Claims for Patent: 11,324,721

Summary for Patent: 11,324,721

Title:	Secnidazole for use in the treatment of trichomoniasis
Abstract:	Embodiments are directed to secnidazole formulations and the use of a secnidazole formulation for the treatment of trichomoniasis in a subject in need thereof.
Inventor(s):	Pentikis; Helen S. (Timonium, MD), Palling; David (Glen Ridge, NJ), Braun; Carol J. (Ellicott City, MD)
Assignee:	Lupin Inc. (Baltimore, MD)
Application Number:	16/890,526
Patent Claims:	1. A method of treating trichomoniasis in a subject in need thereof comprising administering to the subject a therapeutically effective amount of secnidazole in a microgranule formulation, wherein the microgranule formulation comprises a plurality of microgranules, each microgranule comprises secnidazole and has a particle diameter in the range of 400 micrometers to 841 micrometers, wherein each microgranule comprises a sugar sphere core and an outer layer disposed on the sugar sphere core, the outer layer comprising secnidazole, wherein the secnidazole is the sole drug in the microgranule formulation, and wherein the therapeutically effective amount of secnidazole is an amount of secnidazole that exhibits a maximum plasma concentration (C.sub.max) of about 34.5 .mu.g/ml to about 58.3 .mu.g/ml, or about 17.4 .mu.g/ml to about 26.5 .mu.g/ml in the subject. 2. A method of treating trichomoniasis in a subject in need thereof comprising administering to the subject a therapeutically effective amount of secnidazole in a microgranule formulation, wherein the microgranule formulation comprises a plurality of microgranules, each microgranule comprises secnidazole and has a particle diameter in the range of 400 micrometers to 841 micrometers, wherein each microgranule comprises a sugar sphere core and an outer layer disposed on the sugar sphere core, the outer layer comprising secnidazole, wherein the secnidazole is the sole drug in the microgranule formulation, and wherein the therapeutically effective amount of secnidazole is an amount of secnidazole that exhibits a time to maximum plasma concentration (T.sub.max) of about 2 hours to about 6 hours in the subject. 3. A method of treating trichomoniasis in a subject in need thereof comprising administering to the subject a therapeutically effective amount of secnidazole in a microgranule formulation, wherein the microgranule formulation comprises a plurality of microgranules, each microgranule comprises secnidazole and has a particle diameter in the range of 400 micrometers to 841 micrometers, wherein each microgranule comprises a sugar sphere core and an outer layer disposed on the sugar sphere core, the outer layer comprising secnidazole, wherein the secnidazole is the sole drug in the microgranule formulation, and wherein the therapeutically effective amount of secnidazole is an amount of secnidazole that exhibits a T.sub.max of about 3 hours to about 4 hours in the subject. 4. The method of claim 1, wherein the therapeutically effective amount of secnidazole is 2 grams. 5. The method of claim 1, wherein the therapeutically effective amount of secnidazole in the microgranule formulation is administered orally. 6. The method of claim 1, wherein the microgranule formulation further comprises at least one ingredient selected from the group consisting of povidone, polyethylene glycol, a copolymer of ethyl acrylate and methyl methacrylate, talc, and a combination thereof. 7. The method of claim 1, wherein the microgranule formulation is integrated into a food substance. 8. The method of claim 7, wherein the food substance is applesauce, yogurt, or pudding. 9. The method of claim 2, wherein the microgranule formulation is integrated into a food substance. 10. The method of claim 1, wherein the subject is a female. 11. The method of claim 1, wherein the subject is a pregnant female. 12. The method of claim 1, wherein the subject is suffering from bacterial vaginosis. 13. The method of claim 1, wherein the therapeutically effective amount of secnidazole in the microgranule formulation is administered as a single dose. 14. The method of claim 1, wherein the therapeutically effective amount of secnidazole in the microgranule formulation is administered with an additional compound selected from ethinyl estradiol (EE2), norethindrone (NET), or a combination thereof. 15. The method of claim 14, wherein the additional compound is administered on the same day as the therapeutically effective amount of secnidazole in the microgranule formulation. 16. The method of claim 14, wherein the additional compound is administered on a different day as the therapeutically effective amount of secnidazole in the microgranule formulation. 17. The method of claim 1, wherein the microgranule formulation does not affect the contraceptive efficacy of an additional compound selected from EE2, NET, or a combination thereof. 18. The method of claim 2, wherein the subject is suffering from bacterial vaginosis. 19. The method of claim 3, wherein the subject is suffering from bacterial vaginosis. 20. The method of claim 2, wherein the therapeutically effective amount of secnidazole is 2 grams.