US2005220862A1PendingUtilityA1

Compositions with reduced hepatotoxicity

Individually held — no corporate assignee on recordPriority: Mar 31, 2004Filed: Mar 31, 2004Published: Oct 6, 2005
Est. expiryMar 31, 2024(expired)· nominal 20-yr term from priority
A61P 3/06A61P 31/10A61P 7/06A61P 25/08A61P 25/06A61P 29/00A61P 1/16A61K 31/167A61K 31/198A61K 47/18A61K 47/20A61K 9/0019A61K 9/2013A61K 31/44A61K 9/48
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Claims

Abstract

Pharmaceutical compositions of hepatotoxic compounds are provided in which the hepatotoxicity of the compounds is mitigated by including quantities of nicotinamide and methionine in the composition. Folic acid also can be included to further mitigate the hepatotoxic effects. The hepatotoxic compounds can include acetaminophen, methotrexate, atorvastatin, simvastatin, niacin, flucanozole, divalproex sodium, and valproic acid.

Claims

exact text as granted — not AI-modified
1 . A composition comprising one or more standard doses of a hepatotoxic compound in a pharmaceutically acceptable carrier, the composition further comprising about 5 mg to about 500 mg methionine per standard dose and about 10 mg to about 500 mg nicotinamide per standard dose.  
   
   
       2 . The composition of  claim 1  wherein said composition is suitable for oral ingestion.  
   
   
       3 . The composition of  claim 2  wherein said composition is selected from the group consisting of solutions, suspensions, tablets, capsules and caplets.  
   
   
       4 . The composition of  claim 1  wherein said composition is suitable for injection.  
   
   
       5 . The composition of  claim 4  wherein said composition is selected from the group consisting of sterile solutions or suspensions.  
   
   
       6 . The composition of  claim 5  wherein said composition is suitable for intradermal, subcutaneous, intramuscular, intravenous or intrathecal injection.  
   
   
       7 . The composition of  claim 1  wherein said composition also contains folic acid in an amount of about 50 mcg to about 5 mg per standard dose.  
   
   
       8 . The composition of  claim 7  wherein said composition is suitable for oral ingestion.  
   
   
       9 . The composition of  claim 8  wherein said composition is selected from the group consisting of solutions, suspensions, tablets, capsules and caplets.  
   
   
       10 . The composition of  claim 7  wherein said composition is suitable for injection.  
   
   
       11 . The composition of  claim 10  wherein said composition is selected from the group consisting of sterile solutions or suspensions.  
   
   
       12 . The composition of  claim 11  wherein said composition is suitable for intradermal, subcutaneous, intramuscular, intravenous, or intrathecal injection.  
   
   
       13 . The composition of  claim 1  wherein said hepatotoxic compound is selected from the group consisting of acetaminophen, methotrexate, atorvastatin, simvastatin, niacin, flucanozole, divalproex sodium, and valproic acid.  
   
   
       14 . The composition of  claim 13  wherein said hepatotoxic compound is acetaminophen.  
   
   
       15 . The composition of  claim 14  wherein said acetaminophen is present in the amount of about 80-1000 mg per standard dose.  
   
   
       16 . The composition of  claim 13  wherein said hepatotoxic compound is methotrexate.  
   
   
       17 . The composition of  claim 16  wherein said methotrexate is present in the amount of about 25-250 mg per standard dose.  
   
   
       18 . The composition of  claim 13  wherein said hepatotoxic compound is atorvastatin.  
   
   
       19 . The composition of  claim 18  wherein said atorvastatin is present in the amount of about 5-100 mg per standard dose per standard dose.  
   
   
       20 . The composition of  claim 13  wherein said hepatotoxic compound is simvastatin.  
   
   
       21 . The composition of  claim 20  wherein said simvastatin is present in the amount of about 5-100 mg per standard dose.  
   
   
       22 . The composition of  claim 13  wherein said hepatotoxic compound is niacin.  
   
   
       23 . The composition of  claim 22  wherein said niacin is present in the amount of about 250-1000 mg per standard dose.  
   
   
       24 . The composition of  claim 13  wherein said hepatotoxic compound is flucanozole.  
   
   
       25 . The composition of  claim 24  wherein said flucanozole is present in the amount of about 10-250 mg per standard dose.  
   
   
       26 . The composition of  claim 13  wherein said hepatotoxic compound is divalproex sodium.  
   
   
       27 . The composition of  claim 26  wherein said divalproex sodium is present in the amount of 100-750 mg per standard dose.  
   
   
       28 . The composition of  claim 13  wherein said hepatotoxic compound is valproic acid.  
   
   
       29 . The composition of  claim 28  wherein said valproic acid is present in the amount of 25-500 mg per standard dose.  
   
   
       30 . A method of mitigating the hepatotoxicity of a hepatotoxic compound comprising formulating a composition comprising a quantity of the hepatotoxic compound, said composition comprising a quantity of nicotinamide, and a quantity of methionine.  
   
   
       31 . The method of  claim 30  wherein said composition is formulated such that for each standard dose of the hepatotoxic compound in the composition, the nicotinamide is present in the amount of about 5-500 mg, and the methionine is present in the amount of about 25-500 mg.  
   
   
       32 . The method of  claim 31  wherein said nicotinamide is present in the amount of about 25-200 mg per standard dose of the hepatotoxic compound.  
   
   
       33 . The method of  claim 31  wherein said methionine is present in the amount of about 10-100 mg per standard dose of the hepatotoxic compound.  
   
   
       34 . The method of  claim 30  wherein said composition further comprises a quantity of folic acid.  
   
   
       35 . The method of  claim 34  wherein said folic acid is present in the amount of about 50 mcg-5 mg per standard dose of the hepatotoxic compound.  
   
   
       36 . The method of  claim 35  wherein said folic acid is present in the amount of about 500 mg-1 mg per standard dose of the hepatotoxic compound.  
   
   
       37 . The method of  claim 30  wherein said hepatotoxic compound is selected from the group consisting of acetaminophen, methotrexate, atorvastatin, simvastatin, niacin, flucanozole, divalproex sodium, and valproic acid.

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