US 12,303,487 B2
N-acylated fatty amino acids to reduce absorption variability in cannabinoid based compositions
Andrea Leone-Bay, Ridgefield, CT (US); and Gregory Wesner, Bainbridge Island, WA (US)
Assigned to Spoke Sciences, Inc., Seattle, WA (US)
Appl. No. 17/295,405
Filed by Spoke Sciences, Inc., Bainbridge Island, WA (US)
PCT Filed Nov. 19, 2019, PCT No. PCT/US2019/062281
§ 371(c)(1), (2) Date May 19, 2021,
PCT Pub. No. WO2020/106767, PCT Pub. Date May 28, 2020.
Claims priority of provisional application 62/769,395, filed on Nov. 19, 2018.
Prior Publication US 2021/0393575 A1, Dec. 23, 2021
Int. Cl. A61K 31/352 (2006.01); A23L 33/105 (2016.01); A61K 9/00 (2006.01); A61K 9/48 (2006.01); A61K 31/20 (2006.01); A61K 36/185 (2006.01); A61P 43/00 (2006.01)
CPC A61K 31/352 (2013.01) [A23L 33/105 (2016.08); A61K 9/0053 (2013.01); A61K 9/4858 (2013.01); A61K 31/20 (2013.01); A61K 36/185 (2013.01); A61P 43/00 (2018.01)] 8 Claims
 
1. A method of reducing cannabinoid blood absorption inter-subject variability, the method comprising:
administering to a plurality of subjects an oral formulation comprising a cannabinoid with an aqueous solubility of less than 0.1 mg/ml selected from:
Δ9-Tetrahydrocannabinol (THC), cannabidiol (CBD), cannabigerol (CBG), cannabichromene (CBC), cannabinol (CBN), cannabinodiol (CBDL), cannabicyclol (CBL), cannabivarin (CBV), tetrahydrocannabivarin (THCV), cannabidivarin (CBDV), cannabichromevarin (CBCV), cannabigerovarin (CBGV), cannabigerol monomethyl ether (CBGM), cannabinol propyl variant (CBNV), cannabitriol (CBO), and/or mixtures thereof;
and an N-acylated fatty amino acid or salt thereof having a formula:

OG Complex Work Unit Chemistry
wherein X is sodium or potassium, and Z is hydrogen,
wherein the weight/weight (w/w) ratio of cannabinoid/N-acylated fatty amino acid or salt thereof within the oral formulation is 1:6 or 1:10;
thereby reducing the cannabinoid blood absorption inter-subject variability,
wherein the reduced cannabinoid blood absorption inter-subject variability is evidenced by a coefficient of variation (% CV) of area under a plasma concentration-time curve that is less than 50%.