Wound treatment composition

Abstract

Wound care compositions and their use in treating and / or alleviating wounds or sores are disclosed. The compositions include 0.1-5% cannabidiol (CBD), 25-85% water, and one or more penetrants, and optionally one or more additional substances, such as gelling agents, emollients, wound healing compounds, antimicrobial agents, pH stabilizers, and / or chelating agents.

Description

[Technical field]

[0001] The present invention relates to a wound treatment composition for use in the treatment and / or relief of wounds and / or sores in a subject. Treatment may involve the application of a cannabinoid-containing composition, in particular a cannabidiol-containing composition. [Background technology]

[0002] Cannabinoids, such as cannabidiol (CBD; CAS number 3956-29-1), are associated with wound healing, analgesic and anti-inflammatory effects.

[0003] The "transdermal formulation" of WO2020 / 263643 relates to a transdermal formulation comprising 0.05%-50% w / w of an active agent and a pharma- ceutically acceptable carrier.

[0004] WO2019178360, "Transdermal and / or dermal delivery of lipid-soluble active agents," relates to a skin gel composition for wound healing comprising a lipid-soluble active agent.

[0005] WO2020024056, "Compositions Comprising Cannabinoids and Absorbent Materials, and Uses Thereof," relates to topical compositions suitable for topical administration.

[0006] Bruni et al., 2018 (Molecules, 23(10):2478) relates to cannabinoid delivery systems for the treatment of pain and inflammation. [Prior art documents] [Patent documents]

[0007] [Patent Document 1] WO2020 / 263643 [Patent Document 2] WO2019178360 [Patent Document 3] WO2020024056 [Non-patent literature]

[0008] [Non-Patent Document 1] Bruni et al., 2018 (Molecules, 23(10):2478) Summary of the Invention [Problem to be solved by the invention]

[0009] There is a need for compositions for efficient wound and / or sore treatment. [Means for solving the problem]

[0010] As demonstrated herein, surprisingly and / or unexpectedly, and from a wide range of candidate ingredients and concentration ranges, the inventors have found that the following compositions are effective for wound treatment and / or wound care for skin wounds in a subject:

[0011] In a first aspect, the present invention provides a composition, such as a wound care composition, comprising: a) 0.1-5%, 0.2-2%, 0.3-1%, 0.4-0.75%, or about 0.5% (w / w) cannabidiol (CBD); b) 25-85%, 35-75%, 45-70% or 55-65% (w / w) water, and c) one or more penetration agents and / or penetration enhancers, such as propylene glycol and / or pentylene glycol; and optionally, i. one or more gelling agents, such as polyacrylic acid / polyacrylates, such as 2-propenoic acid homopolymer and / or carbomer; ii. one or more skin moisturizers and / or skin conditioners, such as panthenol and / or allantoin; iii. one or more additional wound healing compounds, such as hyaluronic acid and / or its salts; iv. one or more antibacterial agents, such as benzalkonium chloride, and / or v. one or more pH stabilizers and / or buffers, such as aminomethylpropanol (AMP); vi. one or more chelating agents, such as phytic acid and / or its salts; and compositions comprising one or more of any combination of (i)-(vi).

[0012] The composition, e.g., wound care composition, can be formulated as a topical composition, e.g., a gel. Such gels typically include a polyacrylic acid-based gelling agent, e.g., carbomer or sodium polyacrylate / polyacrylic acid.

[0013] In a second aspect, the present invention provides a method of delivering a composition, such as a wound care composition, such as a composition of the first aspect, the method comprising: a) providing CBD in a solid form, preferably in a crystalline form, and / or having a purity of at least 95% (w / w), 98% (w / w), 99% (w / w), 99.5% (w / w), 99.8% (w / w) or more than 99.8% (w / w); b) dissolving the CBD of step (a) in a penetration agent and / or penetration enhancer, such as propylene glycol; c) obtaining an aqueous gel, for example by dissolving hyaluronic acid and / or its salts in water, d) combining the dissolved CBD of step (b) with the aqueous gel of step (c); and e) adding the remaining ingredients to obtain the wound care composition.

[0014] In a third aspect, the present invention relates to a composition, such as a wound care composition, delivered by the method of the second aspect.

[0015] In a fourth aspect, the present invention relates to a container comprising a composition, such as a wound care composition of the first, third or seventh aspect.

[0016] In a fifth aspect, the present invention relates to a kit comprising the container of the fourth aspect, and optionally including instructions for use.

[0017] In a sixth aspect, the present invention relates to a method for the treatment of a wound or sore in a subject comprising the topical application of a composition of the first, third or seventh aspect.

[0018] In a seventh aspect, the present invention relates to a composition of the first or third aspect for use as a medicament or cosmetic, which may include the treatment of one or more of wounds, sores, diseases and / or conditions of the skin, such as the wounds, sores, diseases and / or conditions disclosed herein.

[0019] In an eighth aspect, the present invention relates to a CBD-containing composition, such as a topical composition, in which the CBD used in the formulation is crystalline. In some embodiments, the CBD is form A (needle-shaped crystals) or is capable of forming needle-shaped crystals.

[0020] In a ninth aspect, the present invention relates to a dosing regimen comprising administering a topical composition, in particular a CBD-containing topical composition disclosed herein, in some embodiments, the CBD is "type A". [Brief description of the drawings]

[0021] [Figure 1] A micrograph of cannabinol (CBD) forming needle-like crystals. CBD crystals provided by www.enecta.com. [Diagram 2] A micrograph of cannabinol (CBD) forming clumps or bundles of crystals. CBD crystals provided by www.pharma-hemp.com. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0022] definition For purposes of this invention, the singular form of a word can include the plural, and vice versa, unless the context clearly indicates otherwise. Thus, references to "a," "an," and "the" generally include the plural of the respective term. For example, a reference to "an ingredient" or "a method" can include a plurality of such "ingredients" or "methods."

[0023] Similarly, the words "comprise", "comprises", and "comprising" are to be interpreted inclusively rather than exclusively. The embodiments provided by the present disclosure may lack any element not expressly disclosed herein. Thus, disclosure of an embodiment defined using the term "comprising" is also a disclosure of an embodiment "consisting essentially of" and "consisting of the disclosed components". Thus, the term "comprising" is generally interpreted as specifying the presence of stated parts, steps, features, or components, but does not exclude the presence of one or more additional parts, steps, features, or components. For example, a composition including a compound may thus include an additional compound.

[0024] Typically, the compositions disclosed herein, particularly topical compositions, such as wound treatment compositions and / or sore treatment compositions, may include one or more pharma- ceutically acceptable adjuvants, such as pharma- ceutically acceptable carriers, excipients, stabilizers, salts, or buffers, and the like.

[0025] As used herein, terms such as "for example," "eg," or "such as," particularly when followed by a list of terms, are merely for illustrative purposes and should not be considered as exclusive or inclusive. Any embodiment disclosed herein can be combined with any other embodiment disclosed herein.

[0026] Unless otherwise stated, all percentages expressed herein are by weight of the total weight of the composition, and therefore, unless otherwise indicated, "%" refers to "% weight / weight (w / w)", also known as "weight %" or "% by weight".

[0027] In the context of the present invention, the terms "about", "around", "approximately" or the symbol "about" can be used interchangeably and are meant to include variations and / or uncertainties normally accepted in the art, such as analytical error. Thus, "about" can also refer to the uncertainty of measurement commonly experienced in the art, which can be as large as + / - 1, 2, 5, 10, or even 20 percent (%). Furthermore, "about" can be understood to refer to numbers in a numerical range, such as a range of + / - 20, + / - 15, + / - 10, + / - 5, + / - 2, + / - 1, + / - 0.5, + / - 0.1% of the referenced number. Furthermore, all numerical ranges herein should be understood to include all integers, whole or partial, within the range.

[0028] As used herein, the term "in some embodiments" is meant to include "in one embodiment," "in some embodiments," and "in one or more embodiments."

[0029] In the context of the present invention, the term "subject" or "patient" can be used interchangeably and is meant to include humans, animals, and / or mammals. In particular, human subjects can be selected from, for example, one or more of females, males, elderly, adults, adolescents, children, or infants. Animal subjects can be selected from, for example, pets, farm animals, mammals, reptiles, birds, and / or zoo animals.

[0030] In the context of the present invention, the term "treatment" is meant as an action aimed at alleviating, reducing, improving and / or curing any symptoms, disease or illness in a subject. The efficacy of treatment can also include reduction in pain and / or discomfort. Treatment can also result in faster recovery and / or healing compared to a control. Further efficacy of treatment can also include recovery / healing with less complications compared to a control. The control can be, for example, no treatment or placebo treatment. Usually, "treatment" in this context includes topical application of an appropriate amount of a wound healing composition to and / or around the wound, usually several times per day, as further described herein.

[0031] "Skin" can be described as the usually soft, pliable outer layer of tissue that covers the body of animals, particularly vertebrates. The three main functions of skin are considered to be protection, regulation, and sensation. Skin is considered to comprise three layers: (i) the epidermis, (ii) the dermis, and (iii) the hypodermis, also called subcutaneous tissue. A "wound" or "sore" can refer to one or more of these layers.

[0032] The epidermis can be further divided into the following skins or layers (starting with the outermost layer); stratum corneum, stratum lucidum (only in the palms of the hands and soles of the feet), stratum granulosum, stratum spinosum and stratum basale (also called stratum germinativum).

[0033] In the context of the present invention, a "wound" refers to a type of injury that often, but not necessarily, occurs relatively quickly, in which the skin is burned, frozen, torn, cut, punctured (open wounds), and / or blunt trauma causes bruising (closed wounds). A "wound" also refers to an injury that damages the epidermis of the skin. A "wound" can be, for example, (i) a "clean wound" in which there is no or little life present and the skin is prone to healing without complications, such as a wound made under sterile conditions, (ii) a "contaminated wound" which usually results from an accidental injury and in which pathogens and often foreign bodies are present in the wound, (iii) an "infected wound" in which pathogens are present and grow in the wound and usually show clinical symptoms of infection, such as a yellow appearance, pain, redness, oozing pus, etc., or (iv) a "colonized wound" that contains pathogens and is difficult to heal, such as a chronic condition, such as a bed sore.

[0034] In the context of the present invention, wounds caused by freezing may also be referred to as "frostbite."

[0035] In some embodiments, a "wound" may be the result of a medical and / or cosmetic treatment and / or intervention, such as surgery or tattooing.

[0036] Furthermore, wounds can be caused intentionally (eg surgery) or accidentally.

[0037] The term "wound" also includes: an incision or cut, which is often caused by a clean, sharp object such as a knife, razor, or broken glass; an irregular, tearing wound caused by some blunt trauma; lacerations, lacerations and incisions may appear linear (regularly) or radial (irregularly); abrasions, which are shallow wounds in which the outermost layer of skin (epidermis) is scraped off; abrasions or abrasions, which are often caused by slipping on a rough surface such as asphalt, bark, or concrete; an injury in which a body structure is forcibly separated from its normal insertion point; avulsion, where a limb is cut off. The term "degloving" is also sometimes used as a symptom when used in reference to a type of cut, abrasion of skin, that is pulled rather than cut; can include puncture wounds, caused by an object that pierces the skin, such as a shrapnel, nail or needle; penetration wounds, caused by an object that enters and exits the skin, such as a knife; and gunshot wounds, caused by a bullet or similar projectile that enters and passes through the body, where there may be two wounds, one at an entry site and one at an exit site, usually referred to as "through-and-through."

[0038] Burns - A "burn" or "thermal injury" is a type of injury to the skin or other tissue caused by heat, cold, electricity, chemicals (e.g., anticorrosive chemicals), abrasion, or radiation (e.g., sunlight and / or UV light). Most burns result from heat from hot liquids, solids, fire, or chemicals. Burns that affect only the top skin layers are known as superficial or first-degree burns. They appear red, without blistering or pain, and typically last about 3 days. If the injury extends to some of the lower skin layers, it is a partial-thickness or second-degree burn. Blisters are frequently present, and they are often very painful. Healing may take up to 8 weeks, and scarring may occur. In full-thickness or third-degree burns, the injury extends to all layers of the skin. There is often no pain, and the burned area is hard. Typically, healing does not occur naturally. Additionally, fourth degree burns involve injury to deeper tissues such as muscle, tendons, or bone. The burns are often black in color and frequently result in loss of the burned area.

