US2008064759A1PendingUtilityA1

Process for preparing fenofibrate compositions

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Assignee: PAUL ROYALTY FUND HOLDINGS IIPriority: Jan 17, 1997Filed: Oct 31, 2007Published: Mar 13, 2008
Est. expiryJan 17, 2017(expired)· nominal 20-yr term from priority
Inventors:Andre StammPawan Seth
A61P 3/06A61P 3/04A61P 1/18A61K 9/1635A61K 9/1617A61K 31/215A61K 9/2081A61K 9/14A61K 9/2054A61K 31/12A61K 9/1623A61K 31/216A61K 9/2077A61K 9/16A61K 9/1676A61K 9/2027
68
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Claims

Abstract

The invention provides processes for producing fenofibrate compositions.

Claims

exact text as granted — not AI-modified
1 . A process for producing a fenofibrate composition comprising: 
 (i) preparing a suspension comprising at least one hydrophilic polymer, and micronized fenofibrate;    (ii) spraying the suspension onto inert carriers.    
     
     
         2 . The process of  claim 1 , wherein step (i) of preparing the suspension comprises (a) preparing a solution comprising at least one hydrophilic polymer and (b) adding the micronized fenofibrate to said solution to produce the suspension.  
     
     
         3 . The process of  claim 1 , wherein step (i) of preparing the suspension comprises (a) preparing a solution comprising at least one hydrophilic polymer by dissolving said hydrophilic polymer and (b) adding the micronized fenofibrate to said solution to produce the suspension.  
     
     
         4 . The process of  claim 1 , wherein step (i) of preparing the suspension comprises (a) adding the micronized fenofibrate to a solution to form the suspension, and (b) dissolving at least one hydrophilic polymer in the suspension.  
     
     
         5 . The process of  claim 1 , wherein the suspension is an aqueous suspension.  
     
     
         6 . The process of  claim 1 , wherein the suspension further comprises at least one surfactant.  
     
     
         7 . The process of  claim 1 , wherein said suspension comprises fenofibrate and hydrophilic polymer in a weight ratio of fenofibrate/hydrophilic polymer between 1/10 and 4/1.  
     
     
         8 . The process of  claim 1 , wherein said suspension comprises fenofibrate and hydrophilic polymer in a weight ratio of fenofibrate/hydrophilic polymer between 1/2 and 2/1.  
     
     
         9 . The process of  claim 1 , wherein the fenofibrate has a particle size less than 20 μm.  
     
     
         10 . The process of  claim 1 , wherein the fenofibrate has a particle size less than 10 μm.  
     
     
         11 . The process of  claim 1 , wherein said suspension comprises fenofibrate in an amount from 1 to 40% by weight.  
     
     
         12 . The process of  claim 1 , wherein said suspension comprises fenofibrate in an amount from 10 to 25% by weight.  
     
     
         13 . The process of  claim 1 , wherein said suspension comprises the hydrophilic polymer in an amount from 5 to 40% by weight.  
     
     
         14 . The process of  claim 1 , wherein said suspension comprises the hydrophilic polymer in an amount from 10 to 25% by weight.  
     
     
         15 . The process 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.  
     
     
         16 . The process of  claim 1 , wherein the hydrophilic polymer is a polyvinylpyrrolidone.  
     
     
         17 . The process of  claim 6 , wherein said suspension comprises the surfactant in an amount of up to 10% by weight.  
     
     
         18 . The process of  claim 6 , wherein said suspension comprises the surfactant in an amount of up to 5% by weight.  
     
     
         19 . The process of  claim 6 , wherein said suspension comprises surfactant and hydrophilic polymer in a weight ratio of surfactant/hydrophilic polymer between 1/500 and 1/10.  
     
     
         20 . The process of  claim 6 , wherein said suspension comprises surfactant and hydrophilic polymer in a weight ratio of surfactant/hydrophilic polymer between 1/100 and 5/100.  
     
     
         21 . The process of  claim 6 , 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.  
     
     
         22 . The process of  claim 6 , wherein the surfactant is sodium lauryl sulfate.  
     
     
         23 . The process of  claim 1 , wherein the inert carriers are inert hydrosoluble carriers.  
     
     
         24 . The process of  claim 1 , wherein step (ii) comprises spraying the suspension onto inert carriers to form granulates.  
     
     
         25 - 54 . (canceled)  
     
     
         55 . A process for producing a fenofibrate composition comprising: 
 (i) preparing an aqueous suspension comprising at least one hydrophilic polymer, at least one surfactant, and micronized fenofibrate;    (ii) spraying the aqueous suspension onto inert carriers.    
     
     
         56 . The process of  claim 55 , wherein step (i) of preparing the aqueous suspension comprises (a) preparing an aqueous solution comprising at least one surfactant and at least one hydrophilic polymer and (b) adding the micronized fenofibrate to said aqueous solution to produce the aqueous suspension.  
     
     
         57 . The process of  claim 55 , wherein step (i) of preparing the aqueous suspension comprises (a) preparing an aqueous solution comprising at least one surfactant and at least one hydrophilic polymer by dissolving said surfactant and hydrophilic polymer and (b) adding the micronized fenofibrate to said aqueous solution to produce the aqueous suspension.  
     
