EP1553928A1 - Compositions pharmaceutiques de fenofibrate par voie orale a biodisponibilite elevee - Google Patents

Compositions pharmaceutiques de fenofibrate par voie orale a biodisponibilite elevee

Info

Publication number
EP1553928A1
EP1553928A1 EP03798327A EP03798327A EP1553928A1 EP 1553928 A1 EP1553928 A1 EP 1553928A1 EP 03798327 A EP03798327 A EP 03798327A EP 03798327 A EP03798327 A EP 03798327A EP 1553928 A1 EP1553928 A1 EP 1553928A1
Authority
EP
European Patent Office
Prior art keywords
composition
minutes
fenofibrate
hydro
micronized
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.)
Withdrawn
Application number
EP03798327A
Other languages
German (de)
English (en)
Inventor
Gowri Shankar Miriyala
Ajay Kumar Singla
Rajiv Malik
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.)
Roy Sunilendu Bhushan
Ranbaxy Laboratories Ltd
Original Assignee
Roy Sunilendu Bhushan
Ranbaxy 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 Roy Sunilendu Bhushan, Ranbaxy Laboratories Ltd filed Critical Roy Sunilendu Bhushan
Publication of EP1553928A1 publication Critical patent/EP1553928A1/fr
Withdrawn legal-status Critical Current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
    • A61K9/2004—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
    • 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
    • A61K9/2004—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

