US2009035379A1PendingUtilityA1

Fenofibrate compositions

69
Assignee: CABINET HIRSCHPriority: Jan 17, 1997Filed: Jun 23, 2008Published: Feb 5, 2009
Est. expiryJan 17, 2017(expired)· nominal 20-yr term from priority
Inventors:Andre StammPawan Seth
A61P 3/04A61P 3/06A61P 1/18A61K 9/1617A61K 9/1676A61K 9/2081A61K 9/16A61K 31/216A61K 9/14A61K 9/2077A61K 9/1635A61K 9/2054A61K 9/2027A61K 31/12A61K 31/215A61K 9/1623
69
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Claims

Abstract

The invention provides fenofibrate compositions comprising granulates, where the granulates comprise micronized fenofibrate.

Claims

exact text as granted — not AI-modified
1 .- 15 . (canceled) 
   
   
       16 . A fenofibrate composition comprising granulates, wherein the granulates comprise micronized fenofibrate, inert carrier particles, at least one hydrophilic polymer and at least one disintegrant, wherein the weight ratio of micronized fenofibrate to hydrophilic polymer is between 1:10 and 4:1. 
   
   
       17 . The composition of  claim 16 , wherein the weight ratio of fenofibrate/hydrophilic polymer is between 1/2 and 2/1. 
   
   
       18 . The composition of  claim 16 , wherein the fenofibrate has a size less than 20 μm. 
   
   
       19 . The composition of  claim 16 , wherein the fenofibrate has a size less than 10 μm. 
   
   
       20 . The composition of  claim 16 , wherein the inert carrier particles are inert hydrosoluble carrier particles. 
   
   
       21 . The composition of  claim 16 , wherein the inert carrier particles have a particle size between 50 and 500 microns. 
   
   
       22 . The composition of  claim 16 , wherein the inert carrier particles have a particle size between 100 and 400 microns. 
   
   
       23 . The composition of  claim 16 , wherein the hydrophilic polymer is a polyvinylpyrrolidone, a poly(vinyl alcohol), a hydroxypropylcellulose, a hydroxy-methylcellulose, a hydroxypropylmethylcellulose, a gelatine, or a mixture of two or more thereof. 
   
   
       24 . The composition of  claim 16 , wherein the hydrophilic polymer is a polyvinylpyrrolidone. 
   
   
       25 . The composition of  claim 16 , wherein the at least one disintegrating agent is selected from the group consisting of starch, colloidal silica, cross-linked polyvinyl pyrrolidone and carboxymethyl starch, and a mixture of two or more thereof. 
   
   
       26 . The composition of  claim 16 , wherein the granulates further comprise at least one surfactant. 
   
   
       27 . The composition of  claim 26 , wherein the surfactant is sodium lauryl sulphate, monooleate, monolaurate, monopalmitate, monostearate or another ester of polyoxyethylene sorbitane, sodium dioctylsulfosuccinate, lecithin, stearylic alcohol, cetostearylic alcohol, cholesterol, polyoxyethylene ricine oil, polyoxyethylene fatty acid glycerides, poloxamer, or a mixture of two or more thereof. 
   
   
       28 . The composition of  claim 26 , wherein the surfactant is sodium lauryl sulphate, monooleate, monolaurate, monopalmitate, monostearate or another ester of polyoxyethylene sorbitane, sodium dioctylsulfosuccinate, lecithin, stearylic alcohol, cetostearylic alcohol, cholesterol, polyoxyethylene ricine oil, polyoxyethylene fatty acid glycerides, poloxamer, or a mixture of two or more thereof. 
   
   
       29 . The composition of  claim 26 , wherein the surfactant is sodium lauryl sulphate. 
   
   
       30 . The composition of  claim 26 , wherein the weight ratio of surfactant to hydrophilic polymer is from 1/500 to 1/10. 
   
   
       31 . The composition of  claim 26 , wherein the weight ratio of surfactant to hydrophilic polymer is from 1/100 to 5/100. 
   
   
       32 . The composition of  claim 26 , wherein the granulates comprise, based on the weight of the granules, from 5 to 50% by weight of fenofibrate, from 10 to 75% by weight of carrier, and from 20 to 60% by weight of hydrophilic polymer. 
   
   
       33 . The composition of  claim 26 , wherein the granulates comprise, based on the weight of the granules, from 20 to 45% by weight of fenofibrate, from 20 to 50% by weight of carrier, and from 25 to 45% by weight of hydrophilic polymer. 
   
