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US 2015/0086635 A1Published application
Nanoparticulate megestrol formulations
AssigneeAlkermes Pharma Ireland Limited
InventorsDouglas Hovey, John Pruitt, Tuula Ryde
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Abstract
The present invention is directed to nanoparticulate compositions comprising megestrol. The megestrol particles of the composition have an effective average particle size of less than about 2000 nm.
Claims25
1-112. (canceled)
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 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 particles, wherein about 80% of the particles are between or equivalent to about 250 nm and about 50 nm, and at least one surface stabilizer is associated with the surface of the megestrol particles;
- and
- (c) the administration is once daily;
- wherein after a single administration in a human subject of the formulation the difference in the Cmax of the megestrol when administered in a fed versus a fasted state is less than about 100%,
- wherein fasted state is defined as the subject having no food within at least the previous 10 hours, and
- wherein fed state is defined as the subject having a high-calorie meal within approximately 30 minutes of dosing.
4 more elements
Dependencies are inferred from the claim text.