Claims for Patent: 11,324,696

Summary for Patent: 11,324,696

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):	Fallin; Ken (Diamondhead, MS), Pendon; Zeus (Woburn, MA), Capila; Priya (Wellesley, MA), Muni; Neal (Wellesley, MA)
Assignee:	AZURITY PHARMACEUTICALS, INC. (Woburn, MA)
Application Number:	17/133,415
Patent Claims:	1. A liquid pharmaceutical composition that 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 pharmaceutical composition is between 3.0 and 6.0, and wherein the 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 pharmaceutical composition of claim 1, wherein the 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.degree. C. 3. The pharmaceutical composition of claim 1, wherein the 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.degree. C. 4. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition further comprises a coloring agent, a flavoring agent, or a combination thereof. 5. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition comprises 0.0002% (w/v) of D&C Yellow No. 10. 6. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition comprises 0.000038% (w/v) of FD&C Red No. 40. 7. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition comprises 0.0500% (w/v) of flavor grape 59.266/A. 8. The pharmaceutical composition of claim 1, wherein the pH of the pharmaceutical composition is about 3.6 to 4.6. 9. The pharmaceutical composition of claim 1, wherein the pH of the pharmaceutical composition is about 4.0 to 4.3.