US10336679B2 – July 2, 2019 – Polymorphic forms of sodium benzoate and uses thereof

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Inventors :

Guochuan Emil Tsai; Ching-Cheng Wang; Tien-Lan Hsieh

Owner :

SYNEURX INTERNATIONAL (TAIWAN) CORP., TAIWAN TSAI, GUOCHUAN EMIL, CALIFORNIA SYNEURX INTERNATIONAL (TAIWAN) CORP., TAIWAN

Application Number :

US15452137

Document Number :

US10336679B2

Priority Date :

March 7, 2017

Filing Date :

March 7, 2017

Date of Grant/ Publication :

July 2, 2019

Class :

A23L33 / 16; A61K45 / 06; C07C51 / 41; C07C51 / 43; C07C63 / 08; A61K31 / 192

Abstract

The present disclosure provides polymorphic forms of sodium benzoate with a X-ray diffraction pattern comprising characteristic peaks at a reflection angle 2? of approximately 5.9, 30.2, and 31.2 degrees; or a X-ray diffraction pattern comprising characteristic peaks at a reflection angle 2? of approximately 3.7, 5.9, and 26.6 degrees. Also provided herein are methods of preparing the polymorphic forms of sodium benzoate and uses thereof in treating and/or reducing the risk for a neuropsychiatric disorder (e.g., schizophrenia, psychotic disorders, depressive disorders, or Alzheimer’s disease).

Claim(s)

1. A polymorphic form of sodium benzoate, which has an X-ray diffraction pattern comprising characteristic peaks at a reflection angle 2? of approximately 5.9, 30.2, and 31.2 degrees, wherein the X-ray diffraction pattern further comprises characteristic peaks at a reflection angle 2? of approximately 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, and 39.3 degrees, and wherein the polymorphic form of sodium benzoate has a water solubility of 666 mg/ml at ambient temperature.;
8. A polymorphic form of sodium benzoate, which is prepared by a process comprising (i) fully dissolving sodium benzoate in water followed by gradual addition of isopropyl alcohol to form a slurry, wherein the isopropyl alcohol and water are in a volume ratio of 5:1, (ii) stirring the slurry for 3 to 4 days to produce the polymorphic form of sodium benzoate, and (iii) filtering and collecting the solid thus formed.

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