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WO2013072770A3 - Pharmaceutical formulations comprising atorvastatin and glimepiride - Google Patents

Pharmaceutical formulations comprising atorvastatin and glimepiride 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
French (fr)
Other versions
WO2013072770A2 (en
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/en
Priority to EP12826534.5A priority patent/EP2779999A2/en
Publication of WO2013072770A2 publication Critical patent/WO2013072770A2/en
Publication of WO2013072770A3 publication Critical patent/WO2013072770A3/en
Anticipated expiration legal-status Critical
Priority to ZA2014/03735A priority patent/ZA201403735B/en
Ceased legal-status Critical Current

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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, 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
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered 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
    • 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
    • A61K31/64—Sulfonylureas, e.g. glibenclamide, tolbutamide, chlorpropamide
    • 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
    • A61K9/141—Intimate 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
    • A61K9/145—Intimate 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
    • 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
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • A61K9/2072—Pills, 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
    • A61K9/2077—Tablets 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)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Aspects of the present application relate to pharmaceutical formulations comprising atorvastatin or pharmaceutically acceptable salts thereof, and glimepiride as active agents, wherein both atorvastatin or pharmaceutically acceptable salts thereof, and glimepiride are in immediate release form.
PCT/IB2012/002860 2011-11-15 2012-11-14 Pharmaceutical formulations comprising atorvastatin and glimepiride Ceased WO2013072770A2 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
IN4119CHN2014 IN2014CN04119A (en) 2011-11-15 2012-11-14
RU2014124118/15A RU2014124118A (en) 2011-11-15 2012-11-14 PHARMACEUTICALS, INCLUDING ATORVASTATIN AND GLIMEPIRIDE
EP12826534.5A EP2779999A2 (en) 2011-11-15 2012-11-14 Pharmaceutical formulations comprising atorvastatin and glimepiride
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 (en) 2013-05-23
WO2013072770A3 true WO2013072770A3 (en) 2013-10-24

Family

ID=48430284

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2012/002860 Ceased WO2013072770A2 (en) 2011-11-15 2012-11-14 Pharmaceutical formulations comprising atorvastatin and glimepiride

Country Status (5)

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

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021236581A1 (en) * 2020-05-18 2021-11-25 Board Of Regents, The University Of Texas System Granules for 3d printing technology
CN112618499B (en) * 2020-12-24 2022-09-30 石药集团欧意药业有限公司 Glimepiride dispersible tablet composition and preparation method thereof

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004110431A1 (en) * 2003-06-12 2004-12-23 Warner-Lambert Company Llc Stable compositions of atorvastatin prepared with wet granulation
WO2007072218A2 (en) * 2005-06-10 2007-06-28 Combino Pharm, S.L. Formulations containing glimepiride and/or its salts
CN101103990A (en) * 2006-07-14 2008-01-16 北京华安佛医药研究中心有限公司 Composition containing sulfonylureas sugar-reducing drug and statins lipid-lowering drug
WO2009140341A2 (en) * 2008-05-13 2009-11-19 Dr. Reddy's Laboratories Ltd. Atorvastatin compositions

Family Cites Families (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2951135A1 (en) 1979-12-19 1981-06-25 Hoechst Ag, 6230 Frankfurt SULFONYL UREAS, METHOD FOR THE PRODUCTION THEREOF, PHARMACEUTICAL PREPARATIONS BASED ON THESE COMPOUNDS AND THEIR USE
DE3320582A1 (en) 1983-06-08 1984-12-13 Dr. Karl Thomae Gmbh, 7950 Biberach METHODS OF PREPARATION WITH GLIQUIDONE AND METHOD FOR THE PRODUCTION THEREOF
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 (en) 1989-07-21 1995-08-25 Warner Lambert Co Process for the preparation of pharmaceutically acceptable [R- (R *, R *)] - 2- (4-fluorophenyl) -, - dihydroxy-5- (1-methylethyl) -3-phenyl-4 - [(phenylamino) carbonyl] -1H- for the preparation of pyrrole-1-heptanoic acid and its pharmaceutically acceptable salts
SG45369A1 (en) 1993-01-19 1998-10-16 Warner Lambert Co Stable oral ci-981 formulation and process of preparing same
DE69634054T2 (en) 1995-07-17 2005-12-08 Warner-Lambert Co. Crystalline (R- (R *, R *)) -2- (4-fluorophenyl) -β, δ-dihydroxy-5- (1-methylethyl) -3-phenyl-4 - ((phenylamino) carbonyl) -1H- Pyrrol-1-heptanecarboxylic acid hemi calcium salt (atorvastatin)
SI20109A (en) 1998-12-16 2000-06-30 LEK, tovarna farmacevtskih in kemi�nih izdelkov, d.d. Stable pharmaceutical formulation
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 (en) 2000-06-09 2001-12-13 Lek Pharmaceuticals D.D. Stable pharmaceutical product and formulation
JP2004501121A (en) 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． Compound having stable pharmaceutical effect and pharmaceutical preparation containing the same
AR030379A1 (en) 2000-08-22 2003-08-20 Novartis Ag COMBINATIONS
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 (en) 2002-05-21 2003-11-21 Bernard Charles Sherman Stable dosage forms comprising atorvastatin calcium
SI21302A (en) 2002-10-11 2004-04-30 LEK farmacevtska dru�ba d.d. Stabilized pharmaceutical product with amorphous active ingredient
US20040147564A1 (en) 2003-01-29 2004-07-29 Rao Vinay U. Combinations of glimepiride and the thiazolidinedione for treatment of diabetes
SI21400A (en) 2003-02-12 2004-08-31 LEK farmacevtska družba d.d. Stable pharmaceutical form with hmg-coa reductase inhibitor
US7655692B2 (en) 2003-06-12 2010-02-02 Pfizer Inc. Process for forming amorphous atorvastatin
WO2006006021A2 (en) 2004-06-28 2006-01-19 Glenmark Pharmaceuticals Limited Stabilized pharmaceutical compositions of preferably a statin
JP2008514722A (en) 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 Amorphous atorvastatin calcium
JP5288791B2 (en) 2005-01-28 2013-09-11 武田薬品工業株式会社 Miniaturized composition containing a hardly water-soluble substance
AU2007300071A1 (en) 2006-09-27 2008-04-03 Dr. Reddy's Laboratories Ltd. Atorvastatin pharmaceutical compositions

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004110431A1 (en) * 2003-06-12 2004-12-23 Warner-Lambert Company Llc Stable compositions of atorvastatin prepared with wet granulation
WO2007072218A2 (en) * 2005-06-10 2007-06-28 Combino Pharm, S.L. Formulations containing glimepiride and/or its salts
CN101103990A (en) * 2006-07-14 2008-01-16 北京华安佛医药研究中心有限公司 Composition containing sulfonylureas sugar-reducing drug and statins lipid-lowering drug
WO2009140341A2 (en) * 2008-05-13 2009-11-19 Dr. Reddy's Laboratories Ltd. Atorvastatin compositions

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 (en) 2015-12-27
WO2013072770A2 (en) 2013-05-23
IN2014CN04119A (en) 2015-07-10
EP2779999A2 (en) 2014-09-24
ZA201403735B (en) 2015-12-23

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