IN2014DN11040A - - Google Patents

Info

Publication number
IN2014DN11040A
IN2014DN11040A IN11040DEN2014A IN2014DN11040A IN 2014DN11040 A IN2014DN11040 A IN 2014DN11040A IN 11040DEN2014 A IN11040DEN2014 A IN 11040DEN2014A IN 2014DN11040 A IN2014DN11040 A IN 2014DN11040A
Authority
IN
India
Prior art keywords
beads
dosage form
particles
comparative
binder
Prior art date
Application number
Inventor
Sarat C Chattaraj
Glenn Allen Redelman
Andrew Alan Shaw
Original Assignee
Mylan Inc
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 Mylan Inc filed Critical Mylan Inc
Publication of IN2014DN11040A publication Critical patent/IN2014DN11040A/en

Links

Classifications

    • 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
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/216—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acids having aromatic rings, e.g. benactizyne, clofibrate
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047—Cellulose ethers containing no ester groups, 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
    • 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

Landscapes

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

Abstract

Various fenofibrate dosage forms contain a plurality of beads or particles where the beads or particles include a pharmaceutical composition comprising fenofibrate; from 0.3% to 10% by weight of the beads or particles of a surfactant; and from about 5% to about 15% by weight of the beads or particles of a water soluble or water dispersible cellulosic binder. The mass ratio of the drug to the binder in the dosage form is between about 3.5:1 and 4.5:1; and the dosage form produces a first Cmax in vivo that is between about 10% and about 50% higher than a comparative Cmax produced by a comparative dosage form. The comparative dosage form comprises the drug and the binder in a ratio of between about 5:1 and 15:1.
IN11040DEN2014 2012-06-25 2012-10-23 IN2014DN11040A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US13/531,955 US8722083B2 (en) 2012-06-25 2012-06-25 Fenofibrate formulation
PCT/US2012/061486 WO2014003810A1 (en) 2012-06-25 2012-10-23 Fenofibrate formulation

Publications (1)

Publication Number Publication Date
IN2014DN11040A true IN2014DN11040A (en) 2015-09-25

Family

ID=49774658

Family Applications (1)

Application Number Title Priority Date Filing Date
IN11040DEN2014 IN2014DN11040A (en) 2012-06-25 2012-10-23

Country Status (7)

Country Link
US (1) US8722083B2 (en)
EP (1) EP2863894B1 (en)
BR (1) BR112014032513B1 (en)
CA (1) CA2878011A1 (en)
ES (1) ES2842500T3 (en)
IN (1) IN2014DN11040A (en)
WO (1) WO2014003810A1 (en)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9439860B2 (en) 2012-06-25 2016-09-13 Mylan, Inc. Fenofibrate formulation

Family Cites Families (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2602423B1 (en) 1986-08-08 1989-05-05 Ethypharm Sa PROCESS FOR THE PREPARATION OF A FENOFIBRATE-BASED MEDICINAL PRODUCT, OBTAINED BY THIS PROCESS
FR2627696B1 (en) 1988-02-26 1991-09-13 Fournier Innovation Synergie NEW GALENIC FORM OF FENOFIBRATE
FR2758459B1 (en) 1997-01-17 1999-05-07 Pharma Pass FENOFIBRATE PHARMACEUTICAL COMPOSITION HAVING HIGH BIODAVAILABILITY AND PROCESS FOR PREPARING THE SAME
US7374779B2 (en) 1999-02-26 2008-05-20 Lipocine, Inc. Pharmaceutical formulations and systems for improved absorption and multistage release of active agents
AU3388400A (en) * 1999-03-02 2000-09-21 Human Genome Sciences, Inc. Human glycosylation enzymes
FR2795961B1 (en) 1999-07-09 2004-05-28 Ethypharm Lab Prod Ethiques PHARMACEUTICAL COMPOSITION CONTAINING MICRONIZED FENOFIBRATE, A SURFACTANT AND A BINDING CELLULOSIC DERIVATIVE AND PREPARATION METHOD
US7863331B2 (en) 1999-07-09 2011-01-04 Ethypharm Pharmaceutical composition containing fenofibrate and method for the preparation thereof
US8586094B2 (en) 2000-09-20 2013-11-19 Jagotec Ag Coated tablets
NZ525306A (en) 2000-09-20 2004-11-26 Skyepharma Canada Inc Spray drying process and compositions of fenofibrate
US20080241070A1 (en) 2000-09-21 2008-10-02 Elan Pharma International Ltd. Fenofibrate dosage forms
NZ552390A (en) 2004-08-06 2010-01-29 Transform Pharmaceuticals Inc Novel fenofibrate formulations and related methods of treatment
CA2597492A1 (en) 2005-02-10 2006-08-17 Lifecycle Pharma A/S A stable pharmaceutical composition comprising a fixed dose combination of fenofibrate and an hmg-coa reductase inhibitor
WO2008014175A2 (en) * 2006-07-28 2008-01-31 Dr. Reddy's Laboratories Ltd. Granular pharmaceutical compositions
WO2008075320A2 (en) * 2006-12-21 2008-06-26 Ranbaxy Laboratories Limited Antilipidemic pharmaceutical compositions and process for preparation thereof
AU2008282900B2 (en) 2007-07-27 2014-05-22 Depomed, Inc. Pulsatile gastric retentive dosage forms
FR2940118B1 (en) 2008-12-24 2013-08-09 Ethypharm Sa PHARMACEUTICAL FORMULATION OF NANONIZED FENOFIBRATE
US20100166857A1 (en) * 2008-12-30 2010-07-01 Dong Yan Pharmaceutical dosage forms and methods of manufacturing same
US20110217369A1 (en) * 2009-09-03 2011-09-08 Ranbaxy Laboratories Limited Fenofibrate compositions
US20110311625A1 (en) 2010-06-14 2011-12-22 Amruth Gowda Doddaveerappa Solid dosage forms of fenofibrate

Also Published As

Publication number Publication date
EP2863894A1 (en) 2015-04-29
ES2842500T3 (en) 2021-07-14
US20130344155A1 (en) 2013-12-26
WO2014003810A1 (en) 2014-01-03
BR112014032513B1 (en) 2020-06-30
CA2878011A1 (en) 2014-01-03
BR112014032513A2 (en) 2017-06-27
US8722083B2 (en) 2014-05-13
EP2863894B1 (en) 2020-10-14
EP2863894A4 (en) 2015-12-16

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