Claims for Patent: 11,684,607

Summary for Patent: 11,684,607

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):	Helen S. PENTIKIS, David Palling, Carol J. BRAUN
Assignee:	Evofem Biosciences Inc
Application Number:	US17/335,016
Patent Claims:	1. An oral pharmaceutical composition comprising a plurality of microgranules wherein the plurality of microgranules comprises a therapeutically effective amount of secnidazole, each microgranule comprises a sugar sphere core and an outer layer disposed on the sugar sphere core, the outer layer comprises secnidazole, wherein the therapeutically effective amount of secnidazole in the oral pharmaceutical composition is about 42% w/w based on the total weight of the oral pharmaceutical composition, wherein each microgranule has a particle diameter in the range of 400 micrometers to 841 micrometers, wherein the therapeutically effective amount of secnidazole in the composition is 2 grams and the secnidazole is the sole drug in the oral pharmaceutical composition. 2. The oral pharmaceutical composition of claim 1, wherein the oral pharmaceutical composition 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. 3. The oral pharmaceutical composition of claim 1, wherein the oral pharmaceutical composition is integrated into a food substance prior to administration. 4. The oral pharmaceutical composition of claim 3, wherein the food substance is applesauce, yogurt or pudding. 5. The oral pharmaceutical composition of claim 1, wherein the oral pharmaceutical composition is in a form of a single dose unit. 6. The oral pharmaceutical composition of claim 5, wherein the single dose unit is packaged in a pouch or sachet. 7. A method of treating bacterial vaginosis in a subject in need thereof, the method comprising orally administering to the subject the oral pharmaceutical composition of claim 1 as a single dose. 8. The method of claim 7, wherein the oral pharmaceutical composition 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. 9. The method of claim 7, wherein the subject is a female. 10. The method of claim 7, wherein the subject is a pregnant female. 11. The method of claim 7, wherein the oral pharmaceutical composition is integrated into a food substance prior to administration. 12. The method of claim 11, wherein the food substance is applesauce, yogurt or pudding. 13. The method of claim 7, wherein the oral pharmaceutical composition is packaged in a pouch or sachet. 14. A method for treating bacterial vaginosis in a subject in need thereof, the method comprising orally co-administrating to the subject the oral pharmaceutical composition of claim 1 as a single dose on the same day as a therapeutically effective amount of an additional compound selected from the group consisting of ethinyl estradiol, norethindrone, and a combination thereof. 15. A method of treating a sexually transmitted infection (STI) in a subject in need thereof, the method comprising orally administering to the subject the oral pharmaceutical composition of claim 1 as a single dose. 16. The method of claim 15, wherein the STI is Chlamydia, gonorrhea, trichomoniasis, herpes simplex virus 2 or human papillomavirus. 17. The method of claim 16, wherein the STI is trichomoniasis. 18. A method of reducing a risk of transmitting the human immunodeficiency virus (HIV) from a subject to a sexual partner, the method comprising orally administering to the subject the oral pharmaceutical composition of claim 1 as a single dose. 19. A method of reducing a risk to acquiring HIV from a sexual partner by a subject, the method comprising orally administering to the subject the oral pharmaceutical composition of claim 1 as a single dose. 20. The method of claim 14, wherein the oral pharmaceutical composition does not affect a contraceptive efficacy of the additional compound.