Dietary Supplement prepared from the industrial hemp oil.
Pure-Gold™, manufactured and distributed by Kannaway LLC, is a proprietary product made exclusively from industrial hemp oil. Pure-Gold™ is rich in cannabidiol (CBD), other phyto-cannabinoids, terpenes and medium chain triglycerides (MCT).
Pure Gold™ hemp oil liquid features a powerful botanical combination of hemp sourced cannabidiol (CBD) and medium chain triglyceride (MCT) oil. Pure Gold™ is a supplement that may support healthy function of joint and muscle, evoke a sense of calmness and relaxation, and promote mental tranquility via the endocannabinoid system (ESC), which is known as a vital factor in the regulation of homeostasis, symptomatic relief and overall metabolic functions
Disclaimer: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."
COMMON BRAND NAMES
Pure-Gold™ is an oil tincture for oral and sublingual Administration.
Pure-Gold™ is contained in an amber glass bottle covered with a polyethylene cap. Each bottle contains 120 mL of a clear, colorless to yellow solution of industrial hemp oil with a cannabidiol content at 12.5 mg/mL. The product doesn't contain any measurable amounts of psychotropic △9-tetra-hydro-cannabinol (THC).
Non-medicinal ingredients: MCT coconut oil
INGREDIENTS AND SUPPLEMENT FACTS
Suggested Serving Size: ¾ tps (3.75 mL)
Servings per container: Approx. 30
Amount per Serving % DV
Cannabidiol (CBD) from the stalk, stems, leaves and flowers of hemp plant 47- 50 mg †
Medium Chain Triglycerides 3 g †
Sugar 0 mg 0%
† Daily Value not established
% Daily Values are based on a 2,000 calorie diet
Pure-Gold™ is for oral and/or sublingual use only. The dropper should be directed to below the tongue. It must not be applied into the nose. It is recommended to keep the administered sublingual dose in mouth (sublingual or buccal space) for 0.5 min or longer before the dose is swallowed.
The dosage of Pure-Gold™ will depend on the nature of the desired health benefit. As an antioxidant Pure-Gold™ may be effective at any dose. In order to have measurable wellness and beneficial physiologic effects, the daily intake should be at least around 30 mg (calculated based on CBD content) and then increased gradually according to the tolerance and achieved beneficial effects.
Dosage should be adjusted as needed and tolerated. Some individuals may require and may tolerate a higher number of doses. Individual should titrate to their optimal dosing regimen. They should be advised that it might take a few weeks to find the optimal dosing level.
Dose initiation and stabilization
Dose should be started at 0.6-0.7 mg/kg (~45-50 mg total cannabidiol, i.e. one serving, for the subject with average body weight of 75 kg) on the first day of the first week.
On subsequent 2-3 weeks patient may gradually increase the dose as tolerated.
If unacceptable adverse reactions such as dizziness or other type reactions develop at any time, dosing should be suspended until symptoms are relieved.
Some individuals may be able to continue dosing at the dose reached by increasing the interval between doses; others may require their subsequent doses reduced. Individuals should then carefully re-titrate the dose to a tolerated dosage regimen.
Re-titration of Pure-Gold™ dose upwards or downwards may be appropriate if there are any changes in the tolerability.
Preferably, individual should control their daily doses of Pure-Gold™. In case of missed dose, individuals should follow with the next dose in their dose regimen.
There is no recorded experience of deliberate overdose with Pure-Gold™.
CONSIDERATIONS AND PRECAUTIONS
Despite of a good safety profile of CBD in humans [1-11, 15], Pure-Gold™ should not be recommended for:
- individuals with known or suspected allergy to cannabidiol or coconut oil
- individuals with significant hepatic or renal impairment
- pregnant or nursing women
- Pediatrics: The safety and efficacy of Pure-Gold™ has not been established in adolescents or children under 18 years of age. Therefore, parents and caregivers need to seek their doctor's advice whether Pure-Gold™ can be consumed by adolescents or children.
- Geriatrics: There are limited data available on the use of cannabidiol in elderly patients, therefore, Pure-Gold™ should be recommended cautiously and carefully monitored in this patient population.
Pure-Gold™ should not be used beyond its expiry date. Pure-Gold™ should be stored upright in original container at room temperature (15°C-25°C), away from sources of heat and direct sunlight. Once opened, Pure-Gold™ should be stored in a refrigerator (2°C-8°C).
Pure-Gold™ has been consumed by adult individuals taking conventional pharmaceutical medications at the same time. No information from spontaneous reporting is available on any interactions resulting from simultaneous intake of conventional medicines with Pure-Gold™.