Definitions

  • the present invention relates to oral pharmaceutical compositions of fenofibrate having high bioavailability with improved dissolution and methods for preparing the pharmaceutical compositions.
  • Fenofibrate 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1- methylethyl ester, belongs to the family of fibrates or fibric acid derivatives. It is commercially available as oral capsules containing micronized fenofibrate in the strengths of 67 mg, 134 mg and 200 mg. Fenofibrate is indicated as an adjunctive therapy to diet for the treatment for adult patients with very high elevations of serum triglyceride levels who are at risk of pancreatitis and who do not respond adequately to dietary control. It is particularly useful for the treatment of adult endogenous hyperlipidemia, hypercholesterolemia and hypertriglyceridemia.
  • Fenofibrate is practically insoluble in water and exhibits a low rate of dissolution in aqueous media that results in inadequate bioavailability after oral ingestion. This low rate of dissolution of fenofibrate in aqueous media also is found in gastrointestinal fluids.
  • Several methods of increasing the rate of dissolution of drugs having low solubility in water and other aqueous media have been disclosed in the prior art.
  • U.S. Patent No. 4,895,726 discloses a fenofibrate composition in which fenofibrate is co-micronized with a surfactant to improve the solubility of the fenofibrate.
  • This patent emphasizes that co-micronizing fenofibrate with a solid surfactant improves fenofibrate bioavailability to a much greater extent than either by adding a surfactant to micronized fenofibrate or intimately mixing fenofibrate and surfactant, micronized separately.
  • U.S. Patent No. 6,277,405 discloses an immediate release fenofibrate composition that includes an inert hydro-soluble carrier covered with at least one layer containing fenofibrate in a micronized from having a particle size less than 20 ⁇ m, a hydrophilic polymer, and an optional surfactant.
  • an immediate release fenofibrate composition comprising an inert hydro-insoluble carrier with at least one layer containing fenofibrate in a micronized form, a hydrophilic polymer and a surfactant; and optionally one or several outer phases or layers.
  • an oral pharmaceutical composition of fenofibrate that includes an inert hydro-insoluble carrier having one or more one layers that include fenofibrate in a micronized form, one or more hydrophilic polymers, and one or more surfactants.
  • Embodiments of the composition may include one or more of the following features.
  • the composition may further include two or more outer phases or layers.
  • the two or more outer phases or layers may include one or more of fenofibrate in a micronized form, one or more hydrophilic polymers, and one or more surfactants.
  • the composition may have a dissolution of at least about 10% in about 5 minutes, about 20% in about 10 minutes, about 50% in about 20 minutes, and about 75% in about 30 minutes, as measured using the rotating blade method at 75 rpm according to the European Pharmacopoeia in a dissolution medium constituted by water with 2% by weight of Polysorbate 80 or with 0.025M sodium lauryl sulphate.
  • the micronized fenofibrate may have a size less than or equal to about 20 microns, and more particularly, less than or equal to about 10 microns.
  • the micronized fenofibrate may be present in an amount of from about 20% w/w to about 45% w/w of the composition.
  • the hydro-insoluble carrier may be one or more of microcrystalline cellulose, dicalcium phosphate and pregelatinized starch.
  • the hydro-insoluble carrier may be present in an amount of from about 20% w/w to about 60% w/w of the composition.
  • the hydrophilic polymer may be one or more of polyvinyl pyrrolidone, hydroxy propyl cellulose, hydroxypropyl methylcellulose, polyvinyl alcohol, and gelatin.
  • the hydrophilic polymer may be present in an amount of from about 10% w/w to about 45% w/w of the composition.
  • the surfactant may be one or more of sodium lauryl sulphate, monoleate, monolaurate, monopalmitate, monostearate or other esters of polyoxyethylene sorbitan, polyethylene glycol laurate, lecithins, propylene glycol alginate, bile acids, phospholipids, and propylene glycol laurate.
  • the surfactant may be present in an amount of from about 0.5%) w/w to about 3.0% w/w of the composition.
  • the composition may further include one or more pharmaceutically acceptable excipients that include disintegrants, binders, fillers, glidants, lubricants, colorants, wetting agents, buffers, and coatings.
  • the disintegrant may be one or more of croscarmellose sodium, cross-linked polyvinyl pyrrolidone and sodium starch glycolate.
  • the filler may be one or more of microcrystalline cellulose, lactose, starch, and cross-linked polyvinyl pyrrolidone.
  • the binder may be one or more of hydroxypropyl methylcellulose, hydroxypropyl cellulose, gelatin, and polyvinyl pyrrolidone.
  • the glidant may be one or more of starch, talc, stearates, and colloidal silicon dioxide.
  • the lubricant may be one or more of stearic acid, talc, sodium stearyl fumarate, mineral oil, and magnesium stearate.
