP1635788A1 (es)
JP (1) JP2006527259A (es)
KR (1) KR100760112B1 (es)
CN (1) CN1805732A (es)
AR (1) AR044660A1 (es)
AU (1) AU2004246867A1 (es)
BR (1) BRPI0411354A (es)
CA (1) CA2465693A1 (es)
CO (1) CO5640071A2 (es)
MX (1) MXPA05012955A (es)
NO (1) NO20060149L (es)
RU (1) RU2325903C2 (es)
TW (1) TW200503689A (es)
WO (1) WO2004110406A1 (es)
ZA (1) ZA200508204B (es)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060106230A1 (en) * 2004-10-18 2006-05-18 Michael Pinchasov Processes for preparing amorphous atorvastatin hemi-calcium
CA2547216A1 (en) * 2005-09-21 2007-03-21 Renuka D. Reddy Process for annealing amorphous atorvastatin
KR101381076B1 (ko) 2006-03-29 2014-04-02 코와 가부시키가이샤 트리글리세리드 저하제 및 고인슐린 혈증 개선제
CN101973922B (zh) * 2009-05-27 2013-01-23 天津和美生物技术有限公司 阿伐他汀半锶盐多晶型物、其制备和作为HMG-CoA酶抑制剂的应用
DK2512455T3 (en) 2009-12-18 2014-03-24 Frieslandcampina Nederland Holding B V Co-treated tablet adjuvant composition, its preparation and use
JP2013515076A (ja) * 2009-12-22 2013-05-02 ノバルティス アーゲー 即放性錠剤の形態の１ｈ−キナゾリン−２，４−ジオンａｍｐａ受容体アンタゴニストを含む製剤およびその調製
EP2575757A1 (en) 2010-06-03 2013-04-10 Mahmut Bilgic Water soluble formulation comprising a combination of amlodipine and a statin
EA018867B1 (ru) * 2012-11-01 2013-11-29 Лаборатория Тютор С.А.С.И.Ф.И.А. Способ получения фармацевтической композиции и продукт способа
CN104825449A (zh) * 2014-02-12 2015-08-12 天津药物研究院 含有阿托伐他汀钙和氨氯地平的复方组合物及其制备方法
CN107111055B (zh) * 2014-09-26 2020-02-21 株式会社藤仓 光纤
RU2591079C2 (ru) * 2014-12-10 2016-07-10 Александр Владимирович Диковский Фармацевтическая композиция статинов с пребиотиком для терапии гиперхолестеринемии и гиперлипидимии
US10322169B2 (en) * 2015-06-10 2019-06-18 Evonik Roehm Gmbh Process for preparing a powder comprising a human coagulation factor protein and a lactic acid polymer
US20180303799A1 (en) * 2015-10-16 2018-10-25 Shenzhen Salubris Pharmaceuticals Co., Ltd An Oral Preparation for the Treatment of Cardiovascular Disease and Its Preparation Method
WO2023025672A1 (en) 2021-08-25 2023-03-02 Basf Se Direct tableting auxiliary composition
CN114674944A (zh) * 2022-03-04 2022-06-28 苏州东瑞制药有限公司 一种检测苯磺酸氨氯地平与阿托伐他汀钙复方制剂有关物质的方法

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PT1235799E (pt) * 1999-11-17 2005-05-31 Teva Pharma Forma polimorfica de atorvastatina-calcio
SI20848A (sl) 2001-03-14 2002-10-31 Lek, Tovarna Farmacevtskih In Kemijskih Izdelkov, D.D. Farmacevtska formulacija, ki vsebuje atorvastatin kalcij
RU2003131338A (ru) * 2001-03-27 2005-02-10 Рэнбакси Лабораториз Лимитед (In) Стабильная фармацевтическая композиция на основе правастатина
JP2003055217A (ja) * 2001-08-10 2003-02-26 Taiyo Yakuhin Kogyo Kk 医薬組成物
GB0121436D0 (en) * 2001-09-04 2001-10-24 Pfizer Ltd Biomodulated multiparticulate formulations
CA2385529A1 (en) * 2002-05-21 2003-11-21 Bernard Charles Sherman Stable dosage forms comprising atorvastatin calcium
JP2006513186A (ja) * 2002-12-20 2006-04-20 ファイザー・プロダクツ・インク Ｃｅｔｐ阻害剤およびｈｍｇ−ｃｏａレダクターゼ阻害剤を含む剤形

Also Published As

Publication number Publication date
CA2465693A1 (en) 2004-12-12
RU2005136743A (ru) 2006-07-27
NO20060149L (no) 2006-03-06
JP2006527259A (ja) 2006-11-30
BRPI0411354A (pt) 2006-07-11
KR100760112B1 (ko) 2007-09-18
CN1805732A (zh) 2006-07-19
AR044660A1 (es) 2005-09-21
KR20060025167A (ko) 2006-03-20
AU2004246867A1 (en) 2004-12-23
ZA200508204B (en) 2007-03-28
EP1635788A1 (en) 2006-03-22
MXPA05012955A (es) 2006-02-13
RU2325903C2 (ru) 2008-06-10
TW200503689A (en) 2005-02-01
WO2004110406A1 (en) 2004-12-23

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