CBD isolate is a pure, crystalline powder that contains 99% pure CBD. In order to get this ultra-pure form of isolated CBD, a purifying process. CBD Isolate is purified, concentrated CBD (Cannabidiol). CBD isolate is a white crystalline powder (similar to table sugar or salt) which is CBD Isolate is a highly refined product in a solid form often used in pharmaceutical. CBD Isolate, on the other hand, is simply purified CBD that has been form was more potent and concentrated than full spectrum CBD;.
isolate form purified, highly CBD. powder crystalline of a CBD is
This has been demonstrated in both pre-clinical studies as well as clinical trials on human subjects. These studies have shown CBD to reduce drug-seeking behavior and withdrawal symptoms resulting from chronic use and addiction to commonly abused substances including opiates cocaine, heroin, morphine , nicotine and marijuana Crippa et al, J Clin Pharm Ther, 38 2: Preliminary clinical trials using CBD to treat nicotine addiction have been highly promising.
These studies demonstrate the effective use of CBD to treat substance abuse disorders and addiction to commonly abused substances. Additional studies of medical uses of CBD have also been directed to treatment of epileptic seizures, uncontrollable seizures in pediatric patients, cancer treatment, reducing adverse effects of other cancer treatments, pain management, and treatment of auto-immune disorders, among others.
Treatment of multiple sclerosis, Parkinson's disease, alcohol abuse, tumor metastasis, post-traumatic stress disorders were also documented in humans or animal models. However, medical use of CBD or CBDA, as well as other cannabinoids, is complicated by a lack of standardization in both composition and methods of delivery, as well as poorly known degradation pathways of the various cannabinoids.
In one embodiment, the invention is directed to a cannabidiol CBD extract or a cannabidiolic acid CBDA extract isolated from industrial hemp, and comprising less than 0. In another embodiment, the invention is directed to a dry powder composition of such an extract. In another embodiment, the invention is directed to a method of producing a dry powder composition, the method comprising mixing at least one carrier, an extract containing CBD or CBDA and a supercritical or near supercritical fluid, and rapidly reducing the pressure on the mixture, whereby droplets are formed, and passing the droplets through a flow of heated gas.
In another embodiment, the invention is directed to a method of purifying a CBD extract or a CBDA extract in oil form, the method comprising dissolving the oil extract in near-supercritical carbon dioxide and removing a precipitated impurity exhibiting a peak at 4.
In another embodiment, the invention is directed to method of sterilizing a CBD extract or a CBDA extract, the method comprising dissolving the extract in liquid carbon dioxide, pressurizing the solution to a pressure in a range of to psi, and repeatedly increasing and decreasing the pressure of the solution in the range of to psi. These and additional aspects of the invention and the advantages thereof will be more fully described in and apparent from the detailed description.
The present disclosure will be more fully understood in view of the Drawings, in which:. Additional details of the drawings and specific embodiments of the invention will be more fully apparent in view of the Detailed Description and the Examples. In specific embodiments, the invention is directed to a cannabidiol CBD extract or a cannabidiolic acid CBDA extract isolated from industrial hemp, and comprising less than 0.
In one embodiment, the Cannabis plant material may be self-pollinating, i. In a specific embodiment, the Cannabis plant material contains less than 0. In specific embodiments, the methods result in purified extracts having little or no detectable tetrahydrocannabinol THC or its acid form, tetrahydrocannabinolic acid THCA.
Following extraction, the extract is further treated by removing most or all of the solvent, for example, by heating under a protective blanket of nitrogen gas to a temperature at the boiling point of the solvent.
The heating is, in one embodiment, conducted in the dark. The decarboxylation reaction can be conducted under vacuum and can be monitored by HPLC. The CBD product is in the form of a highly pure oil extract. In an alternate embodiment, the Cannabis plant material, for example in finely ground form, may be first heated to decarboxylate CBDA therein to CBD, prior to extraction, using similar heating temperatures and times.
Advantageously, a crystallized product, rather than an oil, is obtained. Solvent extraction methods can produce an extract which includes an impurity exhibiting a detectable peak at 4. This impurity can be isolated in the form of a white residue in methods according to the invention.
In a specific embodiment, hydrocarbon e. These impurities are believed to be one or more long chain wax esters. Wax esters are commonly encountered in the cuticle of plant leaves and serve to protect the plant from dehydration. It has been discovered that the use of ethanol as an extraction liquid or pressurized liquid carbon dioxide, for example at or near ambient temperature, or supercritical or near supercritical carbon dioxide allows removal of such impurities from a CBD or CBDA extract as they are not soluble in ethanol or the indicated forms of carbon dioxide.
The purified products which are odorless contain no detectable amounts of these components when the products are subjected to high performance liquid chromatography as described herein.
