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WO2010131265A1 - Nouvelles compositions pharmaceutiques de fénofibrate de choline - Google Patents

Nouvelles compositions pharmaceutiques de fénofibrate de choline Download PDF

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Publication number
WO2010131265A1
WO2010131265A1 PCT/IN2010/000298 IN2010000298W WO2010131265A1 WO 2010131265 A1 WO2010131265 A1 WO 2010131265A1 IN 2010000298 W IN2010000298 W IN 2010000298W WO 2010131265 A1 WO2010131265 A1 WO 2010131265A1
Authority
WO
WIPO (PCT)
Prior art keywords
choline fenofibrate
controlled release
poly
pharmaceutical composition
fenofibrate
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/IN2010/000298
Other languages
English (en)
Inventor
Raghu Rami Reddy Kasu
Subhasis Das
Vijaya Kumar Thommandru
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.)
Lupin Ltd
Original Assignee
Lupin 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 Lupin Ltd filed Critical Lupin Ltd
Publication of WO2010131265A1 publication Critical patent/WO2010131265A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A61K9/20—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
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/282—Organic compounds, e.g. fats
    • A61K9/2826—Sugars or sugar alcohols, e.g. sucrose; Derivatives thereof
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846—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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release

Definitions

  • the present invention relates to novel solid oral pharmaceutical compositions of choline fenofibrate.
  • the invention also relates to a process for the preparation of said compositions of choline fenofibrate.
  • Fenofibrate is a well-known lipid-regulating agent, which has been commercially available for a long time. Fenofibrate is usually orally administered. After its absorption, which is known to take place in the duodenum and other parts of the gastrointestinal tract, fenofibrate is metabolized in the body to fenofibric acid. Fenofibric acid represents the active ingredient of fenofibrate, which is a prodrug and which is converted in vivo to the active molecule. After oral administration of fenofibrate, fenofibric acid is found in plasma.
  • the fenofibrate products currently on the market involve a formulation comprising a micronized drug substance in capsules and/or tablets. Fenofibrate is known to be nearly insoluble in water.
  • salts of fenofibric acid are highly soluble in water and are more bioavailable as compared to the fenofibrate.
  • Choline fenofibrate is marketed under the brand name Trilipix ⁇ delayed release oral capsules containing 45mg or 135 mg of fenofibric acid.
  • US 2008/0095851 A1 discloses nanoparticulate compositions of fenofibrate salts.
  • US 2008/0152714 A1 discloses modified release formulation comprising an active agent in a hydrophilic polymer matrix.
  • US 2007/0026062 A1 discloses solid dosage form comprising a solid dispersion or solid solution of fibrate.
  • the first object of the present invention provides controlled release pharmaceutical compositions comprising choline fenofibrate wherein the core comprises choline fenofibrate and auxiliary excipient and a coating layer comprising rate controlling agent(s).
  • Yet another object of the invention provides controlled release pharmaceutical compositions comprising choline fenofibrate comprising an immediate release core wherein said core comprises choline fenofibrate, water soluble inert material with one or more auxiliary pharmaceutical excipient and a coating layer comprising rate controlling hydrophobic agents(s).
  • Yet another object of the invention provides controlled release pharmaceutical compositions comprising choline fenofibrate comprising an immediate release core wherein said core comprises choline fenofibrate, water soluble inert material with one or more auxiliary pharmaceutical excipient and a coating layer comprising rate controlling hydrophobic agents(s) and the core is devoid of hydrophilic polymers which are capable of forming a matrix.
  • Yet another object of the invention provides controlled release pharmaceutical compositions comprising choline fenofibrate comprising an immediate release core wherein said core comprises choline fenofibrate, water soluble inert material with one or more auxiliary pharmaceutical excipient and a coating layer comprising rate controlling hydrophobic agents(s) and the core is devoid of any enteric binder.