[0039] Frostbite - such wounds may be caused by freezing, e.g., wounds caused by exposure of the skin / body part to low temperatures that cause the skin and / or other tissues to freeze. Usually such wounds may be caused by, e.g., cold air, usually due to insufficient protective clothing, liquid gases (e.g., CO 2 , N 2These may be combined with contact with a frozen skin, such as a metal surface, or with contact with a frozen solid material, such as a metal surface. These may be classified and / or described as follows: First degree frostbite is a superficial, superficial skin injury that is usually not permanent. In the early stages, the primary symptom is loss of skin sensation. In the affected area, the skin is numb and may have a blistered, red border. For several weeks after the injury, the surface of the skin may peel off. In second degree frostbite, the skin develops clear blisters in the early stages and the surface of the skin becomes hard. For several weeks after the injury, this hard, blistered skin dries, turns black, and peels. At this stage, persistent cold sensitivity and numbness may occur. In third degree frostbite, the layers of tissue beneath the skin freeze. Symptoms include blood blisters and a "blue-gray discoloration of the skin." For several weeks after the injury, pain persists and a blackened scab (eschar) develops. There may be prolonged ulceration and growth plate damage. Fourth-degree frostbite involves structures beneath the skin, such as muscles, tendons, and bones. Early symptoms include a colorless appearance of the skin, a hard texture, and painless rewarming. The skin then turns black and becomes mummified. The amount of permanent damage can take a month or more to determine.

[0040] A "wound" can also be described as a "sore," especially one relating to the skin. A "sore" can be described, for example, as a term for a lesion on the skin or mucous membrane that is usually painful, uncomfortable, and / or irritating. "Sores" can include, for example, leishmania ulcers (chiclero ulcers); bed sores (decubitus ulcers); stomatitis (recurrent aphthous stomatitis); chrome sores (chrome ulcers); herpes (fever blisters), desert ulcers (a type of erosive ulcer found in South America and Australia that begins as a papular vesicular lesion on the extremities that later herniates and forms a painful ulcer; probably representing an infected ulcer from some previously neglected lesion); bed sores (decubitus ulcers); saddle chafing; soft sores (chancroid); summer sores (habronemannia); prairie ulcers (desert ulcers); chancroid (any sore that occurs in conjunction with or is evidence of a sexually transmitted disease).

[0041] The terms "wound" and "sore" may therefore be overlapping and may be used interchangeably. Apart from "sore", the term "wound" may also include any one of "ulcer", "blister" and / or "rash". In the context of the present invention, the term "wound treatment composition" is meant to include "sore treatment composition".

[0042] In the context of the present invention, the term "ulcer" is meant to include sores of the skin or mucous membranes that occur with the breakdown of tissue. Ulcers can result in the complete loss of the epidermis, and often even loss of part of the dermis and subcutaneous fat. Ulcers are most common in the skin of the lower limbs and in the digestive tract. Ulcers occurring in the skin are often visible as inflamed tissue with areas of reddened skin. Skin ulcers are often visible in cases of exposure to heat or cold, hypersensitivity, or problems with blood circulation. Ulcers can also be caused by lack of mobility resulting in prolonged pressure on the tissue. This stress in blood circulation translates into skin ulcers commonly known as bed sores or decubitus ulcers. Ulcers often become infected and suppurate.

[0043] Although ulcers can be caused by a variety of factors, the main cause seems to be a malfunctioning blood circulation. In particular, chronic wounds and ulcers are caused by poor circulation, either due to cardiovascular problems or external pressure from a bed or wheelchair. A very common and dangerous type of skin ulcer is caused by pressure sores, more commonly called bed sores, which frequently occur in people who are bedridden or who use wheelchairs for long periods of time. Other causes of skin ulcers include bacterial or viral infections, fungal infections, and cancer. Blood diseases and chronic wounds can also result in skin ulcers. Venous leg ulcers, which are caused by malfunctioning circulation or blood flow diseases, are more common in the elderly. Rare causes of skin ulcers include pyoderma gangrenosum, which is a lesion caused by Crohn's disease or ulcerative colitis, granulomatosis with polyangiitis, Behcet's disease, and infections that are usually seen in people with immunodeficiency, such as ecthyma gangrenosum.

[0044] In the context of the present invention, a "rash" is meant to include changes in human skin that affect its color, appearance, or texture. A rash may be located on one part of the body or affect the entire skin. A rash may cause the skin to change color, become itchy, warm, bumpy, cracked, dry, cracked, or blister, swell, and may be painful. The causes of rashes vary widely and include, for example, adverse drug reactions; anxiety; allergies, for example, to foods, dyes, medicines, vaccines, insect stings, metals, for example zinc or nickel; such rashes are often called hives; skin contact with irritants; fungal infections (for example) ringworm; skin diseases, for example eczema or acne; exposure to the sun (sunburn) or heat; chafing due to abrasions of the skin; hypersensitivity, for example caused by an abrasive soaked in clothing rubbing against the skin; secondary syphilis; and / or poor personal hygiene. Less common causes of the rash can include autoimmune diseases, such as psoriasis; lead poisoning; pregnancy; repeated scratching in certain areas; Lyme disease and Lyme borreliosis, which are infections caused by the Borrelia bacteria usually spread by ticks; scarlet fever; and / or COVID-19.

[0045] In the context of the present invention, "blister" is meant to include a usually small pocket of fluid (lymph, serum, plasma, blood or pus) in the upper layer of the skin, usually caused by forceful friction (chafing), burning, freezing, exposure to chemicals or infection. Most blisters are filled with clear fluid, either serum or plasma. However, blisters can be filled with blood (known as blood blisters) or pus (e.g., if they are infected). The terms "vesicle" and "bull" can also be used, usually referring to blisters of smaller or larger size, respectively. Blisters can form when the skin is damaged by rubbing or friction, heat, cold or exposure to chemicals. Fluid collects between the upper layer of skin (epidermis) and the lower layer (dermis). This fluid cushions the underlying tissue and prevents further damage to the tissue, allowing healing.

[0046] Chafing blisters can be caused by vigorous rubbing, any rubbing against the skin if sustained long enough. This type of blisters most commonly occurs after walking long distances or wearing old or ill-fitting shoes. Blisters are most commonly found on the hands and feet, as these limbs are more susceptible to injury while walking, running, or performing repetitive movements, such as using a joystick while playing certain video games, digging with a shovel, playing a guitar or bass, etc. Blisters form more easily on moist skin than on dry or overly wet skin, and are more common in warm conditions. Friction that is not vigorous and lasts for a long time can cause calluses to form rather than blisters. Both blisters and calluses can lead to more serious complications, such as foot ulcers and infections, especially when sensation or circulation is not functioning properly, as in the case of diabetes, neuropathy, or peripheral arterial disease (PAD).

[0047] Burns, especially first- and second-degree burns, can result in blistered skin, but immediate blistering is characteristic of second-degree burns, while first-degree burns may have blisters after 2-3 days. Sunburn or other forms of radiation can also result in blistering.

[0048] Blisters can also form on the hands and feet as a result of tissue damage sustained by frostbite.

[0049] Exposure to chemicals can also cause blisters. Sometimes the skin blister when it comes into contact with cosmetics, detergents, solvents, or other chemicals, such as nickel sulfate, balsam of Peru, or urushiol (poison ivy, poison oak, poison sumac). This is also known as contact dermatitis. Blisters can also occur as a result of an allergic reaction to insect bites or stings. Some chemical weapons known as blistering agents or blistering agents, such as mustard gas, cause large, painful blisters wherever it comes into contact with the skin.

[0050] Blood blisters usually form when tiny blood vessels near the surface of the skin burst (break) and blood leaks into a crack between the layers of skin. This can happen when the skin is crushed, pinched, or crushed violently.

[0051] There are also many diseases that cause blisters. The most common are chicken pox, herpes, impetigo, and a type of eczema called dyshidrosis. Other, usually rarer, diseases that cause blisters can include bullous pemphigoid, a skin disease that produces large, densely filled blisters and usually affects people over the age of 60; pemphigus, a serious skin disease that causes blisters when pressure is applied to the skin, these blisters easily burst and leave raw areas that can become infected; dermatitis herpetiformis, a skin disease that causes extremely itchy blisters usually on the elbows, knees, back, and buttocks, the blisters usually occur in patches of the same shape and size on both sides of the body; chronic bullous disease, a disease that causes lumps or blisters on the face, mouth, or genitals; cutaneous radiation syndrome; and epidermolysis bullosa, a group of rare diseases that cause easy blistering of the skin and mucous membranes. The blisters are caused by minor trauma or abrasion and are painful. Their severity can range from mild to fatal. Mild cases may not cause symptoms until the patient begins to crawl or walk. Complications can include esophageal strictures, squamous cell skin cancer, and the need for amputation.

[0052] Friction blisters are caused by excessive shear stress between the bottom and top of the skin and body. The layers of skin around the stratum spinosum are the most susceptible to shear. As the stratum spinosum pulls away from the connective tissue underneath, protoplasm diffuses out of the cells. This protoplasmic solution helps new cells divide and grow into new connective tissue and epidermal layers. The clear fluid is reabsorbed as new cells form, and the swollen appearance subsides. Painful blisters located on the hands (palmar surface) and feet (plantar surface) are due to tissue shearing deeper near the nerve endings of the epidermis. The tissues below are more susceptible to infection.

[0053] In a first aspect, the present invention relates to a composition, such as a wound treatment composition and / or a sore treatment composition, comprising CBD and a penetrant and / or a penetrant enhancer.Usually, the composition is formulated for topical application, such as, but not limited to, a gel.Such a composition can also be used as a wound care composition.

[0054] In some embodiments, such wound care compositions comprise: a) 0.1-5%, 0.2-2%, 0.3-1%, 0.4-0.75%, or about 0.5% (w / w) cannabidiol (CBD); b) 25-85%, 35-75%, 45-70% or 55-65% (w / w) water, and c) may include one or more penetration agents and / or penetration enhancers, such as propylene glycol and / or pentylene glycol.

[0055] Cannabidiol, CAS number 3956-29-1, is a non-psychoactive cannabinoid. It can be supplied in various purity levels and is usually extracted from Cannabis sativa by methods known in the art. In the context of the present invention, CBD with high purity is usually preferred, for example "crystalline" CBD that does not contain significant amounts of oil or additional cannabinoids, such as psychoactive or non-psychoactive cannabinoids.

[0056] In particular, when the absence of oil and / or lipids is desired, common sources of CBD, such as CBD-containing oils, are undesirable. Thus, in some embodiments, CBD is provided in essentially pure form, such as in crystalline or powder form, and / or with a purity of 95%, 98%, 99%, 99.5%, 99.8% or greater. Without wishing to be bound by any theory, it is believed that the use of crystalline CBD can further contribute in a positive way, for example less CBD is required to obtain a similar efficacy compared to crude CBD preparations. This is surprising, according to the general opinion that the additional cannabinoids present in such crude CBD preparations are believed to provide a synergistic efficacy.

[0057] Typically, the water used in the formulations is of drinking water quality. It can also be distilled or deionized water, such as "MilliQ water."

[0058] The CBD-containing compositions described herein typically include one or more skin penetration enhancers, such as a mixture of two or more skin penetration enhancers. In general, the term "skin penetration enhancer", "penetration enhancer" or "penetration agent" can be used interchangeably herein, and improves the ability of one or more relevant components / ingredients of the composition, such as CBD, to pass through the epidermal and dermal layers of the skin to reach the adipose tissue beneath the skin where the number and / or size of fat cells increases. Without wishing to be bound by any theory, it is believed that this can be achieved by many different mechanisms, such as by drawing lipids out of the stratum corneum, increasing the partitioning of the active ingredient into the skin, and by disrupting the lipid bilayer of the stratum corneum, thereby making the stratum corneum structure more fluid and increasing the ability of the composition containing cannabinoids to diffuse through the stratum corneum.

