US2004057999A1PendingUtilityA1

Fenofibrate compositions having enhanced bioavailability

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 3/06A61P 3/04A61P 1/18A61K 9/1635A61K 31/215A61K 9/16A61K 9/1623A61K 9/1617A61K 31/216A61K 31/12A61K 9/2027A61K 9/2077A61K 9/1676A61K 9/2054A61K 9/14A61K 9/2081
60
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Claims

Abstract

The invention provides fenofibrate compositions having enhanced bioavailability where a therapeutic daily dose is less than 200 mg.

Claims

exact text as granted — not AI-modified
What is claimed is:  
     
         1 . A fenofibrate composition with an enhanced bioavailability, whereby the required daily dose is lower than 200 mg.  
     
     
         2 . The composition of  claim 1 , wherein the composition has 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.  
     
     
         3 . The composition of  claim 1 , wherein the fenofibrate is present in an amount of 5 to 50% by weight.  
     
     
         4 . The composition of  claim 1 , wherein the fenofibrate is present in an amount of 20 to 45% by weight.  
     
     
         5 . The composition of  claim 1  in the form of a tablet.  
     
     
         6 . The composition of  claim 1  in the form of a capsule.  
     
     
         7 . The composition of  claim 1  in the form of granulates.  
     
     
         8 . The composition of  claim 1  which is once-daily.  
     
     
         9 . A fenofibrate composition with an enhanced bioavailability, whereby the required daily dose is lower than 200 mg, and wherein the composition has 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.  
     
     
         10 . The composition of  claim 9 , wherein the fenofibrate is present in an amount of 5 to 50% by weight.  
     
     
         11 . The composition of  claim 10 , wherein the fenofibrate is present in an amount of 20 to 45% by weight.  
     
     
         12 . The composition of  claim 10  in the form of a tablet.  
     
     
         13 . The composition of  claim 10  in the form of a capsule.  
     
     
         14 . The composition of  claim 10  in the form of granulates.  
     
     
         15 . The composition of  claim 10  which is once-daily.  
     
     
         16 . An orally administrable fenofibrate tablet with an enhanced bioavailability, whereby the required daily dose is lower than 200 mg.  
     
     
         17 . The tablet of  claim 16 , wherein the tablet has 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.  
     
     
         18 . The tablet of  claim 16 , wherein the fenofibrate is present in an amount of 5 to 50% by weight.  
     
     
         19 . The tablet of  claim 16 , wherein the fenofibrate is present in an amount of 20 to 45% by weight.  
     
     
         20 . The tablet of  claim 16  which is once-daily.  
     
     
         21 . An orally administrable fenofibrate tablet with an enhanced bioavailability, whereby the required daily dose is lower than 200 mg, and wherein the tablet has 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 tablet of  claim 21 , wherein the fenofibrate is present in an amount of 5 to 50% by weight.  
     
     
         23 . The tablet of  claim 21 , wherein the fenofibrate is present in an amount of 20 to 45% by weight.  
     
     
         24 . The tablet of  claim 21  which is once-daily.  
     
     
         25 . An orally administrable fenofibrate capsule with an enhanced bioavailability, whereby the required daily dose is lower than 200 mg.  
     
     
         26 . The capsule of  claim 25 , wherein the capsule has 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.  
     
     
         27 . The capsule of  claim 25 , wherein the fenofibrate is present in an amount of 5 to 50% by weight.  
     
     
         28 . The capsule of  claim 25 , wherein the fenofibrate is present in an amount of 20 to 45% by weight.  
     
     
         29 . The capsule of  claim 25  which is once-daily.  
     
     
         30 . An orally administrable fenofibrate capsule with an enhanced bioavailability, whereby the required daily dose is lower than 200 mg, and wherein the capsule has 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.  
     
     
         31 . The capsule of  claim 30 , wherein the fenofibrate is present in an amount of 5 to 50% by weight.  
     
     
         32 . The capsule of  claim 30 , wherein the fenofibrate is present in an amount of 20 to 45% by weight.  
     
     
         33 . The capsule of  claim 30  which is once-daily.  
     
     
         34 . The composition according to  claim 1 , wherein the fenofibrate is in a non-reagglomerated form.  
     
     
         35 . The composition according to  claim 9 , wherein the fenofibrate is in a non-reagglomerated form.  
     
     
         36 . The tablet according to  claim 16 , wherein the fenofibrate is in a non-reagglomerated form.  
     
     
         37 . The tablet according to  claim 21 , wherein the fenofibrate is in a non-reagglomerated form.  
     
     
         38 . The capsule according to  claim 25 , wherein the fenofibrate is in a non-reagglomerated form.  
     
     
         39 . The capsule according to  claim 30 , wherein the fenofibrate is in a non-reagglomerated form.

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