  • the composition may be in the form of one or more of granules, tablets, capsules, dry syrup, suspension, and sachets.
  • the composition may further include one or more of simvastatin, lovastatin, atorvastatin, pravastatin, fluvastatin, cerivastatin, rosuvastatin, metformin, niacin, folic acid, and losartan.
  • the fenofibrate and the one or more active ingredients may be combined in a single pharmaceutical composition.
  • an oral pharmaceutical composition includes from about
  • Embodiments of the composition may include one or more of the features described above or the following features.
  • the micronized fenofibrate may have a size less than or equal to about 20 microns.
  • the hydro-insoluble carrier may be one or more of microcrystalline cellulose, dicalcium phosphate and pregelatinized starch.
  • the hydrophilic polymer may be one or more of polyvinyl pyrrolidone, hydroxy propyl cellulose, hydroxypropyl methylcellulose, polyvinyl alcohol and gelatin.
  • the surfactant may be one or more of sodium lauryl sulphate, monoleate, monolaurate, monopalmitate, monostearate or other esters of polyoxyethylene sorbitan, polyethylene glycol laurate, lecithins, propylene glycol alginate, bile acids, phospholipids and propylene glycol laurate.
  • the composition may further include one or more of simvastatin, lovastatin, atorvastatin, pravastatin, fluvastatin, cerivastatin, rosuvastatin, metformin, niacin, folic acid and losartan.
  • the composition may have a dissolution of at least about 10% in about 5 minutes, about 20% in about 10 minutes, about 50% in about 20 minutes, and about 75% in about 30 minutes, as measured using the rotating blade method at 75 rpm according to the European Pharmacopoeia in a dissolution medium constituted by water with 2% by weight of Polysorbate 80 or with 0.025M sodium lauryl sulphate.
  • a process for preparing a pharmaceutical composition of fenofibrate having an improved dissolution profile includes mixing micronized fenofibrate, one or more hydrophilic polymers and one or more surfactants to obtain a solution or dispersion, and layering the solution or dispersion onto a hydro-insoluble carrier to obtain granulates.
  • Embodiments of the process may include one or more of the features described above or the following features.
  • the process may further include mixing the granulates with one or more pharmaceutically acceptable excipients selected from the group that includes one or more of fillers, binders, disintegrants, lubricants, glidants, colorants, lubricants, wetting agents, buffers, and flavoring agents to obtain a mixture.
  • one or more pharmaceutically acceptable excipients selected from the group that includes one or more of fillers, binders, disintegrants, lubricants, glidants, colorants, lubricants, wetting agents, buffers, and flavoring agents to obtain a mixture.
  • the process may further include processing the granulates to obtain the pharmaceutical composition, wherein the pharmaceutical composition has a dissolution profile of at least about 10% in about 5 minutes, about 20% in about 10 minutes, about 50% in about 20 minutes and about 75% in about 30 minutes, as measured using the rotating blade method at 75 rpm according to the European Pharmacopoeia in a dissolution medium constituted by water with 2% by weight of Polysorbate 80 or with 0.025M sodium lauryl sulphate.
  • the process may further include processing the mixture to obtain the pharmaceutical composition, wherein the pharmaceutical composition has a dissolution profile of at least about 10% in about 5 minutes, about 20% in about 10 minutes, about 50% in about 20 minutes and about 75% in about 30 minutes, as measured using the rotating blade method at 75 rpm according to the European Pharmacopoeia in a dissolution medium constituted by water with 2% by weight of Polysorbate 80 or with 0.025M sodium lauryl sulphate.
  • the micronized fenofibrate may have a size less than or equal to about 20 microns, and may be present in an amount of from about 20% w/w to about 45% w/w of the composition.
  • the hydro-insoluble carrier may be selected from the group that includes one or more of microcrystalline cellulose, dicalcium phosphate and pregelatinized starch, and may be present in an amount of from about 20% w/w to about 60% w/w of the composition.
  • the hydrophilic polymer may be selected from the group that includes one or more of polyvinyl pyrrolidone, hydroxy propyl cellulose, hydroxypropyl methylcellulose, polyvinyl alcohol and gelatin, and may be present in an amount of from about 10% w/w to about 45% w/w of the composition.
  • the surfactant may be selected from the group that includes of one or more of sodium lauryl sulphate, monoleate, monolaurate, monopalmitate, monostearate or other esters of polyoxyethylene sorbitan, polyethylene glycol laurate, lecithins, propylene glycol alginate, bile acids, phospholipids, and propylene glycol laurate.
  • the surfactant may be present in an amount of from about 0.5% w/w to about 3.0% w/w of the composition.
  • composition may be processed to be in the form of one or more of granules, tablets, capsules, dry syrup, suspensions or sachets.
  • the process may further include adding one or more of simvastatin, lovastatin, atorvastatin, pravastatin, fluvastatin, cerivastatin, rosuvastatin, metformin, niacin, folic acid and losartan.
