Stability Testing for Cannabis Products

Understanding the stability profile of a product, whether a consumer packaged good or a pharmaceutical drug product, is key to ensuring the consumer has a safe and effective product. In the pharmaceutical realm, the internationally accepted approach to stability testing is codified within the International Conference on Harmonisation (ICH) Guidance: Q1A(R2) (Stability Testing of New Drug Substances and Products) and Q1B (Stability Testing: Photostability Testing of New Drug Substances and Products). Even within the Canadian Cannabis Regulations with regards to Expiry Dating, there is the requirement to have data to demonstrate that the potency is maintained within the proscribed range of label claim and microbial and chemical contaminant limits remain with release specification requirements.
The results of this research project will enhance future stability protocols and design better formulations and/or container closures, a deeper understanding of degradation pathways and appropriate stability indicating assays would be beneficial. The body of scientific literature in this area is limited due to the regulatory restrictions that have existed with regards to cannabis and its derivatives, and this study will contribute to building that body of literature.

Faculty Supervisor:

Barbara Allen;Kari Kramp

Student:

Nolan Baker;Sultan Al Sultan

Partner:

Medipharm Labs

Discipline:

Other

Sector:

Manufacturing

University:

Loyalist College