Pharmaceutical composition comprising sodium benzoate compound and clozapine, and uses thereof

• US 10,098,861 B1
• Filed: 10/24/2017
• Issued: 10/16/2018
• Est. Priority Date: 10/24/2017
• Status: Active Grant

• Current Assignee: SyneuRx International (Taiwan) Corp.
• Original Assignee: SyneuRx International (Taiwan) Corp.
• Inventors: Tsai, Guochuan Emil, Wang, Ching-Cheng
• Primary Examiner(s): Sasan, Aradhana
• Application Number:
  US15/792,088
• Time in Patent Office: 357 Days
• Field of Search: None
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/192 having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid cannabinoids A61K31/658
• CPC Class Codes: A61K 31/5513 1,4-Benzodiazepines, e.g. diazepam or clozapine
• CPC Class Codes: A61K 9/2013 Organic compounds, e.g. phospholipids, fats
• CPC Class Codes: A61K 9/205 Polysaccharides, e.g. alginate, gums; Cyclodextrin
• CPC Class Codes: A61K 9/2059 Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin

Abstract

The present invention relates to a pharmaceutical composition comprising a sodium benzoate compound and clozapine; and a method for preventing, treating and/or reducing the risk of a neuropsychiatric disorder by administering such pharmaceutical composition.

Claims

1. A pharmaceutical composition comprising 50 to 1000 mg of a sodium benzoate compound, 25 to 300 mg of clozapine, and a pharmaceutically acceptable excipient, wherein the pharmaceutical composition is in a solid dosage form, and wherein the sodium benzoate compound comprises a polymorphic form of sodium benzoate, which is characterized by an X-ray powder diffraction pattern comprising characteristic peaks at a reflection angle 2θ

of about 5.9, 30.2, and 31.2 degrees.

2. The pharmaceutical composition of claim 1, wherein the polymorphic form of sodium benzoate is characterized by an X-ray powder diffraction pattern further comprising characteristic peaks at a reflection angle 2θ

of about 4.3, 7.1, 8.6, 10.1, 10.7, 12.9, 13.8, 14.4, 17.2, 17.7, 18.5, 21.5, 22.0, 22.6, 23.7, 25.1, 25.9, 26.2, 26.9, 27.9, 28.2, 28.8, 29.1, 29.7, 33.2, 34.9, 35.8, 36.1, 39.3 degrees.

3. The pharmaceutical composition of claim 1, wherein the excipient is selected from the group consisting of boric acid, sodium alginate, sodium citrate, sodium hyaluronate, chitosan, magnesium stearate, sodium stearyl fumarate, colloidal silicon dioxide, talc, sodium starch glycolate, croscarmellose, crospovidone, and tannic acid.

4. The pharmaceutical composition of claim 1, which comprises 50 to 1000 mg of sodium benzoate, 25-300 mg of clozapine, 50-500 mg of sodium alginate, 50-400 mg of sodium citrate, 5-100 mg of magnesium stearate, and 80-200 mg of sodium starch glycolate.

5. The pharmaceutical composition of claim 1, wherein the solid dosage form is selected from the group consisting of tablet, dragee, capsule, pill, powder, and granule.

6. The pharmaceutical composition of claim 5, wherein the solid dosage form further comprises a film coating.