CO5600997A2 - Formulacion de atorvastatina estabilizada con aditamentos de metales alcalinos - Google Patents

Formulacion de atorvastatina estabilizada con aditamentos de metales alcalinos

Info

Publication number
CO5600997A2
CO5600997A2 CO04079402A CO04079402A CO5600997A2 CO 5600997 A2 CO5600997 A2 CO 5600997A2 CO 04079402 A CO04079402 A CO 04079402A CO 04079402 A CO04079402 A CO 04079402A CO 5600997 A2 CO5600997 A2 CO 5600997A2
Authority
CO
Colombia
Prior art keywords
atorvastatin
formula
pharmaceutical formula
amorphous
pharmaceutical
Prior art date
Application number
CO04079402A
Other languages
English (en)
Inventor
Bharat Singh Romi
Manoj Kumar Pananchukunn
Malik Rajiv
Original Assignee
Ranbaxy Lab Ltd
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 Ranbaxy Lab Ltd filed Critical Ranbaxy Lab Ltd
Publication of CO5600997A2 publication Critical patent/CO5600997A2/es

Links

Classifications

    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
    • 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
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—Inorganic compounds
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Dermatology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Inorganic Chemistry (AREA)
  • Obesity (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

1.- Una fórmula farmacéutica que comprende partículas de atorvastatina amorfa, en la que las partículas tiene un tamaño (d90) menor a 150 µm.2.- La fórmula farmacéutica de la reivindicación 1, en la que el tamaño promedio de partículas (d50) de atorvastatina amorfa es de entre alrededor de 5 y 50 µm.3.- La fórmula farmacéutica de la reivindicación 1, en la que una o ambas tasas y extensión de absorción de la atorvastatina amorfa es igual o mayor que aquella obtenida por la fórmula de atorvastatina cristalina que se comercializa bajo el nombre de marca LipitorTM.4.- La fórmula farmacéutica de la reivindicación 1, en la que uno o ambos intervalos de confianza del 90% de los valores correspondientes al área que cabe bajo la curva de concentración en el tiempo de atorvastatina (AUCo-t) y la máxima concentración de plasma (Cmax) fluctúan entre 0.80 y 1.25 del intervalo fijado por la U.S. Food and Drug Administration en cuando a la fórmula de atorvastatina cristalina que se expende bajo el nombre de marca de LipitorTM.5.- La fórmula farmacéutica de la reivindicación 1, en la que la atorvastatina amorfa comprende entre alrededor del 1% y el 50% según peso de la formulación.6.- La fórmula farmacéutica de la reivindicación 1, en la que la atorvastatina amorfa comprende uno o más de las siguientes: atorvastatina de calcio, atorvastatina de magnesio, atorvastatina de aluminio, atorvastatina de hierro, y atorvastatina de zinc.7.- La fórmula farmacéutica de la reivindicación 1, que comprende ulteriormente uno o más de los excipientes farmacológicamente aceptables que han sido seleccionados del grupo que comprende a agentes diluyentes, surfactantes, antioxidantes, desintegrantes, aglutinantes, lubricantes, deslizantes y quelantes.
CO04079402A 2002-02-14 2004-08-13 Formulacion de atorvastatina estabilizada con aditamentos de metales alcalinos CO5600997A2 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
IN112DE2002 2002-02-14

Publications (1)

Publication Number Publication Date
CO5600997A2 true CO5600997A2 (es) 2006-01-31

Family

ID=27620520

Family Applications (1)

Application Number Title Priority Date Filing Date
CO04079402A CO5600997A2 (es) 2002-02-14 2004-08-13 Formulacion de atorvastatina estabilizada con aditamentos de metales alcalinos

Country Status (23)

Country Link
US (1) US20030175338A1 (es)
EP (1) EP1336405A1 (es)
JP (1) JP2005522444A (es)
KR (1) KR20040101229A (es)
CN (1) CN1642526A (es)
AP (1) AP2004003112A0 (es)
AR (1) AR038839A1 (es)
AU (1) AU2003245736A1 (es)
BR (1) BR0307720A (es)
CA (1) CA2475722A1 (es)
CO (1) CO5600997A2 (es)
EA (1) EA200401059A1 (es)
EC (1) ECSP045235A (es)
HR (1) HRP20040829A2 (es)
IL (1) IL163550A0 (es)
IS (1) IS7404A (es)
MX (1) MXPA04007905A (es)
NO (1) NO20043790L (es)
OA (1) OA12777A (es)
PE (1) PE20030935A1 (es)
PL (1) PL371337A1 (es)
WO (1) WO2003068191A1 (es)
ZA (1) ZA200406970B (es)

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Also Published As

Publication number Publication date
IS7404A (is) 2004-08-13
ZA200406970B (en) 2005-06-20
IL163550A0 (en) 2005-12-18
PL371337A1 (en) 2005-06-13
CA2475722A1 (en) 2003-08-21
HRP20040829A2 (en) 2006-07-31
OA12777A (en) 2006-07-06
EP1336405A1 (en) 2003-08-20
NO20043790L (no) 2004-11-08
PE20030935A1 (es) 2003-10-30
AP2004003112A0 (en) 2004-09-30
ECSP045235A (es) 2004-09-28
US20030175338A1 (en) 2003-09-18
WO2003068191A1 (en) 2003-08-21
EA200401059A1 (ru) 2005-02-24
AR038839A1 (es) 2005-01-26
BR0307720A (pt) 2005-01-25
AU2003245736A1 (en) 2003-09-04
MXPA04007905A (es) 2004-11-26
JP2005522444A (ja) 2005-07-28
KR20040101229A (ko) 2004-12-02
CN1642526A (zh) 2005-07-20

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