PE20030935A1 - Formulacion de atorvastatina estabilizada con aditamentos de metales alcalinos - Google Patents

Formulacion de atorvastatina estabilizada con aditamentos de metales alcalinos

Info

Publication number
PE20030935A1
PE20030935A1 PE2003000161A PE2003000161A PE20030935A1 PE 20030935 A1 PE20030935 A1 PE 20030935A1 PE 2003000161 A PE2003000161 A PE 2003000161A PE 2003000161 A PE2003000161 A PE 2003000161A PE 20030935 A1 PE20030935 A1 PE 20030935A1
Authority
PE
Peru
Prior art keywords
atorvastatin
crusher
alkaline metal
refers
less
Prior art date
Application number
PE2003000161A
Other languages
English (en)
Inventor
Pananchu Kumar
Romi Bharat Singh
Rajiv Malik
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 PE20030935A1 publication Critical patent/PE20030935A1/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

SE REFIERE A FORMULAS FARMACEUTICAS ESTABILIZADAS DE 1% Y 50% DE ATORVASTATINA AMORFA Y/O CRISTALINA QUE COMPRENDE ATORVASTATINA (DE CALCIO, MAGNESIO, ALUMINIO, HIERRO, ZINC) CON UN TAMANO DE PARTICULAS (d90) MENOR DE 150µm; QUE SE CARACTERIZA PORQUE LOS INTERVALOS DE CONFIANZA DEL 90% DE LOS VALORES CORRESPONDIENTES AL AREA QUE CABE BAJO LA CURVA DE CONCENTRACION EN EL TIEMPO DE ATORVASTATINA AUC (0-t) Y LA MAXIMA CONCENTRACION DE PLASMA (CMAX) FLUCTUAN ENTRE 0.80 Y 1.25; EXCIPIENTES SELECCIONADOS ENTRE AGENTES DILUYENTES, SURFACTANTES, ANTIOXIDANTES, DESINTEGRANTES, AGLUTINANTES, LUBRICANTES, DESLIZANTES, QUELANTES; DE 1.2% A NO MENOS DE 5% DE UN ADITIVO COMO SAL DE METAL ALCALINO TAL COMO CARBONATO; BICARBONATO, HIDROXIDO, SILICATO DE SODIO. TAMBIEN SE REFIERE A UN METODO PARA PREPARAR QUE COMPRENDE REDUCIR EL TAMANO DE LAS PARTICULAS DE ATORVASTATINA AMORFA MEDIANTE EL EMPLEO DE UN TRITURADOR CON CHORRO DE AIRE, QUEBRADORA DE BOLAS, TRITURADORA, PULVERIZADOR; FORMAR UNA MEZCLA AL COMBINAR ATORVASTATINA AMORFA CON PARTICULAS DE TAMANO REDUCIDO, CON EXCIPIENTES; COMPRENSION DE LA MEZCLA
PE2003000161A 2002-02-14 2003-02-14 Formulacion de atorvastatina estabilizada con aditamentos de metales alcalinos PE20030935A1 (es)

Applications Claiming Priority (1)

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

Publications (1)

Publication Number Publication Date
PE20030935A1 true PE20030935A1 (es) 2003-10-30

Family

ID=27620520

Family Applications (1)

