Pharmaceutical compositions and methods for treating Alzheimer's disease

• US 10,639,315 B1
• Filed: 05/21/2019
• Issued: 05/05/2020
• Est. Priority Date: 05/21/2019
• Status: Active Grant

• Current Assignee: LA Pharmatech Inc.
• Original Assignee: LA Pharmatech Inc.
• Inventors: Wang, Jianmin, Cui, Geping
• Primary Examiner(s): Anderson, James D.
• Application Number:
  US16/418,614
• Time in Patent Office: 350 Days
• CPC Class Codes: A61K 31/402 1-aryl substituted, e.g. piretanide
• CPC Class Codes: A61K 31/55 having seven-membered rings, e.g. azelastine, pentylenetetrazole
• CPC Class Codes: A61K 9/0053 Mouth and digestive tract, i.e. intraoral and peroral administration rectal administration A61K9/0031
• 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

A pharmaceutical composition containing the therapeutically active ingredients of azelastine or a pharmaceutically acceptable salt of azelastine and donepezil or rivastigmine or galantamine or a pharmaceutically acceptable salt of thereof is disclosed. A method of using the pharmaceutical composition for treating patients suffering from mental, behavioral, cognitive disorders is also disclosed.

Claims

1. A pharmaceutical composition, comprising:

about 12 mg to about 50 mg azelastine or a pharmaceutically acceptable salt of azelastine;

about 1 mg to about 4 mg donepezil or a pharmaceutically acceptable salt thereof, about 1 mg to about 2 mg rivastigmine or a pharmaceutically acceptable salt thereof, or about 1 mg to about 3 mg galantamine or a pharmaceutically acceptable salt thereof, or any combination thereof; and

one or more pharmaceutically acceptable excipients.

2. The pharmaceutical composition of claim 1, wherein the azelastine or the pharmaceutically acceptable salt of azelastine is present in the pharmaceutical composition in an amount in the range of about 12 mg to about 20 mg.

3. The pharmaceutical composition of claim 2, wherein the pharmaceutically acceptable salt of azelastine is azelastine hydrochloride.

4. The pharmaceutical composition of claim 1, wherein the pharmaceutically acceptable salt of donepezil is donepezil hydrochloride, the pharmaceutically acceptable salt of rivastigmine is rivastigmine tartrate, or the pharmaceutically acceptable salt of galantamine is galantamine hydrobromide.

5. The pharmaceutical composition of claim 3, wherein the azelastine hydrochloride is present in an amount in the range of about 12 mg to about 16 mg.

6. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition is formulated as an oral pharmaceutical dosage form.

7. The pharmaceutical composition of claim 6, wherein the oral pharmaceutical dosage form is a solid form or a liquid form.

8. A method comprising orally administering a pharmaceutical composition to a patient having Alzheimer'"'"'s disease, the pharmaceutical composition comprising:

about 12 mg to about 50 mg azelastine or a pharmaceutically acceptable salt of azelastine;

about 1 mg to about 4 mg donepezil or a pharmaceutically acceptable salt thereof, about 1 mg to about 2 mg rivastigmine or a pharmaceutically acceptable salt thereof, or about 1 mg to about 3 mg galantamine or a pharmaceutically acceptable salt thereof, or any combination thereof; and

one or more pharmaceutically acceptable excipients.

9. The method of claim 8, wherein the pharmaceutical composition is administered once or twice a day or once every 2 or 3 or 4 days to the patient in an oral solid or liquid form.

10. The method of claim 9, wherein the azelastine or the pharmaceutically acceptable salt of azelastine is present in the pharmaceutical composition in an amount in the range of about 12 mg to about 20 mg daily.

11. The method of claim 8, wherein:

the azelastine or the pharmaceutically acceptable salt of azelastine is present in the pharmaceutical composition in an amount in the range of about 12 mg to about 20 mg.

12. The method of claim 8, wherein the pharmaceutical composition is administered to the patient daily and for a period of at least twelve weeks.

13. The method of claim 8, wherein the pharmaceutical composition is administered for a period of time to improve one or more symptoms of the patient'"'"'s Alzheimer'"'"'s disease as measured additionally by Neuropsychiatric Inventory (NPI).

14. The method of claim 13, wherein the pharmaceutical composition comprises about 12 mg to about 20 mg of the azelastine or the pharmaceutically acceptable salt of azelastine.

15. The method of claim 8, wherein the pharmaceutical composition is administered for a period of time to improve one or more symptoms of the patient'"'"'s Alzheimer'"'"'s disease as measured by Mini-Mental State Examination (MMSE).