US2004057998A1PendingUtilityA1

Fenofibrate compositions

60
Priority: Jan 17, 1997Filed: Sep 22, 2003Published: Mar 25, 2004
Est. expiryJan 17, 2017(expired)· nominal 20-yr term from priority
Inventors:Andre StammPawan Seth
A61P 3/04A61P 3/06A61P 1/18A61K 9/2027A61K 31/215A61K 9/1623A61K 9/1635A61K 9/1617A61K 9/1676A61K 9/2081A61K 9/2077A61K 9/14A61K 9/2054A61K 31/12A61K 31/216A61K 9/16
60
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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
What is claimed is:  
     
         1 . A fenofibrate composition comprising granulates, wherein the granulates comprise micronized fenofibrate, inert carrier particles, at least one hydrophilic polymer and at least one surfactant, wherein the weight ratio of micronized fenofibrate to hydrophilic polymer is between 1:10 and 4:1.  
     
     
         2 . The composition of  claim 1 , wherein the weight ratio of fenofibrate/hydrophilic polymer is between 1/2 and 2/1.  
     
     
         3 . The composition of  claim 1 , wherein the fenofibrate has a size less than 20 μm.  
     
     
         4 . The composition of  claim 1 , wherein the fenofibrate has a size less than 10 μm.  
     
     
         5 . The composition of  claim 1 , wherein the inert carrier particles are inert hydrosoluble carrier particles.  
     
     
         6 . The composition of  claim 1 , wherein the inert carrier particles have a particle size between 50 and 500 microns.  
     
     
         7 . The composition of  claim 1 , wherein the inert carrier particles have a particle size between 100 and 400 microns.  
     
     
         8 . The composition of  claim 1 , wherein the hydrophilic polymer is a polyvinylpyrrolidone, a poly(vinyl alcohol), a hydroxypropylcellulose, a hydroxy-methylcellulose, a hydroxypropylmethylcellulose, a gelatin, or a mixture of two or more thereof.  
     
     
         9 . The composition of  claim 1 , wherein the hydrophilic polymer is a polyvinylpyrrolidone.  
     
     
         10 . The composition of  claim 1 , wherein the surfactant is sodium lauryl sulfate, monooleate, monolaurate, monopalmitate, monostearate or another ester of polyoxyethylene sorbitane, sodium dioctylsulfosuccinate, lecithin, stearylic alcohol, cetostearylic alcohol, cholesterol, polyoxyethylene ricin oil, polyoxyethylene fatty acid glycerides, poloxamer, or a mixture of two or more thereof.  
     
     
         11 . The composition of  claim 1 , wherein the surfactant is sodium lauryl sulfate.  
     
     
         12 . The composition of  claim 1 , wherein the weight ratio of surfactant to hydrophilic polymer is from 1/500 to 1/10.  
     
     
         13 . The composition of  claim 1 , wherein the weight ratio of surfactant to hydrophilic polymer is from 1/100 to 5/100.  
     
     
         14 . The composition of  claim 1 , 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, from 20 to 60% by weight of hydrophilic polymer, and up to 10% by weight of surfactant.  
     
     
         15 . The composition of  claim 1 , 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, from 25 to 45% by weight of hydrophilic polymer, and from 0.1 to 3% by weight of surfactant.  
     
     
         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 gelatin, 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 sulfate, monooleate, monolaurate, monopalmitate, monostearate or another ester of polyoxyethylene sorbitane, sodium dioctylsulfosuccinate, lecithin, stearylic alcohol, cetostearylic alcohol, cholesterol, polyoxyethylene ricin 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 sulfate, monooleate, monolaurate, monopalmitate, monostearate or another ester of polyoxyethylene sorbitane, sodium dioctylsulfosuccinate, lecithin, stearylic alcohol, cetostearylic alcohol, cholesterol, polyoxyethylene ricin 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 sulfate.  
     
     
         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 16 , 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 16 , 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 gelatin, 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 sulfate, monooleate, monolaurate, monopalmitate, monostearate or another ester of polyoxyethylene sorbitane, sodium dioctylsulfosuccinate, lecithin, stearylic alcohol, cetostearylic alcohol, cholesterol, polyoxyethylene ricin 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 sulfate, monooleate, monolaurate, monopalmitate, monostearate or another ester of polyoxyethylene sorbitane, sodium dioctylsulfosuccinate, lecithin, stearylic alcohol, cetostearylic alcohol, cholesterol, polyoxyethylene ricin 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 sulfate.  
     
