Compositions with reduced hepatotoxicity

a technology of hepatotoxicity and composition, which is applied in the field of compositions of pharmaceutical compounds having hepatotoxicity, can solve the problems of liver toxicity, severe and sometimes fatal liver toxicity, and a significant limitation of its therapeutic usefulness, and achieves the effects of reducing the risk of liver toxicity and reducing the effect of hepatotoxicity

Inactive Publication Date: 2005-10-06
WINSTON LAB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

While acetaminophen is usually well tolerated, its use can be accompanied by a very serious adverse effect—potentially fatal hepatic necrosis.
While methotrexate administration is associated with various other side effects, severe and sometimes fatal liver toxicity is a significant limiting factor in its therapeutic usefulness.
In spite of their widespread use...

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0012] Two tablets, comprised of 500 mg acetaminophen, 50 mg methionine, and 25 mg nicotinamide, are administered to patients with painful osteoarthritis four times daily for 12 weeks producing substantial relief of joint pain without evidence of any hepatotoxicity.

example 2

[0013] Capsules are prepared each containing by weight 325 mg acetaminophen, 50 mg methionine, 50 mg nicotinamide, and 500 mcg folic acid. One to two of such capsules are administered to patients with osteoarthritis or fibromyalgia pain four to six times daily for 6 months for relief of joint or soft tissue pain without evidence of damage to the patients' livers.

example 3

[0014] Two caplets each containing 500 mg acetaminophen, 200 mg methionine, and 100 mg nicotinamide are administered four times daily for twelve (12) weeks to patients with osteoarthritis for relief of osteoarthritis pain without evidence of liver damage.

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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.

Description

BACKGROUND OF THE INVENTION [0001] This invention relates to compositions of pharmaceutical compounds having hepatotoxicity, in which compositions the hepatotoxicity is mitigated. More particularly, this invention relates to compositions of hepatotoxic compounds such as acetaminophen, methotrexate, statin drugs, niacin, divalproex sodium, valproic acid or fluconazole, each of which is known to have hepatotoxic properties, in which compositions the hepatotoxicity of the compound is mitigated. [0002] Acetaminophen is the active metabolite of phenacetin, a drug whose use extends back to the 1880's. Although acetaminophen was first used as an analgesic and antipyretic in 1893, it did not achieve widespread use until after 1949. For many years, acetaminophen was used as a second-line choice to aspirin as an analgesic / antipyretic, but the elucidation of the relationship between aspirin use and Reye's Syndrome and the recognition of aspirin's propensity to produce gastrointestinal bleeding...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K47/18A61K31/44A61K31/16A61K9/48A61K9/20A61K31/415A61K31/198
CPCA61K9/0019A61K31/198A61K47/18A61K47/183A61K31/167A61K9/2013A61K47/20A61P1/16A61P3/06A61P7/06A61P25/06A61P25/08A61P29/00A61P31/10A61K9/48A61K31/44
Inventor BERNSTEIN, JOEL E.
Owner WINSTON LAB
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