  • Yet another object of the invention provides controlled release pharmaceutical compositions comprising choline fenofibrate comprising an immediate release core wherein said core comprises choline fenofibrate, water soluble inert material with one or more auxiliary pharmaceutical excipient and a coating layer comprising rate controlling hydrophobic agents(s) and further an additional enteric coating.
  • Yet another object of the invention provides controlled release pharmaceutical compositions comprising choline fenofibrate comprising an immediate release core wherein said core comprises choline fenofibrate, water soluble inert material with one or more auxiliary pharmaceutical excipient and a coating layer comprising rate controlling hydrophobic agents(s) which is bioequivalent to commercially available choline fenofibrate (Trilipix®) formulations.
  • Fig 1 (a) shows a release profile of controlled release dosage forms of choline fenofibrate of example 1 B, in pH 3.5 buffer followed by pH 6.8 Phosphate buffer, 50 rpm, USP Paddle.
  • Fig 1 (b) shows a release profile of controlled release dosage forms of choline fenofibrate of example 1 B, in pH 4.5 buffer followed by pH 6.8 Phosphate buffer, 50 rpm, USP paddle.
  • Fig 1 (c) shows a release profile of controlled release dosage forms of choline fenofibrate of example 1 B, in pH 6.8 buffer, 900 ml, USP paddle, 50 rpm.
  • the dosage forms of the invention typically contain 25 to 200 mg equivalent to fenofibric acid.
  • immediate release core refers to core comprising choline fenofibrate thereof devoid of any release-controlling agent(s).
  • controlled release compositions refers to any composition or dosage form which comprises an active drug and which is formulated to provide a longer duration of pharmacological response after administration of the dosage form than is ordinarily experienced after administration of a corresponding immediate release composition comprising the same drug in the same amount.
  • Controlled release compositions include, inter alia, those compositions described elsewhere as “extended release”, “delayed release”, “sustained release”, “prolonged release”, “programmed release”, “time release” and/or "rate controlled” compositions or dosage forms.
  • the hydrophobic release controlling agents are selected from but are not limited to polyvinyl acetate dispersion, ethyl cellulose, cellulose acetate, cellulose propionate (lower, medium or higher molecular weight), cellulose acetate propionate, cellulose acetate butyrate, cellulose acetate phthalate, cellulose triacetate, poly (methyl methacrylate), poly (ethyl methacrylate), poly (butyl methacrylate), poly (isobutyl methacrylate), and poly (hexyl methacrylate), poly (isodecyl methacrylate), poly (lauryl methacrylate), poly (phenyl methacrylate), poly (methyl acrylate), poly (isopropyl acrylate), poly (isobutyl acrylate), poly (octadecyl acrylate), waxes such as beeswax, carnauba wax, paraffin wax, microcrystalline wax, and.
  • ozokerite fatty alcohols such as cetostearyl alcohol, stearyl alcohol, cetyl alcohol and myristyl alcohol, and fatty acid esters such as glyceryl monostearate; glycerol monooleate, acetylated monoglycerides, tristearin, tripalmitin, cetyl esters wax, glyceryl palmitostearate, glyceryl behenate, and hydrogenated vegetable oils.
  • controlled release pharmaceutical compositions includes a pharmaceutical composition that encompasses one or more individual coated units.
  • the coated units may be a capsule or tablet or may be in form of granules, pellets, minitablets or beads.
  • the compositions of the present invention can also include other materials such as dissolution enhancing agents, binders, diluents, anti-adherents, glidants and lubricants.
  • Diluents may be, for example, any pharmaceutically acceptable, non-toxic diluent. Particular examples include lactose, dextrose, sucrose, maltose, starch, calcium hydrogen phosphate, mannitol and the like.
  • Binders may be, for example, starch, sugars, gums, low molecular weight hydroxypropyl methylcellulose, hydroxypropyl cellulose, hydroxyethyl cellulose or the like.
  • Lubricants may be, for example, talc, magnesium stearate, calcium stearate, stearic acid, sodium stearyl fumarate, sodium benzoate or the like.
  • Antiadherents and Glidants may be, for example, colloidal silicon dioxide, talc or the like.
