US2004057997A1PendingUtilityA1

Capsules containing 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 9/2054A61K 9/1635A61K 9/2077A61K 9/14A61K 9/16A61K 9/1676A61K 9/2027A61K 9/1623A61K 9/2081A61K 31/12A61K 9/1617A61K 31/216A61K 31/215
60
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Claims

Abstract

The invention provides capsules containing fenofibrate compositions.

Claims

exact text as granted — not AI-modified
What is claimed is:  
     
         1 . A capsule comprising a fenofibrate composition, said fenofibrate composition comprising fenofibrate, at least one hydrophilic polymer and at least one disintegrating agent, wherein the weight ratio of fenofibrate to hydrophilic polymer is between 1:10 and 4:1.  
     
     
         2 . The capsule according to  claim 1 , wherein the weight ratio of fenofibrate/hydrophilic polymer is between 1/2 and 2/1.  
     
     
         3 . The capsule according to  claim 1 , wherein the hydrophilic polymer is polyvinylpyrrolidone, poly(vinyl alcohol), hydroxypropylcellulose, hydroxymethylcellulose, hydroxypropylmethylcellulose, gelatin, or a mixture of two or more thereof.  
     
     
         4 . The capsule according to  claim 1 , wherein the hydrophilic polymer is polyvinylpyrrolidone.  
     
     
         5 . The capsule according to  claim 1 , wherein the hydrophilic polymer is hydroxypropylcellulose.  
     
     
         6 . The capsule according to  claim 1 , 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.  
     
     
         7 . The capsule according to  claim 1 , having a dissolution of at least 10% in 5 minutes, 20% in 10 minutes, 50% in 20 minutes and 75% in 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 polysorbate 80 or 0.025 M sodium lauryl sulfate.  
     
     
         8 . The capsule according to  claim 1 , wherein the fenofibrate is present in an amount of 5 to 50% by weight.  
     
     
         9 . The capsule according to  claim 1 , wherein the fenofibrate is present in an amount of 20 to 45% by weight.  
     
     
         10 . The capsule according to  claim 1 , wherein the fenofibrate is in a non-reagglomerated form.  
     
     
         11 . A capsule comprising a fenofibrate composition, said fenofibrate composition comprising fenofibrate, polyvinylpyrrolidone and at least one disintegrating agent, wherein the weight ratio of fenofibrate to polyvinylpyrrolidone is between 1:10 and 4:1.  
     
     
         12 . The capsule according to  claim 11 , wherein the weight ratio of fenofibrate/polyvinylpyrrolidone is between 1/2 and 2/1.  
     
     
         13 . The capsule according to  claim 11 , 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.  
     
     
         14 . The capsule according to  claim 11 , having a dissolution of at least 10% in 5 minutes, 20% in 10 minutes, 50% in 20 minutes and 75% in 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 polysorbate 80 or 0.025 M sodium lauryl sulfate.  
     
     
         15 . The capsule according to  claim 11 , wherein the fenofibrate is present in an amount of 5 to 50% by weight.  
     
     
         16 . The capsule according to  claim 11 , wherein the fenofibrate is present in an amount of 20 to 45% by weight.  
     
     
         17 . The capsule according to  claim 11 , wherein the fenofibrate is in a non-reagglomerated form.  
     
     
         18 . A capsule comprising a fenofibrate composition, said fenofibrate composition comprising fenofibrate, hydroxypropylcellulose and at least one disintegrating agent, wherein the weight ratio of fenofibrate to hydroxypropylcellulose is between 1:10 and 4:1.  
     
     
         19 . The capsule according to  claim 18 , wherein the weight ratio of fenofibrate/hydroxypropylcellulose is between 1/2 and 2/1.  
     
     
         20 . The capsule according to  claim 18 , 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.  
     
     
         21 . The capsule according to  claim 18 , having a dissolution of at least 10% in 5 minutes, 20% in 10 minutes, 50% in 20 minutes and 75% in 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 polysorbate 80 or 0.025 M sodium lauryl sulfate.  
     