  • a method of treating one or more of hyperlipidemia, hypercholesterolemia and hypertriglyceridemia including administering an oral pharmaceutical composition of fenofibrate that includes an inert hydro- insoluble carrier with at least one layer containing fenofibrate in a micronized form, one or more hydrophilic polymers and one or more surfactants.
  • Embodiments of the treatment method may include one or more of the features described above or the following features.
  • the composition may further include one or more outer phases or layers.
  • the two or more outer phases or layers may include one or more of fenofibrate in a micronized form, a hydrophilic polymer, and a surfactant.
  • the micronized fenofibrate may have a size less than or equal to about 20 microns, and may be present in an amount of from about 20% w/w to about 45% w/w of the composition.
  • the hydro-insoluble carrier may be one or more of microcrystalline cellulose, dicalcium phosphate and pregelatinized starch, and may be present in an amount of from about 20% w/w to about 60% w/w of the composition.
  • the hydrophilic polymer may be one or more of polyvinyl pyrrolidone, hydroxy propyl cellulose, hydroxypropyl methylcellulose, polyvinyl alcohol, and gelatin, and may be present in an amount of from about 10% w/w to about 45% w/w of the composition.
  • the surfactant may be one or more of sodium lauryl sulphate, monoleate, monolaurate, monopalmitate, monostearate or other esters of polyoxyethylene sorbitan, polyethylene glycol laurate, lecithins, propylene glycol alginate, bile acids, phospholipids, and propylene glycol laurate.
  • the surfactant may be present in an amount of from about 0.5% w/w to about 3.0% w/w of the composition.
  • the composition may have a dissolution profile of at least about 10% in about 5 minutes, about 20% in about 10 minutes, about 50% in about 20 minutes and about 75% in about 30 minutes, as measured using the rotating blade method at 75 rpm according to the European Pharmacopoeia in a dissolution medium constituted by water with 2% by weight of Polysorbate 80 or with 0.025M sodium lauryl sulphate.
  • Drug efficacy depends in part upon its bioavailability (i.e., absorption into the systemic circulation) to the patient to whom the drug is administered.
  • bioavailability i.e., absorption into the systemic circulation
  • increased wettability upon exposure to biological fluids can be an objective for those formulating and manufacturing these agents.
  • Fenofibrate is practically insoluble in water. This insolubility characteristic causes fenofibrate to exhibit a low rate of dissolution in aqueous media, e.g., gastrointestinal fluids, which results in inadequate bioavailability after oral ingestion.
  • Micronized fenofibrate as described herein relates to fenofibrate particles having a mean particle size of less than about 20 ⁇ m. Particularly, the mean particle size is less than about 10 ⁇ m.
  • the compositions generally include from about 20% to about 45% by weight of micronized fenofibrate.
  • Size reduction, or micronization may be carried out using any of the conventionally known mills, such as a ball mill, air jet mill, impact mill, etc.
  • Air jet milling is particularly well suited for this application as it is a well proven technique that consistently produces particles of a size less than about 20 microns.
  • Primary advantages of air jet milling are that the predominant particle size reduction occurs through particle to particle collisions, there is limited particle size reduction that results from metal to product contact, and there is no generation of heat that can adversely affect the particles being micronized.
  • inert hydro-insoluble carrier means any pharmaceutically acceptable excipient that is water insoluble and inert.
  • inert, water insoluble carriers include, but are not limited to, microcrystalline cellulose, dicalcium phosphate, partially pregelatinized starch, and other suitable synthetic and organic polymers.
  • the hydro-insoluble carrier may be present in an amount from about 20% w/w to about 60% w/w of the total weight of the pharmaceutical composition.
  • hydrophilic polymer should be taken to mean any high molecular weight substance having sufficient affinity towards water.
  • examples of such polymers include but are not limited to hydroxymethyl cellulose, hydroxypropyl methylcellulose, hydroxypropyl cellulose, polyvinyl pyrrolidone, polyvinyl alcohol, gelatin and their mixtures.
  • the hydrophilic polymer may be present in an amount from about 10% w/w to about 45% w/w of the total weight of the pharmaceutical composition.
  • a surfactant according to this invention may be amphoteric, non-ionic, cationic, or anionic.
  • surfactants include but are not limited to sodium lauryl sulphate, monoleate, monolaurate, monopalmitate, monostearate or other esters of polyoxyethylene sorbitan, polyethylene glycol laurate, lecithins, propylene glycol alginate, bile acids, phospholipids, propylene glycol laurate, etc. Mixtures of surfactants are also suitable.
  • the surfactant may be present in an amount from about 0.5% w/w to about 3% w/w by weight of the total weight of the pharmaceutical composition.
