Claims for Patent: 11,541,035

Summary for Patent: 11,541,035

Title:	Oral formulations of metronidazole and methods of treating an infection using same
Abstract:	The present disclosure provides oral pharmaceutical compositions comprising: 1) metronidazole or a pharmaceutically acceptable salt thereof; and magnesium aluminum silicate; or 2) metronidazole or a pharmaceutically acceptable salt thereof; magnesium aluminum silicate; and a flavoring agent. Methods of treating infection utilizing the oral pharmaceutical compositions are also provided.
Inventor(s):	Bernard J. Guarino, Jr., Jamie L. Doran, Zorana Radovic, Kevin Sullivan
Assignee:	Appili Therapeutics Inc , Appili Therapeutics Inc
Application Number:	US16/959,536
Patent Claims:	1. An oral pharmaceutical composition comprising: metronidazole, sucrose, glycerin, purified water, magnesium aluminum silicate, microcrystalline cellulose, sucralose, sodium phosphate, one or more preservatives, strawberry flavoring agent and peppermint flavoring agent. 2. A method of treating an infection in a patient, said method comprising the step of administering to the patient an effective amount of an oral pharmaceutical composition comprising: metronidazole, sucrose, glycerin, purified water, magnesium aluminum silicate, microcrystalline cellulose, sucralose, sodium phosphate, one or more preservatives, strawberry flavoring agent and peppermint flavoring agent. 3. The method of claim 2, wherein the infection is a bacterial infection, a fungal infection, a protozoan infection, amebiasis, pelvic inflammatory disease, endocarditis, bacterial vaginosis, dracunculiasis, giardiasis, or trichomoniasis. 4. The method of claim 3, wherein the bacterial infection is caused by one or more of a gram-positive bacterium, a gram-negative bacterium, an aerobic bacterium and an anaerobic bacterium. 5. The method of claim 2, wherein the patient is a geriatric patient or a pediatric patient. 6. The oral pharmaceutical composition of claim 1, wherein: a. the metronidazole is present at a range of 1% (w/v) to 20% (w/v); b. the sucrose is present at a range of 30% (w/v) to 65% (w/v); c. the glycerin is present at a range of 5% (w/v) to 20% (w/v); d. the magnesium aluminum silicate is present at a range of 0.1% (w/v) to 1.9% (w/v); e. the microcrystalline cellulose is present at a range of 0.1% (w/v) to 1.5% (w/v); f. the sucralose is present at a range of 0.05% (w/v) to 1.5% (w/v); g. the sodium phosphate is a combination of sodium phosphate monobasic and sodium phosphate dibasic, each present at a range of 0.001% (w/v) to 1% (w/v); h. the one or more preservatives are methylparaben and propylparaben, each present at a range of 0.01% (w/v) to 1% (w/v); i. the strawberry flavoring agent is natural strawberry flavor present at a range of 0.1% (w/v) to 2% (w/v); and/or j. the peppermint flavoring agent is natural peppermint flavor present at a range of 0.1% (w/v) to 2% (w/v). 7. The oral pharmaceutical composition of claim 1, wherein: a. the metronidazole is present at 10% (w/v); b. the sucrose is present at 50% (w/v); c. the glycerin is present at 10% (w/v); d. the magnesium aluminum silicate is present at 1.2% (w/v); e. the microcrystalline cellulose is present at 0.6% (w/v); f. the sucralose is present at 0.25% (w/v); g. the sodium phosphate is a combination of sodium phosphate monobasic and sodium phosphate dibasic, each present at 0.2% (w/v); h. the one or more preservatives are methylparaben and propylparaben, wherein the methylparaben is present at 0.15% (w/v) and the propylparaben is present at 0.02% (w/v); i. the strawberry flavoring agent is natural strawberry flavor present at 0.4% (w/v); and/or j. the peppermint flavoring agent is natural peppermint flavor present at 0.2% (w/v). 8. The oral pharmaceutical composition of claim 1, wherein the magnesium aluminum silicate is Type 1C. 9. The oral pharmaceutical composition of claim 7, wherein the magnesium aluminum silicate is Type 1C. 10. The oral pharmaceutical composition of claim 1, wherein the oral pharmaceutical composition is a suspension. 11. The oral pharmaceutical composition of claim 7, wherein the oral pharmaceutical composition is a suspension. 