NON-ORAL CANNABINOID FORMULATION AND METHOD OF TREATMENT
A pharmaceutically acceptable formulation of cannabinoid for non-oral delivery. The formulation including at least one cannabinoid at 0.05% to 50% by weight of the total formulation. The formulation being delivered to a patient to alleviate symptoms including, but not limited to, pain, nausea, vomiting, and the like.
1 . A pharmaceutically acceptable gel formulation of cannabinoid for non-oral delivery comprising:
(a) at least one cannabinoid at 0.05% to 50% by weight of the total formulation;
(b) optionally a pH adjusting agent in a concentration effective to maintain the pH of the formulation at about 5-8;
(c) a thickener in a concentration effective to impart a viscosity to the formulation in a range of 1,000 to 8,000 cP so that it is suitable for administration by applicator or syringe like injector to a human patient; and
(d) a solvent at 10% to 95% by weight of the total formulation.
2 . The formulation of claim 1 , wherein the at least one cannabinoid is selected from the group consisting of CBD, CBDA, CBDV, THC, THCA, THCV, CBG, CBN, and combinations thereof.
3 . The formulation of claim 2 , wherein the at least one cannabinoid is CBD and wherein CBD comprises 0.1% to 20% by weight of the total formulation.
4 . The formulation of claim 2 , wherein the at least one cannabinoid is THC and wherein THC comprises 0.05% to 2% by weight of the total formulation.
5 . The formulation of claim 2 , wherein the at least one cannabinoid comprises a mixture of CBD and THC, wherein CBD comprises 0.1% to 20% by weight of the total formulation, and THC comprises 0.05% to 2% by weight of the total formulation.
6 . The formulation of claim 1 wherein the concentration of the thickener is 0.05 to 10% by weight of the total formulation.
7 . The formulation of claim 1 wherein the thickener is selected from the group consisting of a cellulose ether; a polyacrylic acid polymer (carbomer); natural gum, and combinations thereof.
8 . The formulation of claim 7 , wherein the cellulose ether is selected from the group consisting of hydroxypropyl methylcellulose, methylcellulose, hydroxypropyl cellulose, carboxyl methylcellulose, and combinations thereof.
9 . The formulation of claim 8 wherein the thickener is hydroxypropyl methylcellulose.
10 . The formulation of claim 1 wherein the solvent is water or a mixture of water and at least one organic solvent.
11 . The formulation of claim 1 , further comprising a pharmaceutically acceptable excipient selected from group consisting of preservatives, buffers, inclusion complexing agents, surfactants and combinations thereof.
12 . The formulation of claim 1 , wherein the at least one cannabinoid is suspended in the gel composition.
13 . The formulation of claim 12 , wherein a size of the suspended cannabinoid is between 10 Nanometer to 50 Micrometer.
14 . The formulation of claim 1 , wherein the formulation is suitable for administration via a rectal route of administration.
15 . The formulation of claim 1 packaged in a suitable rectal applicator.
16 . The formulation of claim 1 , wherein the formulation is suitable for administration in a non-oral cavity of a patient.
17 . The formulation of claim 1 , wherein the formulation is suitable for transdermal application.
18 . A pharmaceutically acceptable liquid or viscous liquid formulation of cannabinoid for non-oral delivery comprising:
a. at least one cannabinoid at 0.05% to 50% by weight of the total formulation;
b. optionally an antioxidant;
c. optionally a pH adjusting agent; and
d. optionally an alcohol-based co-solvent
wherein the formulation is suitable for rectal or vaginal administration.
19 . A liquid or viscous liquid formulation of claim 18 , further comprising:
a pharmaceutical excipient; or
a hydrogenated oil at 10% to 95% by weight of the total formulation.
20 . A liquid or viscous liquid formulation of claim 18 , wherein the at least one cannabinoid is selected from the group consisting of CBD, CBDA, CBDV, THC, THCA, THCV, CBG, CBN and combinations thereof.
21 . A liquid or viscous liquid formulation of claim 20 , wherein the at least one cannabinoid is:
CBD;
THC; or
a combination of CBD and THC.
22 . A kit for administering a formulation of cannabinoid for non-oral delivery, the kit comprising:
a syringe assembly pre-filled with a dose of a formulation according to claim 1 ; and
instructions of use,
wherein the syringe assembly and instructions are placed in packaging.
23 . A kit for administering a formulation of cannabinoid for non-oral delivery, the kit comprising:
a syringe assembly pre-filled with a dose of a formulation according to claim 18 ; and
instructions of use,
wherein the syringe assembly and instructions are placed in packaging.
24 . A method for administering a formulation of cannabinoid to alleviate symptoms exhibited by a patient, the method comprising:
providing a formulation of cannabinoid, the formulation comprising: at least one cannabinoid at 0.05% to 50% by weight of the total formulation; and optionally a pH adjusting agent in a concentration effective to a maintain the pH of the formulation at about 5-8; and
delivering the formulation to a non-oral cavity of the patient,
wherein after said delivery of the gel formulation, the symptoms of the patient are alleviated.