WO2019126872A1 – July 4, 2019 – SUBLINGUAL FORMULATIONS COMPRISING CANNABIS RESIN, METHODS FOR MAKING SAME AND USES THEREOF

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Inventors :

KOTRA, Lakshmi Premakanth - 4 New Haven Drive, Toronto, Ontario M5N 1H7; LEWIS, Melissa Maureen - 108 Stephen Drive, Bolton, Ontario L7E 4Y2; WASILEWSKI, Ewa - 1507-530 Lolita Gardens, Mississauga, Ontario L5A 3T2; GROVER, Har - 70 Haddington Avenue, Toronto, Ontario M5M 2P3; ABDELKHALIK, Ashraf M. - 1-348, Upper Ottawa Street, Hamilton, Ontario L8T 3S7

Owner :

CANNSCIENCE INNOVATIONS INC.

Application Number :

WOCA18051649

Document Number :

WO2019126872A1

Priority Date :

January 1, 1970

Filing Date :

December 21, 2018

Date of Grant/ Publication :

July 4, 2019

Class :

A61K9 / 20; A61J3 / 10; A61K31 / 05; A61K31 / 352; A61K36 / 185; A61K47 / 10; C07C39 / 23; C07D311 / 80

Abstract

The disclosure relates to solid formulations comprising decarboxylated cannabis resin. The disclosure provides rapidly disintegrating sublingual tablet formulations comprising decarboxylated cannabis resin, and methods for making and using same. The formulations provided herein may be useful as pharmaceutical and/or natural health products for the treatment or amelioration of various symptoms, disorders and/or diseases.

Claim(s)

1. A method for making a rapidly disintegrating sublingual tablet from decarboxyl ated cannabis resin, wherein the decarboxyl ated cannabis resin comprises cannabinoids which are at least 50% decarboxylated, the method comprising: (a) dissolving the decarboxylated cannabis resin in a pharmaceutically acceptable organic solvent to produce a first solution; (b) dissolving mannitol in a pharmaceutically acceptable polar solvent to produce a second solution; (c) mixing the first solution of (a) and the second solution of (b); (d) substantially removing the solvents from the mixture of (c) to produce a powder;
(e) adding one or more pharmaceutically acceptable excipients to the powder of (d) to produce a mixture, solid solution or solid suspension; wherein at least one of the pharmaceutically acceptable excipients is a disintegrant; (f) triturating or mixing the mixture, solid solution or solid suspension of (e) to produce a homogenous mixture, homogeneous solid solution or homogeneous solid suspension; and (g) compressing the homogenous mixture, homogeneous solid solution or homogeneous solid suspension of (f) into a tablet using a pressure of up to about 1 ton.;
12. A rapidly disintegrating sublingual tablet from decarboxylated cannabis resin, comprising cannabinoids which are at least 50% decarboxylated, wherein the tablet further comprises mannitol, a disintegrant, and optionally one or more other pharmaceutically acceptable excipients, wherein the tablet disintegrates in less than 60 seconds when contacted with phosphate buffered saline (PBS) and wherein the tablet has a friability of less than 5%.;
20. Use of a decarboxyl ated cannabis resin in the manufacture of a rapidly disintegrating sublingual tablet, wherein the resin comprises decarboxylated cannabinoids from a Cannabis spp. plant, such that A 9 -tetrahydrocannabinolic acid (A 9 -THCA) and cannabidiolic acid (CBD A) cannabinoids are each independently 90%-l00% decarboxylated to yield D 9 -tetrahydrocannabinol (A 9 -THC) and cannabidiol (CBD) respectively in the cannabis resin.

Summary

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