	US 12,478,584 B1
	Atomoxetine hydrochloride oral suspension and use thereof
Paul Sudhakar, Shawnee, KS (US); and Scott Boyer, West Chicago, IL (US)
Filed by OWP Pharmaceuticals, Inc., Naperville, IL (US)
Filed on Apr. 17, 2025, as Appl. No. 19/182,311.
Application 19/182,311 is a continuation in part of application No. 19/179,733, filed on Apr. 15, 2025.
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 9/10 (2006.01); A61K 9/00 (2006.01); A61K 31/138 (2006.01); A61K 47/02 (2006.01); A61K 47/10 (2017.01); A61K 47/12 (2006.01); A61K 47/14 (2017.01); A61K 47/20 (2006.01); A61K 47/22 (2006.01); A61K 47/26 (2006.01); A61K 47/38 (2006.01); A61K 47/46 (2006.01)

CPC A61K 9/10 (2013.01) [A61K 9/0053 (2013.01); A61K 31/138 (2013.01); A61K 47/02 (2013.01); A61K 47/10 (2013.01); A61K 47/12 (2013.01); A61K 47/14 (2013.01); A61K 47/20 (2013.01); A61K 47/22 (2013.01); A61K 47/26 (2013.01); A61K 47/38 (2013.01); A61K 47/46 (2013.01)]

30 Claims

1. A method of treating attention-deficit/hyperactivity disorder (ADHD) in a human, the method comprising orally administering to a human subject in need thereof an oral liquid suspension comprising:

2.2850±0.45 wt. % atomoxetine, or a pharmaceutically acceptable salt thereof;

0.1000±0.05 wt. % methylparaben;

0.0300±0.006 wt. % sodium benzoate;

0.0750±0.015 wt. % saccharin sodium, dihydrate;

1.6000±0.32 wt. % sodium phosphate dibasic;

0.2700±0.054 wt. % sodium phosphate monobasic;

3.0000±0.6 wt. % of a 70% sorbitol solution;

2.2500±0.5 wt. % propylene glycol;

5.0000±1 wt. % glycerin;

1.2600±0.25 wt. % silicified microcrystalline cellulose;

0.2000±0.04 wt. % carboxymethylcellulose sodium;

0.2000±0.04 wt. % xanthan gum;

0.2000±0.04 wt. % cherry flavor;

0.2000±0.04 wt. % FD&C Red No. 40;

0.0020±0.0004 wt. % FD&C Yellow No. 6;

78.4278±7.5 wt. % purified water;

5.0000±1 wt. % polyethylene glycol 400; and

0.1000±0.05 wt. % sucralose;

wherein,

wherein the ratio of methylparaben:sodium benzoate is 2.5:1 to 4:1 w/w;

the oral liquid suspension has a pH of 6.5-8.0;

the oral liquid suspension has a viscosity of 150-250 mPa·s; and

the oral liquid suspension has a specific gravity of 1.000-1.200.