Reliable CBD Dosing Critical to Optimum Patient Care and Product Adoption

The growing consensus in the medical community is that cannabidiol (CBD) can serve as a safe, highly effective treatment option for a wide range of illnesses. And governments around the world are passing pro-medical cannabis regulations. There are a variety of products available for the oral consumption of CBD, but not all of these methods have the ability to control dosage and deliver efficacious results for patients. Precision dosing technologies are essential for ensuring wider adoption of orally delivered medical CBD products and market growth.

CBD has wide-ranging medical uses

Cannabidiol, a natural chemical derived from cannabis, has been shown to boost the endo-cannabinoid system, an important part of the human body’s immune system. CBD is used to treat numerous illnesses including chrohn’s disease, depression, anxiety, epilepsy, diabetes, multiple sclerosis, schizophrenia, and cancer.
A 2013 review published in the British Journal of Clinical Pharmacology found that CBD has the ability to reduce nausea and suppress seizures along with anti-psychotic, anti-oxidant and anti-inflammatory properties. CBD has also been found to inhibit or stop the growth of a variety of cancers including breast cancer. Strong evidence for the use of CBD in the treatment of pediatric epilepsy was presented in results from a major clinical trial were published in the May 2017 issue of the prestigious New England Journal of Medicine.
CBD doesn’t come with the high associated with THC, making it an ideal choice for children and elderly patients who can benefit greatly from cannabis’ medical properties—a much safer alternative to other medications including opioids. In fact, many in the medical community also have good reason to believe CBD may hold the answer to the opioid epidemic. Numerous studies show that the natural chemical can reduce patient reliance on medications, such as opioids, that have the potential for negative side effects and addiction.

Importance of bioavailability

CBD can be delivered to the bloodstream sublingually (under the tongue), orally, inhaled, or topically on the skin through a range of delivery methods including oils, tinctures, sprays, creams, capsules, vaporizers and food products.
These delivery methods vary greatly in terms of absorption which can have a significant impact on bioavailability—how quickly and how much of a drug reaches its intended site of action, in this case, the endo-cannabinoid system. A number of factors can affect absorption, including the drug’s properties, the way the product is designed and even the way the drug is stored. Too low bioavailability can hamper the ability of a drug to provide effective treatment.
The most common forms of approved medical CBD treatments on the market today use oral and sublingual delivery technology. Bioavailability rates for these methods typically range from 3 percent to 6 percent for oral delivery methods and 15 percent to 25 percent for sublingual. The higher rate among the sublingual delivery methods is due in large part to the high abundance of capillaries below the tongue which allow cannabidiol to quickly enter the bloodstream.
Given the permeability of the lungs, inhalation of CBD through a vaporizer does have a much higher rate of bioavailability (reportedly around 30 percent) and a more rapid onset time than orally administered CBD medication. However, in a study comparing oral delivery of CBD to inhalation, oral administration had the longest “clinical effect”—approximately 7 hours compared with 1 to 3 hours for inhalation —due to the slow release of the drug into the bloodstream maintaining concentrations in the blood over a longer period of time.
The major bioavailability hurdles for oral methods of CBD consumption is the acidic environment of the gastrointestinal tract, the low absorption rate by the intestinal wall and the role of the liver in the breaking down of chemicals before they enter the bloodstream. However, there are precision dosing technologies entering the market that can enhance the bioavailability of oral CBD products.

Oral delivery technology enhances bioavailability

Satipharm’s Gelpell® microgel technology produces 2mm-long gelatin beads containing concentrated cannabinoids derived from organic medical-grade cannabis with no detectable levels of THC. The beads are packaged into Gelpell-CBDTM capsules with 10mg and 50mg presentations, the only CBD-based health products produced under the guidance of good manufacturing practice (GMP), used for pharmaceutical products in Europe.

Source: Harvest One

Satipharm’s proprietary natural gelatin matrix, which also contains linseed oil and chlorophyll, protects the cannabinoids from oxidative heat and light degradation, so unlike some other oral CBD formulations, the capsules do not require refrigeration to maintain stability. When ingested, the capsule passes easily through the stomach to the small intestine where it dissolves, distributing the gelatin beads. The gelatin formulation creates a micro-emulsion which substantially enhances the bioavailability of the cannabinoids as they are absorbed through the small intestine.
The results of the phase 1 pharmacokinetic study evaluating the safety and performance of Gelpell® microgel CBD capsules was recently published in Clinical Pharmacology in Drug Development, an international medical journal and the official journal of the American College of Clinical Pharmacology.
The results demonstrated the safety and high performance of this oral CBD delivery technology, including the effective delivery of CBD to trial subjects. In fact, the trial also showed that Gelpell® microgel CBD capsules had a 34 percent higher bioavailability over Sativex, a sublingual spray and a leading product in commercially available medical cannabis treatments.

