Claims for Patent: 10,857,133

Summary for Patent: 10,857,133

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:	16/586,339
Patent Claims:	1. A single dose pharmaceutical composition comprising a therapeutically effective amount of secnidazole, wherein the composition comprises a plurality of microgranules, each microgranule comprises a sugar sphere core and an outer layer disposed on the sugar sphere core, the outer layer comprises secnidazole, 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, wherein the composition is for oral administration, wherein the secnidazole is the sole drug in the composition, and wherein the total weight of the composition is about 4730 mg. 2. The single dose pharmaceutical composition of claim 1, wherein the composition further comprises at least one compound selected from the group consisting of a sugar sphere, povidone, polyethylene glycol, ethyl acrylate methyl--a sugar sphere, and talc. 3. The single dose pharmaceutical composition of claim 1, wherein the single dose pharmaceutical composition is packaged in a single dose unit pouch or sachet. 4. A method of treating bacterial vaginosis in a subject in need thereof comprising orally administering to the subject the single dose pharmaceutical composition of claim 1. 5. The method of claim 4, wherein the 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. 6. The method of claim 4, wherein the subject is a female. 7. The method of claim 4, wherein the subject is a pregnant female. 8. The method of claim 4, wherein the single dose pharmaceutical composition is packaged in a single dose unit pouch or sachet. 9. A single dose pharmaceutical composition comprising a therapeutically effective amount of secnidazole, wherein the composition comprises a plurality of microgranules, each microgranule comprises a sugar sphere core and an outer layer disposed on the sugar sphere core, the outer layer comprises secnidazole, 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, wherein the composition is for oral administration, wherein the total weight of the composition is about 4730 mg, wherein the secnidazole is the sole drug in the composition, and wherein said composition is integrated into a food substance. 10. The single dose pharmaceutical composition of claim 9, wherein the food substance is applesauce, yogurt, or pudding. 11. The single dose pharmaceutical composition of claim 9, wherein the composition further comprises at least one compound selected from the group consisting of a sugar sphere, povidone, polyethylene glycol, ethyl acrylate methyl--a copolymer of ethyl acrylate and methyl methacrylate, and talc. 12. A method of treating bacterial vaginosis in a subject in need thereof comprising orally administering to the subject the single dose pharmaceutical composition of claim 9. 13. The method of claim 12, wherein the composition further comprises at least one compound selected from the group consisting of povidone, polyethylene glycol, a copolymer of ethyl acrylate and methyl methacrylate copolymer, and talc. 14. The method of claim 12, wherein the subject is a female. 15. The method of claim 12, wherein the subject is a pregnant female. 16. The single dose pharmaceutical composition of claim 1, wherein each microgranule further comprises a seal coating disposed on the outer layer, and a delayed release coating disposed on the seal coating. 17. The single dose pharmaceutical composition of claim 16, wherein the seal coating comprises polyethylene glycol and the delayed release coating comprises a copolymer of ethyl acrylate and methyl methacrylate. 18. The single dose pharmaceutical composition of claim 1, wherein the single dose pharmaceutical composition exhibits a time to drug elimination half-life (t.sub.1/2) of about 11.3 hours to about 20.4 hours in the subject as determined by non-compartmental analysis. 19. The method of claim 4, wherein the composition is administered on the same day as a therapeutically effective amount of an additional compound selected from the group consisting of ethinyl estradiol, norethindrone, or a combination thereof. 20. The single dose pharmaceutical composition of claim 9, wherein each microgranule further comprises a seal coating disposed on the outer layer, and a delayed release coating disposed on the seal coating. 21. The single dose pharmaceutical composition of claim 20, wherein the seal coating comprises polyethylene glycol and the delayed release coating comprises a copolymer of ethyl acrylate and methyl-methacrylate. 22. The single dose pharmaceutical composition of claim 9, wherein the single dose pharmaceutical composition exhibits a t.sub.1/2 of about 11.3 hours to about 20.4 hours in the subject as determined by non-compartmental analysis. 23. The method of claim 12, wherein the composition is administered on the same day as a therapeutically effective amount of an additional compound selected from the group consisting of ethinyl estradiol, norethindrone, or a combination thereof.