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WO2013072770A3 - Formulations pharmaceutiques comprenant de l'atorvastatine et du glimépiride - Google Patents

Formulations pharmaceutiques comprenant de l'atorvastatine et du glimépiride Download PDF

Info

Publication number
WO2013072770A3
WO2013072770A3 PCT/IB2012/002860 IB2012002860W WO2013072770A3 WO 2013072770 A3 WO2013072770 A3 WO 2013072770A3 IB 2012002860 W IB2012002860 W IB 2012002860W WO 2013072770 A3 WO2013072770 A3 WO 2013072770A3
Authority
WO
WIPO (PCT)
Prior art keywords
glimepiride
atorvastatin
pharmaceutical formulations
pharmaceutically acceptable
acceptable salts
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/IB2012/002860
Other languages
English (en)
Other versions
WO2013072770A2 (fr
Inventor
Maheshwar KOLLURI
Rajesh Dubey
Rajeev Singh Raghuvanshi
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Dr Reddys Laboratories Ltd
Original Assignee
Dr Reddys Laboratories 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 Dr Reddys Laboratories Ltd filed Critical Dr Reddys Laboratories Ltd
Priority to IN4119CHN2014 priority Critical patent/IN2014CN04119A/en
Priority to RU2014124118/15A priority patent/RU2014124118A/ru
Priority to EP12826534.5A priority patent/EP2779999A2/fr
Publication of WO2013072770A2 publication Critical patent/WO2013072770A2/fr
Publication of WO2013072770A3 publication Critical patent/WO2013072770A3/fr
Anticipated expiration legal-status Critical
Priority to ZA2014/03735A priority patent/ZA201403735B/en
Ceased legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40Heterocyclic 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/64Sulfonylureas, e.g. glibenclamide, tolbutamide, chlorpropamide
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/145Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2027Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

Selon certains aspects, la présente invention concerne des formulations pharmaceutiques comprenant de l'atorvastatine ou des sels pharmaceutiquement acceptables de celle-ci, et du glimépiride en tant qu'agents actifs, à la fois l'atorvastatine ou des sels pharmaceutiquement acceptables de celle-ci et le glimépiride étant sous une forme à libération immédiate.
PCT/IB2012/002860 2011-11-15 2012-11-14 Formulations pharmaceutiques comprenant de l'atorvastatine et du glimépiride Ceased WO2013072770A2 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
IN4119CHN2014 IN2014CN04119A (fr) 2011-11-15 2012-11-14
RU2014124118/15A RU2014124118A (ru) 2011-11-15 2012-11-14 Фармацевтические препараты, включающие аторвастатин и глимепирид
EP12826534.5A EP2779999A2 (fr) 2011-11-15 2012-11-14 Formulations pharmaceutiques comprenant de l'atorvastatine et du glimépiride
ZA2014/03735A ZA201403735B (en) 2011-11-15 2014-05-22 Pharmaceutical formulations comprising atorvastatin and glimepiride

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
IN3920CH2011 2011-11-15
IN3920/CHE/2011 2011-11-15
US201261582566P 2012-01-03 2012-01-03
US61/582,566 2012-01-03

Publications (2)

Publication Number Publication Date
WO2013072770A2 WO2013072770A2 (fr) 2013-05-23
WO2013072770A3 true WO2013072770A3 (fr) 2013-10-24

Family

ID=48430284

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2012/002860 Ceased WO2013072770A2 (fr) 2011-11-15 2012-11-14 Formulations pharmaceutiques comprenant de l'atorvastatine et du glimépiride

Country Status (5)

Country Link
EP (1) EP2779999A2 (fr)
IN (1) IN2014CN04119A (fr)
RU (1) RU2014124118A (fr)
WO (1) WO2013072770A2 (fr)
ZA (1) ZA201403735B (fr)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021236581A1 (fr) * 2020-05-18 2021-11-25 Board Of Regents, The University Of Texas System Granulés pour technologie d'impression 3d
CN112618499B (zh) * 2020-12-24 2022-09-30 石药集团欧意药业有限公司 一种格列美脲分散片剂组合物及其制备方法

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004110431A1 (fr) * 2003-06-12 2004-12-23 Warner-Lambert Company Llc Compositions stables d'atorvastatine preparees par granulation par voie humide
WO2007072218A2 (fr) * 2005-06-10 2007-06-28 Combino Pharm, S.L. Formulations contenant du glimepiride et/ou ses sels
CN101103990A (zh) * 2006-07-14 2008-01-16 北京华安佛医药研究中心有限公司 含有磺脲类降糖药物和他汀类降脂药物的组合物
WO2009140341A2 (fr) * 2008-05-13 2009-11-19 Dr. Reddy's Laboratories Ltd. Compositions d'atorvastatine

