Health Science: Understanding cGMP Manufacturing in Cannabinoid Pharmaceutical Molecules
Current Good Manufacturing Practice (cGMP) is critical in safeguarding manufacturers, end-users and the reputation of the pharmaceutical industry as a whole. Lekhram Changoer, Chief Technology Officer at Axim Biotechnologies explains more, using the company’s brand-new method of extracting purified cannabinoid molecules as an example.
As an industry, we’re aware of the need to maintain the highest of standards when developing our new products and its criticality in achieving product registration with regulatory bodies such as the Food and Drug Administration (FDA) and European Medicines Agency (EMA). All too often however, striving to achieve these high standards has resulted in the industry becoming focused on lengthy manufacturing processes, especially within the cannabinoid industry which is still evolving and gaining its credibility within the markets.
At Axim Biotechnologies, we’re proud to have developed a method for extracting Delta(9)-tetrahydrocannabinol (THC) and cannabidiol (CBD) from the flowers of the cannabis plant and successfully encapsulating these molecules for pharmaceutical use. Our process employs just two steps in order to achieve an average of more than 99% purity – unlike traditional methods that include toxic solvents and multiple steps to produce the final extract or synthesize an API such as dronabinol.
Best Practice and Innovation
In line with Axim’s commitment to best practice and innovation, cGMP standards are in place throughout the whole process of pharmaceutical manufacturing for this process and product, first starting with the raw cannabis plants which are grown at the GMP growing facility, Bedrocan, in the Netherlands.
The next stage sees the extraction of Active Pharmaceutical Ingredients (API) from the cannabis flowers in an innovative process which employs limited purification steps in order to achieve an above-average 99% purity. Importantly, the process also uses less solvents than other methods, including the absence of chromatography, which eliminates certain impurities. We then apply our newly-developed encapsulation method, protecting the cannabinoid from any further oxidation and degradation and preserving its effectiveness for the final stage. Finally, our encapsulated cannabinoids are manufactured into pharmaceutical products within different delivery format categories, such as chewing gum, suppositories, dermatological cremes and oral care products.
Out of all of these delivery methods, it is the chewing gum route that is currently our main focus. This method allows for the release of the APIs in a sustained form and for them to be absorbed by the oral mucosal membrane, bypassing the first pass liver metabolism via the oral route.
The benefits of chewing gum are clear – it is already a familiar product to many and has achieved great success as a popular delivery method for smoking cessation therapy. In addition to the medicinal advantages which are specific to the product, i.e. nicotine, cannabinoids or other, the very act of ‘chewing gum’ or mastication offers a host of benefits, including improved cerebral circulation, the stimulation of basal ganglia, and memory coordination and improvement. From a commercial perspective, chewing gum is also a cost-effective and stable delivery mechanism.
As things currently stand, our clinical trials for this new method are well underway and we have formulated over 20 diversified products and possess 17 patents and 27 trademarks. So far, we have completed a Phase 2 study in Irritable Bowel Syndrome with our nutrition 50 mg CBD gum product, which is derived from industrial hemp. We are pending with PK/PD studies with our MedChewRx program with 5mg THC and 5mg CBD and with 50, 100, 200, 300mg CBD in our chewing gum product. Our next steps will be to initiate phases 1 and 2/3 of multiple sclerosis indication, restless leg syndrome, drug-related psychosis, IBS, IBD and Crohn’s disease.
It’s an exciting time for us – we’re not aware of any comparable cGMP methods where the entire manufacturing process – including the growth of the starting material – is carried out according to cGMP. As a result of this method, Axim has set the highest of quality standards for the cannabinoid industry, ensuring that the proper design, monitoring, and control of processes and facilities are in place from seed to final product.
As a result, we’re looking forward to delivering a series of global pharmaceutical products in 2019 which offer superior safety profiles, fewer side effects than traditional medications and, in some cases, the fulfillment of medical solutions that are currently not met within the industry.
For more information, visit www.AXIMBiotech.com.