Atomoxetine solution

• US 9,326,935 B2
• Filed: 12/19/2013
• Issued: 05/03/2016
• Est. Priority Date: 11/08/2013
• Status: Active Grant

• Current Assignee: Eli Lilly and Company
• Original Assignee: Eli Lilly and Company
• Inventors: Roy, Arup Kumar, Mermey, Matthew Scott
• Primary Examiner(s): Rao, Savitha
• Assistant Examiner(s): BROWN-PETTIGREW, ANGELA C
• Application Number:
  US14/134,183
• Publication Number:
  US 20150133562A1
• Time in Patent Office: 866 Days
• US Class Current: 1/1
• CPC Class Codes: A61K 31/138 Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine atenolol A61K31/165; pindolol A61K31/404; timolol A61K31/5377
• CPC Class Codes: A61K 9/0053 Mouth and digestive tract, i.e. intraoral and peroral administration rectal administration A61K9/0031
• CPC Class Codes: A61K 9/0095 Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches A61K9/0007 takes precedence; eatable gels or foams A61K9/0056; oral mucosa adhesive forms A61K9/006
• CPC Class Codes: A61K 9/08 Solutions composition of solutions A61K47/00
• CPC Class Codes: A61P 25/20 Hypnotics; Sedatives
• CPC Class Codes: A61P 25/28 for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia

Abstract

The present invention provides a novel palatable pharmaceutical composition in the form of aqueous solution of atomoxetine. The oral aqueous solution of this invention will significantly reduce the potently bitter taste of atomoxetine, and further avoid swallow issue for young and elderly patients.

Claims

1. A pharmaceutical composition comprising 0.1-25 mg/mL atomoxetine, water, 1-30 mg/mL F-9999 PFC Artificial Raspberry CA Flavor, and a sweetening agent, wherein the pharmaceutical composition is in the form of a clear homogeneous oral aqueous solution, and the pH of the clear homogeneous oral aqueous solution is in the range of 2.0 to 6.0.

2. A method for treating attention-deficit/hyperactivity disorder (ADHD), comprising orally administering to a patient an effective amount of the pharmaceutical composition as claimed in claim 1.

3. The pharmaceutical composition as claimed in claim 1, wherein the concentration of atomoxetine is in the range of 3-6 mg/mL.

4. The pharmaceutical composition as claimed in claim 3, wherein the pH is in the range of 3.7-4.3.

5. The pharmaceutical composition as claimed in claim 4, wherein atomoxetine is atomoxetine hydrochloride.

6. The pharmaceutical composition as claimed in claim 5, further comprising sodium benzoate, sodium dihydrogen phosphate dihydrate, phosphoric acid, sorbitol solution, xylitol, and sucralose powder.

7. The pharmaceutical composition as claimed in claim 6, comprising 4.6 mg/mL atomoxetine hydrochloride, 0.8 mg/mL sodium benzoate, 17.0 mg/mL sodium dihydrogen phosphate dihydrate, 0.6 mg/mL phosphoric acid, 47.1 mg/mL sorbitol solution (70% w/w), 300.0 mg/mL xylitol, 14.7 mg/mL F-9999 PFC Artificial Raspberry CA Flavor, and 10.0 mg/mL sucralose powder.