[0059] In some embodiments, the "penetration enhancer" is provided at a concentration of 0.1-15% (w / w), 0.5-12% (w / w), 1.0-10% (w / w), 2.0-7.5% (w / w), 4.0-6.0% (w / w), or about 5% (w / w). Suitable skin penetration enhancers can be, for example, sulfoxides, alcohols, fatty acids, fatty acid esters, polyols, amides, surfactants, terpenes, alkanones, and organic acids, among others. Specific examples of suitable sulfoxides include dimethyl sulfoxide (DMSO) and decyl methyl sulfoxide, among others. Suitable alcohols include alkanols such as ethanol, propanol, butanol, pentanol, hexanol, octanol, n-octanol, nonanol, decanol, 2-butanol, 2-pentanol, and benzyl alcohol; fatty alcohols such as capryl alcohol, decyl alcohol, lauryl alcohol, 2-lauryl alcohol, myristyl alcohol, cetyl alcohol, stearyl alcohol, oleyl alcohol, linoleyl alcohol, and linolenyl alcohol; and isopropyl alcohol. Examples of suitable fatty acids include straight chain fatty acids such as valeric acid, heptanoic acid, pelargonic acid, caproic acid, capric acid, lauric acid, myristic acid, stearic acid, oleic acid, and caprylic acid; and branched chain fatty acids such as isovaleric acid, neopentanoic acid, neoheptanoic acid, neononanoic acid, trimethylhexanoic acid, neodecanoic acid, and isostearic acid. Examples of suitable fatty acid esters include aliphatic fatty acid esters, such as isopropyl n-butyrate, isopropyl n-hexanoate, isopropyl n-decanoate, isopropyl myristate, isopropyl palmitate, and octyldodecyl myristate; alkyl fatty acid esters, such as ethyl acetate, butyl acetate, methyl acetate, methyl valerate, methyl propionate, diethyl sebacate, and ethyl oleate; and diisopropyl adipate and dimethyl isosorbide.Examples of suitable alcohols include propylene glycol, butylene glycol, polyethylene glycol, ethylene glycol, diethylene glycol, triethylene glycol, dipropylene glycol, ethoxydiglycol, pentylene glycol, glycerol, propanediol, butanediol, pentanediol, hexanetriol, and glycerin. Examples of suitable amides include urea, dimethylacetamide, diethyltoluamide, dimethylformamide (DMF), dimethyloctamide, dimethyldecamide, biodegradable cyclic ureas (e.g., 1-alkyl-4-imidazolin-2-one), pyrrolidone derivatives, biodegradable pyrrolidone derivatives (e.g., fatty acid esters of N-(2-hydroxyethyl)-2-pyrrolidone), cyclic amides, hexamethylene lauramide and its derivatives, diethanolamine, and triethanolamine. Examples of pyrrolidone derivatives include 1-methyl-2-pyrrolidone, 2-pyrrolidone, 1-lauryl-2-pyrrolidone, 1-methyl-4-carboxy-2-pyrrolidone, 1-hexyl-4-carboxy-2-pyrrolidone, 1-lauryl-4-carboxy-2-pyrrolidone, 1-methyl-4-methoxycarbonyl-2-pyrrolidone, 1-hexyl-4-methoxycarbonyl-2-pyrrolidone, 1-lauryl-4-methoxycarbonyl-2-pyrrolidone, N-cyclohexylpyrrolidone, N-dimethylaminopropylpyrrolidone, N-cocoalkylpyrrolidone, N-tallow alkylpyrrolidone, and N-methylpyrrolidone. Examples of cyclic amines include 1-dodecylazacycloheptan-2-one (e.g., Azone), 1-geranylazacycloheptan-2-one, 1-famecylazacycloheptan-2-one, 1-geranylgeranylazacycloheptan-2-one, H3,7-dimethyloctyl)azacycloheptan-2-one, 1-(3,7,11-trimethyldodecyl)azacycloheptan-2-one, 1-geranylazacyclohexane-2-one, 1-geranylazacyclopentane-2,5-dione, and 1-famecylazacyclopentan-2-one.

[0060] In some embodiments, the penetrant / penetration enhancer is or comprises a polyol. In some embodiments, the penetrant, e.g., polyol, particularly glycol, is present in a concentration of 0.1-1.0% (w / w), 0.5-1.5% (w / w), 1.0-2.5% (w / w), 1.5-5.0% (w / w), 2.5-10% (w / w), or 5-15% (w / w). In some embodiments, the penetrant / penetration enhancer is or comprises a glycol. In some embodiments, the penetrant / penetration enhancer is or comprises propylene glycol. In some embodiments, the penetrant / penetration enhancer is or comprises pentylene glycol. In some embodiments, the penetrant / penetration enhancer is or comprises propylene glycol and pentylene glycol. In some embodiments, one or more penetrants and / or penetration enhancers are or comprise propylene glycol and / or pentylene glycol. In some embodiments, the penetrating agent comprises propylene glycol and / or pentylene glycol, as well as additional glycols.

[0061] In some embodiments, propylene glycol is provided at a concentration of 0.1-15% (w / w), 0.5-12% (w / w), 1.0-10% (w / w), 2.0-7.5% (w / w), 4.0-6.0% (w / w), or about 5% (w / w). In some embodiments, pentylene glycol is provided at a concentration of 0.1-15% (w / w), 0.5-12% (w / w), 1.0-10% (w / w), 1.5-7.5% (w / w), 2.0-6.0% (w / w), 2.5-4.0% (w / w), or about 5% (w / w). In some embodiments, the one or more penetrating agents are selected from the list of penetrating agents disclosed herein. In some embodiments, the penetrating agent is present in a concentration of 0.1-1.0% (w / w), 0.5-1.5% (w / w), 1.0-2.5% (w / w), 1.5-5.0% (w / w), 2.5-10% (w / w), or 5-15% (w / w), which may be, for example, a combination of two glycols, such as pentylene glycol and propylene glycol.

[0062] In some embodiments, CBD can be dissolved in a penetrant, such as propylene glycol. This advantage can be utilized, for example, in manufacturing methods. Generally, CBD is dissolved in oil or alcohol. However, in some embodiments, oil and / or alcohol can be undesirable, for example, for reasons discussed herein.

[0063] The compositions, such as the wound and / or sore treatment compositions disclosed herein, can also include one or more pharma- ceutically acceptable adjuvants. In some embodiments, the adjuvants can be selected from one or more of antioxidants, emulsifiers, pH adjusters, such as acids, bases or salts thereof, stabilizers, colorants, and any combination thereof.

[0064] In many cases, the compositions, e.g., wound treatment compositions and / or sore treatment compositions, include one or more additional substances, such as one or more gelling agents, one or more emollients, one or more skin conditioners, one or more wound healing compounds, one or more antimicrobial agents, one or more pH stabilizers, and one or more chelating agents, and any combination thereof.

[0065] In some embodiments, the composition thus optionally comprises one or more of (i)-(vi), e.g., i. one or more gelling agents, such as polyacrylic acid / polyacrylates, such as 2-propenoic acid, homopolymers and / or carbomers; ii. one or more skin moisturizers and / or skin conditioners, such as panthenol and / or allantoin; iii. one or more additional wound healing compounds, such as hyaluronic acid and / or its salts; iv. one or more antibacterial agents, such as benzalkonium chloride, and / or v. one or more pH stabilizers and / or buffers, such as aminomethylpropanol (AMP); vi. one or more chelating agents, such as phytic acid and / or its salts; As well as any combination of (i) to (vi).

[0066] The compositions, e.g., wound care compositions and / or sore care compositions, can be formulated for topical application, e.g., as a gel. Wound care compositions formulated as gels provide advantages, e.g., ease of proper dosing and application, as well as one or more additional advantages, as disclosed herein.

[0067] Thus, in some embodiments, the composition includes one or more gelling agents to provide a gel-like composition. A "gelling agent" is a substance or compound capable of forming a gel. The gel can be, for example, a hydrogel comprising a polymeric or colloidal network. Examples of suitable gelling agents include 1-methyl-2,4-bis(N'-n-octadecylureido)benzene (MBB18), 1-methyl-2,4-bis(N'-n-dodecylureido)benzene (MBB12), bis(4'-stearamidophenyl)methane (BSM18), bis(4'-octanamidophenyl)methane (BOM8), 12-hydroxystearic acid, nucleobases, phenylalanine, d-glucosamine, RAD16, EAK16, RAD16 I, RAD16-II, KLD-12, nucleopeptides (phenylalanine dipeptides linked to a nucleobase), guanosine derivatives, carbomers such as carbomer 910, 934, 940, 941 and 934P (these numbers indicate the molecular weight and specific components of the polymer), IKVAV-peptide amphiphile, heparin-binding peptide amphiphile LRKKLGKA-PA, glycosylated aminoacetate type hydrogelator 1 C33O12N3H55, Gelator 4b (derivative of d-gluconolactone) C16O7N2H24, Unimer U-15, Unimer U-151, Unimer U-1946, and / or Unimer U-6. In some embodiments, the gelator can be selected from one or more gelators as disclosed above or below.

[0068] In some embodiments, the one or more gelling agents are provided at a concentration of 0.1-5%, 0.2-3% (w / w), 0.5-2% (w / w), 0.6-1.0% (w / w), or about 0.8% (w / w). In some embodiments, the gelling agent is or includes a carbomer, a polyacrylic acid / polyacrylate, such as sodium acrylate. In some embodiments, the gelling agent is or includes a polyacrylic acid, a polyacrylate, and / or a 2-propenoic acid homopolymer. In some embodiments, the gelling agent is or includes a carbomer. Poly(acrylic acid) (PAA; trade name carbomer) is a synthetic high molecular weight polymer of acrylic acid. Its IUPAC name is poly(1-carboxyethylene). They may be homopolymers of acrylic acid and may be crosslinked with allyl ethers of pentaerythritol, allyl ethers of sucrose, or allyl ethers of propylene. In aqueous solutions at neutral pH, PAA is an anionic polymer, i.e., many of the side chains of PAA lose their protons and acquire a negative charge, which makes PAA a polyelectrolyte with the ability to absorb and retain water and expand to many times their original volume.

[0069] In some embodiments, hyaluronic acid / hyaluronate serves as a gelling agent, either alone or in combination with additional gelling agents, such as polyacrylic acid / polyacrylate. Hyaluronic acid is a disaccharide polymer consisting of D-glucuronic acid and N-acetyl-D-glucosamine linked by alternating β(1→4) and β(1→3) glycosidic bonds. The length of hyaluronic acid can be 25,000 disaccharide repeats. Polymers of hyaluronic acid can range in size from 5.000 to 20.000.000 Da in vivo. The average molecular weight in human synovial fluid is 3-4 million Da, hyaluronic acid purified from human umbilical cord is 3.140.000 Da, and other sources cite an average molecular weight of 7 million Da for synovial fluid. Hyaluronic acid binds water and swells to form a gel. Additionally, hyaluronic acid is known to bind and absorb water up to 1000 times its own molecular weight, and thus hyaluronic acid is believed to be relevant to tissue regeneration, for example as a dermal filler for facial wrinkles. In some embodiments, hyaluronic acid / hyaluronates are combined with additional gelling agents, such as carbomers, to act as gelling agents.

[0070] The function of the gelling agent can be described as providing a gel or gel-like texture of the composition, to which one or more thickening agents or gelling substances can be provided. Such thickening agents / gelling substances can be selected from acrylate crosspolymers, in particular C10-C30 acrylate crosspolymers (e.g., those commonly available under the trade name Carbopol®), hydroxyethyl cellulose, xanthan gum, and / or any combination thereof. The amount of gelling agent and / or thickening agent can be considered sufficient to ensure that the gel does not run off during application. In some embodiments, the gel can include a thickening agent and / or gelling substance selected from acrylate crosspolymers, hydroxyethyl cellulose, xanthan gum, and / or any combination thereof.

[0071] In some embodiments, the composition comprises one or more skin moisturizers and / or one or more skin conditioners.

[0072] Generally, the terms "moisturizer", "skin moisturizer" or "emollient" can be used interchangeably and are meant to include cosmetic compositions that provide protection, moisturization and / or lubrication of the skin. Moisturizers can also prevent dryness and irritation of the skin by moisturizing. In the context of the present invention, the terms "moisturizer" or "emollient" also refer to individual compounds that provide or improve such moisturizing effects. Examples of such compounds include panthenol, allantoin, isopropyl myristate, pantothenic acid, sodium hyaluronate, squalene, phenoxyethanol, methylparaben, propylparaben, ethylparaben, butylparaben, lanolin, sorbitol, petrolatum, stearic acid, shea butter, glyceryl stearate, elastin, hyaluronic acid, olive oil, glycerin pharmaceutical grade 99.5% vegetable gum, rhizobian, and / or sea water.

