Claims for Patent: 11,020,377

Summary for Patent: 11,020,377

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:	16/586,372
Patent Claims:	1. An oral, single dose pharmaceutical composition for treating bacterial vaginosis in a subject in need thereof comprising a therapeutically effective amount of secnidazole, wherein the pharmaceutical composition comprises a plurality of microgranules, each microgranule comprises secnidazole, a sugar sphere, a copolymer of ethyl acrylate and methyl methacrylate 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 the pharmaceutical composition provides a maximum plasma concentration of secnidazole in about 3 hours to about 4 hours after administering to the subject, or provides an elimination half-life of secnidazole in plasma in about 11.3 hours to about 20.4 hours after administering to the subject as determined by non-compartmental analysis, and wherein the secnidazole is the sole drug in the pharmaceutical composition. 2. The oral, single dose pharmaceutical composition of claim 1, wherein the pharmaceutical composition further comprises at least one compound selected from the group consisting of povidone, polyethylene glycol and talc. 3. A method of treating bacterial vaginosis in a subject in need thereof comprising orally administering to the subject the oral, single dose pharmaceutical composition of claim 1. 4. The method of claim 3, wherein the each microgranule further comprises at least one compound selected from the group consisting of povidone, polyethylene glycol and talc. 5. The method of claim 3, wherein the subject is female. 6. The method of claim 3, wherein the subject is pregnant female. 7. The method of claim 3, wherein the pharmaceutical composition is integrated into a food substance prior to administration. 8. The method of claim 7, wherein the food substance is applesauce, yogurt or pudding. 9. An oral, single dose pharmaceutical composition for treating bacterial vaginosis in a subject in need thereof comprising a therapeutically effective amount of secnidazole, wherein the composition comprises a plurality of microgranules, each microgranule comprises secnidazole, a sphere core and an outer layer disposed on the sphere core, a copolymer of ethyl acrylate and methyl methacrylate 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 the pharmaceutical composition provides a maximum plasma concentration of secnidazole of about 34.5 .mu.g/ml to about 58.3 .mu.g/ml in the subject, or a time to maximum plasma concentration of secnidazole of about 2 hours to about 6 hours after administering to the subject, or an elimination half-life of secnidazole in plasma in about 11.3 hours to about 20.4 hours after administering to the subject as determined by non-compartmental analysis, and wherein the secnidazole is the sole drug in the pharmaceutical composition. 10. The oral, single dose pharmaceutical composition of claim 9, wherein the each microgranule further comprises a coating layer disposed on top of the outer layer, wherein the coating layer comprises at least one compound selected from the group consisting of povidone, polyethylene glycol, a copolymer of ethyl acrylate and methyl methacrylate, and talc. 11. The oral, single dose pharmaceutical composition of claim 9, wherein the sphere core is a sugar sphere core. 12. The oral, single dose oral pharmaceutical composition of claim 9, wherein the outer layer comprises secnidazole. 13. The oral, single dose oral pharmaceutical composition of claim 9, wherein the outer layer further comprises at least one compound selected from the group consisting of povidone, polyethylene glycol, a copolymer of ethyl acrylate and methyl methacrylate, and talc. 14. The oral, single dose oral pharmaceutical composition of claim 10, wherein the coating layer comprises a copolymer of ethyl acrylate and methyl methacrylate. 15. The oral, single dose oral pharmaceutical composition of claim 10, wherein the coating layer comprises a copolymer of ethyl acrylate and methyl methacrylate and polyethylene glycol. 16. The oral, single dose pharmaceutical composition of claim 9, wherein the time to maximum plasma concentration of secnidazole is about 3 hours to about 4 hours after administering to the subject. 17. The oral, single dose pharmaceutical composition of claim 9, wherein the elimination half-life of secnidazole in plasma is about 14.7 hours to about 20.4 hours after administering to the subject. 18. A method of treating bacterial vaginosis in a subject in need thereof comprising orally administering to the subject the oral, single dose pharmaceutical composition of claim 9. 19. The method of claim 18, wherein the subject is a female. 20. The method of claim 18, wherein the subject is a pregnant female. 21. The method of claim 18, wherein the pharmaceutical composition is integrated into a food substance prior to administration. 22. The method of claim 21, wherein the food substance is applesauce, yogurt or pudding. 23. The oral, single dose pharmaceutical composition of claim 1, wherein said composition is in a form of a single dose unit. 24. The oral, single dose pharmaceutical composition of claim 9, wherein said composition is in a form of a single dose unit. 25. The oral, single dose pharmaceutical composition of claim 23, wherein the single dose unit is in a pouch or sachet. 26. The oral, single dose pharmaceutical composition of claim 24, wherein the single dose unit is in a pouch or sachet. 27. A method for treating bacterial vaginosis in a subject in need thereof, the method comprising co-administering to the subject the oral, single dose pharmaceutical composition of claim 1 with an additional compound selected from the group consisting of ethinyl estradiol (EE2), norethindrone (NET), and a combination thereof. 28. A method for treating bacterial vaginosis in a subject in need thereof, the method comprising co-administering to the subject, the oral, single dose pharmaceutical composition of claim 9 with an additional compound selected from the group consisting of EE2, NET, and a combination thereof. 29. The method of claim 27, wherein the oral, single dose pharmaceutical composition does not affect a contraceptive efficacy of the additional compound. 30. The method of claim 28, wherein the oral, single dose pharmaceutical composition does not affect a contraceptive efficacy of the additional compound. 31. A method of reducing the incidence or risk of a subject acquiring a sexually transmitted infection (STI) from a sexual partner, the method comprising orally administering to the subject the oral, single dose pharmaceutical composition of claim 1. 32. The method of claim 31, wherein the STI is selected from chlamydia, gonorrhea, trichomoniasis, herpes simplex virus 2 (HSV-2), or human papillomavirus (HPV). 33. The method of claim 31, wherein the STI is trichomoniasis. 34. The method of claim 33, wherein the trichomoniasis is caused by infection with protozoan Trichomonas vaginalis. 35. A method of reducing the incidence or risk of a subject acquiring a STI from a sexual partner, the method comprising orally administering to the subject the oral, single dose pharmaceutical composition of claim 9. 36. The method of claim 35, wherein the STI is selected from chlamydia, gonorrhea, trichomoniasis, HSV-2, or HPV. 37. The method of claim 35, wherein the STI is trichomoniasis. 38. The method of claim 37, wherein the trichomoniasis is caused by infection with protozoan Trichomonas vaginalis.