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BRPI0411354A - Atorvastatin pharmaceutical compositions, unit dosage form, methods for preparing a granular pharmaceutical composition and for preparing a unit dosage form, use of the pharmaceutical composition and kit thereof - Google Patents

Atorvastatin pharmaceutical compositions, unit dosage form, methods for preparing a granular pharmaceutical composition and for preparing a unit dosage form, use of the pharmaceutical composition and kit thereof

Info

Publication number
BRPI0411354A
BRPI0411354A BRPI0411354-3A BRPI0411354A BRPI0411354A BR PI0411354 A BRPI0411354 A BR PI0411354A BR PI0411354 A BRPI0411354 A BR PI0411354A BR PI0411354 A BRPI0411354 A BR PI0411354A
Authority
BR
Brazil
Prior art keywords
pharmaceutical composition
preparing
dosage form
unit dosage
atorvastatin
Prior art date
Application number
BRPI0411354-3A
Other languages
Portuguese (pt)
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 BRPI0411354A publication Critical patent/BRPI0411354A/en

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)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (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)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Psychiatry (AREA)
  • Urology & Nephrology (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

"COMPOSIçõES FARMACêUTICAS DE ATORVASTATINA, FORMA DE DOSAGEM UNITáRIA, MéTODOS PARA PREPARAR UMA COMPOSIçãO FARMACêUTICA GRANULADA E PARA PREPARAR UMA FORMA DE DOSAGEM UNITáRIA, USO DA COMPOSIçãO FARMACêUTICA E RESPECTIVO KIT". A presente invenção refere-se a uma composição farmacêutica granulada a seco que compreende atorvastatina ou um seu sal farmaceuticamente aceitável do mesmo, bem como uma composição farmacêutica granulada a seco compreendendo atorvastatina ou um seu sal farmaceuticamente aceitável do mesmo em combinação com pelo menos uma outra droga ativa, métodos para preparar as referidas composições, kits de componentes para conter tais composições, e um método para tratar a hipercolesterolemia e/ou hiperlipidemia, osteoporose, hiperplasia benigna da próstata (HBP), e doença de Alzheimer utilizando uma quantidade terapeuticamente eficaz da composição farmacêutica."PHARMACEUTICAL COMPOSITIONS OF ATORVASTATIN, UNIT DOSAGE FORM, METHODS FOR PREPARING A GRANULATED PHARMACEUTICAL COMPOSITION AND FOR PREPARING A UNIT DOSAGE FORM, USE OF THE PHARMACEUTICAL COMPOSITION, AND THEIR RESPECTIVE KIT." The present invention relates to a dry granulated pharmaceutical composition comprising atorvastatin or a pharmaceutically acceptable salt thereof, as well as a dry granular pharmaceutical composition comprising atorvastatin or a pharmaceutically acceptable salt thereof in combination with at least one other pharmaceutical composition. active drug, methods for preparing said compositions, component kits for containing such compositions, and a method for treating hypercholesterolemia and / or hyperlipidemia, osteoporosis, benign prostate hyperplasia (BPH), and Alzheimer's disease using a therapeutically effective amount of the drug. pharmaceutical composition.

BRPI0411354-3A 2003-06-12 2004-06-01 Atorvastatin pharmaceutical compositions, unit dosage form, methods for preparing a granular pharmaceutical composition and for preparing a unit dosage form, use of the pharmaceutical composition and kit thereof BRPI0411354A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US47791703P 2003-06-12 2003-06-12
PCT/IB2004/001859 WO2004110406A1 (en) 2003-06-12 2004-06-01 Pharmaceutical compositions of atorvastatin

Publications (1)

Publication Number Publication Date
BRPI0411354A true BRPI0411354A (en) 2006-07-11

Family

ID=33551780

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0411354-3A BRPI0411354A (en) 2003-06-12 2004-06-01 Atorvastatin pharmaceutical compositions, unit dosage form, methods for preparing a granular pharmaceutical composition and for preparing a unit dosage form, use of the pharmaceutical composition and kit thereof

Country Status (15)