[0073] In some embodiments, the emollient is or includes panthenol. In some embodiments, the emollient is or includes allantoin. In some embodiments, the emollient is or includes panthenol and allantoin.

[0074] In some embodiments, hyaluronic acid / hyaluronate acts as a gelling agent and / or an emollient.

[0075] In some embodiments, the skin moisturizer is provided in a concentration of 0.1-5% (w / w), 0.15-3.0% (w / w), 0.2-1.5% (w / w), 0.5-0.8% (w / w), or about 0.65% (w / w). In some embodiments, the skin moisturizer is or includes panthenol. In some embodiments, the skin moisturizer is or includes allantoin. In some embodiments, the skin moisturizer includes panthenol and allantoin. In some embodiments, panthenol is provided in a concentration of 0.1-5% (w / w), 0.15-3.0% (w / w), 0.2-1.5% (w / w), 0.5-0.8% (w / w), or about 0.65% (w / w). In some embodiments, allantoin is provided at a concentration of 0.01-5% (w / w), 0.05-2% (w / w), 0.1-1% (w / w), 0.2-0.5% (w / w), or about 0.3% (w / w). In some embodiments, panthenol and allantoin are provided at a concentration of 0.01-5% (w / w), 0.05-2% (w / w), 0.1-1% (w / w), 0.2-0.5% (w / w), or about 0.3% (w / w), respectively. In some embodiments, panthenol and allantoin are provided at a combined concentration of 0.01-5% (w / w), 0.05-2% (w / w), 0.1-1% (w / w), 0.2-0.5% (w / w), or about 0.3% (w / w), respectively. In some embodiments, the emollient is selected from one or more of panthenol, allantoin, isopropyl myristate, pantothenic acid, sodium hyaluronate, squalene, phenoxyethanol, methylparaben, propylparaben, ethylparaben, butylparaben, lanolin, sorbitol, petrolatum, stearic acid, shea butter, glyceryl stearate, elastin, hyaluronic acid, olive oil, glycerin pharmaceutical grade 99.5% vegetable gum, rhizobian, and / or sea water.

[0076] In some embodiments, the composition comprises a skin conditioner. In the context of the present invention, the term "skin conditioner" or "skin essence" is meant to include ingredients or compositions that provide softening of the skin. Often, the skin conditioner also provides moisture to the skin, such as a moisturizer. In some embodiments, the skin conditioner is provided at a concentration of 0.1-5% (w / w), 0.15-3.0% (w / w), 0.2-1.5% (w / w), 0.5-0.8% (w / w), or about 0.65% (w / w). In some embodiments, the skin conditioner is or comprises panthenol. In some embodiments, the skin conditioner is or comprises allantoin. In some embodiments, the skin conditioner comprises panthenol and allantoin. In some embodiments, allantoin is provided at a concentration of 0.1-5% (w / w), 0.15-3.0% (w / w), 0.2-1.5% (w / w), 0.5-0.8% (w / w), or about 0.65% (w / w). In some embodiments, panthenol is provided at a concentration of 0.1-5% (w / w), 0.15-3.0% (w / w), 0.2-1.5% (w / w), 0.5-0.8% (w / w), or about 0.65% (w / w). In some embodiments, allantoin and panthenol are provided at a combined concentration of 0.1-5% (w / w), 0.15-3.0% (w / w), 0.2-1.5% (w / w), 0.5-0.8% (w / w), or about 0.65% (w / w).

[0077] In some embodiments, the skin conditioner is selected from the group consisting of Panthenol, Astrocaryum Vulgare Seed Butter, Astrocaryum Vulgare Seed Butter, Gossypium Hirsutum Seed Extract, Pentaclethra Macrophylla Seed Oil, Abies Alba Extract, Zanthoxylum Bungeanum Peel Extract, Zea Mays Germ Extract, Zymomonas Ferment Filtrate, Zingiber Officinale Root, Diglycoside II, Zostera Marina Callus Extract, Ulva Australis Extract, Actinidia Arguta Juice, Adenosine, Adonis Amurensis Extract, Aloe Barbadensis Leaf Extract, Amaranthus Spinosus Seed Oil, Ananas Sativus Fruit Juice, Black Soldier Fly Larvae Oil, Azurite, Bacillus / Corchorus Olitorius Leaf Ferment Filtrate, Cajanus Cajan leaf extract, and / or calcium polyglutamate crosspolymer.

[0078] In some embodiments, skin conditioners can provide additional benefits, such as moisturizing benefits.

[0079] In some embodiments, a skin conditioner may also act as an emollient, or vice versa, such as, for example, panthenol, which may act as a skin conditioner and / or an emollient.

[0080] The wound and / or sore treatment compositions may benefit from the presence of one or more additional wound healing compounds. In some embodiments, the composition comprises a wound healing compound. In the context of the present invention, a "wound healing compound" is a compound that promotes wound healing and / or tissue regeneration. CBD is an example of a wound healing compound. In some embodiments, the additional wound healing compound is or comprises hyaluronic acid and / or salts thereof. Suitable concentrations of the wound healing compound may vary, for example, about 0.1-5% (w / w). In some embodiments, the one or more additional wound healing compounds are provided at a concentration of 0.1-5% (w / w), 0.2-3% (w / w), 0.3-1% (w / w), 0.35-0.75% (w / w), 0.4-0.6% (w / w), or about 0.5% (w / w). In some embodiments, the additional wound healing compound is selected from one or more of honey (medical grade), hyaluronic acid, vitamin E, Aloe vera, benzalkonium chloride 0.13%, propylene glycol, glycerin 20.0%, propolis, petrolatum, curcumin, garlic, carbonoid oil, collagen, sorbitol, silver, Anethum graveolens, Anethum graveolens, Cinnamomum verum, Eucalyptus, Securigera securidaca, Trigonella foenum-graecum, Nelumbo nucifera, Neem leaf extract, Chamomilla recutita, Nitrofurazone, Bael, Moltkia coerulea, and Allium sativum L. (Amaryllidaceae), and any combination thereof.

[0081] In some embodiments, hyaluronic acid / hyaluronate acts as a wound healing compound. In some embodiments, hyaluronic acid / hyaluronate acts as one or more of a gelling agent, an emollient, and / or a wound healing compound, and any combination thereof.

[0082] The CBD-containing compound, e.g., wound / sore treatment composition, can further include an "antiseptic." Antiseptics provide stability and / or increased stability of the composition, e.g., by preventing microbial growth in the composition, and are also referred to herein as "antimicrobials." In some embodiments, one or more suitable preservatives and / or antimicrobials can be selected from, e.g., biocides, methylparaben, ethylparaben, propylparaben, butylparaben, organic acids, citric acid, sorbic acid, acetic acid, propionic acid, sulfites, nitrites, sodium sorbate, potassium sorbate, calcium sorbate, benzoic acid, sodium benzoate, potassium benzoate, calcium benzoate, sodium metabisulfite, propylene glycol, benzaldehyde, butylated hydroxytoluene, butylated hydroxyanisole, formaldehyde donors, plant extracts, monoglycerides, phenols, mercury components, and any combination thereof. In some embodiments, the one or more suitable antibacterial agents can be selected from one or more of organic acids, salts of organic acids, and any combination thereof.Without wishing to be bound by any theory, CBD is believed to have antibacterial efficacy that is probably comparable to some traditional antibiotics.CBD is believed to be active against pathogens, such as Staphylococcus aureus, Streptococcus pneumoniae, and / or Clostridioides difficile.

[0083] The compositions, e.g., wound and / or sore treatment compositions, may also benefit from the presence of one or more antimicrobial agents or stabilizers, e.g., for product storability and / or microbial safety. In some embodiments, the antimicrobial agent is or includes benzalkonium chloride. In some embodiments, the one or more antimicrobial agents are provided at a concentration of 0.01-5% (w / w), 0.02-2% (w / w), 0.04-1% (w / w), 0.075-0.2% (w / w), or about 0.1% (w / w). In some embodiments, the antimicrobial agent is provided at a concentration of 0.01-2.5% (w / w), 0.025-0.1.0% (w / w), 0.05-0.5% (w / w), 0.075-0.2% (w / w), or about 0.1% (w / w). In some embodiments, a preservative may provide an additional benefit, e.g., a pH adjusting effect and / or a buffering effect. In some embodiments, the antimicrobial agent is selected from one or more antimicrobial / antiseptic agents disclosed herein.

[0084] In some embodiments, the CBD-containing composition is formulated to provide a defined pH. Typically, a neutral, near neutral, and / or slightly acidic pH, such as a pH similar to that of the skin, for example, about 6.0-6.8, or about 6.5, such as 6.5±0.20, 6.25±0.25, or 6.0±0.25, is often preferred. In some embodiments, the CBD-containing composition can be formulated at a pH of 5-7, 5-6, 5.5-6.5, or about 6. In some embodiments, the pH is about 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, or 7.0. In some embodiments, the pH may be about 5.2-5.8, 5.6-5.7, or about 5.5. In some embodiments, the pH is about 6-6.5. In some embodiments, the pH is greater than 6.8 or 7.0. In some embodiments, the pH is less than 5.0.

[0085] Providing a defined pH can be achieved using methods known in the art, including the addition of one or more acids, bases, salts of the acids and / or bases, buffers and / or pH stabilizers, and any combination thereof. In some embodiments, citric acid, particularly citric acid monohydrate, is used in this context. In some embodiments, other pharma-ceutically acceptable acids or bases and their salts can be used. In some embodiments, triethanolamine and / or citrate / citric acid are used to provide and / or maintain the desired pH. In some embodiments, alkanolamines, such as aminomethylpropanol (AMP), are used as buffers.

[0086] A "chelating agent" or "chelator" is a compound capable of forming a chelate complex with an ion, e.g., a metal ion. It is usually an organic compound capable of reacting with a metal ion to produce a chelate compound. Examples of suitable chelating agents can include EDTA, citric acid, tartaric acid, phytic acid, triethanolamine, and salicylaldehyde. In some embodiments, phytic acid and / or its salts are used as the chelating agent. In some embodiments, the chelator is present at a concentration of 0.075-0.2% (w / w), or about 0.1% (w / w). In some embodiments, the chelator is phytic acid or a phytate, e.g., sodium phytate.

[0087] Typically, the presence of oils and / or lipids is undesirable in the CBD-containing compositions of the present invention, especially in the context of topical compositions formulated as gels to be applied to the skin of a subject. In some embodiments, the compositions are not formulated as oil-in-water or water-in-oil emulsions. Thus, in some embodiments, the compositions contain minor amounts, e.g., less than 1.0, 0.5, or 0.1% (w / w), of oil, e.g., edible oils, dehydrated oils, and / or dehydrated edible oils, or are free of them. This may seem counterintuitive, for example, for skin burns, where goat lipids are used to treat burns, especially in traditional wound care recipes, where oils / lipids are typically used to keep the skin soft and smooth. However, in the present invention, it is believed that the potential disadvantages of lipid / oil-free wound care formulations are greatly outweighed by current CBD-containing recipes, especially when they contain, e.g., hyaluronic acid / hyaluronate. Without wishing to be bound by any theory, it is believed that the presence of such lipids and / or oils contributes negatively to the efficacy of the formulation, since CBD is hydrophobic and the oils / lipids form a kind of barrier and / or layer on the skin, thereby preventing the relevant active compounds from being able to actively participate in the wound healing process.Furthermore, the oils and / or lipids can impede, block or even destroy the carbomer hydrogel, so that the composition can no longer form a protective layer covering the wound and providing a perfect environment for wound healing.

[0088] As a result, in some embodiments, the CBD-containing compositions disclosed herein contain only trace amounts of oils and / or lipids or no oils and / or lipids. In some embodiments, the compositions contain less than 1.0, 0.5, 0.1% oils and / or lipids. In some embodiments, the compositions do not contain one or more of: (i) oils, e.g., edible oils; (ii) lipids, e.g., edible fats. Typically, the compositions disclosed herein do not contain oil-in-water emulsions or water-in-oil emulsions.

