Nanoparticulate megestrol formulations

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 or equivalent to 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 the difference in the C max of the megestrol acetate when administered in a fed versus a fasted state is less than about 60%,

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.

2. The method of claim 1 , wherein about 80% of the particles are between or equivalent to about 230 nm and about 70 nm.

3. The method of claim 1 , wherein the anorexia, cachexia or loss of body mass is associated with a diagnosis of HIV or AIDS in the human patient.

4. The method of claim 1 , wherein the anorexia, cachexia or loss of body mass is associated with a diagnosis of cancer in the human patient.

5. The method of claim 1 , wherein the difference in C max of the megestrol when administered in a fed versus a fasted state is less than about 50%.

6. The method of claim 1 , wherein the difference in C max of the megestrol when administered in a fed versus a fasted state is less than about 40%.

7. The method of claim 1 , wherein the difference in C max of the megestrol when administered in a fed versus a fasted state is less than about 30%.

8. The method of claim 1 , wherein the difference in C max of the megestrol when administered in a fed versus a fasted state is less than about 20%.

9. The method of claim 1 , wherein the difference in C max of the megestrol when administered in a fed versus a fasted state is less than about 15%.

10. The method of claim 1 , wherein the difference in C max of the megestrol when administered in a fed versus a fasted state is less than about 10%.

11. The method of claim 1 , wherein the difference in C max of the megestrol when administered in a fed versus a fasted state is less than about 5%.

12. The method of claim 1 , wherein the difference in C max of the megestrol when administered in a fed versus a fasted state is less than about 3%.

13. The method of claim 1 , wherein there is a difference in the mean T max for the megestrol acetate formulation when administered in fed versus fasted states, and that difference is selected from the group consisting of less than about 100%, less than about 90%, less than about 80%, less than about 70%, less than about 60%, less than about 50%, less than about 40%, less than about 30%, less than about 20%, less than about 15%, less than about 10%, less than about 5%, and less than about 3%.

14. The method of claim 1 , wherein the formulation exhibits a mean C max selected from the group consisting of greater than about 5%, greater than about 10%, greater than about 15%, greater than about 20%, greater than about 30%, greater than about 40%, greater than about 50%, greater than about 60%, greater than about 70%, greater than about 80%, greater than about 90%, greater than about 100%, greater than about 110%, greater than about 120%, greater than about 130%, greater than about 140%, and greater than about 150% than the mean Cmax exhibited by a standard commercial, non-nanoparticulate composition of megestrol, administered at the same dosage.

15. The method of claim 1 , wherein there is a difference in absorption (AUC) when the formulation is administered in fed versus fasted states, and the difference is selected from the group consisting of less than about 35%, less than about 30%, less than about 25%, less than about 20%, less than about 15%, less than about 10%, less than about 5%, and less than about 3%.

16. The method of claim 1 , wherein a maximum blood plasma concentration of megestrol is attained in about 1 hour or less after administration of the megestrol formulation in fasting subjects.

17. The method of claim 1 , wherein a maximum blood plasma concentration of megestrol of at least about 700 ng/ml is obtained.

18. The method of claim 15 , wherein the maximum blood plasma concentration of megestrol is at least about 700 ng/ml and is attained in less than 5 hours after administration of the megestrol formulation.

19. The method of claim 1 , wherein the maximum blood plasma concentration of megestrol is at least about 400 ng/ml and is attained in less than 5 hours after administration of the megestrol formulation.

20. The method of claim 1 , wherein a mean C max of about 300 ng/ml to about 2000 ng/ml is obtained after a single administration of the formulation in the human subject in a fasted state.

21. The method of claim 1 , wherein the surface stabilizer is selected from the group consisting of nonionic surfactants, cationic surfactants, ionic surfactants, and zwitterionic surfactants.

22. The method of claim 1 , wherein the surface stabilizer is selected from the group consisting of hydroxypropyl methylcellulose, hydroxypropylcellulose, polyvinylpyrrolidone, sodium lauryl sulfate, dioctylsulfosuccinate, polyoxyethylene alkyl etherspolyoxyethylene sorbitan fatty acid esters, 4-(1,1,3,3-tetramethylbutyl)-phenol polymer with ethylene oxide and formaldehyde, lysozyme, and random copolymers of vinyl pyrrolidone and vinyl acetate.

23. The method of claim 17 , wherein the surface stabilizer is selected from the group consisting of hydroxypropyl methylcellulose, dioctylsulfosuccinate, and a combination thereof.