     
         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 . A fenofibrate composition comprising granulates, wherein the granulates comprise micronized fenofibrate, inert carrier particles, at least one hydrophilic polymer, at least one surfactant, wherein the weight ratio of micronized fenofibrate to hydrophilic polymer is between 1:10 and 4:1 and the weight ratio of surfactant/hydrophilic polymer is between 1/500 and 1/10.  
     
     
         57 . The composition of  claim 56 , wherein the weight ratio of fenofibrate/hydrophilic polymer is between 1/2 and 2/1.  
     
     
         58 . The composition of  claim 56 , wherein the fenofibrate has a size less than 20 μm.  
     
     
         59 . The composition of  claim 56 , wherein the fenofibrate has a size less than 10 μm.  
     
     
         60 . The composition of  claim 56 , wherein the inert carrier particles are inert hydrosoluble carrier particles.  
     
     
         61 . The composition of  claim 56 , wherein the inert carrier particles have a particle size between 50 and 500 microns.  
     
     
         62 . The composition of  claim 56 , wherein the inert carrier particles have a particle size between 100 and 400 microns.  
     
     
         63 . The composition of  claim 56 , wherein the hydrophilic polymer is a polyvinylpyrrolidone, a poly(vinyl alcohol), a hydroxypropylcellulose, a hydroxy-methylcellulose, a hydroxypropylmethylcellulose, a gelatin, or a mixture of two or more thereof.  
     
     
         64 . The composition of  claim 56 , wherein the hydrophilic polymer is a polyvinylpyrrolidone.  
     
     
         65 . The composition of  claim 56 , wherein the surfactant is sodium lauryl sulfate, monooleate, monolaurate, monopalmitate, monostearate or another ester of polyoxyethylene sorbitane, sodium dioctylsulfosuccinate, lecithin, stearylic alcohol, cetostearylic alcohol, cholesterol, polyoxyethylene ricin oil, polyoxyethylene fatty acid glycerides, poloxamer, or a mixture of two or more thereof.  
     
     
         66 . The composition of  claim 56 , wherein the surfactant is sodium lauryl sulfate.  
     
     
         67 . The composition of  claim 56 , wherein the weight ratio of surfactant to hydrophilic polymer is from 1/100 to 5/100.  
     
     
         68 . The composition of  claim 56 , 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, from 20 to 60% by weight of hydrophilic polymer, and up to 10% by weight of surfactant.  
     
     
         69 . The composition of  claim 56 , 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, from 25 to 45% by weight of hydrophilic polymer, and from 0.1 to 3% by weight of surfactant.  
     
     
         70 . A fenofibrate composition comprising granulates, wherein the granulates comprise micronized fenofibrate, inert carrier particles, polyvinylpyrrolidone, sodium lauryl sulfate, wherein the weight ratio of micronized fenofibrate to polyvinylpyrrolidone is between 1:10 and 4:1 and the weight ratio of sodium lauryl sulfate/polyvinylpyrrolidone is between 1/500 and 1/10.  
     
     
         71 . The composition of  claim 70 , wherein the weight ratio of fenofibrate/polyvinylpyrrolidone is between 1/2 and 2/1.  
     
     
         72 . The composition of  claim 70 , wherein the fenofibrate has a size less than 20 μm.  
     
     
         73 . The composition of  claim 70 , wherein the fenofibrate has a size less than 10 μm.  
     
     
         74 . The composition of  claim 70 , wherein the inert carrier particles are inert hydrosoluble carrier particles.  
     
     
         75 . The composition of  claim 70 , wherein the inert carrier particles have a particle size between 50 and 500 microns.  
     
     
         76 . The composition of  claim 70 , wherein the inert carrier particles have a particle size between 100 and 400 microns.  
     
     
         77 . The composition of  claim 70 , wherein the weight ratio of sodium lauryl sulfate to polyvinylpyrrolidone is from 1/100 to 5/100.  
     
     
         78 . The composition of  claim 70 , 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, from 20 to 60% by weight of polyvinylpyrrolidone, and up to 10% by weight of sodium lauryl sulfate.  
     
     
         79 . The composition of  claim 70 , 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, from 25 to 45% by weight of polyvinylpyrrolidone polymer, and from 0.1 to 3% by weight of sodium lauryl sulfate.  
     
     
         80 . The composition of  claim 1 , wherein the fenofibrate is in a non-reagglomerated form.  
     
     
         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.  
     
     
         83 . The composition of  claim 56 , wherein the fenofibrate is in a non-reagglomerated form.  
     
     
         84 . The composition of  claim 70 , wherein the fenofibrate is in a non-reagglomerated form.

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