[0089] In some embodiments, the wound treatment composition, e.g., wound composition and / or sore composition, comprises 0.1-5%, 0.2-2%, 0.3-1%, 0.4-0.75%, or about 0.5% (w / w) CBD, 25-85%, 35-75%, 45-70%, or 55-65% (w / w) water, and one or more penetration agents and / or penetration enhancers, e.g., propylene glycol and / or pentylene glycol, (i) one or more gelling agents, e.g., polyacrylic acid / polyacrylates (e.g., 2-propenoic acid homopolymer and / or carbomer), and optionally (ii) one or more (iii) one or more further wound healing compounds, such as hyaluronic acid and / or its salts, (iv) one or more antimicrobial agents, such as benzalkonium chloride, (v) one or more pH stabilizers and / or buffers, such as aminomethylpropanol (AMP), and / or (vi) one or more chelating agents, such as phytic acid and / or its salts, and any combination of (ii)-(vi).

[0090] In some embodiments, the compositions disclosed herein, for example wound and / or sore treatment compositions optionally formulated as gels, comprise components (i) and (ii), and optionally one or more of components (iii)-(vi). In some embodiments, the compositions comprise components (i) and (iii), and optionally one or more of components (ii), (iv)-(vi). In some embodiments, the compositions comprise components (i) and (iv), and optionally one or more of components (ii), (iii), (v), (vi). In some embodiments, the compositions comprise components (i) and (v), and optionally one or more of components (ii)-(iv) and (vi). In some embodiments, the compositions comprise components (i) and (vi), and optionally one or more of components (ii)-(iv) and (vi). In some embodiments, the compositions comprise components (i) and (vi), and optionally one or more of components (ii)-(v). Components (i)-(vi) are disclosed in detail herein.

[0091] In some embodiments, the composition includes some alcohol. In some embodiments, the composition includes no alcohol or only a small amount of alcohol. In some embodiments, the composition includes no more than 10%, no more than 5%, no more than 2%, no more than 1%, no more than 0.5%, no more than 0.25%, or no more than 0.1% alcohol by weight. Typically, the alcohol is a low molecular weight alcohol, such as one or more low molecular weight alcohols, such as one or more C1-C4 alcohols, such as methanol, ethanol, propanol, butanol, and any isomers and / or any combinations thereof. In some embodiments, the wound treatment composition includes and / or includes no more than 0.25% (w / w), such as no more than 0.20% (w / w), or no more than 0.10 (w / w) alcohol. In some embodiments, the composition includes no more than C1-C4 alcohol. In some embodiments, the composition includes no more than 0.25% (w / w), such as no more than 0.20% (w / w), or no more than 0.10 (w / w) C1-C4 alcohol. Generally, the presence of alcohol, especially low molecular weight alcohols, such as C1-C4 alcohols, is undesirable in the context of the present invention. Generally, alcohol is used to clean and / or disinfect wounds. However, alcohol can actually harm sensitive tissues and slow healing. Furthermore, applying alcohol to wounds, especially open wounds, and / or sensitive tissues, can cause stinging and / or burning discomfort. Alcohol also has an undesirable dehydrating effect on the skin.

[0092] Depending on the manufacturing method used, different cannabis is used for the CBD composition. When extracted, they may contain different amounts of impurities, such as additional cannabinoids. Usually, the presence of such impurities is undesirable, especially when the nature, concentration and / or composition of these impurities is unknown and / or they vary significantly between batches. Thus, in some embodiments, the CBD has a purity of at least 95% (w / w), 98% (w / w), 99% (w / w), 99.5 (w / w), or more than 99.8% (w / w).

[0093] The compositions, e.g. wound treatment compositions and / or sore treatment compositions, may comprise one or more further cannabinoids, e.g. one or more psychoactive cannabinoids or one or more non-psychoactive cannabinoids, such as one or more of THC (tetrahydrocannabinol), THCA (tetrahydrocannabinolic acid), CBDA (cannabidiolic acid), CBG (cannabigerol), CBC (cannabichromene), CBL (cannabicyclol), CBV (cannabivarin), THCV (tetrahydrocannabivarin), THCP (tetrahydrocannabiphorol), CBDV (cannabidivarin), CBCV (cannabichromevarin), CBGV (cannabigerovarin), CBGM (cannabigerol monomethyl ether), CBE (cannabiersoin), and or CBT (cannabicitran), and any combination thereof.

[0094] However, as summarized above, significant amounts, particularly physiologically active amounts, of one or more additional cannabinoids are generally undesirable. As a result, in some embodiments the composition comprises less than 1.5, 1.0, 0.5 or 0.1% (w / w) of one or more further cannabinoids, such as one or more psychoactive cannabinoids or one or more non-psychoactive cannabinoids, such as one or more of THC (tetrahydrocannabinol), THCA (tetrahydrocannabinolic acid), CBDA (cannabidiolic acid), CBN (cannabinol), CBG (cannabigerol), CBC (cannabichromene), CBL (cannabicyclol), CBV (cannabivarin), THCV (tetrahydrocannabivarin), THCP (tetrahydrocannabiphorol), CBDV (cannabidivarin), CBCV (cannabichromevarin), CBGV (cannabigerovarin), CBGM (cannabigerol monomethyl ether), CBE (cannabiersoin), and or CBT (cannabicitran), and any combination thereof. In some embodiments, the CBD or composition contains less than 0.1 (w / w) THC. In some embodiments, the CBD or composition contains less than 1.5% (w / w) of any one of CBDV, CBDA, CBG, CBN. In some embodiments, the CBD contains less than 1.0, 0.5, 0.2, or 0.1% (w / w) by weight of CBDV, CBDA, CBG, CBN, or THC.

[0095] The absence of any significant amount of additional cannabinoids seems counterintuitive and contrary to common opinion calling for the positive synergistic efficacy of additional cannabinoids in compositions for wound and / or pain treatment.

[0096] In some embodiments, a) 20-85% (w / w), 40-75% (w / w), 50-70% (w / w), 55-65% (w / w), approximately 61% (w / w) water; b) 0.1-60% (w / w), 5-55% (w / w), 10-50% (w / w), 30-50% (w / w), 35-45% (w / w), or about 30% (w / w) propylene glycol; c) 0.1-15% (w / w), 0.5-12% (w / w), 1.0-10% (w / w), 1.5-7.5% (w / w), 2.0-6.0% (w / w), 2.5-4.0% (w / w), or about 5% (w / w) of pentylene glycol; d) 0.1-10% (w / w), 0.2-5% (w / w), 0.4-2.0% (w / w), 0.6-1.0% (w / w), or about 0.8% (w / w) of polyacrylic acid and / or polyacrylates, such as sodium polyacrylate, carbomer, and / or 2-propenoic acid homopolymer; e) 0.1-5% (w / w), 0.15-2% (w / w), 0.2-1% (w / w), 0.25-0.75% (w / w), or about 0.5% (w / w) CBD, and optionally CBD having a purity of at least 98% (w / w); f) 0.1-5% (w / w), 0.15-3.0% (w / w), 0.2-1.5% (w / w), 0.3-0.8% (w / w), or about 0.5% (w / w) of panthenol; g) 0.1-5% (w / w), 0.2-2% (w / w), 0.3-1% (w / w), 0.4-0.75% (w / w), or about 0.5% (w / w) of hyaluronic acid and / or a hyaluronate salt, such as sodium hyaluronate; h) 0.01 to 2.5% (w / w), 0.025 to 0.1.0% (w / w), 0.05 to 0.5% (w / w), 0.075 to 0.2% (w / w), or about 0.1% (w / w) benzalkonium chloride; i) 0.01-5% (w / w), 0.05-2% (w / w), 0.1-1% (w / w), 0.2-0.5% (w / w), or about 0.3% (w / w) of allantoin, and j) Compositions are provided which contain 0.01-2.5% (w / w), 0.025-0.1.0% (w / w), 0.05-0.5% (w / w), 0.075-0.2% (w / w), or about 0.1% (w / w) of phytic acid or a phytate, such as sodium phytate.

[0097] In some embodiments, a) 50-70% (w / w), 55-65% (w / w), approximately 61% (w / w) water; b) 30-50% (w / w), 35-45% (w / w), or about 30% (w / w) propylene glycol; c) 2.0-6.0% (w / w), 2.5-4.0% (w / w), or about 5% (w / w) pentylene glycol; d) 0.4-2.0% (w / w), 0.6-1.0% (w / w), or about 0.8% (w / w) of 2-propenoic acid, homopolymer, carbomer, polyacrylic acid and / or polyacrylates, such as sodium polyacrylate; e) 0.2-1% (w / w), 0.25-0.75% (w / w), or about 0.5% (w / w) CBD; f) 0.2-1.5% (w / w), 0.3-0.8% (w / w), or about 0.5% (w / w) panthenol; g) 0.3-1% (w / w), 0.4-0.75% (w / w), or about 0.5% (w / w) of hyaluronic acid and / or a hyaluronate salt, such as sodium hyaluronate; h) 0.05 to 0.5% (w / w), 0.075 to 0.2% (w / w), or about 0.1% (w / w) benzalkonium chloride; i) 0.1-1% (w / w), 0.2-0.5% (w / w), or about 0.3% (w / w) of allantoin, and j) 0.05-0.5% (w / w), 0.075-0.2% (w / w), or about 0.1% (w / w) of phytic acid or a phytate, such as sodium phytate; Compositions are provided that include one or more of the following:

[0098] In some embodiments, the composition comprises at least 4, 5, 6, 7, 8, 9 or all 10 of components (a)-(j). In some embodiments, the composition comprises components / components (a)-(c) and at least 1, 2, 3, 4, 5, 6 or all 7 of components (d)-(j). In some embodiments, the formulation is formulated as a gel and comprises components (a)-(d) and optionally at least 1, 2, 3, 4 or all 5 of components (e)-(j). Such compositions can be formulated, for example, at a near neutral, typically slightly acidic pH, for example, about 6.0-6.9, 6.2-6.8, 6.4-6.6, or about 6.5.

[0099] In some embodiments, a) 55-65% (w / w), about 61% (w / w) water; b) 35-45% (w / w), or about 30% (w / w) propylene glycol; c) 2.5 to 4.0% (w / w), or about 5% (w / w) pentylene glycol; d) 0.6-1.00% (w / w), or about 0.8% (w / w) of polyacrylic acid and / or polyacrylates; e) 0.25-0.75% (w / w), or about 0.5% (w / w) CBD; f) 0.3 to 0.8% (w / w), or about 0.65% (w / w) panthenol; g) 0.4 to 0.75% (w / w), or about 0.5% (w / w) of hyaluronic acid and / or hyaluronate, such as sodium hyaluronate; h) 0.075 to 0.2% (w / w), or about 0.1% (w / w) benzalkonium chloride; i) 0.2-0.5% (w / w), or about 0.3% (w / w) allantoin, and j) A composition is provided comprising 0.075-0.2% (w / w), or about 0.1% (w / w) of phytic acid or a phytate, such as sodium phytate.

[0100] In some embodiments, the formulation is formulated as a gel and / or has a near neutral, typically slightly acidic pH, for example, about 6.0-6.9, 6.2-6.8, 6.4-6.6, or about 6.5.

[0101] In some embodiments, the CBD used in delivering the composition, e.g., the topical wound healing composition, is crystalline, e.g., "Form A CBD" as disclosed herein. In some embodiments, the CBD is delivered as or capable of forming needle-like crystals.

[0102] In some embodiments, the CBD-containing composition of the first aspect may further comprise a further cannabinoid, such as THC (tetrahydrocannabinol), THCA (tetrahydrocannabinolic acid), CBDA (cannabidiolic acid), CBN (cannabinol), CBG (cannabigerol), CBC (cannabichromene), CBL (cannabicyclol), CBV (cannabivarin), THCC (tetrahydrocannabiolcol), THCV (tetrahydrocannabivarin), THCP (tetrahydrocannabiphorol), CB It may comprise one or more cannabinoids selected from DV (cannabidivarin), CBCV (cannabichromevarin), CBGV (cannabigerovarin), CBGM (cannabigerol monomethyl ether), CBE (cannabielsoin), CBT (cannabicitran), and one or more cannabinoids of the following types: CBG type, CBC type, "CBD type other than CBD", THC type, CBN type, CBE type, iso-THC type, CBL type, CBT type, and any combination thereof. Such additional cannabinoids may comprise hallucinogenic and / or non-hallucinogenic cannabinoids. In general, non-hallucinogenic cannabinoids are preferred in order to prevent undesirable side effects during use or treatment with compositions comprising such compounds, especially when they are present in physiologically active amounts.

