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AR038839A1 - Formulacion de atorvastatina estabilizada con aditamentos de metales alcalinos. metodo para su elaboracion - Google Patents

Formulacion de atorvastatina estabilizada con aditamentos de metales alcalinos. metodo para su elaboracion

Info

Publication number
AR038839A1
AR038839A1 ARP030100494A ARP030100494A AR038839A1 AR 038839 A1 AR038839 A1 AR 038839A1 AR P030100494 A ARP030100494 A AR P030100494A AR P030100494 A ARP030100494 A AR P030100494A AR 038839 A1 AR038839 A1 AR 038839A1
Authority
AR
Argentina
Prior art keywords
atorvastatin
magnesium
sodium
crushing
particles
Prior art date
Application number
ARP030100494A
Other languages
English (en)
Inventor
Romi Bharat Singh
Rajiv Malik
Pananchukunnath Manoj Kumar
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 AR038839A1 publication Critical patent/AR038839A1/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)
  • Inorganic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Dermatology (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

Una fórmula farmacéutica que tiene mejor biodisponibilidad y bioequivalencia e incluye partículas de atorvastatina amorfa y/o cristalina, cuyo tamano de partículas (d90) corresponde a menos de 150 mm, con tamano promedio de partículas (d50) de atorvastatina que oscila entre alrededor de 5 y 50 mm. La atorvastatina puede corresponder a una o más de las siguientes: atorvastatina de calcio, atorvastatina de magnesio, atorvastatina de aluminio, atorvastatina de hierro, y atorvastatina de zinc. Las fórmulas de atorvastatina pueden ser estabilizadas al mezclar la atorvastatina con un aditivo consistente en sales de un metal alcalino que corresponde entre alrededor del 1.2% y menos del 5% peso en agua de la fórmula. El aditivo consistente de sales de metales alcalinos puede corresponder a uno o más de los siguientes: carbonato de sodio, bicarbonato de sodio, hidróxido de sodio, silicato de sodio, ortofosfato de hidrógeno de disodio, fosfato de dihidrógeno de sodio, fosfato de hidrógeno de disodio, fosfato de sodio, aluminato de sodio, carbonato de calcio, hidróxido de calcio, carbonato de magnesio, hidróxido de magnesio, silicato de magnesio, aluminato de magnesio, e hidróxido de magnesio, silicato de magnesio, aluminato de magnesio, e hidróxido de magnesio aluminado. Las fórmulas de atorvastatina pueden utilizarse para el tratamiento de condiciones médicas que incluyen hipercolesterolemia primaria, disbetalpoproteinemia, e hipercolesterolemia familiar homocigota. Reivindicación 83: Un método para procesar la atorvastatina amorfa con el fin de disminuir el tamano de las partículas de atorvastatina amorfa, el método comprende la trituración de partículas de atorvastatina amorfa empleando para ello uno o varios de los siguientes métodos: trituración con chorro de aire, trituración con quebradora de bolas, trituración cad y multi-trituración a fin de reducir el tamano de las partículas de atorvastatina amorfa de tal manera que las partículas tengan un tamano (d90) inferior a 150 mm y alcancen un tamano de partícula promedio (d50) comprendido entre aproximadamente 5 y 50 mm.
ARP030100494A 2002-02-14 2003-02-14 Formulacion de atorvastatina estabilizada con aditamentos de metales alcalinos. metodo para su elaboracion AR038839A1 (es)

Applications Claiming Priority (1)

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

Publications (1)

Publication Number Publication Date
AR038839A1 true AR038839A1 (es) 2005-01-26

Family

ID=27620520

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP030100494A AR038839A1 (es) 2002-02-14 2003-02-14 Formulacion de atorvastatina estabilizada con aditamentos de metales alcalinos. metodo para su elaboracion

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
PE20030935A1 (es) 2003-10-30
IL163550A0 (en) 2005-12-18
PL371337A1 (en) 2005-06-13
CA2475722A1 (en) 2003-08-21
EP1336405A1 (en) 2003-08-20
HRP20040829A2 (en) 2006-07-31
EA200401059A1 (ru) 2005-02-24
ZA200406970B (en) 2005-06-20
KR20040101229A (ko) 2004-12-02
IS7404A (is) 2004-08-13
OA12777A (en) 2006-07-06
MXPA04007905A (es) 2004-11-26
BR0307720A (pt) 2005-01-25
CO5600997A2 (es) 2006-01-31
JP2005522444A (ja) 2005-07-28
ECSP045235A (es) 2004-09-28
CN1642526A (zh) 2005-07-20
AU2003245736A1 (en) 2003-09-04
WO2003068191A1 (en) 2003-08-21
NO20043790L (no) 2004-11-08
AP2004003112A0 (en) 2004-09-30
US20030175338A1 (en) 2003-09-18

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