US 12,303,599 B2
Self-emulsifying cannabidiol formulations
Kiran Kumar Vangara, Phoenix, AZ (US); Thrimoorthy Potta, Phoenix, AZ (US); and Venkat Goskonda, Phoenix, AZ (US)
Assigned to Benuvia Operations, LLC, Round Rock, TX (US)
Filed by Benuvia Operations, LLC, Round Rock, TX (US)
Filed on Dec. 8, 2023, as Appl. No. 18/534,301.
Application 18/534,301 is a continuation of application No. 16/874,225, filed on May 14, 2020, granted, now 11,857,678.
Claims priority of provisional application 62/847,991, filed on May 15, 2019.
Prior Publication US 2024/0099971 A1, Mar. 28, 2024
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 9/107 (2006.01); A61K 9/48 (2006.01); A61K 31/05 (2006.01); A61K 47/10 (2017.01); A61K 47/14 (2017.01); A61K 47/22 (2006.01)
CPC A61K 9/107 (2013.01) [A61K 9/4808 (2013.01); A61K 9/4825 (2013.01); A61K 31/05 (2013.01); A61K 47/10 (2013.01); A61K 47/14 (2013.01); A61K 47/22 (2013.01)] 18 Claims
 
1. A self-emulsifying cannabidiol composition consisting essentially of
from about 5% to about 35% w/w cannabidiol,
from about 40% to about 99% w/w of one or more surfactants,
from about 0.1% to about 2% w/w of an antioxidant, and
one or more cosolvents selected from the group consisting of propylene glycol, polyethylene glycol, and ethanol,
which does not comprise sesame oil, castor oil, olive oil, or water, and wherein the composition,
(i) forms an emulsion having an average globule size from about 30 to about 600 nanometers in less than 30 minutes when dispersed in gastric fluid, and
(ii) has the pharmacokinetic profile between 0 and 8 hours shown in FIG. 2 following a single oral administration of said composition to beagle dogs at a dose equivalent to 200 mg cannabidiol.