To avoid first pass removal by the liver and for faster action, the CBD can be vaporized, or formulated as a dry powder as discussed below, and inhaled. The compositions may be in any conventional administration form, including solid unit dosage forms such as tablets, wafers, pellets, lozenges, solutions for example, in water or ethanol , salves, creams, lotions, and the like, and may contain conventional additives, including pharmaceutical carriers, excipients, and the like.
The extracts, compositions and products of the invention may be administered to a mammal human, rat, mouse, monkey, dog, cat, horse, etc. Treatment of multiple sclerosis, Parkinson's disease, alcohol abuse, tumor metastasis, stress, including, post-traumatic stress disorders, migraines, pain, concussion, anxiety, diabetes, and the like may be treated with the extracts, compositions and products of the invention.
Such methods are disclosed in the Sievers et al U. Examples of suitable additives include, but are not limited to, myo-inositol, mannitol, sucrose, trehalose, leucine, lactose, tricine, sodium phosphate buffer, arginine, histidine, alanine, gelatin, lactalbumin hydrolysate, hydroxyethylstarch, maltodextrin, Tween 80, sodium citrate, phosphatidylcholine, alpha lipoic acid, methionine, glucosamine sulfate, phenylalanine polyethylene glycol PEG , poly lactic-co-glycolic acid PLGA , and polyvinylpyrrolidone PVP , and the like.
One suitable surfactant comprises lecithin, but one skilled in the art will appreciate that other conventional surfactants may also be employed. The composition may also include a physiologically acceptable antioxidant, for example, methionine, or other additive, as desired.
Various PVPs are commercially available at different molecular weights weight average and are suitable for use in the present compositions. In a specific embodiment, the PVP has a molecular weight in a range of from about to , Da, or, more specifically, from about to about 50, Da.
In more specific embodiments, the PVP has a molecular weight of about 10, or 40, Da. Formulation of the cannabinoid active pharmaceutical ingredients into dry powders facilitates the incorporation of such excipients which have been shown to increase solubility and dissolution rate, and therefore bioavailability, of lipophilic molecules such as cannabinoids. The dry powder formulations are advantageous in exhibiting good storage stability and are much less susceptible to loss of material to packaging walls, in contrast to oils in which the active ingredients are dissolved in solution.
In one specific embodiment, dry powder formulations are provided in single-dose blister packaging, for example formed of an aluminum-polymer laminate, to protect the powders from ambient moisture, bacterial and fungal ingress, and degradation by light.
Additionally, the dry powders may be compressed into a solid unit dosage form, for example, a tablet, wafer or pellet form, alone or, optionally, in compositions including one or more excipients or additives.
In specific embodiments, the dosage form is a tablet having a thickness of at least about 1 mm or, more specifically, of at least 2 mm. In additional embodiments, the dosage form is a wafer having a thickness less than about 1 mm, or, more specifically, less than about 0. The wafers, in one embodiment, are quick dissolving, i. As noted above, CBD has been disclosed as useful in the treatment of a wide variety of disorders and conditions, including, inter alia, anxiety, post-traumatic stress disorder, cancer and epileptic seizures.
As with any pharmaceutical compound, discovery of the optimal dosage form with which the compound can be delivered most effectively is highly desirable. Derivatization and methods of delivery that increase bioavailability, provide a time-release for consistent delivery throughout the day, or decrease the occurrence of side-effects or toxicity serve to enhance the inherent pharmacological properties of the compound and should be thoroughly explored and developed.
Non-covalent interactions have the potential to alter the effect that CBD has on the body through differences in solubility, absorption, and time-release, while not permanently or irreversibly altering the composition or properties of the CBD moiety within the adduct molecule. An ideal method for examining the formation of adducts is nuclear magnetic resonance NMR spectroscopy. Paramagnetic transition metal complexes that are also coordinatively unsaturated can also form useful adducts with Lewis bases.
In a specific embodiment, the metal ion is europium Eu or ytterbium Yb. Suitable ligands include, but are not limited to tris 1,1,1,2,2,3,3-heptafluoro-7,7-dimethyloctane-4,6-dionato ; tris 1,1,1,2,2,3,3,7,7,7-decafluoro-4,6-heptanedionato ; tris 1,1,1,2,2,3,3,3-heptafluoro-7,7-dimethyloctane-4,6-dionato ; tris 1,1,1,5,5,5-hexafluoro-2,4-pentanedionato ; perdeuterated tris 1,1,1,2,2,3,3-heptafluoro-7,7-dimethyloctane-4,6-dionato ; perdeuterated tris 1,1,1,2,2,3,3-heptafluoro-7,7-dimethyloctane-4,6-dionato ; tris trifluoroacetyl-d-camphorato ; tris dipivaloylmethanato , and the like as disclosed in U.
