Current Topics in the Cannabis Industry-

Short and Long Term Stability of Cannabinoids in Manufactured Products.

(reposted in entirety with the Author’s Permission)

  • Published on July 22, 2019 .

David Galvez, Ph.D.Adviser | Chief Scientific Officer | R&D |Extraction and Purification | Man… See more9 articles

David Galvez Ph.D

Slowly but surely medical professionals and their organizations are starting to recognize the medical value of Cannabis and cannabinoids. In an almost equally slow fashion local, provincial and Federal governments across the world are also recognizing the right of their citizens to use cannabinoid-containing products recreationally. This change in legal status and overall perception has resulted in an increasing number of cannabinoid-containing products been added to shelves and websites on daily basis. As simple formats and formulations (e.g., cannabinoids dissolved in MCT oil) saturate the market, more complex products are expected to start appearing in pharmacies and dispensaries around you: from simply infused products (i.e., adding cannabinoids to a finished product like topical creams) and novelty beverages to, eventually, well-thought-out consumer product brands developed from the ground up with clear points of differentiation, great brand purpose and image, clear benefits and innovative image, packaging and marketing (if anyone is interested in learning how to build great brands, follow the daily notes of Rob McPherson).

Unfortunately there is a critical, yet sadly ignored, obstacle for the emergence of any truly successful cannabinoid-containing edible, beverage or cosmetic product brand: lack of basic research on how our current manufacturing processes and technologies impact the stability of cannabinoids in the short and long term. Why is this so important? Without well understood manufacturing practices we simply can not develop products that consistently deliver, time after time, on the brand promises for effectiveness, benefits and over all consumer experience. Imagine you and your R&D, Extraction, and QA/QC Teams work for months to carefully create an amazing beverage that delivers on claims such as “THC-free”, “Full spectrum” and “Terpene-rich”. After manufacturing starts you check bottles from every lot. All looks as it should. No THC, lots of different cannabinoids and terpenes. All that money invested in proper extraction and post-extraction equipment paid off.

How could this happened?

Four months later you start receiving complains from consumers followed by a FDA warning letter telling you that THC is present in your “THC-Free” product. Further analysis shows you all terpenes are gone and there are barely any cannabinoids in the product. Now you need to recall every bottle from every shelf in three states, face a lengthy battle with the Feds and the name of your great brand is mentioned in the morning news as part of a poorly written, but highly clickable, piece.

1) Your formulated this product for the Premium market therefore has no chemical preservatives. As a standard practice to maintain microbial growth in check your R&D Team formulated the product to have a pH below 3.5. Unfortunately, we know that although it is unlikely CBD converts into THC in the gastrointestinal track [1] for sure it does in acidic stable environments [2] and your amazing beverage has been in bottles for months now (think in the time needed to transport, distribute and store at retail). During that time the CBD in it has been slowly but surely converting to THC. There is not really that much THC in the product, just enough for it not be compliant with the THC-Free claim. Class Action in the forecast?

2) In addition to modulating pH your beverage was sterilized by conveying it through a hot-tunnel or maybe a hot-filling line. You know terpenes are very temperature sensitive (that is one of the reasons you so carefully removed and preserved them during extraction, right?) Although the sterilization process takes only few minutes (and you checked samples from every lot) that sudden change in temperature is enough to slowly start degrading both terpenes and cannabinoids. We have known this for decades [3].

3) The bottling line of your manufacturing partner leaves a small amount of empty space between the liquid and the bottle rim. This needs to be done to allow expansion and contraction of the liquid and air during and after the hot-fill or hot tunneling process. This also allows a cleaner operation and reduces waste. That air forms a oxygen-rich environment that can slowly degrade cannabinoids. CBD in particular follows a very complex degradation path in the presence of oxygen [4, 5].

Now try to better estimate how all three points interact over time. And we are not even taking in consideration how the other ingredients in your formulation modulate the above reactions. All three problems above are common to manufacturing. We have the experience and expertise to address these challenges. We just don’t have enough data to actually establish standardized best manufacturing practices to solve them reliably.

Someone once said “First-to-Market is only an advantage until Best-in-Market arrives”. Everybody is rushing to be the first. I truly hope there are also a group of intelligent, well-seasoned, experienced groups looking to be the Best. That will start with reliable and consistent products. Solving these questions do not require millions of dollars and years of work. You just need to support and trust the right Team. The recent accomplishments of Jeremie Doiron, with the full support of OrganiGram, are a great example of this.

#dataisking #thirdpartymanufacturing #compliance #qualitycontrol #science #r&d

[1] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5744690/

[2] https://www.liebertpub.com/doi/full/10.1089/can.2015.0004

[3] https://www.ncbi.nlm.nih.gov/pubmed/6643

[4] https://www.researchgate.net/publication/236170001_Long_-_term_Storage_and_Cannabis_Oil_Stability

[5] https://pubs.rsc.org/en/content/articlehtml/2016/np/c6np00074f

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