Precision dosing builds confidence in the product

As with any drug, precise dosage is critical to safe and effective treatment. Enhanced bioavailability means a product can more effectively deliver a consistent and reliable dosage of CBD molecules into the bloodstream and ultimately the endo-cannabinoid system.
“How to dose CBD in patient?” and “How reliable is the dosage in this product?” are common questions asked by health practitioners, especially given the fact that we are still in the early days of medical cannabis. Up until this past year cannabis was a prohibited substance like cocaine or heroin, so the modern practice of using cannabis for medical purposes is still in its infancy.
“At present, there is a real imbalance in the system caused by patients who want to move away from illicit cannabis, which offers zero dose information or dose reliability, and doctors who have little to no training in cannabis or the endo-cannabinoid system. This is very distressing for patients who know cannabis can be a worthwhile medical agent,” Catherine Harvey, COO of MMJ PhytoTech (ASX:MMJ) told INN. “At this point in time, medicinal cannabis is only considered where conventional treatments have proven unsuccessful in managing the patient’s symptoms. Doctors are very clear when it comes to medical cannabis: they want dose reliability in the products they prescribe.”
Israeli-based Phytotech Therapeutics, the clinical R&D arm of MMJ PhytoTech, conducted the Phase 1 trials for Satipharm’s Gelpell® microgel technology. “The Satipharm CBD capsules deliver a controlled dose of 10 mg or 50 mg CBD with each and every capsule,” said Harvey. “The quality controls applied to the product mean that patients can rely on receiving the same dose with each capsule from each manufacturing batch.  Importantly, the dose reliability is unchanged over time.”
Satipharm’s Gelpell-CBDTM capsules are already available in the EU market and were recently approved for Australian patients. “The market entry of Satipharm’s Gelpell capsules into the Australian prescription drug market proves the concept of our science based product development,” said Andreas Gedeon, CEO of Canadian-based Harvest One (TSXV:HVST), which owns Satipharm, which as the exclusive distribution and marketing rights for the Gelpell® migcrogel technology for all cannabis-based applications. MMJ PhtoTech holds a 60 percent interest in Harvest One. Satipharm is also seeking approval to import the capsules to Canada.
“The combination of controlled production of the raw materials, GMP processing into a pharmaceutical grade product and clinical testing proving safety and efficacy has made it possible to bring this unique product after years of R&D to Australian patients,” added Gedeon.
As with any drug, medical cannabis professionals recommend that new CBD patients follow the old age “start low, go slow”, or more scientifically “titrating to effect” which involves slowly increasing the dosage until the desired clinical effect is achieved. “Patients want to be able to trial a dose, assess the effect, and then adjust the dose up or down in a controlled manner,” said Harvey. “The Gelpell-CBDTM capsules make this very easy for patients as they deliver the same CBD dose every time. There’s no measuring, no calculating, and no need to check the concentration which makes it extremely easy for patients to titrate the dose up or down.”

Medical cannabis drug trials important to market growth

Very few medical cannabis products have undergone vigorous phases of testing to achieve government approval, and recognition in the medical community. Which is why under government regulations, medical cannabis products are not permitted as a first-line treatment. Doctor’s must first treat patients with approved drugs that have known side effects and efficacy profiles.
MMJ PhytoTech believes the Gelpell-CBDTM capsules are suitable for the treatment of a variety of medical conditions and is moving forward with Phase 2 clinical trials in refractory pediatric epilepsy, multiple sclerosis as well as palliative care. The Phase 2 trial  for children not responding to conventional epilepsy treatment, conducted by Phytotech Therapeutics in Israel, is now underway.
Following the completion of this Phase 2 trial, Phytotech would only be the third company, behind GW Pharmaceuticals and Insys Therapeutics Inc., to present results of a formal Phase 2 trial into refractory pediatric epilepsy.
Phytotech will also be conducting a Phase 2 trial for multiple sclerosis patients to evaluate Gelpell® microgel capsules containing CBD and THC. In Australia, a Phase 2 clinical study will assess the potential for the CBD-only and CBD-THC combo versions of the drug in the treatment of a variety of palliative care indications including patient issues with pain, appetite, anxiety and sleep problems.

The Takeaway

Although it’s still early days, it’s clear that pharmaceutical-grade cannabis products will play a strong role in the future of global healthcare. According to a Grand View Research report, the global medical marijuana market is expected to grow at a CAGR of 17.1 percent to reach a value of US$55.8 billion by 2025.
The report cites “increasing interest amongst the academic researchers and healthcare providers regarding the therapeutic uses of marijuana” along with the “growing number of countries legalizing the use of medical marijuana” as significant factors in this market growth.
Investors looking to take advantage in this early stage of a growing market would benefit from considering companies with an early foothold into this emerging global market. Especially those companies focused on non-psychoactive CBD products, as these are widely accepted by governments who are increasingly approving their legal sale and distribution.
Companies with CBD products in their portfolio have a greater potential to diversify into as many geographic markets as possible, positioning themselves as early-entry leaders once more restrictive cannabis laws begin to ease concerning products that contain THC.
This article was written according to INN editorial standards to educate investors.