Avecho Biotechnology’s soft-gel capsule showed no significant changes after two years at room temperature with barely any degradation of the CBD itself, a stability test has found.
The drug levels of the capsule, which contained a 75mg unit dose of CBD, remained at 99.5% of the label claims, the company said.
Its physical nature, including the hardness and dissolution profile, were also unchanged.
Avecho said it confirms the stability of the capsule, which is required for registration with the Therapeutic Goods Administration (TGA).
The results will come as a relief to the company which is soon to conduct a clinical trial into the effectiveness of its product for the treatment of insomnia.
If successful, Avecho could become one of the first to register a schedule 3 over-the-counter CBD product with the TGA.
Chief executive Paul Gavin said: “Cannabinoids are not as stable as everyone assumes, especially when they are held to pharmaceutical standards.
“We saw CBD degradation in early prototypes that required further formulation optimisation to overcome. Passing two-year stability is an important milestone, as it proves the additional formulation work we conducted was successful over the longer timeframe.”
It means the product can be manufactured reproducibly, while maintaining stability and potential effectiveness over time, Gavin added.
“That is an essential requirement of pharmaceutical registration,” he said. “In anticipation of our phase III study… we are now manufacturing product for use in the clinical trial as well as formal registration batches that will be included in future TGA and FDA submissions.”
Along with being susceptible to degradation from oxygen, light and heat, Avecho said CBD, along with other cannabinoids, can be converted into psychoactive compounds over time, including THC.
That did not occur, the company said, with the capsule within TGA limits that allows for up to 2% of non-CBD cannabinoids, of which THC must be 1% or less.
Avecho’s phase III clinical trial will enrol 540 patients across three treatment groups to compare nightly CBD doses of 75 and 150 mg with a placebo over an eight-week dosing period.
The trial will begin imminently, the company said.
