US 12,390,480 B2
Transdermal formulation for the treatment of pain and/or inflammation
Joseph M. Fracassi, San Clemente, CA (US); and Thomas J. Scarlata, San Clemente, CA (US)
Assigned to NEXZOL PHARMA, INC., San Clemente, CA (US)
Filed by NEXZOL PHARMA, INC., San Clemente, CA (US)
Filed on Jun. 30, 2023, as Appl. No. 18/217,105.
Application 18/217,105 is a continuation of application No. 17/470,788, filed on Sep. 9, 2021, granted, now 11,723,880.
Application 17/470,788 is a continuation of application No. 16/818,755, filed on Mar. 13, 2020, granted, now 11,116,730.
Application 16/818,755 is a continuation of application No. 16/457,746, filed on Jun. 28, 2019, granted, now 10,588,871.
Prior Publication US 2023/0346715 A1, Nov. 2, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/05 (2006.01); A61K 9/00 (2006.01); A61K 9/06 (2006.01); A61K 9/127 (2025.01); A61K 9/50 (2006.01); A61K 47/18 (2017.01); A61K 47/36 (2006.01); A61K 47/58 (2017.01); A61P 37/02 (2006.01)
CPC A61K 31/05 (2013.01) [A61K 9/0014 (2013.01); A61K 9/06 (2013.01); A61K 9/127 (2013.01); A61K 9/5005 (2013.01); A61K 47/183 (2013.01); A61K 47/36 (2013.01); A61K 47/58 (2017.08); A61P 37/02 (2018.01)] 20 Claims
 
1. A transdermal formulation consisting of:
from about 0.05% w/w to about 50% w/w phytocannabinoid dispersed in a pharmaceutically acceptable carrier consisting of:
from about 3% w/w to about 30% w/w penetration enhancer selected from the group consisting of diethylene glycol monoethyl ether, lauryl alcohol, dimethyl sulfoxide (DMSO), dimethyl acetamide, N-methyl pyrrolidone, oleic acid, azone, urea, terpene, and combinations of any two or more thereof,
from about 0.8% w/w to about 1.3% w/w thickening agent selected from the group consisting of cross-linked polyacrylic acid polymers; hydroxyethylcellulose, ethyl cellulose, hydroxypropyl cellulose, carboxymethyl cellulose, sodium carboxymethyl cellulose; xanthan gum, locust beam gum, guar gum; alginic acid; PEMULEN™ (a copolymer of acrylic acid and C10-C30 alkyl acrylate cross-linked with allyl pentaerythritol); and combinations of any two or more thereof,
from about 0.25% w/w to about 6% w/w buffering agent selected from the group consisting of triethanolamine, potassium hydroxide, cocoamidodiethylamine, and combinations of any two or more thereof,
from about 0.05% w/w to about 0.08% w/w sequestering agent selected from the group consisting of EDTA and salts and solvates thereof; citric acid; tartaric acid; and combinations of any two or more thereof,
from about 0.4% w/w to about 0.8% w/w of preservative selected from the group consisting of phenoxyethanol, ethylhexylglycerine, hydantoin, sorbic acid, anisic acid, and combinations or any two or more thereof, and
up to about 95.45% w/w of deionized water;
wherein the phytocannabinoid comprises one or more selected from the group consisting of cannabidiol, cannabigerol, cannabichromene, cannabinol, cannabitriol, cannabidiolic acid, cannabigerolic acid, cannabidivarin, beta caryophyllene, and tetrahydrocannabinol;
wherein all percentages are based on the total weight of the formulation; and
wherein the transdermal formulation is a semi-solid formulation selected from the group consisting of a gel, a lotion, a cream, an ointment, a serum, and a foam.