Patent ID: 6746691
Filing Date: 2004-06-08
Classification: A61K

Abstract:
An intermediate release nicotinic acid formulation suitable for oral administration once-a-day as a single dose for treating hyperlipidemia without causing drug-induced (i) hepatotoxicity and (ii) elevations in uric acid or glucose or both, to levels which would require use of said intermediate release nicotinic acid formulation to be discontinued, said intermediate release nicotinic acid formulation comprisinga 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 1510 apparatus, (b) between about 15% and about 30% of the nicotinic acid is released after about 3 hours in the 1510 apparatus, (c) between about 30% and about 45% of the nicotinic acid is released after about 6 hours in the 1510 apparatus, (d) between about 40% and about 60% of the nicotinic acid is released after about 9 hours in the 1510 apparatus, (e) between about 50% and about 75% of the nicotinic acid is released after about 12 hours in the 1510 apparatus, and (f) at least about 75% is released after about 20 hours in the 1510 apparatus.