  • Solid oral dosage forms of the present invention may be prepared by any conventional techniques for example dry granulation, direct compression, wet granulation, and extrusion- spheronization. Wet granulation and extrusion-spheronization are the preferred techniques.
  • choline fenofibrate and other auxiliary pharmaceutical ingredients are granulated with a granulating fluid (e.g., isopropyl alcohol, ethyl alcohol, and water) in a planetary mixer, high shear mixer, or fluidized bed granulator.
  • a granulating fluid e.g., isopropyl alcohol, ethyl alcohol, and water
  • the binder and organic acid solution is prepared in suitable vehicles, both can be mixed. Only binder or mixed solution of binder and organic acid can be used to granulate the powder mass.
  • the wet granules are dried in an oven or fluidized bed dryer, and then sieved through a suitable screen to obtain free flowing granules.
  • the resulting granules are blended with a suitable lubricant and glidant.
  • These granules are compressed into solid dosage from of suitable size. These are further coated with the one or more hydrophobic controlling agent(s) effective for the controlled release
  • choline fenofibrate is geometrically mixed with water soluble inert material.
  • the binder and organic acid solution is prepared in suitable vehicles, both can be mixed. Only binder or mixed solution of binder and organic acid is used to granulate the blend of active material with water insoluble inert material. Then wet mass is extrudated using suitable extruder and spheronized using spheronizer. Pellets or spheroids thus obtained are dried and coated with release controlling hydrophobic controlling agent(s). The so-formed multiple units may be filled into hard shell capsules or compressed into a tablet.
  • the mini tablets can be prepared as per example 1A and can additionally have an enteric coating.
  • Eudragit coating Above ethyl cellulose and PVP coated tablets were coated with Eudragit dispersion to give a 14 % w/w by preparing 20 % w/w dispersion in purified water.
  • the mini tablets can be prepared as per Example 2A and can have an additional enteric coating.
  • Granulation Prepare Starch paste in water and add to the above dry mix under mixing, and continue mixing till granular mass of desired consistency is obtained
  • the mini tablets can be prepared as per example 3A and can have an additional enteric coating.
  • the mini tablets can be prepared as per example 4A and can have an additional enteric coating.
  • the mini tablets were coated with the solution of Ethyl cellulose and Lactose to a desired weight gain.
  • the mini tablets can be prepared as per example 5A and can have an additional enteric coating.
  • bioequivalent as used herein is intended to illustrate bioequivalence of the compositions of the present invention in comparison to the reference composition.
  • Bioequivalence studies are conducted to demonstrate equivalence in the bioavailability of the active ingredient in different formulations.
  • Bioequivalence study involves statistical analysis for pharmacokinetic measures, such as area under the curve (AUC) and peak concentration (Cmax) for a test (T) and reference (R) drug product, where T and R can vary, depending on the comparison to be performed (e.g., to-be-marketed dosage form versus clinical trial material, generic drug versus reference listed drug, drug product changed after approval versus drug product before the change).
  • AUC area under the curve
  • Cmax peak concentration
  • Bioequivalence comparisons normally rely on (1) a criterion, (2) a confidence interval for the criterion, and (3) a predetermined bioequivalence limit.
  • bioequivalence involves the calculation of a 90% confidence interval for the ratio of the averages of the measures for the T and R products.
  • the calculated confidence interval should fall within a limit of 80-125% for the ratio of the product averages.
  • a bioequivalence limit of 80 to 125% for the ratio of the product averages has been adopted for use of a bioequivalence criterion.
  • the bioequivalence limit of 80 to 125% is based on a clinical judgment that a test product with bioavailability measures outside this range should be denied market access.
  • Example 1A of the present invention was compared with the bioavailability of the reference product (Trilipix 145 mg Capsule, Abbott) on 10 and 12 healthy subjects in standard fasting and fed conditions respectively.
  • AUC- Area under the plasma concentration vs. time curve from 0 hours to infinity