Family Cites Families (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2951135A1 (de) 1979-12-19 1981-06-25 Hoechst Ag, 6230 Frankfurt Sulfonylharnstoffe, verfahren zu ihrer herstellung, pharmazeutische praeparate auf basis dieser verbindungen und ihre verwendung
DE3320582A1 (de) 1983-06-08 1984-12-13 Dr. Karl Thomae Gmbh, 7950 Biberach Gliquidonhaltige zubereitungsformen und verfahren zu ihrer herstellung
US4681893A (en) 1986-05-30 1987-07-21 Warner-Lambert Company Trans-6-[2-(3- or 4-carboxamido-substituted pyrrol-1-yl)alkyl]-4-hydroxypyran-2-one inhibitors of cholesterol synthesis
FI94339C (fi) 1989-07-21 1995-08-25 Warner Lambert Co Menetelmä farmaseuttisesti käyttökelpoisen /R-(R*,R*)/-2-(4-fluorifenyyli)- , -dihydroksi-5-(1-metyylietyyli)-3-fenyyli-4-/(fenyyliamino)karbonyyli/-1H-pyrroli-1-heptaanihapon ja sen farmaseuttisesti hyväksyttävien suolojen valmistamiseksi
SG45369A1 (en) 1993-01-19 1998-10-16 Warner Lambert Co Stable oral ci-981 formulation and process of preparing same
DE69634054T2 (de) 1995-07-17 2005-12-08 Warner-Lambert Co. Kristalline (R-(R*, R*))-2-(4-Fluorophenyl)-β, δ-Dihydroxy-5-(1-Methylethyl)-3-Phenyl-4-((Phenylamino)Carbonyl)-1H-Pyrrol-1-Heptancarbonsäure Hemi Calcium Salz (Atorvastatin)
SI20109A (sl) 1998-12-16 2000-06-30 LEK, tovarna farmacevtskih in kemi�nih izdelkov, d.d. Stabilna farmacevtska formulacija
GB0001662D0 (en) 1999-02-06 2000-03-15 Zeneca Ltd Pharmaceutical compositions
AU2001253287B2 (en) 2000-04-10 2005-04-28 Teva Pharmaceutical Industries Ltd. Stable pharmaceutical compositions containing 7-substituted-3,5-dihydroxyheptanoic acids or 7-substituted-3,5-dihydroxyheptenoic acids
WO2001093859A1 (fr) 2000-06-09 2001-12-13 Lek Pharmaceuticals D.D. Produit et preparation pharmaceutiques stables
JP2004501121A (ja) 2000-06-09 2004-01-15 エルイーケー ファーマシューティカルズ ディー.ディー. 安定した医薬効果を有する合成物、及びそれを含む医薬製剤
AR030379A1 (es) 2000-08-22 2003-08-20 Novartis Ag Combinaciones
US7074818B2 (en) 2001-07-30 2006-07-11 Dr. Reddy's Laboratories Limited Crystalline forms VI and VII of Atorvastatin calcium
AU2003245736A1 (en) 2002-02-14 2003-09-04 Ranbaxy Laboratories Limited Formulations of atorvastatin stabilized with alkali metal additions
US20030171407A1 (en) 2002-03-07 2003-09-11 Upsher-Smith Laboratories, Inc. Composition for reducing blood glucose and cholesterol
CA2385529A1 (fr) 2002-05-21 2003-11-21 Bernard Charles Sherman Formulations posologiques stables contenant de l'atorvastatin calcium
SI21302A (sl) 2002-10-11 2004-04-30 LEK farmacevtska dru�ba d.d. Stabiliziran farmacevtski izdelek z amorfno aktivno učinkovino
US20040147564A1 (en) 2003-01-29 2004-07-29 Rao Vinay U. Combinations of glimepiride and the thiazolidinedione for treatment of diabetes
SI21400A (sl) 2003-02-12 2004-08-31 LEK farmacevtska družba d.d. Stabilna farmacevtska oblika z inhibitorjem HMG-CoA reduktaze
US7655692B2 (en) 2003-06-12 2010-02-02 Pfizer Inc. Process for forming amorphous atorvastatin
WO2006006021A2 (fr) 2004-06-28 2006-01-19 Glenmark Pharmaceuticals Limited Compositions pharmaceutiques stabilisees
JP2008514722A (ja) 2004-09-30 2008-05-08 ドクター レディズ ラボラトリーズ リミテッド 非結晶性アトルバスタチンカルシウム
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Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004110431A1 (fr) * 2003-06-12 2004-12-23 Warner-Lambert Company Llc Compositions stables d'atorvastatine preparees par granulation par voie humide
WO2007072218A2 (fr) * 2005-06-10 2007-06-28 Combino Pharm, S.L. Formulations contenant du glimepiride et/ou ses sels
CN101103990A (zh) * 2006-07-14 2008-01-16 北京华安佛医药研究中心有限公司 含有磺脲类降糖药物和他汀类降脂药物的组合物
WO2009140341A2 (fr) * 2008-05-13 2009-11-19 Dr. Reddy's Laboratories Ltd. Compositions d'atorvastatine

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
CHOWDHURY S ET AL: "Statistical optimization of fixed dose combination of glimepiride and atorvastatin calcium in immediate release tablet Formulation", INTERNATIONAL JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES : IJPPS, MADHYA PRADESH, IN, vol. 2, no. Suppl. 4, 1 November 2010 (2010-11-01), pages 194 - 200, XP008163345, ISSN: 0975-1491 *
DATABASE WPI Week 200874, Derwent World Patents Index; AN 2008-M50691, XP002700007 *

Also Published As

Publication number Publication date
RU2014124118A (ru) 2015-12-27
WO2013072770A2 (fr) 2013-05-23
IN2014CN04119A (fr) 2015-07-10
EP2779999A2 (fr) 2014-09-24
ZA201403735B (en) 2015-12-23

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