New CBD bioavailability study with CBtru®

Gamechanger in CBD innovation: the key takeaways from our new clinical study 

• While cannabidiol (CBD) has gained significant recognition in the pharmaceutical industry for its promising therapeutic potential, its low bioavailability challenged the development of patient-friendly solid oral dosage forms - until now.
• New clinical research validates that dsm-firmenich’s first-of-its-kind CBD drug product intermediate, CBtru®, offers optimized bioavailability in solid dosage forms, which is as good as the current gold-standard, liquid oil-based CBD medicine. 
• Discover how CBtru® can help overcome the bioavailability challenge, paving the way for CBD-based therapies that support patient convenience and compliance.

CBD has been gaining increasing attention in the pharmaceutical industry thanks to its notable therapeutic benefits for a number of conditions, including neurological disorders (like central nervous system (CNS) diseases), mood disorders, cancers, chronic pain, and even sleep disorders, like insomnia. Research in this field has already led to the launch of the oil-based drug product Epidiolex® for the management of treatment-resistant epilepsy. While this represents a major step forward for patient health, liquid oil-based CBD formulations still present notable challenges, including difficulties with accurate dosing and sensory hurdles. Developing more convenient CBD-based medicines, such as solid oral dosage forms, could help to overcome these challenges. And we’ve created a solution that exactly meets these needs: CBtru®. 

Keep reading to explore the exciting results from our new clinical study comparing the bioavailability of CBtru® to the current gold-standard CBD medicine on the market, and its potential to expand treatment options for patients globally. But first, let’s discuss why bioavailability has been such a hindrance in the CBD space. 

Breaking down bioavailability

In the last few years, the term ‘bioavailability’ has become of increasing interest in the cannabinoids field. Why? Because cannabinoids like CBD are poorly processed in the body, due to incomplete absorption in the gut and significant metabolism (broken down) in the liver. This means that limited CBD is available for uptake into the blood circulation, diminishing its therapeutic potential. In fact, the bioavailability of CBD in humans can be as low as 6%.¹ What’s more, the solubility and absorption of CBD generally increases when co-administered with a high-fat meal. This is because CBD is a lipophilic molecule and can dissolve in the fat content of food. As individuals have different diets and mealtimes, this leads to considerable variability in the bioavailability of CBD and increases the potential for sub-optimal CBD efficacy.^2,3,4

Due to limited bioavailability of CBD, large doses are needed to be effective. And these are typically delivered in inconvenient and unpleasant liquid oil-based oral solutions; potentially affecting medicine acceptance and compliance. Take CBD for epilepsy as an example. The daily dosage required to treat drug resistant epilepsy with CBD varies between 5-20 mg/kg body weight.⁵ In adults, this can translate to more than 1 g of active ingredient in 10 mL of oil.

Clinical breakthrough: CBtru® matches oil-based CBD bioavailability 

To overcome these challenges and unlock drug product innovation in the CBD arena, dsm-firmenich developed CBtru®, an innovative formulated CBD drug product intermediate and patent-pending solution.

To validate the bioavailability of CBtru® for use in solid oral dosage forms, a clinical study set out to investigate the absorption and pharmacokinetic profile of CBtru® compared to the only market-approved CBD drug, Epidiolex® - a liquid sesame oil-based product. The randomized cross-over study was conducted in 32 healthy subjects, half of them men and half of them women, aged between 19 and 55. The trial involved four treatment phases, with each participant receiving 400 mg of both powder CBtru® (in capsule format) and liquid reference product (via a syringe) under fed and fasted conditions, separated by a two-week washout period between treatments. The plasma concentration of CBD was analyzed over 24 hours post treatment and the results speak for themselves:

1.       CBtru® matched the reference product’s bioavailability in fed conditions.

2.       In fasted conditions, CBtru® demonstrated superior bioavailability compared to the reference product.

3.       CBtru® may offer a more reliable and consistent uptake, less dependent on food intake.

4.       It is safe and well tolerated in humans.

The impact for patients and the wider pharmaceutical industry

These exciting results represent a significant breakthrough in the CBD space and for the wider pharmaceutical market, opening new pathways for the development of CBD-based therapies in solid oral dosage forms. This is truly innovative, because it paves the way for more patient-friendly delivery systems, such as tablets and capsules. These dosage forms help enhance efficacy, while simultaneously increasing patient convenience and compliance. What’s more, beyond improving patient experience, this significant development could accelerate research in therapeutic areas where CBD has shown potential, such as pain management, inflammation, cancer, diabetes, as well as sleep, mood, and psychotic disorders.