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Emergency Medicine (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)

Abstract

L'invention porte sur une ou plusieurs compositions pharmaceutiques à libération contrôlée comprenant du fénofibrate de choline, dans lesquelles le cœur comprend du fénofibrate de choline et un excipient auxiliaire et une couche d'enrobage comprend un ou plusieurs agents régissant la vitesse de libération ; une ou plusieurs compositions pharmaceutiques à libération contrôlée comprenant du fénofibrate de choline comprenant un cœur à libération immédiate, ledit cœur comprenant du fénofibrate de choline, une matière inerte hydrosoluble avec un ou plusieurs excipients pharmaceutiques auxiliaires, et une couche d'enrobage comprenant un ou plusieurs agents hydrophobes régissant la vitesse de libération ; une ou plusieurs compositions pharmaceutiques à libération contrôlée comprenant du fénofibrate de choline, comprenant un cœur à libération immédiate, ledit cœur comprenant du fénofibrate de choline, une matière inerte hydrosoluble avec un ou plusieurs excipients pharmaceutiques auxiliaires, et une couche d'enrobage comprenant un ou plusieurs agents hydrophobes régissant la vitesse de libération ; qui sont biologiquement équivalentes aux formulations de fénofibrate de choline (Trilipix®) disponibles dans le commerce.
PCT/IN2010/000298 2009-05-11 2010-05-10 Nouvelles compositions pharmaceutiques de fénofibrate de choline Ceased WO2010131265A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN724/KOL/2009 2009-05-11
IN724KO2009 2009-05-11

Publications (1)

Publication Number Publication Date
WO2010131265A1 true WO2010131265A1 (fr) 2010-11-18

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PCT/IN2010/000298 Ceased WO2010131265A1 (fr) 2009-05-11 2010-05-10 Nouvelles compositions pharmaceutiques de fénofibrate de choline

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TR (1) TR201111143T1 (fr)
WO (1) WO2010131265A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104473909A (zh) * 2014-11-21 2015-04-01 哈尔滨圣吉药业股份有限公司 一种非诺贝酸胆碱缓释微丸及其制备方法
CN105748445A (zh) * 2016-03-31 2016-07-13 武汉药谷生物工程有限公司 一种非诺贝酸胆碱缓释胶囊的制备方法

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040058009A1 (en) * 2002-05-24 2004-03-25 Elan Pharma International, Ltd. Nanoparticulate fibrate formulations
WO2006135480A2 (fr) * 2005-04-08 2006-12-21 Abbott Laboratories Formulations pharmaceutiques
US20080051411A1 (en) * 2002-12-17 2008-02-28 Cink Russell D Salts of Fenofibric Acid and Pharmaceutical Formulations Thereof
US20080152714A1 (en) * 2005-04-08 2008-06-26 Yi Gao Pharmaceutical Formulations
WO2009057138A2 (fr) * 2007-10-29 2009-05-07 Lupin Limited Compositions pharmaceutiques à libération régulée de toltérodine

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040058009A1 (en) * 2002-05-24 2004-03-25 Elan Pharma International, Ltd. Nanoparticulate fibrate formulations
US20080051411A1 (en) * 2002-12-17 2008-02-28 Cink Russell D Salts of Fenofibric Acid and Pharmaceutical Formulations Thereof
WO2006135480A2 (fr) * 2005-04-08 2006-12-21 Abbott Laboratories Formulations pharmaceutiques
US20080152714A1 (en) * 2005-04-08 2008-06-26 Yi Gao Pharmaceutical Formulations
WO2009057138A2 (fr) * 2007-10-29 2009-05-07 Lupin Limited Compositions pharmaceutiques à libération régulée de toltérodine

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104473909A (zh) * 2014-11-21 2015-04-01 哈尔滨圣吉药业股份有限公司 一种非诺贝酸胆碱缓释微丸及其制备方法
CN105748445A (zh) * 2016-03-31 2016-07-13 武汉药谷生物工程有限公司 一种非诺贝酸胆碱缓释胶囊的制备方法

Also Published As

Publication number Publication date
TR201111143T1 (tr) 2012-05-21

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