AR111501A2 - PHARMACEUTICAL COMPOSITION OF PHENOFIBRATE AND METHOD TO PREPARE IT - Google Patents

PHARMACEUTICAL COMPOSITION OF PHENOFIBRATE AND METHOD TO PREPARE IT

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Publication number
AR111501A2
AR111501A2 ARP170101422A ARP170101422A AR111501A2 AR 111501 A2 AR111501 A2 AR 111501A2 AR P170101422 A ARP170101422 A AR P170101422A AR P170101422 A ARP170101422 A AR P170101422A AR 111501 A2 AR111501 A2 AR 111501A2
Authority
AR
Argentina
Prior art keywords
surface stabilizer
fenofibrate
weight
fenofibrate nanoparticles
nanoparticles
Prior art date
Application number
ARP170101422A
Other languages
Spanish (es)
Original Assignee
Alkermes Pharma Ireland Ltd
Fournier Laboratories Ireland 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 Alkermes Pharma Ireland Ltd, Fournier Laboratories Ireland Ltd filed Critical Alkermes Pharma Ireland Ltd
Publication of AR111501A2 publication Critical patent/AR111501A2/en

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  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)

Abstract

Reivindicación 1: Una composición farmacéutica de fenofibrato para administración oral, caracterizada porque comprende: (i) nanopartículas de fenofibrato que tienen un tamaño de partícula efectivo promedio inferior a 300 nm; (ii) un estabilizador de superficie adsorbido sobre la superficie de las nanopartículas de fenofibrato; en donde las nanopartículas de fenofibrato están presentes en una cantidad de 99,5% a 0,001% en peso, basada en el peso combinado total de las nanopartículas de fenofibrato y un estabilizador de superficie; en donde el estabilizador de superficie está presente en una cantidad seleccionada entre 0,5% y 99,999% en peso, basada en el peso seco combinado total de las nanopartículas de fenofibrato y un estabilizador de superficie; en donde el estabilizador de superficie se selecciona entre el grupo que consiste en hipromelosa, docusato sódico, laurilsulfato sódico, hidroxipropilcelulosa SL, un copolímero aleatorio de acetato de vinilo y vinil pirrolidona, y sus combinaciones. Reivindicación 2: La composición de acuerdo con la reivindicación 1, caracterizada porque además comprende: (iii) celulosa microcristalina silicificada; (iv) uno o más agentes de relleno o diluyentes seleccionados entre el grupo que consiste en almidones, lactosa, sacarosa, glucosa, manitol, ácido silícico; (v) crospovidona; y (vi) estearato de magnesio.Claim 1: A pharmaceutical composition of fenofibrate for oral administration, characterized in that it comprises: (i) fenofibrate nanoparticles having an average effective particle size of less than 300 nm; (ii) a surface stabilizer adsorbed on the surface of the fenofibrate nanoparticles; wherein the fenofibrate nanoparticles are present in an amount of 99.5% to 0.001% by weight, based on the total combined weight of the fenofibrate nanoparticles and a surface stabilizer; wherein the surface stabilizer is present in an amount selected between 0.5% and 99.999% by weight, based on the total combined dry weight of the fenofibrate nanoparticles and a surface stabilizer; wherein the surface stabilizer is selected from the group consisting of hypromellose, sodium docusate, sodium lauryl sulfate, hydroxypropylcellulose SL, a random copolymer of vinyl acetate and vinyl pyrrolidone, and combinations thereof. Claim 2: The composition according to claim 1, characterized in that it further comprises: (iii) silicified microcrystalline cellulose; (iv) one or more fillers or diluents selected from the group consisting of starches, lactose, sucrose, glucose, mannitol, silicic acid; (v) crospovidone; and (vi) magnesium stearate.

ARP170101422A 2002-05-24 2017-05-24 PHARMACEUTICAL COMPOSITION OF PHENOFIBRATE AND METHOD TO PREPARE IT AR111501A2 (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US38329402P 2002-05-24 2002-05-24

Publications (1)

Publication Number Publication Date
AR111501A2 true AR111501A2 (en) 2019-07-24

Family

ID=38170635

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP170101422A AR111501A2 (en) 2002-05-24 2017-05-24 PHARMACEUTICAL COMPOSITION OF PHENOFIBRATE AND METHOD TO PREPARE IT

Country Status (2)

Country Link
AR (1) AR111501A2 (en)
ZA (1) ZA200410209B (en)

Also Published As

Publication number Publication date
ZA200410209B (en) 2006-04-26

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