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CO5640072A2 - Composiciones farmaceuticas que comprenden atorvastatina fabricada sin granulacion - Google Patents

Composiciones farmaceuticas que comprenden atorvastatina fabricada sin granulacion

Info

Publication number
CO5640072A2
CO5640072A2 CO05125195A CO05125195A CO5640072A2 CO 5640072 A2 CO5640072 A2 CO 5640072A2 CO 05125195 A CO05125195 A CO 05125195A CO 05125195 A CO05125195 A CO 05125195A CO 5640072 A2 CO5640072 A2 CO 5640072A2
Authority
CO
Colombia
Prior art keywords
dosage form
unit dosage
atorvastatin
per
combination
Prior art date
Application number
CO05125195A
Other languages
English (en)
Inventor
Alfred Berchielli
Kenneth Craig Waterman
Patrick David Daugherity
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=33551781&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CO5640072(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Warner Lambert Co filed Critical Warner Lambert Co
Publication of CO5640072A2 publication Critical patent/CO5640072A2/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
    • 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
    • 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
    • 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
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • 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
    • 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
    • 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
    • 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
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics

Landscapes

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

Abstract

1.- Una forma farmacéutica unitaria que comprende (a) atorvastatina o una sal farmaceuticamente aceptable de los mismos, en la que dicha atorvastatina o una de sus sales farmacéuticamente aceptable, es una forma de atorvastatina que está, al menos, algo desordenada, o es una mezcla de formas cristalina y desordenada de atorvastatina, un excipiente o combinación de excipientes que contiene al menos aproximadamente 5% en peso, de un aditivo constituido por un agente alcalinizante, en donde dicha forma farmacéutica unitaria es preparada sin etapa de granulación, en la que la potencia de atorvastatina medida de dicha forma farmacéutica de administración, muestra una desviación típica relativa para la actividad de la atorvastatina por forma farmacéutica unitaria, no mayor que 7,8%, aproximadamente, cuando dicha forma farmacéutica unitaria se prepara a una velocidad mayor que 10.000 formas farmacéuticas unitarias por hora, por forma farmacéutica unitaria única, por hora, por máquina.2.- La forma farmacéutica unitaria según la reivindicación 2, en la que dicho excipiente o combinación de excipientes comprende aproximadamente más del 50% en peso, de un diluyente o de una combinación de diluyentes.3.- La forma farmacéutica unitaria según la reivindicación 6, en la que dicho diluyente es lactosa monohidratada, lactosa anhidra, celulosa microcristalina o cloruro de sodio.4.- La forma farmacéutica unitaria según la reivindicación 6, en la que dicha forma farmacéutica unitaria es un comprimido o una cápsula y contiene también al menos un fármaco activo además de la atorvastatina.
CO05125195A 2003-06-12 2005-12-12 Composiciones farmaceuticas que comprenden atorvastatina fabricada sin granulacion CO5640072A2 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US47791803P 2003-06-12 2003-06-12

Publications (1)

Publication Number Publication Date
CO5640072A2 true CO5640072A2 (es) 2006-05-31

Family

ID=33551781

Family Applications (1)

Application Number Title Priority Date Filing Date
CO05125195A CO5640072A2 (es) 2003-06-12 2005-12-12 Composiciones farmaceuticas que comprenden atorvastatina fabricada sin granulacion

Country Status (23)

Country Link
US (2) US20050271717A1 (es)
EP (2) EP1977738A1 (es)
JP (1) JP2006527256A (es)
KR (1) KR20060028768A (es)
CN (1) CN100446757C (es)
AR (1) AR044775A1 (es)
AT (1) ATE399537T1 (es)
AU (1) AU2004246866A1 (es)
BR (1) BRPI0411079A (es)
CA (1) CA2465621A1 (es)
CO (1) CO5640072A2 (es)
DE (1) DE602004014765D1 (es)
DK (1) DK1635791T3 (es)
ES (1) ES2305775T3 (es)
MX (1) MXPA05013392A (es)
NO (1) NO20055185L (es)
PL (1) PL1635791T3 (es)
PT (1) PT1635791E (es)
RU (1) RU2314804C2 (es)
SI (1) SI1635791T1 (es)
TW (1) TW200509905A (es)
WO (1) WO2004110409A1 (es)
ZA (1) ZA200509906B (es)

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WO2004110409A1 (en) 2004-12-23
EP1635791A1 (en) 2006-03-22
SI1635791T1 (sl) 2008-10-31
ES2305775T3 (es) 2008-11-01
AR044775A1 (es) 2005-10-05
KR20060028768A (ko) 2006-04-03
PT1635791E (pt) 2008-09-10
EP1977738A1 (en) 2008-10-08
AU2004246866A1 (en) 2004-12-23
BRPI0411079A (pt) 2006-07-25
DK1635791T3 (da) 2008-08-25
NO20055185D0 (no) 2005-11-04
RU2005138496A (ru) 2006-04-27
ZA200509906B (en) 2007-01-31
JP2006527256A (ja) 2006-11-30
US20050271717A1 (en) 2005-12-08
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CA2465621A1 (en) 2004-12-12
US20090226510A1 (en) 2009-09-10
NO20055185L (no) 2006-03-09
EP1635791B1 (en) 2008-07-02
CN1794978A (zh) 2006-06-28
RU2314804C2 (ru) 2008-01-20
CN100446757C (zh) 2008-12-31
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PL1635791T3 (pl) 2008-11-28
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