The licit commerce of cannabis products is based on expectations of their safety and efficacy. Consumers expect that the products will be distributed much as other drugs and edibles, in a package with known potency and assurance of safety and efficacy. Further, they will expect the products to be stable enough for use. Statements of manufacturing date, shelf life, and use-by dates will thus be required.
Some cannabis products involve processing that entails adding a fraction of cannabis to another matrix such as cookies, candies, salad oil, etc. These new formulations are often not characterized. Today, stability of the product is seldom considered. This will change with experience.
In contrast, stability is a major consideration in preparing a drug for market approval. Formulation labs are tasked with engineering the active pharmaceutical ingredient (API) to meet the critical quality attributes while simultaneously meeting the idiosyncrasies of the distribution system from origin to the patient. Factors include container, closure, labeling, drug form (pill, injectable, topical, spray), excipients, storage conditions, degradation products, impurity profile, shelf life, and more.
How should one deal with stability when cannabis products are so varied and poorly characterized? Let’s start with the critical quality attributes (CQA), which are product-dependent (Table 1).
Table 1 – Market segmentation for cannabis products
The recreational market is the most complex. Products range from flowers and leaves from a wide range of poorly characterized phenotypes to extracts and oils. Processed plants are often smoked or vaporized. Extracts are used to add THC and perhaps flavor to candies, oils, and baked goods.
Traditionally, recreational users have relied on the black market. Products were seldom characterized. Packaging was often a plastic bag. Labeling was minimal and not traceable. Other potential contaminants such as pesticides, microbe toxins, trace metals, and solvents were ignored.
Replacing the black market with a licit supply chain is the task at hand. Fortunately, there is a lot of precedence. In the U.S.A., due to the Schedule I classification, the federal government is not participating—and indeed is antagonistic to—cannabis commerce. But, other countries, such as Holland and Canada, and a majority of American states recognize the need for science-based regulation of the cannabis industry. However, each program seems different, and some are in conflict. There is a need for harmonization. Since the harmonization is unlikely to come from the American government, ASTM International is working with other standards institutions such as the U.S. Pharmacopeia and the American Herbal Products Association (Silver Spring, MD) to create appropriate, harmonized, regulatory science-based data required for cannabis commerce.
I’ve been asked to lead a small task group in ASTM D-37 to develop documents related to the stability of cannabis products. Would you be interested in helping? If so, please contact me at [email protected]; tel.: 925-283-7619.
Robert L. Stevenson, Ph.D., is Editor Emeritus, American Laboratory/Labcompare; e-mail: [email protected]