Intermediate release nicotinic acid compositions for treating hyperlipidemia having unique biopharmaceutical characteristics
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United States of America Patent
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Jun 8, 2004
Grant Date -
Aug 16, 2001
app pub date -
Oct 31, 1997
filing date -
Sep 20, 1993
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Abstract
Intermediate release nicotinic acid formulations having unique biopharmaceutical characteristics, which are suitable for oral administration once per day as a single dose preferably administered during the evening or at night for treating hyperlipidemia without causing drug-induced hepatotoxicity to such a level that requires the therapy to be discontinued, are disclosed. The intermediate nicotinic acid formulations can be administered as tablets in dosage strengths of, for example, 375 mg, 500 mg, 750 mg and 1000 mg. The 375 mg, 500 mg and 750 mg nicotinic acid tablets of the present invention have a dissolution curve similarity fit factor F.sub.2 of at least about 79, and the 1000 mg nicotinic acid tablets of the present invention have a dissolution curve similarity fit factor F.sub.2 of at least 44.
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