Cannabinoids have become an intense area of research due to rising interest across the scientific community in their possible therapeutic benefits for human health. The most well-known cannabinoids are cannabidiol (CBD) and tetrahydrocannabinol (THC), with CBD yielding significant medicinal potential through its non-psychoactive properties. Advancements in the field of CBD research have demonstrated the promising prospects of the molecule to treat various disease states, especially in treating neurological conditions. However, CBD is still very much in the early stages of drug development, with investigators and clinical scientists, exploring potential therapeutic benefits of this molecule, still facing challenges in their pre-clinical and clinical development. These are mainly related to the variable quality of the API being made available for clinical research, as well as to inherent difficulties in formulating this highly lipophilic molecule, leading to an overall poor and variable oral bioavailability. To this end only a small amount of orally consumed CBD makes it into the systemic circulation, where it ultimately achieves its therapeutic effects. In humans, it is estimated that 6-12% of CBD enters systemic circulation, due to partial gastric absorption and pre-systemic elimination in the liver1.
This year, leading researchers, clinicians, biopharmaceutical innovators, and other related experts in the cannabinoid space gathered from around the world at the International Congress on Clinical Trials Cannabis (CT-Cann) in London, United Kingdom. At the congress, important discussions unfolded to identify learnings and ways of improving current research strategies, new discoveries in the field, and future avenues for innovation. DSM and Brains Bioceutical, together a leading partner in the medical cannabinoid space, had the pleasure of attending CT-Cann 2023. Terry O’Regan, President of Brains Bioceutical, and Alexandru Zabara, Innovation Manager Pharma at DSM, showcased how solution-oriented and innovation-driven partnerships are key in facing the challenges associated with cannabinoid-based early drug development, to unlock the full potential of this unique class of molecules and create new opportunities in this space.
Read on to discover their take on the current landscape and how the industry can help to advance the medical cannabinoid field benefiting patient health worldwide.
Entering early-drug development in the cannabinoid space is challenging. Getting the right expert support to conduct a thorough due diligence process, to minimize the risk of research failure and increase the probabilities for real scientific and therapeutic advancements, is key. Terry O’Regan highlights how researchers in the cannabinoid space can increase the prospect of success in developing potential therapeutics that would benefit patients: “Despite the rising popularity of CBD products, there are still some significant challenges to clinical trial success primarily due to the absence of rigorous due diligence of the clinical trial programme and inconsistency of API quality. Thus, if researchers want to support rapid and scalable CBD drug development they must take tactical measures, such as:
Terry O’Regan remarks: “Together, DSM and Brains Bioceutical are strategically positioned to support the research and development of cannabinoid-based therapeutics and products powered by a high-quality, GMP-certified portfolio of cannabinoid API and ingredients, including CBD and other minor cannabinoids. DSM and Brains Bioceutical offer end-to-end services to unlock bespoke cannabinoid-based pharmaceuticals to expand treatment options for patients worldwide. Together, we can support a drug development programme with our end-to-end services, including:
Alexandru Zabara comments: “The demand for novel formulations capable of enhancing CBD’s absolute oral bioavailability is a well-defined market need. The foundational elements required for developing novel formulations lie with the purity and physico-chemical stability of the active ingredient. However, there are many other important factors that need to be considered when formulating with CBD, such as the route of delivery. A number of CBD oral dosage forms are currently being explored in clinical trials across the globe, including CBD in liquid formulations, soft- and hard-shell capsules, tablets, orally disintegrating tablets (ODTs) and orally disintegrating films (ODFs). Each product format comes with its own set of advantages and potential limitations. For example, ODTs and ODFs are patient-friendly, but can only comprise a limited dose of CBD in each unit. With this in mind, experts across the industry are trying to identify which technologies, solutions and formulations are best suited to different applications to uplift the effects of CBD.”
1. Perucca and Bialer. Critical aspects affecting cannabidiol oral bioavailability and metabolic elimination, and related clinical implications. Cannabinoids in Neurology and Psychiatry, 2020.
29 March 2023
3 min read
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