Comparison between different CBD and the market in Italy

Cannabidiol (CBD) is one of the main cannabinoids of Cannabis. The therapeutic use of CBD in various diseases, such as epilepsy or ADHD (attention deficit / hyperactivity disorder) and many others is documented by numerous studies that report its use, even in diseases due to treatment with drugs conventional has not found success.

To date it has not been clarified how CBD interacts at the receptor level, in fact, compared to THC, it does not seem to have direct affinity for the CB1 and CB2 receptors. Observing several studies we note that CBD decreases the psychotropic effect of THC, which leads to the hypothesis that CBD behaves like a reverse agonist.

The therapeutic benefits got it by the medical use of cannabidiol concern different areas like oncology, pain and neurology, where CBD has reported a considerable success. In fact, CBD a success documented by many studies in the treatment of epilepsy in pediatric and adult age. The therapy with CBD for epilepsy is prescribed in addition to other medicines or as a single therapy.

The success of CBD with epilepsies that are more resistant to common therapies such as Dravet's and Lennox-Gastaut's syndrome or West has led to the development and introduction of Epidiolex, a medicine that currently isn't in Italy yet. We’re talking about CBD from extract medicine .

...Be careful...I wrote CBD from extract...

Why? Because the CBD is not all the same! Yes, we can distinguish different types, including:

• CBD from extract
• Synthetic CBD - the only one admitted in cosmetic
• CBD pharma grade GMP
• CBD tech-use (R&D)
• CBD novel food (not allowed using flowers)

Let's get to know them together!

CBD from extract

CBD from extract is the pure cannabinoid extracted from the plant (Cannabis). When we say "extract" we mean "pulled out" from the plant and placed in a special solvent. Although today there are many extraction methods, there is a tendency to prefer extraction in olive oil or alcohol, you get lower concentration in the first solvent and higher in the second.

Cannabinoids such as CBD and / or THC are lipophilic so it tends to solubilize in specific lipophilic solvents (oils and fats), they also accumulate in our body and are then slowly released.

It’s possible to get CBD from extract in the lab of compounding pharmacies in different ways, including:

1) By extraction from the plant (Bedrolite, Bediol, Pedanios etc.) And then get an oily or alcoholic extract ready to be swallow

2) Pure crystals in capsules by oral ingestion, opening capsules for decoction or vaporization, certified for tech-use or pharma grade (the difference between these see below).

CBD from extract is also present in two medicines: Sativex and Epidiolex.

Synthetic CBD

Synthetic CBD it is not extracted from the plant (Cannabis). Do you think that is same as CBD from extract? Only in part. Since the therapeutic properties of cannabinoids have been noted, synthetic homologues have been development in the laboratories. Many times they present differences in the molecular structure.

So, changes in the molecular structure = not equal to the CBD from but "similar". Of course without mention that cannabinoids are "only a part" of the plant and not "all" of the plant, for example Bedrocan from Netherlands has 22% THC, the rest (78%) is composed of chlorophylls, flavonoids, terpenes etc.

The complete profile of the plant is necessary so that the cannabinoids work in synergy reflecting themselves in therapeutic efficacy. The complete profile is not possible to get it with synthetic CBD.

Examples of synthetic cannabinoids medicines are Cesamet and Marinol.

CBD pharma grade GMP

The CBD pharma grade is the only one GMP certified. What does it mean in few words? Simple: the manufacturing company boasts of quality, safety and efficacy of the drug in the development, production and control phases of medicines. Compliance with these guidelines guarantees the pharmaceutical quality of the CBD (in our case). The process to get it is proceeded using high quality standard from beginning to the end.

It will therefore be present in the manufacturer that boasts GMP production, for example:

1) A quality assurance system

2) A staff with adequate skills

3) A structure in which cleaning is guaranteed

4) The traceability of all operations

5) Analytical checks of the product from the beginning to the end

At the end certificates will be issued that indicate the quality and SAFETY of the drug, in our case of CBD pharma grade crystals. The quality and safety of the pharmaceutical CBD in the GMP production process indicates for example:

- Absence of heavy metals

- Absence of aflatoxins

- Absence of potentially toxic and harmful substances for the body

The price of pharmaceutical CBD is very high, around € 70/gram. It’s possible to get it in compounding pharmacies in different pharmaceutical forms, including:

- Extracts for oral ingestion

- Opening capsules for decoctions

- Opening bags for vaporization

- Capsules for oral ingestion

- In addition to cannabis extracts with low CBD (to increase it), such as Cannabis Bedrocan (Netherlands) that has less than 1% CBD and 22% THC

CBD tech-use (R&D)

CBD tech-use is not produced following the strict GMP rules and guidelines described above. The much lower price (around € 18-30 per gram) is synonymous with lower quality, and is reflected in the product that does not pass throught to GMP health / quality safety regulations.

THEN WARNING!

CBD is a synthetic molecule or extracted from a plant (Cannabis), until reaching white crystals and once the production process is finished you get a certificate of analysis. Being not GMP certified, the product for tech-use does not have to meet the requirements of these regulations, therefore we may incur in a CBD with the presence, for example, of: heavy metals, molds, extraction solvent residues, bacteria, etc.

The reason for all this?

Very simple, the product (CBD) for tech-use IS NOT INTENDED FOR ORAL INGESTION, consequently the company must not respond to the restricted GMP health and quality safety regulations; it does not therefore present certifications suitable for oral intake (quality for health safety) but self-certifications or certifications with limits (of heavy metals, bacteria etc.) even below those considered safe for the human body.

So there are no serious companies and noT-serious companies, but there are companies that must meet safety requirements for human health and product quality (GMP) and companies that do not have to answer because the product is not intended for oral intake (tech-use).

Making an example if I use CBD for R&D I do not care if is not GMP, because I have to use injecting to HPLC that is totally different with oral ingestion.

Probably with CBD tech-use I take care of my son's epilepsy, but introducing into his body substances that are dangerous for his health such as heavy metals and / or bacteria? Unfortunately yes it is. The only CBD that can be used and is safe for the human body is pharma grade GMP.

So with CBD tech-use is there a danger of encountering unpleasant contamination by heavy metals or bacterial infections from molds and/or bacteria cause its poor quality? Again, unfortunately yes it is.

Where I can get CBD for tech-use?

In compounding pharmacies in different pharmaceutical forms including:

- Extracts for oral ingestion

- Opening capsules for decoction

- Opening bags for vaporization

- Capsules for ingestion

- In addition to extracts with low CBD (to increase it), such as Cannabis Bedrocan which has less than 1% CBD and 22% THC

But we just said that you can't use it for oral ingestion!!!

Unfortunately many compounding pharmacies NOT specialized (or not very serious, or unprofessional, you decide ...) they do it. Can they do it? Only in part.

The pharmacopoeia (a text of the law) says that the compounding pharmacist must ALWAYS use the pharma grade of the raw material and, if the latter is not available, he can use a not pharma grade, so for example a tech-use CBD. Using a not pharma grade material the compounding pharmacist is the only one responsible about what could be happen.

Author:

Dr. Fabio Di Francesco

Compounding Pharmacist

Expert in medical Cannabis

E-mail: [email protected]