US20190030165A1 – January 31, 2019 – NEGATIVE CONTROL CANNABIS FORMULATIONS

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Inventors :

Kyle Kingsley; Eric Greenbaum

Owner :

Vireo Health LLC

Application Number :

US15592133

Document Number :

US20190030165A1

Priority Date :

May 10, 2017

Filing Date :

May 10, 2017

Date of Grant/ Publication :

January 31, 2019

Class :

A61K47 / 06; A61K47 / 28; A61K47 / 22; A61K49 / 00; A61K36 / 185; A23L33 / 105; A23L27 / 20

Abstract

Compositions and methods useful for providing negative control formulations for clinical trials involving whole plant cannabis extracts are provided. The formulations include a plurality of odorants and flavorants designed to mimic the unique odor and flavor profile of whole plant cannabis extracts. The odorants and flavorants may include the terpenes and terpinoids.

Claim(s)

1 . A composition comprising a plurality of flavorants in a suitable excipient/carrier such that the composition possesses the odor and flavor profile of cannabis and/or a cannabis extract, while being substantially free from cannabinoids.;
2 . The composition of claim one wherein the odor/flavor profile is designed to match a particular strain of cannabis or extract therefrom.;
5 . A method for providing negative control compositions for use in placebo controlled trials comprising the steps of formulating a composition having the odorant and flavor profile of a cannabis based therapeutic being tested in the same dosage form as the cannabis based therapeutic being tested.;
7 . A method for testing the hypothesis that one or more whole plant extracts are responsible for a particular biological effect or effects comprising: selecting a whole plant extract to be tested for a particular biological effect or effects; creating a negative control formulation that has a substantially similar odor/flavor profile of the whole plant extract while being substantially free of cannabinoids; and running comparative tests between the whole plant extract and the negative control formulation.

Summary

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