Avecho Biotechnology passes two-year stability point for CBD soft-gel capsule to treat insomnia

Pharmaceutical company Avecho Biotechnology (ASX: AVE) has passed a crucial two-year stability point milestone for its tocopheryl phosphate mixture (TPM)-enhanced cannabidiol (CBD) soft-gel capsule.

Cannabinoids are susceptible to degradation from a number of external sources including oxygen, light, heat and acidity, which can often create challenges with long-term pharmaceutical stability.

Specific cannabinoids (such as non-psychoactive CBD) can be converted during the degradation process into psychoactive cannabinoids such as tetrayhydrocannabinol (THC).

A CBD product with significant chemical degradation, or interconversion to additional cannabinoids, would be unable to be registered as a pharmaceutical medicine.

Formulation optimisation

Avecho’s TPM-enhanced capsule was subject to specific formulation optimisation to protect the CBD content from chemical degradation over time.

Optimisation was completed in May 2021, resulting in a soft-gel capsule containing 75 milligrams of CBD.

The dosage aligns with a downscheduling of CBD by the Therapeutic Goods Association (TGA), which specifies that over-the-counter CBD products can have a maximum daily dose of 150mg.

Avecho’s initial batches of the 75mg capsule were submitted to formal stability studies to determine the long-term chemical stability of CBD.

After two years at room temperature, assessments were conducted on capsule hardness and the dissolution profile, with results showing the properties remained unchanged.

No degradation of the CBD was observed, with drug levels remaining at 99.5% of the label claim.

Critical part of the process

Avecho chief executive officer Dr Paul Gavin said pharmaceutical stability was a critical part of the company’s process to register the soft-gel capsules with the TGA.

“Cannabinoids are not as stable as everyone assumes, especially when they are held to pharmaceutical standards,” he said.

“Passing the two-year stability point is an important milestone, as it proves the formulation work we conducted on earlier prototypes was successful over a longer timeframe shows the product can be manufactured reproducibly while maintaining stability and potential effectiveness over time, which is an essential requirement of pharmaceutical registration.”

Phase III study

Avecho’s imminent Phase III Study of its proprietary CBD soft-gel capsule for the treatment of insomnia will be the largest of its kind to date, enrolling 540 patients across three treatment groups.

The study will compare nightly doses of 75mg and 150mg CBD with a placebo over an eight-week period.

It is marked to be of relevance to the TGA, the US Food and Drug Administration and the European Medicines Agency as a key factor to support potential product registration in global healthcare markets.