US2013303612A1PendingUtilityA1

Solid dosage form comprising a fibrate

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Assignee: HOLM PERPriority: Oct 10, 2003Filed: Feb 25, 2013Published: Nov 14, 2013
Est. expiryOct 10, 2023(expired)· nominal 20-yr term from priority
Inventors:Per HolmTomas Norling
A61P 3/06A61P 7/00A61P 3/10A61P 3/00A61K 9/20A61K 31/216A61K 31/40A61P 19/06A61K 31/22A61K 9/2018A61K 31/195A61K 45/06A61K 31/192A61K 9/2013A61K 9/16
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Claims

Abstract

The invention provides stable, solid dosage forms and pharmaceutical compositions in particulate form comprising a fibrate, for example fenofibrate, dissolved in a non-aqueous vehicle in order to ensure improved bioavailability of the active ingredient upon oral administration relative to known fibrate formulations.

Claims

exact text as granted — not AI-modified
1 - 62 . (canceled) 
     
     
         63 . A tablet for treating hypercholesterolemia, mixed dislipidemia and/or hypertriglyceridemia comprising:
 (a) fenofibrate,   (b) polyethylene glycol,   (c) at least one oily material chosen from poloxamer and hydrogenated castor oil, and   (d) lactose,   
       wherein said tablet comprises at most about 80% w/w as much fenofibrate as, and is at least as effective as, a commercially available 160 mg TRICOR® tablet for treating said hypercholesterolemia, mixed dislipidemia, and/or hypertriglyceridemia. 
     
     
         64 . The tablet of  claim 63 , wherein the fenofibrate is in crystalline form. 
     
     
         65 . The tablet of  claim 63 , wherein said tablet comprises at most about 75% w/w as much fenofibrate as a commercially available 160 mg TRICOR® tablet for treating said hypercholesterolemia, mixed dislipidemia, and/or hypertriglyceridemia. 
     
     
         66 . The tablet of  claim 65 , wherein the fenofibrate is in crystalline form. 
     
     
         67 . The tablet for treating hypercholesterolemia, mixed dislipidemia, and/or hypertriglyceridemia according to  claim 63 , wherein the tablet is prepared by a process comprising:
 (i) spraying a carrier composition on lactose, the carrier composition comprising dissolved fenofibrate, polyethylene glycol and the at least one oily material; and   (ii) forming said tablet from the product of step (i).   
     
     
         68 . The tablet of  claim 67 , wherein the fenofibrate is in crystalline form. 
     
     
         69 . The tablet for treating hypercholesterolemia, mixed dislipidemia, and/or hypertriglyceridemia according to  claim 63 , wherein the tablet is prepared by a process comprising:
 (i) preparing a carrier composition comprising dissolved fenofibrate, polyethylene glycol, and the at least one oily material;   (ii) forming granules by spraying the carrier composition on the lactose; and   (iii) forming said tablet from said granules.   
     
     
         70 . The tablet of  claim 69 , wherein the fenofibrate is in crystalline form. 
     
     
         71 . The tablet for treating hypercholesterolemia, mixed dislipidemia, and/or hypertriglyceridemia according to  claim 63 , wherein the tablet is prepared by a process comprising:
 (i) spraying onto lactose a mixture of dissolved fenofibrate, polyethylene glycol and the at least one oily material; and   (ii) forming said tablet from the product of step (i).   
     
     
         72 . The tablet of  claim 71 , wherein the fenofibrate is in crystalline form. 
     
     
         73 . The tablet for treating hypercholesterolemia, mixed dislipidemia, and/or hypertriglyceridemia according to  claim 63 , wherein the tablet comprises granules, said granules comprising a mixture of fenofibrate, polyethylene glycol, and the at least one oily material on lactose particles. 
     
     
         74 . The tablet of  claim 73 , wherein the fenofibrate is in crystalline form. 
     
     
         75 . A tablet for treating hypercholesterolemia, mixed dislipidemia and/or hypertriglyceridemia comprising:
 (a) fenofibrate,   (b) polyethylene glycol,   (c) at least one oily material chosen from poloxamer and hydrogenated castor oil, and   (d) lactose,   
       wherein said tablet comprises at most about 80% w/w as much fenofibrate as, and is at least as effective as, a commercially available 54 mg TRICOR® tablet for treating said hypercholesterolemia, mixed dislipidemia, and/or hypertriglyceridemia. 
     
     
         76 . The tablet of  claim 75 , wherein the fenofibrate is in crystalline form. 
     
     
         77 . The tablet of  claim 75 , wherein said tablet comprises at most about 75% w/w as much fenofibrate as a commercially available 54 mg TRICOR® tablet for treating said hypercholesterolemia, mixed dislipidemia, and/or hypertriglyceridemia. 
     
     
         78 . The tablet of  claim 77 , wherein the fenofibrate is in crystalline form. 
     
     
         79 . The tablet for treating hypercholesterolemia, mixed dislipidemia, and/or hypertriglyceridemia according to  claim 75 , wherein the tablet is prepared by a process comprising:
 (i) spraying a carrier composition on lactose, the carrier composition comprising dissolved fenofibrate, polyethylene glycol and the at least one oily material; and   (ii) forming said tablet from the product of step (i).   
     
     
         80 . The tablet of  claim 79 , wherein the fenofibrate is in crystalline form. 
     
     
         81 . The tablet for treating hypercholesterolemia, mixed dislipidemia, and/or hypertriglyceridemia according to  claim 75 , wherein the tablet is prepared by a process comprising:
 (i) preparing a carrier composition comprising dissolved fenofibrate, polyethylene glycol, and the at least one oily material;   (ii) forming granules by spraying the carrier composition on the lactose; and   (iii) forming said tablet from said granules.   
     
     
         82 . The tablet of  claim 81 , wherein the fenofibrate is in crystalline form. 
     
     
         83 . The tablet for treating hypercholesterolemia, mixed dislipidemia, and/or hypertriglyceridemia according to  claim 75 , wherein the tablet is prepared by a process comprising:
 (i) spraying onto lactose a mixture of dissolved fenofibrate, polyethylene glycol and the at least one oily material; and   (ii) forming said tablet from the product of step (i).   
     
     
         84 . The tablet of  claim 83 , wherein the fenofibrate is in crystalline form. 
     
     
         85 . The tablet for treating hypercholesterolemia, mixed dislipidemia, and/or hypertriglyceridemia according to  claim 75 , wherein the tablet comprises granules, said granules comprising a mixture of fenofibrate, polyethylene glycol, and the at least one oily material on lactose particles. 
     
     
         86 . The tablet of  claim 85 , wherein the fenofibrate is in crystalline form.

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