[0103] Further, suitable concentrations and / or concentration ranges may be disclosed herein.

[0104] With respect to the CBD used in the preparation or formulation of a CBD-containing composition, such as a topical formulation, in some embodiments, the CBD used to deliver the composition is crystalline.

[0105] In some embodiments, the CBD used to deliver the compositions disclosed above is characterized by certain features, such as crystal structure, type and / or conformation. For example, referring to Example 12, the inventors have observed that CBD having a needle-like crystal structure (=crystal structure A, see FIG. 1) surprisingly and unexpectedly appears to be significantly more potent than CBD having a different crystal structure, a non-needle-like structure, also referred to herein as "bundle-like" or "lump-like" (=crystal structure B, see FIG. 2).

[0106] In some embodiments, when CBD is crystalline, it has or can form a needle-like crystal structure. In some embodiments, CBD of crystal structure A (or capable of forming needle-like crystals) is at least 1.2, 1.5, 2, 3, 4, 5, 7.5, 10, 15, or 20 times more "potent" on a weight / weight basis than CBD of crystal structure B (or capable of forming clumped / bundled crystals). In many cases, "type A" CBD is at least 2.5, 5, 7.5, or 10 times more "potent" on a weight / weight basis than "type B" CBD. The "potency" of "type A" CBD can be determined, for example, by measuring the time required for wound healing and / or sore healing using a composition that is essentially the same except for the type of CBD used. Alternatively, potency can be determined by the amount of CBD required to provide the same potency, for example wound healing time and / or sore healing time. In some embodiments, the use of more potent CBD results in a reduction in wound and / or sore healing time. In some embodiments, the use of more potent CBD allows for a reduction in the amount of CBD used in the wound and / or sore healing composition formulation. In some embodiments, the use of more potent CBD allows for a reduction in the amount of formulation required to provide comparable wound and / or sore healing efficacy.

[0107] A CBD of crystal structure A, or capable of forming needle-like crystals, is also referred to herein as "A-type CBD," while a CBD of crystal structure B, or capable of forming "bundle-like" or "clump-like" crystals, is referred to as "B-type CBD." In some embodiments, the CBD is "A-type CBD." In many cases, "A-type CBD" is preferred, as opposed to "B-type CBD."

[0108] For example, in a topical formulation, it can be assumed that CBD must be in one or more specific conformations that are active in order to be active upon administration to a subject. Lack of activity or efficacy can also be caused by lower uptake rates and / or difficulty in permeating the skin.

[0109] Without wishing to be bound by any theory, it is believed that the difference in crystal structure may be caused by different molecular structures, e.g., different conformations. This may be due, for example, to the subject's body being unable to recognize the "wrong" CBD conformation, etc. It is believed that the difference in CBD crystal structure is caused by different extraction methods. In particular, the CBD disclosed in FIG. 1 is provided by an extraction method including extraction with isopropanol, distillation and crystallization with heptane (see, e.g., Example 12), while the CBD disclosed in FIG. 2 is provided by extraction with supercritical CO 2 Provided by extraction.

[0110] Generally, crystalline CBD may be provided by methods and techniques known in the art, such as those disclosed in US10413845 and / or US10414709.

[0111] In short, crystalline CBD: Extracting the hemp fiber or cannabis, for example with isopropanol, to produce an extract rich in cannabinoids, THC, CBD and terpenes; evaporating the solvent portion of the extract to produce a substantially solvent-free extract; distilling the substantially solvent-free extract to isolate the CBD; and crystallizing the distilled and isolated CBD to produce crystallized and isolated CBD, and optionally one or more recrystallizations using a suitable organic solvent, such as an alkane, e.g., heptane, typically followed by It can be sourced from hemp fibre or cannabis (Cannabis sativa) by a process consisting essentially of solvent removal, for example by vacuum drying, to remove volatile residues.

[0112] Thus, in some embodiments, the CBD crystals used in the formulation of the topical composition are needle-shaped crystals, such as the crystals shown in Figure 1. Similarly, in some embodiments, the CBD crystals used in the formulation of the topical composition are not clump- or bundle-shaped crystals, such as crystals similar to those shown in Figure 2.

[0113] In some embodiments, the CBD crystals used in the formulation of the topical composition are 2 Not provided by extraction methods, including extraction.

[0114] In some embodiments, the CBD crystals used in the formulation of the topical composition are 3 ~C 4 Extraction with alcohol, e.g. isopropanol, and C 6 ~C 8 In some embodiments, the method comprises one or more crystallization steps with an alkane, such as heptane. 3 ~C 4 The alcohol is isopropanol. 6 ~C 8 The alkane is heptane. In some embodiments, 3 ~C 4 The alcohol is isopropanol, and C 6 ~C 8The alkane is heptane. This combination is believed to provide CBD crystals of satisfactory quality, e.g., no or reduced inhibitors and / or desired CBD conformation.

[0115] In some embodiments, a suitable CBD product is one in which CBD crystals are grown under critical CO 2 Extraction and C 6 ~C 8 It can be obtained when it is supplied by a process which includes one or more crystallization steps with an alkane, for example heptane.

[0116] As can be seen in Table 1, the cannabinoid profiles of CBD-A and CBD-B can be quite similar.

[0117] [Table 1]

[0118] However, it is also believed that differences in crystal structure may be caused by different extraction methods. Different crystal structures may also exhibit different concentrations of "CBD inhibitors" and / or different concentrations of "CBD enhancers." In some embodiments, terpenes, such as naturally occurring terpenes, particularly those found in plants, such as Cannabis sativa, act as CBD inhibitors and are undesirable.

[0119] Thus, in some embodiments, CBD of crystal structure B, also known as "CBD type B", can be converted to CBD of crystal structure A, also known as "CBD type A" (and / or CBD capable of forming crystal structure A) by organic extraction and / or recrystallization steps. In such embodiments, the change in crystal structure is believed to be related to the presence of inhibitors that are significantly reduced in further extraction and / or crystallization steps. Alternatively, the organic extraction step can provide a conformational change in CBD, also making it more active. In some embodiments, recrystallization with heptane can convert CBD type B to CBD type A.

[0120] In some embodiments, the CBD of crystal structure B is 2 CBD crystals sourced by extraction and sourced from, for example, www.pharma-hemp.com and / or following similar extraction protocols as its manufacturers.

[0121] In some embodiments, the presence of terpenes and / or terpenoids, particularly Cannabis sativa terpenes, in the CBD-containing topical compositions disclosed herein provides one or more undesirable effects, such as reduced efficiency or effectiveness, inability or reduced ability to recognize CBD, the need for more advanced CBD formulations to obtain similar effects, and increased non-CBD cannabinoids in the formulation. In some embodiments, the composition comprises 0.0001% or less, 0.001% or less, 0.01% or less, or 0.1% or less of terpenes, particularly Cannabis sativa terpenes, by weight.

[0122] In some embodiments, the crystalline CBD does not contain significant amounts of terpenes, for example less than 0.1% by weight, less than 0.05% by weight, less than 0.02% by weight, less than 0.01% by weight, less than 0.005% by weight, less than 0.002% by weight, less than 0.001% by weight.

[0123] It is also believed that other plant components, such as terpenoids, may act as inhibitors. In some embodiments, the presence of terpenoids, such as Cannabis sativa terpenoids, may be undesirable. In some embodiments, the crystalline CBD does not contain a significant amount of terpenoids, for example, the amount of terpenoids is less than 0.1% by weight, less than 0.05% by weight, less than 0.02% by weight, less than 0.01% by weight, less than 0.005% by weight, less than 0.002% by weight, less than 0.001% by weight.

[0124] In some embodiments, the use of CBD having or available as crystals of crystal structure A as shown in FIG. 1 in the CBD-containing compositions disclosed herein provides one or more of positive benefits, such as improved efficacy, the possibility of reducing the total amount of CBD in the formulation, the subject needing less topical composition, such as wound healing formulations and / or sore healing formulations, to achieve the same efficacy, improved cognition and / or uptake of CBD by the subject's body, reduction in non-CBD cannabinoids and / or other impurities in the formulation.

[0125] Generally, the composition of the first aspect can be provided using methods, procedures and / or unit operations known in the art. In some embodiments, the composition of the first aspect can be provided as set forth in the second aspect.

[0126] In a second aspect, the present invention provides a method of delivering a composition of the first aspect, e.g. a topical wound treatment composition formulated as a gel, comprising the steps of: i. the step or act of providing CBD, preferably in a solid form, such as a crystalline form and / or in a powder form, and / or having a purity of at least more than 95% (w / w), 98% (w / w), 99% (w / w), 99.5% (w / w), or 99.8% (w / w); ii. the step or act of dissolving the CBD of step (a) in a penetration agent and / or penetration enhancer, such as propylene glycol; iii. Obtaining an aqueous gel, for example by dissolving hyaluronic acid and / or its salts in water; iv. combining the dissolved CBD of step (b) with the aqueous gel of step (c); and v. The step or act of adding and mixing the remaining ingredients to obtain the composition, optionally vi. the step or act of adjusting the pH to a desired set point, e.g., between 6.0 and 6.8, e.g., about 6.5; and / or vii. The method comprises the step or act of aliquoting the composition into containers.

[0127] In some embodiments, the remaining components are: a) 20-85% (w / w), 40-75% (w / w), 50-70% (w / w), 55-65% (w / w), approximately 61% (w / w) water; b) 0.1-60% (w / w), 5-55% (w / w), 10-50% (w / w), 30-50% (w / w), 35-45% (w / w), or about 30% (w / w) propylene glycol; c) 0.1-15% (w / w), 0.5-12% (w / w), 1.0-10% (w / w), 1.5-7.5% (w / w), 2.0-6.0% (w / w), 2.5-4.0% (w / w), or about 5% (w / w) of pentylene glycol; d) 0.1-10% (w / w), 0.2-5% (w / w), 0.4-2.0% (w / w), 0.6-1.0% (w / w), or about 0.8% (w / w) of a carbomer, a polyacrylic acid homopolymer, and / or a polyacrylate, such as sodium polyacrylate; e) 0.1-5% (w / w), 0.15-2% (w / w), 0.2-1% (w / w), 0.25-0.75% (w / w), or about 0.5% (w / w) CBD; f) 0.1-5% (w / w), 0.15-3.0% (w / w), 0.2-1.5% (w / w), 0.3-0.8% (w / w), or about 0.5% (w / w) of panthenol; g) 0.1-5% (w / w), 0.2-2% (w / w), 0.3-1% (w / w), 0.4-0.75% (w / w), or about 0.5% (w / w) of hyaluronic acid and / or a hyaluronate salt, such as sodium hyaluronate; h) 0.01 to 2.5% (w / w), 0.025 to 0.1.0% (w / w), 0.05 to 0.5% (w / w), 0.075 to 0.2% (w / w), or about 0.1% (w / w) benzalkonium chloride; i) 0.01-5% (w / w), 0.05-2% (w / w), 0.1-1% (w / w), 0.2-0.5% (w / w), or about 0.3% (w / w) of allantoin, and j) 0.01 to 2.5% (w / w), 0.025 to 0.1.0% (w / w), 0.05 to 0.5% (w / w), 0.075 to 0.2% (w / w), or about 0.1% (w / w) of phytic acid or a phytate, such as sodium phytate; and optionally one or more pharma- ceutically acceptable adjuvants. One or more of the following:

[0128] In some embodiments, the CBD is crystalline CBD. In some embodiments, the CBD is "Type A CBD." In many cases, the use of "Type A CBD" is preferred, as opposed to "Type B CBD" or other types of CBD.

[0129] In a third aspect, the present invention relates to a composition, such as a wound care composition, provided according to the second aspect.

[0130] In a fourth aspect, the present invention relates to a container comprising a composition, such as a wound care composition of the first, third or seventh aspect.

