Cannabis-Based Extracts and Topical Formulations for Use in Skin Disorders

Abstract

The present invention discloses a pharmaceutical topical composition comprising cannabidiol (CBD) or a derivative thereof and Tetrahydrocannabinol (THC) or a derivative thereof in an about 1:1 ratio, useful for treatment or prevention of inflammatory skin disorders, and treatment methods thereof.

1 . A pharmaceutical topical composition comprising:
 a. a carrier formulation comprising at least two of:
 i. Glycerin; 
 ii. Niacinamide; 
 iii. Salicylic Acid; and 
 iv. Caryophyllene; and 
   b.  cannabis  oil comprising cannabidiol (CBD) or a derivative thereof and Tetrahydrocannabinol (THC) or a derivative thereof in an about 1:1 ratio,
 wherein said composition provides a synergistic effect with respect to treatment of inflammatory skin conditions as compared to the effect provided by said carrier formulation or said  Cannabis  oil administered separately in similar concentrations. 
   
     
     
         2 . The pharmaceutical topical composition according to  claim 1 , wherein said composition further comprises at least one ingredient selected from the group consisting of: Glyceryl Stearate & PEG-100 Stearate, Cetyl Alcohol, Allantoin, Butyrospermum Parkii, Petrolatum, Steareth-21, Tocopheryl Acetate,  Lavandula angustifolia  oil, Xanthan Gum, Dipotassium Glycyrrhizate, Aloe Barbadensis Leaf Juice, Triethanolamine, Bisabolol, Disodium EDTA, vitamin B3, keratolytic agent, anti irritation agent, anti oxidant, terpene,  cannabis  terpene, anti skin redness agent, antiadherent, binder, coating, disintegrant, flavour, colour, lubricant, glidant, sorbent, preservative, filler, emulsifier, humectant, thickener, skin nourishing agent, skin moistening agent, occlusive agent, emollient agent, calming agent, natural smell agent, suspending agent, soothing agent, pH adjustment agent, complexant, purified water, Shea Butter, Lavender Oil, and any combination thereof. 
     
     
         3 . The pharmaceutical topical composition according to  claim 1 , wherein the concentration of said CBD or said derivative thereof and said THC or a derivative thereof is about CBD:THC 3%:3%. 
     
     
         4 . The pharmaceutical topical composition according to  claim 1 , wherein said composition comprises β-caryophyllene in about 0.5% concentration. 
     
     
         5 . The pharmaceutical topical composition according to  claim 1 , wherein said composition comprises  cannabis  oil in about 10% concentration. 
     
     
         6 . The pharmaceutical topical composition according to  claim 1 , wherein said composition reduces Lipopolysaccharide (LPS) and/or Epidermal Growth Factor (EFG) and/or TNFα induced hyperproliferation of skin cells ex vivo or in vitro. 
     
     
         7 . The pharmaceutical topical composition according to  claim 1 , wherein said composition provides a synergistic effect with respect to at least one of: (a) inhibition of proliferation (b) inhibition of inflammation, as compared to the effect provided by said carrier formulation or said  Cannabis  oil administered separately in similar concentrations. 
     
     
         8 . The pharmaceutical topical composition according to  claim 1 , wherein said composition provides a synergistic effect with respect to inhibition of cytokines secretion as compared to the effect provided by said carrier formulation or said  Cannabis  oil comprising said CBD or a derivative thereof and said THC or a derivative thereof administered separately in similar concentrations. 
     
     
         9 . The pharmaceutical topical composition according to  claim 8 , wherein said cytokines are selected from the group consisting of: IL-8, IL-33 and any combination thereof. 
     
     
         10 . The pharmaceutical topical composition according to  claim 1 , wherein said composition reduces epidermal turnover rate. 
     
     
         11 . The pharmaceutical topical composition according to  claim 1 , wherein said composition provides a synergistic effect with respect to improvement of inflammatory skin disorders as compared to the effect provided by the THC or a derivative thereof or by the CBD or a derivative thereof, or their combination, or said carrier formulation, administered separately in a similar concentration. 
     
     
         12 . The pharmaceutical topical composition according to  claim 1 , wherein said composition provides a synergistic effect with respect to improvement of inflammatory skin disorders as compared to the effect provided by said composition absent of said  Cannabis  oil and/or said β-caryophyllene. 
     
     
         13 . The pharmaceutical topical composition according to  claim 11 , wherein said improvement of inflammatory skin disorders comprises an effect selected from the group consisting of: reduction of hyperproliferation, reduction of IL-8 secretion, reduction of IL-33 secretion, reduction of skin inflammation, reduction of epidermal turnover rate and any combination thereof. 
     