However, since the cannabidiol (CBD) is the major ingredient of Pure-Gold™ there may be minor drug-drug interactions due to well-known CBD driven CYP450 inhibition and induction. CBD showed to be a weak inhibitor of CYP1A2, CYP2C6, CYP2D6, CYP2C19 and CYP3A4 with an EC50 approximately two orders of magnitude greater than the plasma levels seen in clinical use [1, 2].
In preclinical studies with P-gp, BCRP, and P-gp/BCRP knockout mice, where CBD at 10 mg/kg was injected subcutaneously, showed that CBD is not a substrate of these transporters itself.
CBD is highly bound to human plasma proteins. Although this displacement has not been confirmed in vivo, the dosing should be carefully monitored when administering Pure-Gold™ to patients who are receiving other drugs which are tightly protein-bound, such as warfarin and diclofenac [1, 2].
FOOD AND HERB INTERACTIONS
No interactions with food or herbs have been established.
MECHANISM OF ACTION
There are two main cannabinoid (CB) receptors, CB1 which is primarily located in the central nervous system with some expression in peripheral tissues and CB2 receptors, which can be found in the periphery on cells with immune function and in the gastrointestinal tract and at low densities in the central nervous system [2-5].
CBD does not appear to act directly at CB1 receptors, with a number of studies reporting that there is no measurable response in binding assays. In studies examining potential agonist effects at CB1 receptors, most find no effect, with one report of a weak agonist and one of a weak antagonist effect, each at high concentrations (>10 µM). CBD also shows low affinity at CB2 receptors [2-10]. Across a range of measures in humans and animals, CBD had been shown to have very different effects from those of THC. In mice, CBD failed to produce the behavioral characteristics (e.g. suppression of locomotor activity, hypothermia, anti-nociception) associated with CB1 activation, whereas THC generated all of the effects which occur when CB1 is activated. Neuroimaging studies in humans and animals have shown that CBD has effects which are generally opposite to those of THC. In contrast to THC, CBD has no effect on heart rate or blood pressure under normal conditions, but in animal models of stress it reduces heart rate and blood pressure. Other differences between THC and CBD are discussed below [6-9, 11-10].
Some studies have shown that CBD may reduce or antagonize some of the effects of THC. The mechanism for this is unclear, with some suggesting that it may be a weak CB1 antagonist. Recent evidence suggests that it may be a negative allosteric modulator of the CB1 receptor, thereby acting as a noncompetitive antagonist of the actions of THC and other CB1 agonists [2- 17].
CBD may also interact with the endocannabinoid system through indirect mechanisms such as enhanced action of the endogenous cannabinoid ligand anandamide [17, 18]. This results from blockade of anandamide reuptake and the inhibition of its enzymatic degradation. CBD has been shown to modulate several non-endocannabinoid signaling systems. It is not clear which, if any, of these mechanisms are responsible for any of CBD's potential clinical or other effects. Some of these mechanisms include:
Inhibition of adenosine uptake, possibly resulting in indirect agonist activity at adenosine receptors.
Enhanced activity at the 5-HT1a receptor.
Enhanced activity at a glycine receptor subtype.
Enhanced activity at the peroxisome proliferator-activated receptor (PPAR)
Agonist at the transient receptor potential channel vanilloid receptor (TRPV1)
Blockade of the orphan G-protein-coupled receptor GPR55 [3-11, 17,18].
The principal pharmacological effects of CBD include analgesic, anti-convulsant, muscle relaxant, anxiolytic, neuroprotective, anti-oxidant (US Patent 6,630,507 hold by NIH), anti-inflammatory and anti-psychotic activity. The mechanisms by which the biological actions of endogenous cannabinoids are terminated, have not been fully evaluated. However, it appears likely that they are removed from the extracellular space by tissue uptake and that intracellular metabolism via an enzyme system, fatty acid amide hydrolase (FAAH), is also involved [20-21].
PHARMACOKINETICS IN HUMAN
Although human pharmacokinetic studies with Pure-Gold™ have not been performed yet, there exists sufficient published information on CBD (the major bio-active cannabinoid of Pure-Gold™) to allow an assessment of the pharmacokinetic profile of Pure-Gold™ in human.
Limited single dose pharmacokinetic data obtained from the human healthy volunteers following a under the tongue administration of EPIDIOLEX®, an oral formulation containing CBD at 100 mg/mL.
Absorption and Distribution
Due to its poor aqueous solubility, the absorption of CBD from the gastrointestinal tract is erratic, and the resulting pharmacokinetic profile is variable. Bioavailability from oral delivery was estimated to be 6% due to significant first-pass metabolism. Bioavailability (%F) from oral-mucosal and sublingual routes are less variable, but similar to oral delivery.