[0131] It may be desirable to protect the compositions disclosed herein, e.g., wound care compositions formulated as, for example, gels, from the damaging effects of visible and / or UV light. Thus, in some embodiments, the container is adapted to provide light and / or UV protection to the wound care composition.

[0132] In a fifth aspect, the present invention relates to a kit comprising the container of the fourth aspect, and optionally including instructions for use.

[0133] In some embodiments, the kit includes packaging for the container and / or instructions for use, such as a carton, etc. In some embodiments, the packaging can provide light and / or UV protection, such as additional protection during storage.

[0134] In a sixth aspect, the present invention relates to a method for the treatment of a wound or sore in a subject comprising the topical application of a composition of the first, third or seventh aspect.

[0135] In some embodiments, the subject is an animal or a human.In some embodiments, the subject is a human, for example, a woman, a man, an elderly person, an adult, an adolescent, a child, or an infant.In some embodiments, the subject is an animal, for example, one or more of pets, livestock, mammals, reptiles, birds, and / or zoo animals.In some embodiments, the subject is a mammal.

[0136] Typically, treatment involves topical application of an appropriate amount of the wound / sore treating composition. In some embodiments, the dosing regimen and / or the appropriate amount is 20-30 cm per application. 2 Application of an appropriate amount of the composition will provide a thin film or layer of the composition on the area of ​​application, covering the wound and usually some of the surrounding area as well.

[0137] In some embodiments, the treatment involves more than one application of the treatment composition. In some embodiments, the treatment involves one or several applications of the wound treatment composition per day. In some embodiments, the wound treatment composition is applied 1×, 2×, 3×, 4× or more than 4× per day. In some embodiments, the composition is applied as needed. In some embodiments, the composition is applied typically 3-4 times per day.

[0138] In some embodiments, the wounds, sores and / or rashes include clean wounds, contaminated wounds, infected wounds, colonized wounds; associated with medical treatments, cosmetic treatments, surgery, tattoos; cuts, lacerations, abrasions, abrasions, puncture wounds, gunshot wounds; burns, e.g., first, second, third or fourth degree burns; sunburn, UV light; frostbite, e.g., first, second, third or fourth degree frostbite; blisters; chemical wounds due to contact with chemicals; rashes; allergies; associated with a disease; sores, such as leishmania ulcers, bed sores, stomatitis, herpes, desert ulcers, bed sores, saddle chafing, habronematosis, grass ulcers or chancroid; animal bites, animal stings, such as bites and / or stings by invertebrates, such as insects, for example mosquitoes, bees, wasps, hornets, flies, ants, spiders, corals, jellyfish, aquatic stinging animals, poisonous animals, poisonous fish; and any combination thereof.

[0139] In some embodiments, the wound is, or is associated with and / or caused by one or more of a clean wound, a contaminated wound, an infected wound, a colonized wound. In some embodiments, the wound is, or is associated with and / or caused by one or more of a medical and / or cosmetic treatment, surgery, tattooing. In some embodiments, the wound is, or is associated with and / or caused by one or more of an incision, a laceration, an abrasion, a puncture wound, a gunshot wound. In some embodiments, the wound is, or is associated with and / or caused by one or more of a burn, first degree, second degree, third degree, and / or fourth degree burn. In some embodiments, the wound is, or is associated with and / or caused by a sunburn, UV light, and / or electromagnetic radiation. In some embodiments, the wound is, is associated with, and / or is caused by one or more of frostbite, first degree, second degree, third degree, and / or fourth degree frostbite. In some embodiments, the wound or sore is, is associated with, and / or is caused by a blister. In some embodiments, the wound is, is associated with, and / or is caused by chemical contact. In some embodiments, the wound is, is associated with, and / or is caused by a rash. In some embodiments, the wound is, is associated with, and / or is caused by an allergy. In some embodiments, the wound or sore is, is associated with, and / or is caused by a disease. In some embodiments, the wound is, is associated with, and / or is caused by one or more of a sore, a leishmania ulcer, a bed sore, a canker sore, herpes, a desert ulcer, a pressure ulcer, a saddle chafing, habronemaniasis, a grass ulcer, or a chancroid.In some embodiments, the wound is, is associated with, and / or is caused by one or more of an animal bite, an animal bite, an invertebrate, an insect, a mosquito, a bee, a wasp, a hornet, a fly, an ant, or a spider, a coral, a jellyfish, an aquatic stinging animal, and / or a poisonous fish.

[0140] In a seventh aspect, the present invention relates to a composition according to the first or third aspect for use as a medicament and / or cosmetic. This may be used to treat skin diseases or conditions, such as clean wounds, contaminated wounds, infected wounds, colonized wounds; those associated with medical treatments, cosmetic treatments, surgery, tattoos; cuts, lacerations, abrasions, abrasions, puncture wounds, gunshot wounds; burns, such as first, second, third or fourth degree burns; sunburn, burns associated with UV light, burns associated with electromagnetic radiation, frostbite, such as first, second, third or fourth degree frostbite; blisters; chemical wounds due to contact with chemicals; rashes; allergies; those associated with diseases; sores, e.g. For example, the present invention may include treatment of one or more of wounds, sores and / or rashes selected from one or more of: leishmania ulcers, bed sores, stomatitis, herpes, desert ulcers, bed sores, saddle chafing, habronematosis, grass ulcers or chancroid; animal bites, animal stings, such as bites and / or stings by invertebrates, such as insects, for example mosquitoes, bees, wasps, hornets, flies, ants, spiders, corals, jellyfish, aquatic stinging animals, poisonous animals, poisonous fish; and any combination thereof.

[0141] The composition as disclosed herein has surprising and unexpected properties. Test results show surprising good results, and it seems to be not only comparable to traditional formulations, but even faster and / or better in terms of wound healing and / or sore healing. In some embodiments, the topical composition of the present invention is comparable to and / or better than, for example, (a) Hansaplast Wound Healing Ointment, which contains white petrolatum, thin paraffin oil, ceresin wax, glycerin, panthenol, glyceryl stearate; (b) Klinion L-Mesitran, which contains medical honey, water, sunflower oil, vitamin A, vitamin C, vitamin E, and purified lanolin (medilan); and / or (c) Aloe Vera gel AVIVIR, which contains Aloe barbadensis leaf extract, xanthan gum, sodium benzoate, calcium sorbate, and citric acid.

[0142] Without wishing to be bound by any theory, it is believed that the high content of penetrants, such as polyols, glycols, particularly propylene glycol and / or pentylene glycol, contributes to the positive efficacy of the wound care compositions of the present invention. In some embodiments, the penetrants provide efficacy in promoting stability to the gel and / or improvements regarding wound healing, such as shortening the time for wound healing.

[0143] Generally, wound treatment preparations, such as gels as disclosed herein, are effective and are comparable to or even better than the common preparations / products on the market.Apart from efficient wound healing, the preparations of the present invention provide one or more additional benefits in terms of providing a pleasant sensation when applying the gel due to external moisturization and cooling, and additional pain relief.Furthermore, topical preparations appear to provide reliable beneficial benefits in terms of wound environment and wound healing, reducing the risk of complications, such as infection, and the absence or reduction of scar formation. Thus, in some embodiments, application or use of the wound compositions disclosed herein, e.g., wound compositions formulated as gels, provides one or more of: faster healing, pain relief, forming a protective layer on the wound, forming a physical barrier, biocompatible, non-toxic, adaptable to and capable of filling and / or treating irregular wound shapes, providing a moist environment, providing and / or drawing in moisture to the wound, providing a germicidal effect, preventing infection, removing excess exudate, providing a good wound healing environment, reducing or eliminating scar formation, and / or being easy to use and / or apply, and any combination thereof.

[0144] In an eighth aspect, the present invention relates to a CBD-containing composition, wherein the CBD used in the formulation is crystalline and / or "Form A". In some embodiments, the composition is a topical composition as disclosed herein, such as a wound-healing composition and / or a sore-healing composition of the first, third and / or seventh aspects. In some embodiments, the CBD is Form A (needle-shaped crystals) or is capable of forming needle-shaped crystals, for example as disclosed in the first aspect and / or the Examples.

[0145] In a ninth aspect, the present invention relates to a dosing regimen comprising administering a topical composition, in particular a CBD-containing topical composition disclosed herein, in some embodiments, the CBD is "type A".

[0146] The present invention will now be described in more detail and specifically with reference to examples, which are not intended to limit the invention. EXAMPLES

[0147] Percentages are by weight. Typically, crystalline CBD is supplied by Enecta unless otherwise indicated.

[0148] Example 1 - Delivery of Wound Care Composition Methods, unit operations, protocols and / or know-how in accordance with the practice of the art can be used to provide the CBD-containing compositions of the invention, for example as disclosed herein, for example in accordance with the third aspect of the invention and / or in particular in the Examples below.

[0149] [Table 2]

[0150] Step I: At least 98% (w / w) pure CBD, for example crystalline CBD in powder form as supplied by enecta®, is dissolved in propylene glycol. Step II: Hyaluronic acid sodium salt is dissolved in water with stirring to obtain a gel. Step III: Combine propylene glycol and gel pieces with stirring. Step IV: The remaining ingredients are added with stirring to obtain the wound care composition. Step V (optional): Adjust the pH if necessary, for example to pH 6.5.

[0151] [Table 3]

[0152] [Table 4]

[0153] [Table 5]

[0154] Example 2 - Application / Use of Wound Care Composition The wound and / or sore treatment composition ("wound gel") may be applied as disclosed herein, for example according to the sixth aspect of the invention.

[0155] Typically, an appropriate amount, such as about 0.25g (about the size of a pea) is applied per 20-30cm 2 Application of an appropriate amount of the composition results in a thin film or layer of the composition in the area of ​​application, covering the wound and usually some of the surrounding area as well.

[0156] Apply as needed, for example, 3 to 4 times per day.

[0157] Example 3 - Test Setup Recruitment criteria Human subjects with abrasions, tattoos, burns, and sunburns Subjects taking no medications except for NSAIDs for pain For all ages, genders or disabilities

[0158] Clinical outcomes Completion of wound healing Time to complete or nearly complete wound healing

[0159] Exclusion criteria Human subjects with surgical or traumatic wounds We excluded studies reporting wound healing rates without reporting complete wound healing.

[0160] Example 4 - Test Results

[0161] [Table 6]

[0162] [Table 7]

[0163] [Table 8]

[0164] Example 5 - CBD production by alcohol extraction, distillation and crystallization Crystalline CBD can be provided by methods and techniques known in the art, such as those disclosed in US10413845 and / or US10414709.

[0165] In short, crystalline CBD: extracting the hemp fiber or cannabis with a solvent selected from the group consisting of propanol, isopropanol, butanol, pentanol, hexanol, heptanol, and octanol to produce an extract from the extracted hemp fiber or cannabis consisting essentially of tetrahydrocannabinol, terpenes, or cannabidiol; evaporating the solvent portion of the extract to produce a substantially solvent-free extract containing CBD; distilling the substantially solvent-free extract to isolate the CBD; and It can be sourced from hemp fiber or cannabis (Cannabis sativa) by a process that essentially consists of crystallizing distilled and isolated CBD to produce crystallized and isolated CBD.

[0166] Often, if necessary, the crystallized and isolated CBD is subjected to vacuum drying to remove volatile residues, particularly the solvent used in crystallization or recrystallization.

[0167] In particular, a process involving extraction with isopropanol and crystallization using heptane, optionally including one or more recrystallization steps, followed by vacuum drying, can provide CBD having crystalline structure A, i.e., needle-like crystals. Moreover, such CBD can be very low in undesirable compounds, such as terpenes.

[0168] GC chromatography or other analytical methods known in the art can be used to monitor the process, for example to ensure high yield and / or purity of the desired product.

[0169] With regard to the raw material, for example, hemp fiber containing 2-3% CBD is dried and ground and then extracted with isopropanol, for example food grade isopropanol.

[0170] Advice for selecting appropriate reactions based on the boiling points or boiling ranges of different compounds can be found, for example, here: www.nwsci.com / customer / docs / SKUDocs / RMR / Technical%20Data_Extractions_03.28.18.pdf.