An exemplary transition metal complexes are those formed with copper, such as bis 1,1,1,5,5,5-hexafluoro-2,4-pentanedionato copper II. NMR spectroscopy is based upon the differential absorption of electromagnetic radiation by nuclear spin states of nuclei of atoms whose energy levels have been made non-degenerate by the presence of a strong magnetic field.
A hydrogen nucleus contains one proton, which possesses an angular momentum and may exist in one of two possible spin states: The energy levels of the two spin states are degenerate, and the spin produces a local magnetic field near the nucleus.
Upon introduction of a strong external magnetic field by the instrument, the energy levels of the spin states diverge; the spin state aligned with the magnetic field becomes lower energy than the unaligned state and an energy gap between the spin states is produced.
The instrument then irradiates the sample with electromagnetic radiation in the radio frequency range while holding it in a strong magnetic field created by a superconducting magnet. A number of the hydrogen protons that possess spin states of the lower energy level will absorb the radiation, reversing their spins to match those of the higher energy level.
The frequency of radiation absorbed is recorded by the instrument and displayed as the difference in parts per million ppm from the absorption of an arbitrary standard, tetramethylsilane.
The local environment around the nucleus affects the size of the energy gap produced between spin state energy levels. Electronegative atoms such as oxygen draw electron density away from carbon and hydrogen, thus removing interference from the spins of the electrons, which produce their own local magnetic fields that obscure the nuclear magnetic field.
The energy gap increases as deshielding increases, as the external magnetic field of the instrument is able to exert a more pronounced effect on the exposed nuclei. CBD is capable of acting as a Lewis base and is capable of forming acid-base adducts with sufficiently strong Lewis acids, including the metal complexes formed between the metal ions and ligands described above. Depending on the ratio of concentrations of CBD or other Lewis bases to the metal ion, and steric crowding and electronegativity considerations, adducts with more than one CBD or other Lewis base may form with molar ratios other than 1: The ligands may be rapidly exchanging in steady state equilibria with other adducts when dissolved in solvents.
The following Examples illustrate various aspects of the methods, compositions and products of the invention. Seeds were removed and leaves and blossoms were dried for cannabinoid analysis, with focus on cannabidiolic acid CBDA content in leaves and buds. The pulverized sample was placed in a glass vial to which 10 ml of anhydrous ethanol was added. A portion of the supernatant was removed and filtered through a cellulose acetate 0. The extract was diluted 2: Detection Wavelength nm Column C Because the three peaks with retention times of minutes eluted very close together, the identity of each was examined by UV spectrophotometry, and the UV Spectra of minor peaks are shown in FIGS.
The presence of three peaks in the UV spectrum of this peak suggests that it is predominately the THCA cannabinoid acid, while the shapes of the other two UV spectra curves suggest that they are neutral cannabinoids. The order of elution from the column corresponds with the order of elution from Backer et al.: The weight percent of cannabinoids, based on the dry sample mass, were as follows:.
Federal law as having less than 0. Finally, the isolate is activated by decarboxylation. There are many possibilities for how to use CBD isolate, and it is also very easy to control and manage dosing. While it can be ingested directly by putting some into the mouth or onto food, imagination is the limit with how to use CBD isolate.
It can be infused into liquids and cooking oils, dissolved into sweeteners like honey, dabbed, vaped, or even added to existing cannabis products for an extra boost of CBD. You can also use CBD isolate powder to create your own products, including edibles, tinctures, recipes, supplements, and more. For those who enjoy the aromas and tastes of cannabis which are courtesy of terpenes , mixing it with a terpene isolate can customize the powder.
Physician and medical cannabis expert David Bearman, MD, adds that it is important to look for lab-tested goods. Cannabidiol may actually be more therapeutic when taken as whole-plant medicine, rather than in isolation. When one compound, such as CBD, is isolated from the rest and taken alone, the user misses out on the value of this effect. CBD products are becoming more and more popular. It is made by extracting CBD from the cannabis plant. CBD isolate can be consumed in many different ways, including vaporizing, dabbing and sprinkled on food.
PURIFIED CBD AND CBDA, AND METHODS, COMPOSITIONS AND PRODUCTS EMPLOYING CBD OR CBDA
CBD isolate powder is a highly purified, crystalline form of CBD. are now many cannabis strains and products that boast a high CBD content. CBD isolate is a white crystalline form of the non-psychoactive As a standalone product, an isolate will be found as a white powder or other plant materials including the high-inducing cannabinoid THC. This substance is produced via extraction and purification techniques applied to the hemp plant. When extracting CBD oil, the quality of a hemp source is extremely important. . optional process called winterization which works to further purify the extract. At their purest form, these isolates are a crystalline white powder.