     
         22 . The capsule according to  claim 18 , wherein the fenofibrate is present in an amount of 5 to 50% by weight.  
     
     
         23 . The capsule according to  claim 18 , wherein the fenofibrate is present in an amount of 20 to 45% by weight.  
     
     
         24 . The capsule according to  claim 18 , wherein the fenofibrate is in a non-reagglomerated form.  
     
     
         25 . A capsule comprising a fenofibrate composition, said fenofibrate composition comprising fenofibrate, at least one hydrophilic polymer and at least one disintegrating agent, wherein the weight ratio of fenofibrate to hydrophilic polymer is between 1:10 and 4:1, and having a dissolution of at least 10% in 5 minutes, 20% in 10 minutes, 50% in 20 minutes and 75% in 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 polysorbate 80 or 0.025 M sodium lauryl sulfate.  
     
     
         26 . The capsule according to  claim 25 , wherein the weight ratio of fenofibrate/hydrophilic polymer is between 1/2 and 2/1.  
     
     
         27 . The capsule according to  claim 25 , wherein the hydrophilic polymer is polyvinylpyrrolidone, poly(vinyl alcohol), hydroxypropylcellulose, hydroxymethylcellulose, hydroxypropylmethylcellulose, gelatin, or a mixture of two or more thereof.  
     
     
         28 . The capsule according to  claim 25 , wherein the hydrophilic polymer is polyvinylpyrrolidone.  
     
     
         29 . The capsule according to  claim 25 , wherein the hydrophilic polymer is hydroxypropylcellulose.  
     
     
         30 . The capsule according to  claim 25 , 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.  
     
     
         31 . The capsule according to  claim 25 , wherein the fenofibrate is present in an amount of 5 to 50% by weight.  
     
     
         32 . The capsule according to  claim 25 , wherein the fenofibrate is present in an amount of 20 to 45% by weight.  
     
     
         33 . The capsule according to  claim 25 , wherein the fenofibrate is in a non-reagglomerated form.  
     
     
         34 . A capsule comprising a fenofibrate composition, said fenofibrate composition comprising fenofibrate, polyvinylpyrrolidone and at least one disintegrating agent, wherein the weight ratio of fenofibrate to polyvinylpyrrolidone is between 1:10 and 4:1, and having a dissolution of at least 10% in 5 minutes, 20% in 10 minutes, 50% in 20 minutes and 75% in 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 polysorbate 80 or 0.025 M sodium lauryl sulfate.  
     
     
         35 . The capsule according to  claim 34 , wherein the weight ratio of fenofibrate/polyvinylpyrrolidone is between 1/2 and 2/1.  
     
     
         36 . The capsule according to  claim 34 , 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.  
     
     
         37 . The capsule according to  claim 34 , wherein the fenofibrate is present in an amount of 5 to 50% by weight.  
     
     
         38 . The capsule according to  claim 34 , wherein the fenofibrate is present in an amount of 20 to 45% by weight.  
     
     
         39 . The capsule according to  claim 34 , wherein the fenofibrate is in a non-reagglomerated form.  
     
     
         40 . A capsule comprising a fenofibrate composition, said fenofibrate composition comprising fenofibrate, hydroxypropylcellulose and at least one disintegrating agent, wherein the weight ratio of fenofibrate to hydroxypropylcellulose is between 1:10 and 4:1, and having a dissolution of at least 10% in 5 minutes, 20% in 10 minutes, 50% in 20 minutes and 75% in 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 polysorbate 80 or 0.025 M sodium lauryl sulfate.  
     
     
         41 . The capsule according to  claim 40 , wherein the weight ratio of fenofibrate/hydroxypropylcellulose is between 1/2 and 2/1.  
     
     
         42 . The capsule according to  claim 40 , 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.  
     
     
         43 . The capsule according to  claim 40 , wherein the fenofibrate is present in an amount of 5 to 50% by weight.  
     
     
         44 . The capsule according to  claim 40 , wherein the fenofibrate is present in an amount of 20 to 45% by weight.  
     
     
         45 . The capsule according to  claim 40 , wherein the fenofibrate is in a non-reagglomerated form.

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