[0171] CBD having crystal structure A can be sourced, for example, from www.enecta.com, and / or following similar extraction and / or purification protocols as its manufacturers.

[0172] Example 6 - Comparison of compositions formulated with different crystalline CBD Two compositions were prepared according to Example 1, e.g., formulations A or B, with the only difference being that the crystalline CBD used in the formulations was either type A (needle-like crystals, FIG. 1) or type B (bundles / lumps, FIG. 2).

[0173] Crystalline CBD form A is supplied by Enecta, while CBD form B is supplied by Pharma Hemp.

[0174] Both compositions were tested and it can be surprisingly and unexpectedly found and / or concluded that CBD form A is significantly more active than CBD form B.

Claims

1. A composition formulated as a wound and / or sore treatment composition for topical application, comprising, by weight: a) 0.1-5%, 0.2-2%, 0.3-1%, 0.4-0.75%, or about 0.5% (w / w) cannabidiol (CBD); b) 25-85%, 35-75%, 45-70% or 55-65% (w / w) water, and c) one or more penetration agents and / or penetration enhancers, such as propylene glycol and / or pentylene glycol; and optionally, i. one or more gelling agents, such as polyacrylic acid / polyacrylates, 2-propenoic acid homopolymers, and / or carbomers; ii. one or more skin moisturizers and / or skin conditioners, such as panthenol and / or allantoin; iii. one or more additional wound healing compounds, such as hyaluronic acid and / or its salts; iv. one or more antibacterial agents, such as benzalkonium chloride, and / or v. one or more pH stabilizers and / or buffers, such as aminomethylpropanol (AMP), and / or vi. one or more chelating agents, such as phytic acid and / or its salts; and any combination of one or more of (i)-(vi); the composition comprises one or more of 10% (w / w) or less, 5% (w / w) or less, 2% (w / w) or less, 1% (w / w) or less, or 0.5% (w / w) or less, 0.25% (w / w) or less, or 0.1% or less alcohol, such as one or more low molecular weight alcohols, such as one or more C 1 -C 4 alcohols, such as methanol, ethanol, propanol, butanol, and any isomers and / or any combination thereof, and optionally the composition is formulated as a gel comprising one or more gelling agents, the one or more gelling agents being provided in a concentration of 0.1-5%, 0.2-3% (w / w), 0.5-2% (w / w), 0.6-1.0% (w / w), or about 0.8% (w / w); the composition has a slightly acidic pH, e.g., a pH of about 6.0 to 6.8, e.g., 6.5±0.25, 6.25±0.25, or 6.0±0.25; and / or A composition, wherein said composition is not formulated as an oil-in-water emulsion or a water-in-oil emulsion.

2. 2. The composition of claim 1, wherein the composition comprises no or a small amount of oil, e.g., less than 1.0, 0.5 or 0.1% (w / w), and optionally the oil is an edible oil, a dehydrated oil, and / or a dehydrated edible oil.

3. 3. The composition of claim 1 or 2, wherein the CBD has a purity of at least 95% (w / w), 98% (w / w), 99% (w / w), 99.5 (w / w), or greater than 99.8% (w / w).

4. 3. The composition of claim 1 or 2, wherein the composition comprises one or more further cannabinoids, such as one or more psychoactive cannabinoids or one or more non-psychoactive cannabinoids, such as one or more of THC (tetrahydrocannabinol), THCA (tetrahydrocannabinolic acid), CBDA (cannabidiolic acid), CBN (cannabinol), CBG (cannabigerol), CBC (cannabichromene), CBL (cannabicyclol), CBV (cannabivarin), THCV (tetrahydrocannabivarin), THCP (tetrahydrocannabiphorol), CBDV (cannabidivarin), CBCV (cannabichromevarin), CBGV (cannabigerovarin), CBGM (cannabigerol monomethyl ether), CBE (cannabielsoin), and / or CBT (cannabicitran), and any combination thereof.

5. The composition or CBD may contain less than 1.5, 1.0, 0.5 or 0.1% (w / w) of one or more further cannabinoids, such as one or more psychoactive cannabinoids or one or more non-psychoactive cannabinoids, such as THC (tetrahydrocannabinol), THCA (tetrahydrocannabinolic acid), CBDA (cannabidiol acid), CBN (cannabinol), CBG (cannabigerol), CBC (cannabichromene), CBL (cannabicyclol), C 3. The composition of claim 1 or 2, comprising or not comprising one or more of BV (cannabivarin), THCV (tetrahydrocannabivarin), THCP (tetrahydrocannabiphorol), CBDV (cannabidivarin), CBCV (cannabichromevarin), CBGV (cannabigerovarin), CBGM (cannabigerol monomethyl ether), CBE (cannabiersoin), and / or CBT (cannabicitran), and any combination thereof.

6. said one or more further wound healing compounds are or comprise hyaluronic acid and / or salts thereof and / or said one or more further wound healing compounds are provided in a concentration of 0.1-5% (w / w), 0.2-2% (w / w), 0.3-1% (w / w), 0.4-0.75% (w / w), or about 0.5% (w / w); the one or more penetration agents and / or penetration enhancers are propylene glycol and / or pentylene glycol; Propylene glycol is provided in a concentration of 0.1-60% (w / w), 5-55% (w / w), 10-50% (w / w), 30-50% (w / w), 35-45% (w / w), or about 30% (w / w); Pentylene glycol is provided in a concentration of 0.1-15% (w / w), 0.5-12% (w / w), 1.0-10% (w / w), 1.5-7.5% (w / w), 2.0-6.0% (w / w), 2.5-4.0% (w / w), or about 5% (w / w); and / or the antimicrobial agent is or comprises benzalkonium chloride, and / or the one or more antimicrobial agents are provided in a concentration of 0.01-2.5% (w / w), 0.025-1.0% (w / w), 0.05-0.5% (w / w), 0.075-0.2% (w / w), or about 0.1% (w / w); the one or more skin moisturizers and / or skin conditioners are or comprise panthenol, and / or panthenol is provided in a concentration of 0.1-5% (w / w), 0.15-3.0% (w / w), 0.2-1.5% (w / w), 0.5-0.8% (w / w), or about 0.65% (w / w); and / or 3. A composition according to claim 1 or 2, wherein the one or more skin moisturizers and / or skin conditioners is or comprises allantoin, and / or allantoin is provided in a concentration of 0.01 to 5% (w / w), 0.05 to 2% (w / w), 0.1 to 1% (w / w), 0.2 to 0.5% (w / w), or about 0.3% (w / w).

7. I) a) 20-85% (w / w), 40-75% (w / w), 50-70% (w / w), 55-65% (w / w), or about 61% (w / w) water; b) 0.1-60% (w / w), 5-55% (w / w), 10-50% (w / w), 30-50% (w / w), 35-45% (w / w), or about 30% (w / w) propylene glycol; c) 0.1-15% (w / w), 0.5-12% (w / w), 1.0-10% (w / w), 1.5-7.5% (w / w), 2.0-6.0% (w / w), 2.5-4.0% (w / w), or about 5% (w / w) pentylene glycol; d) 0.1-10% (w / w), 0.2-5% (w / w), 0.4-2.0% (w / w), 0.6-1.0% (w / w), or about 0.8% (w / w) of a carbomer, a polyacrylic acid homopolymer, and / or a polyacrylate, e.g., sodium polyacrylate; e) 0.1-5% (w / w), 0.15-2% (w / w), 0.2-1% (w / w), 0.25-0.75% (w / w), or about 0.5% (w / w) CBD; f) 0.1-5% (w / w), 0.15-3.0% (w / w), 0.2-1.5% (w / w), 0.3-0.8% (w / w), or about 0.5% (w / w) of panthenol; g) 0.1-5% (w / w), 0.2-2% (w / w), 0.3-1% (w / w), 0.4-0.75% (w / w), or about 0.5% (w / w) of hyaluronic acid and / or a hyaluronate salt, such as sodium hyaluronate; h) 0.01-2.5% (w / w), 0.025-1.0% (w / w), 0.05-0.5% (w / w), 0.075-0.2% (w / w), or about 0.1% (w / w) benzalkonium chloride; i) 0.01-5% (w / w), 0.05-2% (w / w), 0.1-1% (w / w), 0.2-0.5% (w / w), or about 0.3% (w / w) of allantoin, and j) containing 0.01-2.5% (w / w), 0.025-1.0% (w / w), 0.05-0.5% (w / w), 0.075-0.2% (w / w), or about 0.1% (w / w) of phytic acid or a phytate, such as sodium phytate; or II) a) 55-65% (w / w), or about 61% (w / w) water; b) 35-45% (w / w), or about 30% (w / w) propylene glycol; c) 2.5-4.0% (w / w), or about 5% (w / w) pentylene glycol; d) 0.6-1.00% (w / w), or about 0.8% (w / w) of carbomer, polyacrylic acid and / or polyacrylate; e) 0.25-0.75% (w / w), or about 0.5% (w / w) CBD; f) 0.3-0.8% (w / w), or about 0.65% (w / w) panthenol; g) 0.4-0.75% (w / w), or about 0.5% (w / w) of hyaluronic acid and / or a hyaluronate salt, such as sodium hyaluronate; h) 0.075-0.2% (w / w), or about 0.1% (w / w) benzalkonium chloride; i) 0.2-0.5% (w / w), or about 0.3% (w / w) allantoin, and j) 0.075-0.2% (w / w), or about 0.1% (w / w) of phytic acid or a phytate, such as sodium phytate; 3. The composition of claim 1 or 2, including any combination thereof.

8. 3. The composition of claim 1 or 2, wherein the CBD used to deliver the topical composition is crystalline, and optionally the CBD crystals are needle-shaped crystals.

9. The CBD crystals are ２ and / or 9. The composition of claim 8, wherein the CBD crystals are provided by a process comprising extraction with a C3-C4 alcohol, such as isopropanol, and one or more crystallization steps with a C6-C8 alcohol, such as heptane.

10. 13. A method of delivering the wound care composition of claim 1, comprising: i. providing CBD in a solid form, preferably in a crystalline form, and / or having a purity of at least 95% (w / w), 98% (w / w), 99% (w / w), 99.5% (w / w), or greater than 99.8% (w / w); ii. dissolving the CBD of step (a) in a penetration agent and / or penetration enhancer, such as propylene glycol; iii. Obtaining an aqueous gel, for example by dissolving hyaluronic acid and / or its salts in water; iv. combining the dissolved CBD of step (b) with the aqueous gel of step (c); and v. adding the remaining ingredients to obtain said wound care composition.

11. 11. A wound care composition provided by the method of claim 10.

12. 12. A wound care composition according to any one of claims 1, 2 or 11 for use as a medicament or cosmetic.

13. Clean wounds, contaminated wounds, infected wounds, colonised wounds; associated with medical treatment, cosmetic treatment, surgery, tattooing; cuts, lacerations, abrasions, puncture wounds, gunshot wounds; burns, e.g. first, second, third or fourth degree burns; burns associated with electromagnetic radiation, sunburn, burns associated with UV light, frostbite, e.g. first, second, third or fourth degree frostbite; blisters; chemical wounds due to contact with chemicals; rashes; allergies; associated with disease; sores, e.g. leishmanial ulcers, bedsores, stomatitis, herpes simplex.

12. A wound care composition as claimed in any one of claims 1, 2 or 11 for use in the treatment of wounds, sores and / or rashes selected from one or more of: pes, desert ulcers, bed sores, saddle chafing, habronematosis, grass ulcers or chancroid; animal bites, animal stings, bites and / or stings by invertebrates such as insects such as mosquitoes, bees, wasps, hornets, flies, ants, spiders, corals, jellyfish, aquatic stinging animals, poisonous animals, poisonous fish; and any combination thereof, optionally comprising the subject is an animal or a human; the dosing regimen is about 0.25 g (about the size of a pea) per 20-30 cm2 per application; and / or A wound care composition, wherein said wound care composition is applied 1x, 2x, 3x, 4x or more than 4x per day.

14. 12. A container comprising a wound care composition according to any one of claims 1, 2 or 11, optionally said container providing light and / or UV protection to said wound care composition.

15. 15. A container according to claim 14, optionally Instructions for use, The kit includes packaging, such as a carton, for said container and / or instructions for use, and optionally said packaging provides light and / or UV protection.

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