Claims for Patent: 10,849,884

Summary for Patent: 10,849,884

Title:	Secnidazole for use in the treatment of bacterial vaginosis
Abstract:	Embodiments are directed to a secnidazole formulations and the use of a secnidazole formulation for the treatment of bacterial vaginosis (BV).
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:	16/403,176
Patent Claims:	1. A single dose pharmaceutical composition comprising a therapeutically effective amount of secnidazole, wherein the pharmaceutical composition comprises a plurality of microgranules, each microgranule comprises secnidazole, a sugar sphere, povidone, ethyl acrylate-methyl methacrylate copolymer and has a particle diameter in the range of 400 micrometers to 841 micrometers, wherein the therapeutically effective amount of secnidazole in the pharmaceutical composition is 2 grams and exhibits a maximum plasma concentration (Cmax) of 34.5 .mu.g/ml to 58.3 .mu.g/ml in a subject after 2 hours to 6 hours from administering the pharmaceutical composition to the subject, wherein the pharmaceutical composition is for oral administration, and wherein secnidazole is the sole drug in the pharmaceutical composition. 2. A single dose pharmaceutical composition comprising a therapeutically effective amount of secnidazole, wherein the pharmaceutical composition comprises a plurality of microgranules, each microgranule comprises secnidazole, a sugar sphere, povidone, ethyl acrylate-methyl methacrylate copolymer and has a particle diameter in the range of 400 micrometers to 841 micrometers, wherein the therapeutically effective amount of secnidazole in the pharmaceutical composition is 2 grams and exhibits a Cmax of 34.5 .mu.g/ml to 58.3 .mu.g/ml in a subject after 3 hours to 4 hours from administering the pharmaceutical composition to the subject, wherein the pharmaceutical composition is for oral administration, and wherein secnidazole is the sole drug in the pharmaceutical composition. 3. A method for treating bacterial vaginosis in a subject in need thereof, the method comprising co-administrating the single dose pharmaceutical composition of claim 1, to the subject in combination with an additional compound selected from the group consisting of ethinyl estradiol (EE2), norethindrone (NET), and a combination thereof, and wherein the additional compound is administered on the same day as the single dose pharmaceutical composition. 4. A method for treating bacterial vaginosis in a subject in need thereof, the method comprising co-administrating the single dose pharmaceutical composition of claim 2, to the subject in combination with an additional compound selected from the group consisting of EE2, NET, and a combination thereof, and wherein the additional compound is administered on the same day as the single dose pharmaceutical composition. 5. A method for treating bacterial vaginosis in a subject in need thereof, the method comprising co-administrating the single dose pharmaceutical composition of claim 1, to the subject in combination with a pharmaceutical composition comprising a therapeutically effective amount of an additional compound selected from the group consisting of EE2, NET, and a combination thereof. 6. A method for treating bacterial vaginosis in a subject in need thereof, the method comprising co-administrating the single dose pharmaceutical composition of claim 1, to the subject in combination with a therapeutically effective amount of an additional compound selected from the group consisting of EE2, NET, and a combination thereof, and wherein secnidazole in the single dose pharmaceutical composition does not affect a contraceptive efficacy of the additional compound selected from the group consisting of EE2, NET, and a combination thereof. 7. The single dose pharmaceutical composition of claim 1, wherein the each microgranule further comprises at least one compound selected from a group consisting of polyethylene glycol and talc. 8. The single dose pharmaceutical composition of claim 1, wherein the pharmaceutical composition is integrated with a food substance. 9. The single dose pharmaceutical composition of claim 8, wherein the food substance is applesauce, yogurt or pudding. 10. The single dose pharmaceutical composition of claim 1, wherein the subject is a female. 11. The single dose pharmaceutical composition of claim 1, wherein the subject is a pregnant female. 12. The single dose pharmaceutical composition of claim 1, wherein the subject is a female having had bacterial vaginosis 3 or more times within the past 12 months. 13. The single dose pharmaceutical composition of claim 1, wherein the subject is a female having had bacterial vaginosis 4 or more times within the past 12 months. 14. A method for treating bacterial vaginosis in a subject in need thereof, the method comprising co-administrating the single dose pharmaceutical composition of claim 1, to the subject in combination with a therapeutically effective amount of an additional compound selected from the group consisting of EE2, NET, and a combination thereof, and wherein the additional compound is administered on a different day as the single dose pharmaceutical composition. 15. A method for treating bacterial vaginosis in a subject in need thereof, the method comprising co-administrating the single dose pharmaceutical composition of claim 2, to the subject in combination with a therapeutically effective amount of an additional compound selected from the group consisting of EE2, NET, and a combination thereof, and wherein the additional compound is administered on a different day as the single dose pharmaceutical composition. 16. A method for treating bacterial vaginosis in a subject in need thereof, the method comprising co-administrating the single dose pharmaceutical composition of claim 2, to the subject in combination with a pharmaceutical composition comprising a therapeutically effective amount of an additional compound selected from the group consisting of EE2, NET, and a combination thereof. 17. A method for treating bacterial vaginosis in a subject in need thereof, the method comprising co-administrating the single dose pharmaceutical composition of claim 2, to the subject in combination with an additional compound selected from the group consisting of EE2, NET, and a combination thereof, and wherein secnidazole in the single dose pharmaceutical composition does not affect a contraceptive efficacy of the additional compound selected from the group consisting of EE2, NET, and a combination thereof. 18. The single dose pharmaceutical composition of claim 2, wherein the each microgranule further comprises at least one compound selected from a group consisting of polyethylene glycol and talc. 19. The single dose pharmaceutical composition of claim 2, wherein the pharmaceutical composition is integrated with a food substance. 20. The single dose pharmaceutical composition of claim 19, wherein the food substance is applesauce, yogurt or pudding. 21. The single dose pharmaceutical composition of claim 2, wherein the subject is a female. 22. The single dose pharmaceutical composition of claim 2, wherein the subject is a pregnant female. 23. A method of reducing a risk of acquiring a sexually transmitted infection (STI) from a sexual partner by a subject, the method comprising orally administering to the subject the single dose pharmaceutical composition of claim 1. 24. The method of claim 23, wherein the STI is chlamydia, gonorrhea, trichomoniasis, herpes simplex virus 2 or human papillomavirus. 25. The method of claim 23, wherein the STI is trichomoniasis. 26. The method of claim 25, wherein the trichomoniasis is caused by infection with protozoan Trichomonas vaginalis.