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

Families Citing this family (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1716114A1 (en) * 2004-10-18 2006-11-02 Teva Pharmaceutical Industries Ltd. Process for preparing amorphous atorvastatin hemi-calcium by dissolving the salt in an organic solvent which is a mixture of an alcohol and a ketone and/or an ester and removing the solvent
CA2547216A1 (en) * 2005-09-21 2007-03-21 Renuka D. Reddy Process for annealing amorphous atorvastatin
US8124622B2 (en) 2006-03-29 2012-02-28 Kowa Co., Ltd. Triglyceride-lowering agent and hyperinsulinism-ameliorating agent
CN102976996B (en) * 2009-05-27 2015-08-19 峡江和美药业有限公司 Atorvastatin semi strontium salt polymorphic form, its preparation and the application as HMG-CoA enzyme inhibitors
RU2404767C1 (en) * 2009-08-11 2010-11-27 Закрытое Акционерное Общество "БИОКОМ" Solid dosage form having hypolipidemic and hypocholesteremic activity, and method of its production
WO2011074961A1 (en) 2009-12-18 2011-06-23 Frieslandcampina Nederland Holding B.V. Co-processed tablet excipient composition its preparation and use
CN104013587A (en) * 2009-12-22 2014-09-03 诺华股份有限公司 Formulation comprising 1H-quinazoline-2,4-dione AMPA receptor antagonists, in the form of immediate release tablets and preparation thereof
EP2575757A1 (en) 2010-06-03 2013-04-10 Mahmut Bilgic Water soluble formulation comprising a combination of amlodipine and a statin
EA018867B1 (en) * 2012-11-01 2013-11-29 Лаборатория Тютор С.А.С.И.Ф.И.А. Method of producing pharmaceutical composition and product therefrom
CN104825449A (en) * 2014-02-12 2015-08-12 天津药物研究院 Compound composition containing atorvastatin calcium and amlodipine and preparation method of same
WO2016047749A1 (en) * 2014-09-26 2016-03-31 株式会社フジクラ Optical fiber
RU2591079C2 (en) * 2014-12-10 2016-07-10 Александр Владимирович Диковский Pharmaceutical composition of statins with prebiotic for therapy of hypercholesteremia and hyperlipidemia
KR20180016732A (en) * 2015-06-10 2018-02-19 에보니크 룀 게엠베하 Process for preparing a powder comprising a human coagulation factor protein and a lactic acid polymer
WO2017063581A1 (en) * 2015-10-16 2017-04-20 深圳信立泰药业股份有限公司 Oral preparation for the treatment of cardiovascular diseases and preparation method thereof
EP4392024A1 (en) 2021-08-25 2024-07-03 Basf Se Direct tableting auxiliary composition
CN114674944A (en) * 2022-03-04 2022-06-28 苏州东瑞制药有限公司 Method for detecting related substances of amlodipine besylate and atorvastatin calcium compound preparation

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SK286789B6 (en) * 1999-11-17 2009-05-07 Teva Pharmaceutical Industries Ltd. A crystalline form of atorvastatin calcium or hydrate thereof, method for producing thereof and pharmaceutical compositions comprising said compound
SI20848A (en) * 2001-03-14 2002-10-31 Lek, Tovarna Farmacevtskih In Kemijskih Izdelkov, D.D. Pharmaceutical formulation containing atorvastatin calcium
CA2442280A1 (en) * 2001-03-27 2002-10-03 Ranbaxy Laboratories Limited A stable pharmaceutical composition of pravastatin
JP2003055217A (en) * 2001-08-10 2003-02-26 Taiyo Yakuhin Kogyo Kk Pharmaceutical composition
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
EP1578415B1 (en) * 2002-12-20 2008-09-10 Pfizer Products Inc. Dosage forms comprising a cetp inhibitor and an hmg-coa reductase inhibitor

Also Published As

Publication number Publication date
CO5640071A2 (en) 2006-05-31
TW200503689A (en) 2005-02-01
AU2004246867A1 (en) 2004-12-23
KR100760112B1 (en) 2007-09-18
MXPA05012955A (en) 2006-02-13
EP1635788A1 (en) 2006-03-22
NO20060149L (en) 2006-03-06
CN1805732A (en) 2006-07-19
AR044660A1 (en) 2005-09-21
JP2006527259A (en) 2006-11-30
RU2005136743A (en) 2006-07-27
CA2465693A1 (en) 2004-12-12
WO2004110406A1 (en) 2004-12-23
ZA200508204B (en) 2007-03-28
KR20060025167A (en) 2006-03-20
RU2325903C2 (en) 2008-06-10

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Legal Events

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B08F Application fees: application dismissed [chapter 8.6 patent gazette]

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B08K Patent lapsed as no evidence of payment of the annual fee has been furnished to inpi [chapter 8.11 patent gazette]

Free format text: REFERENTE AO DESPACHO 8.6 PUBLICADO NA RPI 2125 DE 27/09/2011.