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US 2024/0197631 A1Published application
Atomoxetine oral solution
AssigneeOWP Pharmaceuticals, Inc.
InventorsPaul Sudhakar, Scott Boyer
Life of this patent
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Abstract
The present invention provides for an oral solution that includes atomoxetine, or pharmaceutically acceptable salt thereof, methods of manufacturing the oral solution, and methods of treating attention deficit hyperactivity disorder (ADHD) in a human subject that include orally administering the oral solution to a human subject in need thereof.
Claims23
An oral solution comprising:
- (i) atomoxetine, or pharmaceutically acceptable salt thereof;
- (ii) antimicrobial preservative comprising methylparaben and sodium benzoate;
- (iii) buffering agent comprising citric acid and trisodium citrate dihydrate;
- (iv) sweetening agent comprising sucralose and sorbitol;
- (v) solvent comprising water, propylene glycol, and glycerin;
- (vi) optionally flavoring agent comprising cherry flavor;
- and
- (vii) optionally coloring agent comprising FD & C Red No. 40 and Allura Red AC.
5 more elements
An oral solution comprising:
- (i) 11.43±3 mg/mL atomoxetine hydrochloride;
- (ii) antimicrobial preservative comprising 1±0.2 mg/mL methylparaben and 1±0.2 mg/mL sodium benzoate;
- (iii) buffering agent comprising 1.50±0.3 mg/mL citric acid and 1.34±0.27 mg/mL trisodium citrate dihydrate;
- (iv) sweetening agent comprising 1±0.2 mg/mL sucralose and 56.25±11 mg/mL sorbitol;
- (v) solvent comprising 811.70±50 mg/mL water, 20±4 mg/mL propylene glycol, and 75±15 mg/mL glycerin;
- (vi) flavoring agent comprising 2±0.4 mg/mL cherry flavor;
- and
- (vii) coloring agent comprising 0.001±0.0002 mg/mL FD & C Red No. 40 and 0.001±0.0002 mg/mL Allura Red AC.
5 more elements
Dependencies are inferred from the claim text.