US10245237B2 – April 2, 2019 – Compressed tablet containing cannabidiol, method for its manufacture and use of such tablet in oral treatment of psychosis or anxiety disorders

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Inventors :

Jan Albert De Vries; Maria Vanesa Fernandez Cid; Ana Maria Heredia Lopez; Cristina Maria Eiroa Martinez

Owner :

Echo Pharmaceuticals B.V.

Application Number :

US15874544

Document Number :

US10245237B2

Priority Date :

October 29, 2013

Filing Date :

January 18, 2018

Date of Grant/ Publication :

April 2, 2019

Class :

; A61K31 / 05; A61K9 / 20

Abstract

The present invention relates to compressed tablets for peroral delivery of the cannabinoid cannabidiol (CBD). More particularly, the invention provides a compressed tablet having a tablet weight of 60-1200 mg, said tablet being composed of: 50-95 wt. % of a granulate; 5-50 wt. % of lactose; and 0-30 wt. % of other tablet excipients; wherein the granulate contains: a. 2-15 wt. % of cannabidiol; b. 2-30 wt. % of sucrose fatty acid mono-ester; c. 30-96 wt. % of lactose; and d. 0-25 wt. % of other granulate excipients. The compressed tablets according to the invention can conveniently be used in the treatment of psychosis disorders or anxiety disorders. The invention further provides a method for the manufacture of the compressed tablets.

Claim(s)

1. A compressed tablet having a tablet weight of 60-1200 mg and comprising: (a) 50-95 wt. % of a granulate; (b) 5-50 wt. % of lactose; and (c) 0-30 wt. % of other tablet excipients; wherein the granulate comprises: (i) 2-15 wt. % of cannabidiol; (ii) 2-30 wt. % of sucrose fatty acid mono-ester; (iii) 30-96 wt. % of lactose; and (iv) 0-25 wt. % of other granulate excipients, wherein the granulate is composed of granules comprising lactose particles that are held together by a solid dispersion comprising cannabidiol and sucrose fatty acid mono-ester and optionally other granulate excipients; and wherein the compressed tablet is obtained by: (a) providing a lactose powder; (b) combining the lactose powder with a granulation fluid comprising a solution of cannabidiol, sucrose fatty acid mono-ester and optionally other granulate excipients in an organic solvent; (c) removing the organic solvent by evaporation to produce a granulate; (d) mixing the granulate with lactose and optionally other tablet excipients to produce a tablet mixture; and (e) compressing the tablet mixture into a tablet.

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