US 7,320,802 B2 | ||
Methods of treatment using nanoparticulate fenofibrate compositions | ||
Tuula Ryde, Malvern, Pa. (US); Evan E. Gustow, Villanova, Pa. (US); Stephen B. Ruddy, Schwenksville, Pa. (US); Rajeev Jain, Collegeville, Pa. (US); Rakesh Patel, Bensalem, Pa. (US); and Michael John Wilkins, Midleton (Ireland) | ||
Assigned to Elan Pharma International, Ltd., Athlone, County Westmath (Israel); and Fournier Laboratories Ireland Ltd., Cork (Israel) | ||
Filed on Oct. 27, 2003, as Appl. No. 10/692,855. | ||
Application 10/692855 is a division of application No. 10/444066, filed on May 23, 2003, granted, now 7,276,249. | ||
Application 10/444066 is a continuation in part of application No. 10/370277, filed on Feb. 21, 2003, abandoned. | ||
Claims priority of provisional application 60/383294, filed on May 24, 2002. | ||
Prior Publication US 2004/0058009 A1, Mar. 25, 2004 | ||
Int. Cl. A61K 9/20 (2006.01); A61K 9/48 (2006.01); A61K 9/14 (2006.01); A06K 9/14 (2006.01) |
U.S. Cl. 424—451 [424/458; 424/464; 424/469; 424/470; 424/489; 424/490] | 396 Claims |
1. A method of treating a condition selected from the group consisting of hypercholesterolemia, hypertriglyceridemia, coronary
heart disease, cardiovascular disorders, peripheral vascular disease, symptomatic carotid artery disease, mixed dyslipidemia,
and increased risk of pancreatitis comprising administering to a subject an effective amount of a composition, wherein:
(a) the composition comprises particles of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or
a salt thereof having a D50 particle size of less than 500 nm and at least one surface stabilizer;
(b) the 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof particles present in
the composition redisperse in a biorelevant media; and
(c) administration of the composition to a human subject in a fasted state is bioequivalent to administration of the composition
to a human subject in a fed state, wherein bioequivalency of the composition is established by:
(i) a 90% Confidence Interval for AUC which is between 0.80 and 1.25; and
(ii) a 90% Confidence Interval for Cmax, which is between 0.80 and 1.25.
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