     
         14 . The pharmaceutical topical composition according to  claim 1 , wherein said composition provides a synergistic effect with respect to treating symptoms of psoriasis selected from the group consisting of inhibition of cell proliferation, inhibition proinflammatory cytokine mediators in psoriasis, and a combination thereof. 
     
     
         15 . The pharmaceutical topical composition according to  claim 1 , wherein said composition reduces inflammation characteristics of said skin in a comparable manner to a positive steroid control such as dexamethasone. 
     
     
         16 . The pharmaceutical topical composition according to  claim 1 , wherein said composition provides a synergistic effect with respect to inhibition of skin hyperproliferation and of skin inflammation as compared to the effect provided by each of the carrier formulation components of (a) and/or each of the  Cannabis  oil components of (b) when administered separately in a similar concentration. 
     
     
         17 . The pharmaceutical composition of  claim 1 , wherein said composition is formulated in a dosage form selected from the group consisting of cream, ointment, lotion, foam, film, transdermal patch and any combination thereof. 
     
     
         18 . The pharmaceutical composition of  claim 1 , wherein said composition is administered in combination with an additional psoriasis therapeutic agent; said additional psoriasis therapeutic agent is selected from the group consisting of methotrexate, ciclosporin, hydroxycarbamide, fumarates, retinoids, efalizumab and alefacept, vitamin D and derivatives thereof and any combination thereof. 
     
     
         19 . The composition of  claim 18 , wherein said composition combined with said at least one psoriasis therapeutic agent provides a synergistic or additive effect with respect to treating or preventing hyperproliferative or inflammatory skin conditions relative to the effect provided by said psoriasis therapeutic agent administered separately. 
     
     
         20 . The pharmaceutical composition of  claim 1 , wherein said composition is dissolved in a lipophilic solvent or suspension carrier selected from a group consisting of medium-chain triglyceride, short-chain triglyceride, medium-chain partial glyceride, polyoxyethylated fatty alcohol, polyoxyethylated fatty acid, polyoxyethylated fatty acid triglyceride or partial glyceride, ester of fatty acids with low molecular weight alcohols, a partial ester of sorbitan with fatty acids, a polyoxyethylated partial ester of sorbitan with fatty acids, a partial ester of sugars or oligomeric sugars with fatty acids, a polyethylene glycol, lecithin, vegetable oil, and any combination thereof. 
     
     
         21 . A pharmaceutical topical composition comprising:
 a. a carrier formulation comprising:
 i. Glyceryl Stearate & PEG-100 Stearate 
 ii. Glycerin 
 iii. Niacinamide 
 iv. Cetyl Alcohol 
 v. Salicylic Acid 
 vi. Allantoin 
 vii. Butyrospermum Parkii 
 viii. Petrolatum 
 ix. Steareth-21 
 x. Tocopheryl Acetate 
 xi.  Lavandula angustifolia  oil 
 xii. Xanthan Gum 
 xiii. Dipotassium Glycyrrhizate 
 xiv. Aloe Barbadensis Leaf Juice 
 xv. Triethanolamine 
 xvi. Bisabolol 
 xvii. Disodium EDTA 
 xviii. β-Caryophyllene 0.5% 
   b.  Cannabis  oil comprising cannabidiol (CBD) or a derivative thereof and Tetrahydrocannabinol (THC) or a derivative thereof in an about 1:1 ratio,   wherein said composition provides a synergistic effect with respect to treatment of, or inhibition of hyperproliferative and/or inflammatory skin conditions as compared to the effect provided by said carrier formulation or said  Cannabis  oil administered separately to said skin tissue in similar concentrations.   
     
     
         22 . A method of treating or inhibiting hyperproliferative and/or inflammatory skin conditions in a subject, said method comprises steps of:
 a. providing a topical composition according to  claim 1 ; and   b. administering said composition to said subject topically at a therapeutically effective dosage.   
     
     
         23 . The method according to  claim 22 , wherein said step (b) comprises at least one step selected from the group consisting of:
 a. administering said composition in a therapeutic dosage of up to about 1500 mg, preferably a dosage in the range of about 100 mg to about 1500 mg of said composition, more preferably a dosage of up to about 30 mg of said CBD, THC, about 5 mg β-caryophyllene and any combination thereof, per day;   b. administering said composition in a therapeutic dosage of CBD of up to 100 mg per day, preferably in the range of about 10 mg to about 100 mg per day, more preferably in a dosage of up to about 30 mg per day;   c. administering the composition in a dosage of THC of up to 100 mg per day, preferably in the range of about 10 mg to about 100 mg per day, more preferably in a dosage of up to about 30 mg per day; and   d. administering the composition in a dosage of β-Caryophyllene of up to 100 mg per day, preferably in the range of about 3 mg to about 10 mg per day, more preferably in a dosage of up to about 5 mg per day.