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Business & Regulation Small Molecules, Ingredients, Standards & Regulation

The Marijuana Medicine Makers

sponsored by Johnson Matthey

The umbrella term “cannabinoids” covers a variety of compounds that are derived from the cannabis plant, including tetrahydrocannabinol (THC) – the chemical predominantly responsible for the psychoactive effect that accompanies cannabis use. THC was the first cannabinoid to be studied extensively for its therapeutic potential. Indeed, the first cannabinoid-based product to be approved by the FDA was a synthetic version of THC called Marinol in 1985. By improving appetite and reducing nausea and vomiting in patients undergoing chemotherapy or being treated for HIV, Marinol saw great success and continues to be the standard of care in such patients.

Johnson Matthey got involved in the cannabinoid field over 15 years ago when we developed a generic substitute for Marinol. Working with cannabinoids is very complex and APIs produced based on cannabinoids can be challenging to work with. In Marinol, the API oxidizes quickly and is prone to impurities. To add to the challenge, many countries – particularly the US – have strict rules and requirements around the use of controlled substances However, Johnson Matthey already had a great deal of experience with manufacturing controlled substances, so it was a logical step to enter the cannabinoid space. We already had the expertise to handle the complex chemistry and stability challenges, coupled with the infrastructure and resources to navigate the legal landscape.

Plant potential

Today, interest in cannabinoids in the pharma industry and medical community is increasing rapidly as further research emerges. Cannabinoid receptors are being found all over the body and there is potential for cannabis-derived medicines to help in unexpected therapeutic areas; for example, there is a lot of work taking place in employing cannabinoids for dermatological conditions, such as eczema. There is also interest in using cannabinoids as an adjuvant in chemotherapy patients to help manage pain. There could be huge rewards for companies that develop alternative medicines and approaches.

In addition, research with cannabis – historically hindered by the legal landscape – is becoming easier as a number of US states and countries around the world begin to relax rules and regulations around medicinal (and, in some cases, recreational) cannabis use. This has led to increased availability of cannabis for research purposes and fewer restrictions about what researchers can do. With ongoing research about how cannabinoids can potentially treat a plethora of conditions, the medical community is pushing for GMP-grade products that have been subject to rigorous safety studies. More patients are becoming aware of cannabis’ potential health benefits but many of them want to gain access to a controlled, safe and effective product.

Meeting new and natural needs

We have already established large scale expertise in the cannabinoid space, which means we’ve been able to adapt scale up operations to meet rapidly increasing market demands. Although we initially started with THC, we have since grown our offerings to include other synthetic cannabinoids, including cannabidiol (CBD) and nabilone.

Clearly, to gain FDA approval, you need to produce a very pure product, which requires the right equipment and a significant amount of technical know how. As well as developing a validated process for cannabidiol synthesis (filed with a US DMF), we have also created reference standards for our cannabinoids, which help our customers understand what they are getting, and gives them the confidence to use our APIs in their formulations. We have also considered ease of formulation – our cannabidiol is a free-flowing crystalline powder and the particle size can be adjusted to suit a variety of formulations.

Beyond THC and CBD, there are well over one hundred different cannabinoids within the cannabis plant, and pharma companies are interested in assessing the therapeutic potential of a number of these. In response, we are planning to expand our portfolio to include other synthetic cannabinoids.

The FDA recently approved the seizure drug, Epidiolex, which contains naturally extracted cannabidiol, and we see increasing interest in the use of natural cannabinoids. As one of the largest API manufacturers in the world, Johnson Matthey has gained significant expertise in the extraction of APIs from natural sources, and so we are also expanding our offerings to help those customers wishing to explore botanical cannabinoids.

Kevin Hennessy is Commercial Director at Johnson Matthey.

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About the Author
Kevin Hennessy

Kevin Hennessy is Commercial Director at Johnson Matthey.

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