12. An oral pharmaceutical composition comprising: 10.0% (w/v) metronidazole, 50% (w/v) sucrose, 10.0% (w/v) glycerin, purified water, 1.2% (w/v) magnesium aluminum silicate, 0.6% (w/v) microcrystalline cellulose, 0.25% (w/v) sucralose, 0.2% (w/v) sodium phosphate monobasic, 0.2% (w/v) sodium phosphate dibasic, 0.15% (w/v) methylparaben, 0.02% (w/v) propylparaben, 0.4% (w/v) natural strawberry flavor and 0.2% (w/v) natural peppermint flavor. 13. The oral pharmaceutical composition of claim 12, wherein the magnesium aluminum silicate is Type 1C. 14. The oral pharmaceutical composition of claim 12, wherein the oral pharmaceutical composition is a suspension. 15. The method of claim 2, wherein: a. the metronidazole in the oral pharmaceutical composition is present at a range of 1% (w/v) to 20% (w/v); b. the sucrose in the oral pharmaceutical composition is present at a range of 30% (w/v) to 65% (w/v); c. the glycerin in the oral pharmaceutical composition is present at a range of 5% (w/v) to 20% (w/v); d. the magnesium aluminum silicate in the oral pharmaceutical composition is present at a range of 0.1% (w/v) to 1.9% (w/v); e. the microcrystalline cellulose in the oral pharmaceutical composition is present at a range of 0.1% (w/v) to 1.5% (w/v); f. the sucralose in the oral pharmaceutical composition is present at a range of 0.05% (w/v) to 1.5% (w/v); g. the sodium phosphate in the oral pharmaceutical composition is a combination of sodium phosphate monobasic and sodium phosphate dibasic, each present at a range of 0.001% (w/v) to 1% (w/v); h. the one or more preservatives in the oral pharmaceutical composition are methylparaben and propylparaben, each present at a range of 0.01% (w/v) to 1% (w/v); i. the strawberry flavoring agent in the oral pharmaceutical composition is natural strawberry flavor present at a range of 0.1% (w/v) to 2% (w/v); and/or j. the peppermint flavoring agent in the oral pharmaceutical composition is natural peppermint flavor present at a range of 0.1% (w/v) to 2% (w/v). 16. The method of claim 2, wherein: a. the metronidazole in the oral pharmaceutical composition is present at 10% (w/v); b. the sucrose in the oral pharmaceutical composition is present at 50% (w/v); c. the glycerin in the oral pharmaceutical composition is present at 10% (w/v); d. the magnesium aluminum silicate in the oral pharmaceutical composition is present at 1.2% (w/v); e. the microcrystalline cellulose in the oral pharmaceutical composition is present at 0.6% (w/v); f. the sucralose in the oral pharmaceutical composition is present at 0.25% (w/v); g. the sodium phosphate in the oral pharmaceutical composition is a combination of sodium phosphate monobasic and sodium phosphate dibasic, each present at 0.2% (w/v); h. the one or more preservatives in the oral pharmaceutical composition are methylparaben and propylparaben, wherein the methylparaben is present at 0.15% (w/v) and the propylparaben is present at 0.02% (w/v); i. the strawberry flavoring agent in the oral pharmaceutical composition is natural strawberry flavor present at 0.4% (w/v); and/or j. the peppermint flavoring agent in the oral pharmaceutical composition is natural peppermint flavor present at 0.2% (w/v). 17. The method of claim 15, wherein the magnesium aluminum silicate is Type 1C. 18. The method of claim 16, wherein the magnesium aluminum silicate is Type 1C. 19. The method of claim 15, wherein the oral pharmaceutical composition is a suspension. 20. The method of claim 16, wherein the oral pharmaceutical composition is a suspension. 21. The method of claim 2, wherein the oral pharmaceutical composition comprises: 10.0% (w/v) metronidazole, 50% (w/v) sucrose, 10.0% (w/v) glycerin, purified water, 1.2% (w/v) magnesium aluminum silicate, 0.6% (w/v) microcrystalline cellulose, 0.25% (w/v) sucralose, 0.2% (w/v) sodium phosphate monobasic, 0.2% (w/v) sodium phosphate dibasic, 0.15% (w/v) methylparaben, 0.02% (w/v) propylparaben, 0.4% (w/v) natural strawberry flavor and 0.2% (w/v) natural peppermint flavor. 22. The method of claim 21, wherein the magnesium aluminum silicate is Type 1C. 23. The method of claim 21, wherein the oral pharmaceutical composition is a suspension.