Methods of treatment using nanoparticulate fenofibrate compositions

  • US 7,320,802 B2
  • Filed: 10/27/2003
  • Issued: 01/22/2008
  • Est. Priority Date: 05/24/2002
  • Status: Active Grant
First Claim
Patent Images

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.

View all claims
    ×
    ×

    Thank you for your feedback

    ×
    ×