   
       34 . The composition of  claim 32 , wherein the granulates comprise, based on the weight of the granules, up to 10% by weight of surfactant. 
   
   
       35 . The composition of  claim 33 , wherein the granulates comprise, based on the weight of the granules, from 0.1 to 3% by weight of surfactant. 
   
   
       36 . A fenofibrate composition comprising granulates and at least one disintegrant, wherein the granulates comprise micronized fenofibrate, inert carrier particles and at least one hydrophilic polymer, wherein the weight ratio of micronized fenofibrate to hydrophilic polymer is between 1:10 and 4:1. 
   
   
       37 . The composition of  claim 36 , wherein the weight ratio of fenofibrate/hydrophilic polymer is between 1/2 and 2/1. 
   
   
       38 . The composition of  claim 36 , wherein the fenofibrate has a size less than 20 μm. 
   
   
       39 . The composition of  claim 36 , wherein the fenofibrate has a size less than 10 μm. 
   
   
       40 . The composition of  claim 36 , wherein the inert carrier particles are inert hydrosoluble carrier particles. 
   
   
       41 . The composition of  claim 36 , wherein the inert carrier particles have a particle size between 50 and 500 microns. 
   
   
       42 . The composition of  claim 36 , wherein the inert carrier particles have a particle size between 100 and 400 microns. 
   
   
       43 . The composition of  claim 36 , wherein the hydrophilic polymer is a polyvinylpyrrolidone, a poly(vinyl alcohol), a hydroxypropylcellulose, a hydroxy-methylcellulose, a hydroxypropylmethylcellulose, a gelatine, or a mixture of two or more thereof. 
   
   
       44 . The composition of  claim 36 , wherein the hydrophilic polymer is a polyvinylpyrrolidone. 
   
   
       45 . The composition of  claim 36 , wherein the at least one disintegrating agent is selected from the group consisting of starch, colloidal silica, cross-linked polyvinyl pyrrolidone and carboxymethyl starch, and a mixture of two or more thereof. 
   
   
       46 . The composition of  claim 36 , wherein the granulates further comprise at least one surfactant. 
   
   
       47 . The composition of  claim 36 , wherein the surfactant is sodium lauryl sulphate, monooleate, monolaurate, monopalmitate, monostearate or another ester of polyoxyethylene sorbitane, sodium dioctylsulfosuccinate, lecithin, stearylic alcohol, cetostearylic alcohol, cholesterol, polyoxyethylene ricine oil, polyoxyethylene fatty acid glycerides, poloxamer, or a mixture of two or more thereof. 
   
   
       48 . The composition of  claim 46 , wherein the surfactant is sodium lauryl sulphate, monooleate, monolaurate, monopalmitate, monostearate or another ester of polyoxyethylene sorbitane, sodium dioctylsulfosuccinate, lecithin, stearylic alcohol, cetostearylic alcohol, cholesterol, polyoxyethylene ricine oil, polyoxyethylene fatty acid glycerides, poloxamer, or a mixture of two or more thereof. 
   
   
       49 . The composition of  claim 46 , wherein the surfactant is sodium lauryl sulphate. 
   
   
       50 . The composition of  claim 46 , wherein the weight ratio of surfactant to hydrophilic polymer is from 1/500 to 1/10. 
   
   
       51 . The composition of  claim 46 , wherein the weight ratio of surfactant to hydrophilic polymer is from 1/100 to 5/100. 
   
   
       52 . The composition of  claim 36 , wherein the granulates comprise, based on the weight of the granules, from 5 to 50% by weight of fenofibrate, from 10 to 75% by weight of carrier, and from 20 to 60% by weight of hydrophilic polymer. 
   
   
       53 . The composition of  claim 36 , wherein the granulates comprise, based on the weight of the granules, from 20 to 45% by weight of fenofibrate, from 20 to 50% by weight of carrier, and from 25 to 45% by weight of hydrophilic polymer. 
   
   
       54 . The composition of  claim 52 , wherein the granulates comprise, based on the weight of the granules, up to 10% by weight of surfactant. 
   
   
       55 . The composition of  claim 53 , wherein the granulates comprise, based on the weight of the granules, from 0.1 to 3% by weight of surfactant. 
   
   
       56 - 80 . (canceled) 
   
   
       81 . The composition of  claim 16 , wherein the fenofibrate is in a non-reagglomerated form. 
   
   
       82 . The composition of  claim 36 , wherein the fenofibrate is in a non-reagglomerated form.

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