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pharmaceutical cbd oil

In most countries it is forbidden to create concentrates from cannabis, because cannabis is a controlled substance .. Nonetheless, the appearance of numerous CBD-rich extracts have appeared on the global market.

Home or unregulated production can pose risks to patients who consume them. The exact composition of different available oils is frequently unknown. They are not checked for quality by external certified laboratories for the presence of residual solvents, or contaminants such as microbes, pesticides, heavy metals or mycotoxins. The lack of standardisation of both the cannabis starting material and oils makes it impossible to fully evaluate their therapeutic effects over time and, hence, their medicinal value.

Consequently, there is a significant need to standardise and control cannabis extracts and to regulate their distribution as potential medicinal products.

Cannabis oils or concentrated extracts are obtained by the extraction of cannabinoids from the dried flowers (cannabis flos) of the cannabis plant. The purpose of producing cannabis oil is to make cannabinoids and other components (i.e. terpenes), available in a highly concentrated form.

In recent years, a large, unregulated market for CBD (cannabidiol) oils has emerged. These products are typically derived from fibre-type cannabis strains (hemp), which contain large concentrations of CBD, but negligible of THC.

Unregulated production

Bedrocan does not produce nor sell oil for oral sublingual dosing. Please refer to our contact page for an overview of Dutch compounding pharmacists.

CBD is metabolized in the liver, mainly by CYP2C19, CYP3A4, and UGT. This can lead to interactions with prescription drugs, OTC medications, and herbal supplements. 1,14

ABSTRACT: Cannabidiol (CBD) is becoming more prevalent, and pharmacists must be knowledgeable about these products in order to counsel patients effectively. CBD laws and regulations are determined at the state level in the United States. Non–FDA-approved CBD products are not regulated and may contain harmful chemicals. Pharmacists must counsel patients on where and how to obtain products and to check the amount of CBD and delta-9-tetrahydrocannabinol in the product. CBD has numerous drug interactions that should be evaluated by a pharmacist. CBD is most promising for treatment-resistant seizures, and more research is necessary to evaluate its use for other indications. Sativex is currently being investigated in the U.S. for treatment of spasticity associated with multiple sclerosis and schizophrenia. In general, more studies of CBD are needed.

More evidence is needed to support the use of CBD for anxiety. Studies have found that CBD 300 mg may be effective for anxiety related to public speaking, and doses of 400 mg to 600 mg may help patients with social anxiety disorder and public speaking–related anxiety. Studies are inconclusive concerning the utility of CBD for anxiety. 13

Drug Interactions

The inhibition of CYP2C19 by CBD can increase levels of carisoprodol, citalopram, clopidogrel, diazepam, phenytoin, proton pump inhibitors (PPIs), valproic acid, and warfarin. As a strong CYP3A4 inducer, CBD may lessen the efficacy of amlodipine, atorvastatin, buprenorphine, bupropion, diltiazem, eplerenone, fentanyl, loperamide, midazolam, paclitaxel, pioglitazone, sildenafil, solifenacin, tamsulosin, testosterone, topiramate, zolpidem, and other 3A4 substrates. 7

Other interactions to be aware of are presented in TABLE 1.

Studies have reported various properties and potential benefits of CBD. Some undesired side effects of CBD use are decreased appetite, dry mouth, diarrhea, dizziness, drowsiness, fatigue, lightheadedness, orthostatic hypotension, psychomotor slowing, sedation, somnolence, weight loss, and increased risk of liver injury with dosages of 20 mg/kg/day or the use of clobazam or valproate. Monitoring of liver enzymes, weight, and cognitive function may be warranted. CBD can pass through the placenta, so it is recommended that CBD be avoided during pregnancy and while breastfeeding. Because CBD oils may contain trace amounts of THC, operating heavy machinery and driving should be avoided when treatment is initiated. 1

U.S. laws and regulations concerning CBD are determined at the state level. Currently, 33 states have legalized CBD use for medical purposes, and 10 states (Alaska, California, Colorado, Maine, Massachusetts, Michigan, Nevada, Oregon, Vermont, and Washington) and the District of Columbia have legalized marijuana for recreational use. In states such as New York, Minnesota, and Connecticut, pharmacists are required to dispense the products in authorized dispensaries. Marijuana-derived CBD oil is still considered illegal under the Controlled Substances Act in accordance with the DEA’s classification of marijuana as a Schedule I substance. 2