Claims for Patent: 11,446,246

Summary for Patent: 11,446,246

Title:	Suspensions and diluents for metronidazole and baclofen
Abstract:	Suspensions of metronidazole or baclofen and/or salts or ester derivative thereof, such as metronidazole benzoate, are disclosed. The suspension my include metronidazole or baclofen, and/or a salt or ester derivative thereof a hydrocolloid stabilizer, simethicone emulsion, a buffer, such as sodium citrate, (dihydrate), a preservative, a thickening agent, a sweetener, and water.
Inventor(s):	Ken Fallin, Zeus Pendon, Priya CAPILA, Neal Muni
Assignee:	Azurity Pharmaceuticals Inc
Application Number:	US17/725,923
Patent Claims:	1. A method of treating spasticity in a subject comprising administering to the subject a liquid oral pharmaceutical composition, wherein the liquid oral pharmaceutical composition comprises: a) 5 mg/ml of baclofen or a salt thereof; b) 0.12% (w/v) of citric acid (anhydrous); c) 0.5% (w/v) of hydroxyethyl cellulose; d) 5% (w/v) of propylene glycol; e) 0.15% (w/v) of simethicone emulsion (30%); f) 0.1% (w/v) of sodium benzoate; g) 0.2% (w/v) of sucralose; and h) water, wherein a pH of the liquid oral pharmaceutical composition is between 3.0 and 6.0, and wherein the liquid oral pharmaceutical composition retains less than +/−5% variation of baclofen concentration measured by a USP assay for at least 30 days when stored at room temperature. 2. The method of claim 1, wherein the liquid oral pharmaceutical composition further retains less than +/−5% variation of baclofen concentration measured by a USP assay for at least 30 days when stored at 38-42° C. 3. The method of claim 1, wherein the liquid oral pharmaceutical composition further retains less than +/−5% variation of baclofen concentration measured by a USP assay for at least 30 days when stored at 15-30° C. 4. The method of claim 1, wherein the liquid oral pharmaceutical composition retains less than +/−2% variation of baclofen concentration measured by a USP assay for at least 30 days when stored at room temperature. 5. The method of claim 1, wherein the liquid oral pharmaceutical composition further comprises a coloring agent, a flavoring agent, or a combination thereof. 6. The method of claim 1, wherein the liquid oral pharmaceutical composition comprises 0.0002% (w/v) of D&C Yellow No. 10. 7. The method of claim 1, wherein the liquid oral pharmaceutical composition comprises about 0.000038% (w/v) of FD&C Red No. 40. 8. The method of claim 1, wherein the liquid oral pharmaceutical composition comprises 0.0500% (w/v) of flavor grape 59.266/A. 9. The method of claim 1, wherein the pH of the liquid oral pharmaceutical composition is between 3.6 and 4.6. 10. The method of claim 1, wherein the pH of the liquid oral pharmaceutical composition is 4.0 to 4.3. 11. The method of claim 1, wherein treating spasticity comprises alleviating one or more muscle symptoms selected from spasms, pain, stiffness, tightness, or cramping. 12. The method of claim 11, wherein the one or more muscle symptoms are caused by multiple sclerosis. 13. The method of claim 1, wherein the subject is a human. 14. The method of claim 13, wherein the human is a child. 15. The method of claim 13, wherein the human is an adult or elderly. 16. The method of claim 13, wherein the human has multiple sclerosis.