Patent ID: 6676967
Filing Date: 2004-01-13
Classification: A61K,A61P

Abstract:
A method of reducing flushing in an individual being treated for a lipidemic disorder and effectively treating the lipidemic disorder with an intermediate release nicotinic acid formulation suitable for oral administration once-a-day as a single dose without causing treatment-limiting hepatotoxicity and treatment-limiting elevations in uric acid or glucose levels or both in the individual to a level which would require use of the nicotinic acid formulation to be discontinued by the individual, comprising:orally administering to the individual once per day as a single dose an effective amount of an intermediate release nicotinic acid formulation without causing treatment-limiting hepatotoxicity and treatment-limiting elevations in uric acid or glucose levels or both in the individual to a level which would require use of the intermediate nicotinic acid formulation by the individual to be discontinued, the intermediate release nicotinic acid formulation having a dissolution curve similarity fit factor F2 of at least about 79, and an in vitro dissolution profile, when measured in a type I dissolution apparatus (basket) according to U.S. Pharmacopeia XXII, at about 37Â° C. in deionized water at about 100 rpm, as follows (a) less than about 15% of the nicotinic acid is released after about 1 hour in the apparatus, (b) between about 15% and about 30% of the nicotinic acid is released after about 3 hours in the apparatus, (c) between about 30% and about 45% of the nicotinic acid is released after about 6 hours in the apparatus, (d) between about 40% and about 60% of the nicotinic acid is released after about 9 hours in the apparatus, (e) between about 50% and about 75% of the nicotinic acid is released after about 12 hours in the apparatus, and (f) at least about 75% of the nicotinic acid is released after about 20 hours in the apparatus.