  • One suitable process for making the improved bioavailability dosage form includes spraying a suspension of the active ingredient in micronized form and a hydrophilic polymer onto a hydro-insoluble carrier resulting in a pharmaceutical composition of the active ingredient (e.g., fenofibrate) with an improved dissolution profile.
  • a pharmaceutical composition of the active ingredient e.g., fenofibrate
  • compositions having improved bioavailability additionally may contain other excipients that are used in the pharmaceutical and chemical fields and are compatible with the active ingredient (e.g., fenofibrate), such as disintegrants, glidants, lubricants, binders, fillers, pigments, wetting agents, buffers, etc.
  • disintegrants used in the compositions include but are not limited to those known in the art, such as croscarmellose sodium, cross-linked polyvinyl pyrrolidone, sodium starch glycolate, and mixtures thereof.
  • glidants used in the compositions include but are not limited to those known in the art, such as starch, talc, stearates, colloidal silica, and mixtures thereof.
  • lubricants used in the compositions include but are not limited to those known in the art, such as stearic acid, talc, magnesium stearate, sodium stearyl fumarate, mineral oil and the like, and mixtures thereof.
  • binders used in the compositions include but are not limited to those known in the art, such as hydroxypropyl methylcellulose, hydroxypropyl cellulose, gelatin, polyvinyl pyrrolidone and the like, and mixtures thereof.
  • fillers used in the compositions include but are not limited to those known in the art, such as microcrystalline cellulose, lactose, starch, cross-linked polyvinyl pyrrolidone, etc., and mixtures thereof.
  • compositions in accordance with the present inventions may be filled into capsules, formulated as dry syrups, suspensions or mixed with other pharmaceutically acceptable excipients and compressed into tablets.
  • the tablets may further be coated.
  • film forming polymers examples include but are not limited to those known in the art, such as cellulose derivatives (hydroxypropyl methylcellulose, hydroxyethylcellulose, hydroxypropyl cellulose and their derivatives), acrylic and methacrylic copolymers of different molecular weights, and mixtures thereof.
  • compositions generally include, based on the total composition weight, an inert hydro-insoluble carrier representing about 20% to about 60% by weight, micronized fenofibrate representing from about 20% to about 45% by weight, one or more hydrophilic polymers representing from about 10% to about 45% by weight, and one or more surfactants representing about 0.5% to about 3% by weight.
  • a process for preparing a pharmaceutical composition of fenofibrate with improved dissolution profile includes the following steps: a. mixing micronized fenofibrate, one or more hydrophilic polymers, and one or more surfactants to obtain a solution or dispersion; b. layering the solution or dispersion onto a hydro-insoluble carrier to obtain granulates; c. mixing the granulates with one or more pharmaceutically acceptable excipients selected from the group that includes fillers, binders, disintegrants, lubricants, glidants, colorants and flavoring agents to obtain a mixture; and d.
  • a pharmaceutical composition having a dissolution profile of at least about 10% in 5 minutes, about 20% in 10 minutes, about 50% in 20 minutes and about 75% in 30 minutes, as measured using the rotating blade method at 75 rpm according to European Pharmacopoeia in a dissolution medium constituted by water with 2% by weight of Polysorbate 80 or with 0.025M sodium lauryl sulphate.
  • the oral pharmaceutical compositions of fenofibrate described herein may be used for the treatment of hyperlipidemia, hypercholesterolemia, and/or hypertriglyceridemia.
  • the pharmaceutical compositions may further include one or more of simvastatin, lovastatin, atorvastatin, pravastatin, fluvastatin, cerivastatin, rosuvastatin, metformin, niacin, folic acid and losartan.
  • the fenofibrate and the one or more of the active ingredients may be combined in a single pharmaceutical composition.
  • the corresponding release profiles are provided in Table 1.
  • Table 1 Release profile of tablets prepared according to Example 1 and Fournier's marketed tablets (II) in 1000 ml water/rotating blade method (European Pharmacopoeia)/37°C/75 rpm
  • a fenofibrate (micronized) suspension was prepared in a similar way to that of Example 1 and sprayed onto microcrystalline cellulose powder in Glatt process technology using bottom spray to form a granulate.
  • the granulate thus prepared was mixed with a cross- linked polyvinyl pyrrolidone, colloidal silicon dioxide and sodium stearyl fumarate and compressed to form tablets. These tablets were film coated.
  • the tablets of this example were subjected to dissolution studies using the rotating blade method at 50 rpm according to European Pharmacopoeia in a dissolution medium constituted by 1000 ml water containing 0.025M sodium lauryl sulphate at 37°C. The results are provided in Table 2.
  • Table 2 Release profile of tablets prepared according to Example 2 in 1000 ml water/rotating blade method (European Pharmacopoeia)/37°C/50 rpm