Following a daily administration of CBD 10 mg/kg in 15 neuroleptic-free patients for 6 weeks, a mean CBD plasma level ranging from 5.9–11 ng/ml. CBD is rapidly distributed into the tissues with a high volume of distribution of ~32 L/kg. It may preferentially accumulate in adipose tissues due to its high lipophilicity. It is highly bound to plasma proteins and red blood cells. The release of CBD from fatty tissue is responsible for the prolonged terminal elimination half-life [1,2, 12, 13, 19-21].
Metabolism and Excretion
CBD is extensively metabolized in the liver . The primary route is hydroxylation to 7-OH-CBD which is then metabolized further resulting in a number of metabolites that are excreted in feces and urine. Seven human CYP450 enzymes were identified as capable of metabolizing CBD: CYP1A1, CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP3A4, and CYP3A5. The two main isoforms involved are CYP3A4 and CYP2C19. CBD undergoes CYP3A- and CYP2C-dependent phase I metabolism to 7-hydroxy-CBD, which is further metabolized into 7-COOH-CBD and its glucuronide conjugated phase II metabolites and excreted, more in feces and to a lesser extent in urine. In a number of studies, CBD has been shown to inhibit CYP isozymes in vitro, but it is not clear that this occurs at concentrations achieved with doses used clinically. CBD has an estimated terminal half-life of 18–32 hours and a clearance of 57.6–93.6 L/hour [1,2, 11, 12].
Production and Control Information
Pure-Gold™ is made from the non-genetically modified (non-GMO) of hemp cultivars. Only certified seeds of approved low-THC fiber hemp varieties are used for the cultivation of hemp for the extraction of CBD enriched oil. The hemp is cultivated and comply with the high internal quality standards, required for the cultivation of the medicinal plants. Farming facilities hold a special permit for the cultivation of hemp, issued by the authorities.
Botanical Raw Material
Our hemp plants are lawfully sourced industrial hemp originating from non-genetically modified (non-GMO) of cultivars, grown by pesticide and chemical fertilizer-free farming. All farms are registered and appropriately equipped with valid licenses and permits to operate issued by local authorities.
Harvesting takes place at the time of the hemp plants' highest quality shortly before flowering, observing hygienic standards which are comparable to high requirements for medicinal plants. Only high-quality plants containing a concentration of tetrahydrocannabinol (THC) far less than 0.3% are used for producing CBD oil.
Our source farm utilizes hemp plant biomass derived from the stalk, stems, leaves and flowers of Cannabis sativa L. plant, also known as industrial hemp. A comprehensive quality control of the harvest is carried out upon arrival at the extracting facility. CBD and other cannabinoids as well as other plant substances are analyzed and thoroughly documented. In addition to that, each batch is tested for conceivable germ or contaminant loads and is only accepted if it meets strict requirements. The dried harvest is stored in purpose-designed, modern warehouses in compliance with the storage of medicinal plants according to the principles of Good Manufacturing Practice (GMP). Temperature and humidity are constantly monitored.
Manufacturing of Botanical Substance (Hemp Oil)
All extraction processes of the hemp oil meet the strict requirements of the GMP. Hemp oil is extracted from ground biomass of hemp plants including the stalk, stems, leaves and flowers by adding plant material into denatured ethanol (EtOH) followed by a multi-step process, including a high temperature assisted decarboxylation. The extraction and decarboxylation process parameters are optimized for a higher cannabinoid yield that results in a phyto-cannabinoid rich hemp oil. The extracted hemp oil is subjected to a rigorous analytical testing to ensure the absence of pesticides, microbes and organic solvents according to established acceptance criteria.
The flow of industrial hemp manufacture is shown below. Quality control checks are indicated in purple – the reason for each of these checks can be traced back either to a risk management document or is a normal technical measurement for the process concerned.
Manufacturing of Finished Product Pure-Gold™
As a final formulation step, decarboxylated and filtered hemp oil is diluted with the medium chain triglyceride (MCT) coconut oil (vehicle) to achieve a predetermined final concentration of CBD and terpenes. The final formulation is subjected to the analytical testing to verify the concentration of CBD, other cannabinoids and terpenes, as well as the metals, pesticides, microbes and organic solvents by convergence chromatography, head-space gas chromatography, ISO/IEC-17025, Liquid chromatography with mass spectrometry, respectively. The analytical testing is performed by independent qualified and certified analytical laboratory. The analysis results are documented in a corresponding Certificate of Analysis.
The efficacy of Pure-Gold™ was not evaluated in clinical trials yet.