Granted Patent B2

US 12,458,593 · App. 18/402,960 · Granted Nov 4, 2025

Inventors: Ken Fallin (Diamondhead, MS); Zeus Pendon (Woburn, MA); Priya Capila (Wellesley, MA); Neal Muni (Wellesley, MA)

Assignee: AZURITY PHARMACEUTICALS, INC.

A61K9/10A61K9/0053A61K9/0095A61K31/197A61K31/4164A61K47/08A61K47/10A61K47/12A61K47/26A61K47/34A61K47/36A61K47/38A61P21/02A61P31/04A61P33/02A61P21/00A61P25/28Y02A50/30

Abstract

Claims (23)

1 . A pharmaceutical composition comprising:

50 mg/mL or 100 mg/mL of metronidazole;

0.03% (w/v) of sodium saccharin;

0.05% (w/v) of ammonium glycyrrhizate;

0.1% (w/v) of sucralose;

1.5% (w/v) of a combination of microcrystalline cellulose and carboxymethylcellulose sodium;

0.1% (w/v) of xanthan gum;

0.2% (w/v) of simethicone emulsion (30%);

0.5% (w/v) of citric acid;

0.2% (w/v) of sodium citrate;

0.15% (w/v) of sodium benzoate; and

water;

wherein the pharmaceutical composition has a pH of about 3.0 to about 6.0, and

wherein the pharmaceutical composition retains less than ±5% variation of metronidazole 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 metronidazole is present in the pharmaceutical composition at a concentration of 50 mg/mL.

3 . The pharmaceutical composition of claim 1 , wherein the metronidazole is present in the pharmaceutical composition at a concentration of 100 mg/mL.

4 . The pharmaceutical composition of claim 1 , wherein the pH is about 3 to about 5.

5 . The pharmaceutical composition of claim 1 , wherein the pH is about 3 to about 4.

6 . The pharmaceutical composition of claim 5 , wherein the pH is about 3.7.

7 . The pharmaceutical composition of claim 1 , further comprising a flavoring agent, a coloring agent, or a both.

8 . The pharmaceutical composition of claim 7 , wherein the flavoring agent provides grape flavor.

9 . The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition retains less than ±5% variation of metronidazole concentration measured by a USP assay for at least 60 days when stored at room temperature.

10 . The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition retains less than ±5% variation of metronidazole concentration measured by a USP assay for at least 90 days when stored at room temperature.

Assignments (3)

Continuity (10)

References Cited (96)