NANOPARTICULATE MEGESTROL FORMULATIONS
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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.
5 Citations
141 Claims
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1-112. -112. (canceled)
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113. 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:
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(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 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 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, and wherein fed state is defined as the subject having a high-calorie meal within approximately 30 minutes of dosing. - View Dependent Claims (114, 115, 116, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127)
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128. 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:
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(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 90% of the particles are less than or equivalent to about 250 nm, and about 10% of the particles are less than or equivalent to 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 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, and wherein fed state is defined as the subject having a high-calorie meal within approximately 30 minutes of dosing. - View Dependent Claims (129, 130, 131, 132, 133, 134, 141)
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135. 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:
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(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 90% of the particles have a size less than or equivalent to about 250 nm and about 90% of particles have a size greater than or equivalent to 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 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, and wherein fed state is defined as the subject having a high-calorie meal within approximately 30 minutes of dosing. - View Dependent Claims (136, 137, 138, 139, 140)
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Specification