Application Number Title Priority Date Filing Date
PE2003000161A PE20030935A1 (es) 2002-02-14 2003-02-14 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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WO2002057229A1 (en) 2001-01-19 2002-07-25 Biocon India Limited FORM V CRYSTALLINE [R-(R*,R*)]-2-(4-FLUOROPHENYL)-ß,$G(D)-DIHYDROXY-5-(1-METHYLETHYL)-3-PHENYL-4-[(PHENYLAMINO)CARBONYL]-1H-PYRROLE-1- HEPTANOIC ACID HEMI CALCIUM SALT. (ATORVASTATIN)
US7361772B2 (en) * 2001-08-16 2008-04-22 Biocon Limited Process for the production of atorvastatin calcium
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US7179942B2 (en) 2002-07-05 2007-02-20 Bicon Limited Halo-substituted active methylene compounds
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US20050271717A1 (en) * 2003-06-12 2005-12-08 Alfred Berchielli Pharmaceutical compositions of atorvastatin
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AU2003272080A1 (en) 2003-09-18 2005-04-06 Biocon Limited Novel process for the preparation of tert-butyl 6-cyano-5-hydroxy-3-oxohexanoate
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CA2588216A1 (en) * 2004-11-22 2006-05-26 Dexcel Pharma Technologies Ltd. Stable atorvastatin formulations
EP1819319A1 (en) * 2004-12-02 2007-08-22 Warner-Lambert Company LLC Pharmaceutical compositions of amorphous atorvastatin and process for preparing same
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US20070004671A1 (en) * 2005-05-20 2007-01-04 Agarwal Sudeep K Stable desloratadine compositions
CA2613875C (en) * 2005-07-04 2018-09-25 Ramu Krishnan Improved drug or pharmaceutical compounds and a preparation thereof
CN101500555A (zh) * 2005-08-04 2009-08-05 变换药品公司 包含非诺贝特和他汀的新型制剂及相关治疗方法
CA2628716C (en) * 2005-11-10 2016-09-27 Alphapharm Pty Ltd Process to control particle size
AU2006313009B2 (en) * 2005-11-10 2013-10-24 Alphapharm Pty Ltd Process to control particle size
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US20090111997A1 (en) * 2005-11-23 2009-04-30 Aaron Cote Method of Generating Amorphous Solid for Water-Insoluble Pharmaceuticals
CA2631549A1 (en) * 2005-11-29 2007-06-07 Biocon Limited Polymorphs of [r-(r*, r*)]-2-(4-fluorophenyl)-.beta.,.delta.-dihydroxy-5-(methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-lh-pyrrole-l-heptanoic acid magnesium salt (2: 1)
EP1810667A1 (en) * 2006-01-20 2007-07-25 KRKA, tovarna zdravil, d.d., Novo mesto Pharmaceutical composition comprising amorphous atorvastatin
US20070202159A1 (en) * 2006-02-02 2007-08-30 Mathur Rajeev S Pharmaceutical composition comprising stabilized statin particles
EP1818049A3 (en) * 2006-02-10 2008-11-19 LifeCycle Pharma A/S Stabilized Atorvastatin
WO2007099552A2 (en) * 2006-03-02 2007-09-07 Matrix Labaratories Ltd Novel crystalline form of atovastatin hemi-magnesium
HU227696B1 (en) * 2006-04-13 2011-12-28 Egyt Gyogyszervegyeszeti Gyar Zinc salt of rosuvastatin, process for its preparation and pharmaceutical compositions containing it
SI22255A (sl) * 2006-04-14 2007-10-31 Krka, Tovarna Zdravil, D.D., Novo Mesto Novi polimorfi statinovih soli in njihova uporabav farmacevtskih formulacijah
EP2016048A4 (en) 2006-05-11 2010-06-23 Biocon Ltd CRYSTALLINE FORM B4 OF ATORVASTATIN MAGNESIUM AND METHOD THEREFOR
US20080038332A1 (en) * 2006-08-10 2008-02-14 Cai Gu Huang Stable pharmaceutical formulation comprising atorvastatin calcium
HU227610B1 (en) * 2006-09-18 2011-09-28 Richter Gedeon Nyrt Pharmaceutical compositions containing rosuvastatin potassium
US20100029743A1 (en) * 2006-09-27 2010-02-04 Dr. Reddy's Laboratories Ltd. Atorvastatin pharmaceutical compositions
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CN101224205B (zh) * 2007-01-20 2010-11-17 石药集团中奇制药技术（石家庄）有限公司 一种阿托伐他汀和左旋氨氯地平的组合物及其制备方法
IS8607A (is) * 2007-02-09 2008-08-10 Actavis Group Hf. Stöðugar atorvastatin samsetningar
CZ300047B6 (cs) * 2007-03-02 2009-01-21 Zentiva, A. S. Farmaceutická kompozice s obsahem úcinné látky atorvastatinu
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CN102105427A (zh) * 2008-07-25 2011-06-22 阿尔法制药有限公司 粒度直径范围(D90)为大于3μm至约10μm的阿托伐醌
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CN101791297B (zh) * 2010-02-10 2012-03-28 中国药科大学 阿托伐他汀钙口崩片及其制备方法
WO2011121823A1 (ja) * 2010-03-29 2011-10-06 アステラス製薬株式会社 経口投与用粒子状医薬組成物
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HUP1000299A2 (hu) 2010-06-08 2012-02-28 Nanoform Cardiovascular Therapeutics Ltd Nanostrukturált Atorvastatint, gyógyszerészetileg elfogadott sóit és kokristályait tartalmazó készítmény és eljárás elõállításukra
WO2011154009A1 (en) * 2010-06-10 2011-12-15 Lifecycle Pharma A/S Composition comprising an active principle in an amorphous form and a porous adsorbent material
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IN2014CN04119A (es) 2011-11-15 2015-07-10 Reddys Lab Ltd Dr
CN104069502B (zh) * 2013-03-29 2018-02-16 北京罗诺强施医药技术研发中心有限公司 复合骨架材料及其药物组合物
JP6507808B2 (ja) * 2015-04-09 2019-05-08 ニプロ株式会社 口腔内崩壊錠
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CN108421045B (zh) * 2018-04-02 2021-09-24 北京海晶生物医药科技有限公司 一种阿托伐他汀钙组合物、制剂及其制备方法
CN109044989A (zh) * 2018-10-09 2018-12-21 河南师范大学 一种阿托伐他汀钙胶囊制剂及其制备方法

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Also Published As

Publication number Publication date
BR0307720A (pt) 2005-01-25
NO20043790L (no) 2004-11-08
EA200401059A1 (ru) 2005-02-24
IL163550A0 (en) 2005-12-18
AP2004003112A0 (en) 2004-09-30
HRP20040829A2 (en) 2006-07-31
ZA200406970B (en) 2005-06-20
CN1642526A (zh) 2005-07-20
EP1336405A1 (en) 2003-08-20
WO2003068191A1 (en) 2003-08-21
OA12777A (en) 2006-07-06
CA2475722A1 (en) 2003-08-21
JP2005522444A (ja) 2005-07-28
ECSP045235A (es) 2004-09-28
US20030175338A1 (en) 2003-09-18
AU2003245736A1 (en) 2003-09-04
CO5600997A2 (es) 2006-01-31
PL371337A1 (en) 2005-06-13
MXPA04007905A (es) 2004-11-26
AR038839A1 (es) 2005-01-26
IS7404A (is) 2004-08-13
KR20040101229A (ko) 2004-12-02

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