Avecho reaches two-year stability milestone for its CBD softgel capsule
Avecho has today announced that the first batch of its proprietary oral TPM®-enhanced CBD softgel capsule product has passed a pivotal two-year milestone in ongoing stability trials.
Cannabinoids are susceptible to degradation. However, testing results have demonstrated that the optimised TPM formulation used in our soft gel has been effective in preventing the CBD from chemical degradation, with composition remaining at 99.5% of the original label claim during its two-year shelf life.
Avecho CEO, Dr Paul Gavin, said:
“Passing two year-stability is an important milestone, as it proves the additional formulation work we conducted was successful over the longer time-frame. The product can be manufactured reproducibly, whilst maintaining stability and potential effectiveness over time, which is an essential requirement of pharmaceutical registration. In anticipation of our Phase III Study testing our CBD soft-gel capsule for the treatment of insomnia, 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.”
Manufacturing is now underway for use in the clinical trial, as well as formal registration batches that will be submitted to the TGA/FDA, pending the successful outcome of our pivotal Phase III sleep study.