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Emergency Medicine (AREA)
  • Medicinal Preparation (AREA)

Abstract

L'invention concerne des compositions pharmaceutiques de fénofibrate par voie orale à biodisponibilité élevée, qui présentent une dissolution améliorée, et des procédés d'élaboration correspondants. Ce type de composition comprend un vecteur inerte non hydrosoluble à une ou plusieurs couches renfermant du fénofibrate sous forme micronisée, un ou plusieurs polymères hydrophiles, et un ou plusieurs tensioactifs. Ladite composition peut présenter un profil de dissolution d'au moins environ 10 % en environ 5 minutes, d'environ 20 % en environ 10 minutes, d'environ 50 % en environ 20 minutes et d'environ 75 % en environ 30 minutes, ce profil étant mesuré selon la technique de la lame rotative à 75 tours/minute (norme de la Pharmacopée européenne), dans un milieu de dissolution constitué d'eau, avec 2 % en poids de polysorbate 80 ou 0,025M de sulfate sodique de lauryle.
EP03798327A 2002-09-24 2003-09-24 Compositions pharmaceutiques de fenofibrate par voie orale a biodisponibilite elevee Withdrawn EP1553928A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
INDE09612002 2002-09-24
IN961DE2002 2002-09-24
PCT/IB2003/004162 WO2004028506A1 (fr) 2002-09-24 2003-09-24 Compositions pharmaceutiques de fenofibrate par voie orale a biodisponibilite elevee

Publications (1)

Publication Number Publication Date
EP1553928A1 true EP1553928A1 (fr) 2005-07-20

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EP03798327A Withdrawn EP1553928A1 (fr) 2002-09-24 2003-09-24 Compositions pharmaceutiques de fenofibrate par voie orale a biodisponibilite elevee

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EP (1) EP1553928A1 (fr)
AU (1) AU2003263480A1 (fr)
WO (1) WO2004028506A1 (fr)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006060817A1 (fr) * 2004-12-03 2006-06-08 Abbott Laboratories Compositions pharmaceutiques
WO2008075320A2 (fr) * 2006-12-21 2008-06-26 Ranbaxy Laboratories Limited Compositions pharmaceutiques antilipidémiques et leur procédé de préparation
US20110097414A1 (en) * 2007-02-26 2011-04-28 Sandal Roshan Lal Pharmaceutical compositions comprising adsorbate of fenofibrate
EP2842547A1 (fr) 2013-08-27 2015-03-04 Freund Pharmatec Ltd. Compositions de fénofibrate améliorées
EP2878311A1 (fr) 2013-11-27 2015-06-03 Freund Pharmatec Ltd. Amélioration de la solubilité de médicaments hydrophobes
CN109481437B (zh) * 2017-09-13 2020-12-18 北京福元医药股份有限公司 一种氯沙坦钾药物制剂

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FR2494112B1 (fr) * 1980-11-19 1986-01-10 Laruelle Claude
FR2758459B1 (fr) * 1997-01-17 1999-05-07 Pharma Pass Composition pharmaceutique de fenofibrate presentant une biodisponibilite elevee et son procede de preparation
FR2783421B1 (fr) * 1998-09-17 2000-11-24 Cll Pharma Procede de preparation de nouvelles formulations galeniques du fenofibrate, formulations galeniques obtenues par ledit procede et leurs applications
FR2795961B1 (fr) * 1999-07-09 2004-05-28 Ethypharm Lab Prod Ethiques Composition pharmaceutique contenant du fenofibrate micronise, un tensioactif et un derive cellulosique liant et procede de preparation
US6531158B1 (en) * 2000-08-09 2003-03-11 Impax Laboratories, Inc. Drug delivery system for enhanced bioavailability of hydrophobic active ingredients
FR2819720B1 (fr) * 2001-01-22 2004-03-12 Fournier Lab Sa Nouveaux comprimes de fenofibrate
EP2087882A1 (fr) * 2002-03-26 2009-08-12 Teva Pharmaceutical Industries Ltd. Microparticules de médicament

Non-Patent Citations (1)

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Title
See references of WO2004028506A1 *

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AU2003263480A1 (en) 2004-04-19
AU2003263480A8 (en) 2004-04-19

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