US2008045476A1PendingUtilityA1

Methods and compositions using sulodexide for the treatment of diabetic nephropathy

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Assignee: ALFA WASSERMANN INCPriority: Jun 7, 2000Filed: Jul 19, 2007Published: Feb 21, 2008
Est. expiryJun 7, 2020(expired)· nominal 20-yr term from priority
Inventors:Ernesto PalazziniGiovanni Gambaro
A61P 13/12A61K 31/726A61K 35/38A61K 31/70A61K 9/48A61K 31/737A61K 31/727
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Claims

Abstract

The present invention provides oral formulations of Sulodexide for the treatment of diabetic nephropathy in patients with both insulin dependent and non-insulin dependent diabetes mellitus. Oral formulations containing doses adapted for administration to obtain a reduction in albumin. excretion in patients with both micro and macro albuminuria and to produce lasting improvement in albumin excretion rate are provided. Methods of treating diabetic nephropathy using these formulations are also provided.

Claims

exact text as granted — not AI-modified
1 . A pharmaceutical composition in unit dosage form comprising, per dosage unit, an amount of Sulodexide or a pharmaceutically acceptable salt thereof within the range from about 100 mg.(1000 LRU) to about 1000 mg.(10,000 LRU); and a pharmaceutically acceptable carrier, diluent or excipient.  
   
   
       2 . A pharmaceutical composition in accordance with  claim 1  in a form adapted for oral administration.  
   
   
       3 . A pharmaceutical composition in accordance with  claim 2  in the form of soft gelatin capsule.  
   
   
       4 . The pharmaceutical composition of  claim 1 ,  2  or  3  wherein the amount of Sulodexide is about 100 mg per unit dose.  
   
   
       5 . The pharmaceutical composition of  claim 1 ,  2  or  3  wherein the amount of Sulodexide is about 125 mg per unit dose.  
   
   
       6 . The pharmaceutical composition of  claim 1 ,  2  or  3  wherein amount of Sulodexide is about 150 mg per unit dose.  
   
   
       7 . The pharmaceutical composition of  claim 1 ,  2  or  3  wherein the amount of Sulodexide is about 175 mg per unit dose.  
   
   
       8 . The pharmaceutical composition of  claim 1 ,  2 , or  3  wherein the amount of Sulodexide is about 200 mg. per unit dose.  
   
   
       9 . The pharmaceutical composition of  claim 1 ,  2 , or  3  wherein the amount of Sulodexide is about 225 mg. per unit dose.  
   
   
       10 . The pharmaceutical composition of  claim 1 ,  2 , or  3  wherein the amount of Sulodexide is about 250 mg. per unit dose.  
   
   
       11 . The pharmaceutical composition of  claim 1 ,  2 , or  3  wherein the amount of Sulodexide is about 275 mg. per unit dose.  
   
   
       12 . The pharmaceutical composition of  claim 1 ,  2 , or  3  wherein the amount of Sulodexide is about 300 mg. per unit dose.  
   
   
       13 . The pharmaceutical composition of  claim 1 ,  2 , or  3  wherein the amount of Sulodexide is about 325 mg. per unit dose.  
   
   
       14 . The pharmaceutical composition of  claim 1 ,  2 , or  3  wherein the amount of Sulodexide is about 350 mg. per unit dose.  
   
   
       15 . The pharmaceutical composition of  claim 1 ,  2 , or  3  wherein the amount of Sulodexide is about 375 mg. per unit dose.  
   
   
       16 . The pharmaceutical composition of  claim 1 ,  2 , or  3  wherein the amount of Sulodexide is about 400 mg. per unit dose.  
   
   
       17 . The pharmaceutical composition of  claim 1 ,  2 , or  3  wherein the amount of Sulodexide is about 425 mg. per unit dose.  
   
   
       18 . The pharmaceutical composition of  claim 1 ,  2 , or  3  wherein the amount of Sulodexide is about 450 mg. per unit dose.  
   
   
       19 . The pharmaceutical composition of  claim 1 ,  2 , or  3  wherein the amount of Sulodeixde is about 475 mg. per unit dose.  
   
   
       20 . The pharmaceutical composition of  claim 1 ,  2 , or  3  wherein the amount of Sulodexide is about 500 mg. per unit dose.  
   
   
       21 . The pharmaceutical composition of  claim 1 ,  2 , or  3  wherein the amount of Sulodexide is about 525 mg. per unit dose.  
   
   
       22 . The pharmaceutical composition of  claim 1 ,  2 , or  3  wherein the amount of Sulodexide is about 550 mg. per unit dose.  
   
   
       23 . The pharmaceutical composition of  claim 1 ,  2 , or  3  wherein the amount of Sulodexide is about 575 mg. per unit dose  
   
   
       24 . The pharmaceutical composition of  claim 1 ,  2 , or  3  wherein the amount of Sulodexide is about 600 mg. per unit dose.  
   
   
       25 . The composition of  claim 1  wherein said composition is a controlled release pharmaceutical composition.  
   
   
       26 . A method of treating a patient with diabetic nephropathy comprising administering to a human in need of treatment from diabetic nephropathy, an amount of Sulodexide or a pharmaceutically acceptable salt thereof, of at least 100 mg/day, up to 1000 mg/day, said amount being sufficient to decrease albumin excretion rate without causing adverse side effects.  
   
   
       27 . The method of  claim 15  wherein Sulodexide is administered orally as a tablet, a capsule or a liquid suspension.  
   
   
       28 . The method of  claim 15  or  claim 16  wherein the amount of Sulodexide administered is at least 200 mg/day to about 1000 mg/day.  
   
   
       29 . The method of  claim 15 , 16 or 17 wherein the Sulodexide is administered in one to four unit doses per day. - 15 - NY2 - 1205928.1 E00014547

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