- Cannabinoids, specifically cannabidiol (CBD), have received intense and growing interest from the scientific community in recent years, opening new research avenues to explore their therapeutic potential in numerous health areas. Several review papers have suggested that modulating the endocannabinoid system (ECS) may have a therapeutic potential in almost every disease affecting humans. However, researchers and developers face clinical trial challenges such as the variance in quality of the active pharmaceutical ingredient (API), coupled with the intrinsic poor oral bioavailability of the molecule.
- DSM and Brains Bioceutical attended the International Congress on Clinical Trials on Cannabis (CT-Cann) in London, United Kingdom, from 15-16 February, to discuss the challenges facing the cannabinoid industry and provide future solutions in support of the research and scientific community, creating differentiated opportunities within this rapidly evolving field.
- Read on to get expert views on how novel approaches can help unlock the unlimited potential of CBD and discover how DSM and Brains Bioceutical’s – a leading end-to-end solution provider in the medical cannabinoid space – can support due diligence considerations that minimize risk of research failure and increase the odds for scientific and therapeutic advancements.
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, a leading end-to-end 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.
Due diligence considerations for advancing drug development in the cannabinoid market:
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:
- Choose the right API right from the start. Make sure the API you select is clinical-trial ready with the required certifications, licenses and documents, such as GMP and a DMF/ASMF, increasing the approvability of your drug development programme, aby the relevant regulatory body.
- Don’t be alone in your CBD journey. Identify partners that have experience in the cannabinoid and pharmaceutical market, as well as expertise in assessing commercial viability, clinical trial design and implementation, regulatory evaluation, and CMC strategies”
How can DSM and Brains Bioceutical together support pharma innovation in the cannabinoid space?
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:
- A robust cannabinoids portfolio, including a GMP certified (human and veterinary), THC-free, natural CBD API, and a rich pipeline of minor cannabinoids to unlock a new medical frontier of pioneering cannabinoid-based therapeutics in healthcare.
- Capability to support bespoke CBD API FDF (Finished Dosage Forms) and formulation, technical and application support, regulatory and scientific expertise to evaluate existing pre-clinical and clinical programmes, identify data gaps and support pre-IND preparations.”
How are formulators approaching the CBD bioavailability challenge?
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.”
“To date, a lot of research has been focused on liquid oral solutions for boosting bioavailability, such as self-emulsifying drug delivery systems, as well as cyclodextrin encapsulation and liposomal delivery systems. Theoretically, these formulation technologies have the potential to boost bioavailability, however, as of yet, there is limited clinical evidence demonstrating any significant increase in the bioavailability of CBD formulated using these approaches.”
How is DSM contributing to new advancements in the field of CBD formulation?
Alexandru Zabara continues: “DSM has identified the market and patient need associated with the enhancement of CBD bioavailability for several years. That’s why we created an innovation platform that revolves around exploring different technologies for this exact purpose. We took an unbiased approach to our investigations and developed formulations using a range of different technologies, such as nano-emulsification, amorphous solid dispersions, liposomal encapsulation and lipid nanoparticles. As part of our pre-clinical analysis, we are screening each technology using in-vitro bioaccessibility assays and in-vivo pharmacokinetic evaluations to decipher which technologies perform best. Once this is confirmed, the next step is to clinically evaluate the bioavailability of CBD in the best performing formulations and ensure our products provide a tried and tested benefit to our customers and most importantly, patients.”
What are the benefits of enhanced CBD bioavailability for patients?
Alexandru Zabara comments: “A current limitation in CBD-based therapies can be linked to the applied dosing regimen in both market authorized products and clinical investigations. This means that CBD – at the current bioavailability levels – doesn’t have a therapeutic effect unless dosed in very high amounts, potentially causing many clinical trials to not reach their primary endpoint. One of the positives of making CBD more bioavailable is that it will change the therapeutic window of the drug, reducing the amount needed to achieve a therapeutic outcome and potentially leading to more positive clinical outcomes at lower dosages. This could be a major benefit for patients with respect to the ease of administration, but also for the CBD industry, as this could unlock the therapeutic potential of CBD in new health areas.”
To get more expert insights from Terry O’Regan and Alexandru Zabara on how the cannabinoid landscape is evolving, watch our on-demand webinar from the CT-Cann 2023 congress.
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