     
         58 . The process of  claim 55 , wherein step (i) of preparing the aqueous suspension comprises (a) dissolving at least one surfactant in an aqueous solution, (b) dissolving at least one hydrophilic polymer in the aqueous solution, and (c) adding the micronized fenofibrate to said aqueous solution to produce the aqueous suspension.  
     
     
         59 . The process of  claim 55 , wherein step (i) of preparing the aqueous suspension comprises (a) dissolving at least one hydrophilic polymer in an aqueous solution, (b) dissolving at least one surfactant in the aqueous solution, and (c) adding the micronized fenofibrate to said aqueous solution to form the aqueous suspension.  
     
     
         60 . The process of  claim 55 , wherein step (i) of preparing the aqueous suspension comprises (a) dissolving at least one surfactant in an aqueous solution, (b) adding the micronized fenofibrate to said aqueous solution to form the aqueous suspension, and (c) dissolving at least one hydrophilic polymer in the aqueous suspension.  
     
     
         61 . The process of  claim 55 , wherein step (i) of preparing the aqueous suspension comprises (a) dissolving at least one hydrophilic polymer in an aqueous solution, (b) adding the micronized fenofibrate to said aqueous solution to form the aqueous suspension, and (c) dissolving at least one surfactant in the aqueous suspension.  
     
     
         62 . The process of  claim 55 , wherein step (i) of preparing the aqueous suspension comprises (a) adding the micronized fenofibrate to an aqueous solution to form the aqueous suspension, (b) dissolving at least one surfactant in the aqueous suspension, and (c) dissolving at least one hydrophilic polymer in the aqueous suspension.  
     
     
         63 . The process of  claim 55 , wherein step (i) of preparing the aqueous suspension comprises (a) adding the micronized fenofibrate to an aqueous solution to form the aqueous suspension, (b) dissolving at least one hydrophilic polymer in the aqueous suspension, and (c) dissolving at least one surfactant in the aqueous suspension.  
     
     
         64 . The process of  claim 55 , wherein said suspension comprises fenofibrate and hydrophilic polymer in a weight ratio of fenofibrate/hydrophilic polymer between 1/10 and 4/1.  
     
     
         65 . The process of  claim 55 , wherein said suspension comprises fenofibrate and hydrophilic polymer in a weight ratio of fenofibrate/hydrophilic polymer between 1/2 and 2/1.  
     
     
         66 . The process of  claim 55 , wherein the fenofibrate has a particle size less than 20 μm.  
     
     
         67 . The process of  claim 55 , wherein the fenofibrate has a particle size less than 10 μm.  
     
     
         68 . The process of  claim 55 , wherein said suspension comprises fenofibrate in an amount from 1 to 40% by weight.  
     
     
         69 . The process of  claim 55 , wherein said suspension comprises fenofibrate in an amount from 10 to 25% by weight.  
     
     
         70 . The process of  claim 55 , wherein said suspension comprises the hydrophilic polymer in an amount from 5 to 40% by weight.  
     
     
         71 . The process of  claim 55 , wherein said suspension comprises the hydrophilic polymer in an amount from 10 to 25% by weight.  
     
     
         72 . The process of  claim 55 , 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.  
     
     
         73 . The process of  claim 55 , wherein the hydrophilic polymer is a polyvinylpyrrolidone.  
     
     
         74 . The process of  claim 55  wherein said suspension comprises the surfactant in an amount of up to 10% by weight.  
     
     
         75 . The process of  claim 55 , wherein said suspension comprises the surfactant in an amount of up to 5% by weight.  
     
     
         76 . The process of  claim 55 , wherein said suspension comprises surfactant and hydrophilic polymer in a weight ratio of surfactant/hydrophilic polymer between 1/500 and 1/10.  
     
     
         77 . The process of  claim 55 , wherein said suspension comprises surfactant and hydrophilic polymer in a weight ratio of surfactant/hydrophilic polymer between 1/100 and 5/100.  
     
     
         78 . The process of  claim 55 , 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.  
     
     
         79 . The process of  claim 55 , wherein the surfactant is sodium lauryl sulfate.  
     
     
         80 . The process of  claim 55 , wherein the inert carriers are inert hydrosoluble carriers.  
     
     
         81 . The process of  claim 55 , wherein step (ii) comprises spraying the suspension onto inert carriers to form granulates.  
     
     
         82 - 182 . (canceled)  
     
     
         183 . The process of  claim 1 , wherein the composition comprises 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.  
     
     
         184 . The process of  claim 1 , wherein the composition comprises 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.  
     
     
         185 . The process of  claim 183 , wherein the composition further comprises up to 10% by weight of surfactant.  
     
     
         186 . The process of  claim 184 , wherein the composition further comprises from 0.1 to 3% by weight of surfactant.  
     
     
         187 - 190 . (canceled)  
     
     
         191 . The process of  claim 55 , wherein the composition comprises 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.  
     
     
         192 . The process of  claim 55 , wherein the composition comprises 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.  
     
     
         193 - 202 . (canceled)

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