US 12,458,593 B2
Suspensions and diluents for metronidazole and baclofen
Ken Fallin, Diamondhead, MS (US); Zeus Pendon, Woburn, MA (US); Priya Capila, Wellesley, MA (US); and Neal Muni, Wellesley, MA (US)
Assigned to AZURITY PHARMACEUTICALS, INC., Woburn, MA (US)
Filed by Azurity Pharmaceuticals, Inc., Woburn, MA (US)
Filed on Jan. 3, 2024, as Appl. No. 18/402,960.
Application 18/402,960 is a continuation of application No. 17/888,737, filed on Aug. 16, 2022, abandoned.
Application 17/888,737 is a continuation of application No. 17/888,611, filed on Aug. 16, 2022, abandoned.
Application 17/888,611 is a continuation of application No. 17/882,223, filed on Aug. 5, 2022, abandoned.
Application 17/882,223 is a continuation of application No. 17/881,785, filed on Aug. 5, 2022, abandoned.
Application 17/881,785 is a continuation of application No. 17/736,291, filed on May 4, 2022, abandoned.
Application 17/736,291 is a continuation of application No. 17/725,923, filed on Apr. 21, 2022, granted, now 11,446,246, issued on Sep. 20, 2022.
Application 17/725,923 is a continuation of application No. 17/133,415, filed on Dec. 23, 2020, granted, now 11,324,696, issued on May 10, 2022.
Application 17/133,415 is a continuation of application No. 16/331,733, abandoned, previously published as PCT/US2017/050714, filed on Sep. 8, 2017.
Claims priority of provisional application 62/385,325, filed on Sep. 9, 2016.
Prior Publication US 2024/0285527 A1, Aug. 29, 2024
Int. Cl. A61K 9/10 (2006.01); A61K 9/00 (2006.01); A61K 31/197 (2006.01); A61K 31/4164 (2006.01); A61K 47/08 (2006.01); A61K 47/10 (2017.01); A61K 47/12 (2006.01); A61K 47/26 (2006.01); A61K 47/34 (2017.01); A61K 47/36 (2006.01); A61K 47/38 (2006.01); A61P 21/00 (2006.01); A61P 21/02 (2006.01); A61P 25/28 (2006.01); A61P 31/04 (2006.01); A61P 33/02 (2006.01)
CPC A61K 9/10 (2013.01) [A61K 9/0053 (2013.01); A61K 9/0095 (2013.01); A61K 31/197 (2013.01); A61K 31/4164 (2013.01); A61K 47/08 (2013.01); A61K 47/10 (2013.01); A61K 47/12 (2013.01); A61K 47/26 (2013.01); A61K 47/34 (2013.01); A61K 47/36 (2013.01); A61K 47/38 (2013.01); A61P 21/02 (2018.01); A61P 31/04 (2018.01); A61P 33/02 (2018.01); A61P 21/00 (2018.01); A61P 25/28 (2018.01); Y02A 50/30 (2018.01)] 10 Claims
 
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.