The Vancouver-based company said the results came from a three-month physico-chemical stability test on cannabinoid sol-gel formulations designed for nose-to-brain (NTB) delivery.
PreveCeutical said it looked at the physical and chemical stability of formulations’ components, which underwent three months of cold storage (2-8ºC) as well as room temperature storage.
READ: PreveCeutical executes pact for developing CBD Sol-Gel nasal spray formulation as a potential coronavirus treatment
As a result, “there was minimal indication of physical or chemical instability of the cannabinoid formulation over the study period,” the company said in a statement.
Quality evaluation testing of cannabis extracts was conducted using high-performance liquid chromatography (HPLC) and liquid chromatography-mass spectrometry (LC-MS) profiles to generate chemical fingerprints that were later qualified, validated and verified using analytical grade cannabinoid standards, it added.
Based on the before and after HPLC testing, the company said the study found that the cannabinoid content within the formulation generally remained within the study's acceptance criteria.
PreveCeutical said it will conduct a further stability study program as and when required by the regulatory authorities, and in accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.
With the use of an applicator, the sustained-released Sol-gel formulations allow for the direct and prolonged delivery of cannabinoids to a patient's central nervous system.
PreveCeutical and its Australian partner are now developing a Sol-gel CBD formula that could fight off the ability of SARS-CoV-2, the virus that causes the coronavirus (COVID-19) disease, to infect nasal tissue.
"We are very pleased with these results. With the increasing evidence of the clinical benefit of cannabinoids, our cannabinoid sol-gel solution aims to meet our study target,” said CEO Stephen Van Deventer. “We plan to protect this IP and will be looking to work with a suitable partner and progressing through preclinical to clinical study development."
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