Rapid Development Of A Liquid-Filled, Hard-Shell Capsule Formulation Of Cannabidiol

Cannabidiol (CBD) exhibits promising potential in addressing various health issues, such as epilepsy, anxiety, pain, and inflammation. The pharmaceutical industry strives to develop reliable CBD products that effectively meet patients' needs and address unmet health challenges.

In this collaborative study involving Emyria and Altasicences, the teams focused on creating oral formulations for CBD over-the-counter (OTC) products in Australia. Nine liquid-filled, hard-shell capsule (LFC) formulations were meticulously designed, manufactured, and compared in vitro using a dissolution assay at Altasciences' CDMO site in Philadelphia. Three promising candidates underwent pharmacokinetic (PK)/toxicokinetic analysis in dogs, with 3,000 capsules of each formulation containing 50 mg of CBD manufactured. A crossover study in beagles at Altasciences' preclinical research facility confirmed the correlation between in vitro dissolution and in vivo PK data. The best-performing formulation significantly outperformed the commercial product Epidiolex in both Cmax and AUC. Remarkably, the entire project, from formulation design to reporting data, was completed in just over three months. This achievement was facilitated by close program coordination across three Altasciences sites and the oversight of a dedicated project manager.

Delve into the details of how the teams were able to create alternative oral formulations that have the potential to match or improve upon the PK profile of oral CBD in the fastest and most cost-effective manner possible by accessing the case study below.