Nanoparticulate megestrol formulations

  • US 9,040,088 B2
  • Filed: 11/07/2014
  • Issued: 05/26/2015
  • Est. Priority Date: 04/12/2002
  • Status: Active Grant
First Claim
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1. A method of increasing the body mass in a human patient suffering from anorexia, cachexia, or loss of body mass comprising administering to the human patient a megestrol acetate formulation, wherein:

  • (a) the megestrol acetate formulation is a dose of about 40 mg to about 800 mg in about a 5 mL dose of an oral suspension;

    (b) the megestrol acetate formulation comprises megestrol acetate particles, wherein about 80% of the particles are between about 250 nm and about 50 nm, and at least one surface stabilizer is associated with the surface of the megestrol acetate particles; and

    (c) the administration is once daily;

    wherein after a single administration in a human subject of the formulation there is no substantial difference in the Cmax of megestrol when the formulation is administered to the subject in a fed versus a fasted state,wherein fasted state is defined as the subject having no food within at least the previous 10 hours, andwherein fed state is defined as the subject having a high-calorie meal within approximately 30 minutes of dosing.

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