GB Sciences has selected Catalent Pharma Solutions to provide oral delivery systems, formulation development, and clinical-scale oral dose manufacture of GB Sciences’ active pharmaceutical ingredients for its Parkinson’s disease therapies. Catalent will conduct a proof of concept study at its Swindon, UK facility to evaluate GB Sciences’ clinical candidates GBS101, GBS102, and GBS103 using Catalent’s Zydis Orally Disintegrating Tablet (ODT) technology.

GB Sciences’ APIs for Parkinson’s disease are complex mixtures containing up to nine individual components that function synergistically. Preclinical studies have shown that these cannabinoid-containing complex mixtures are more potent than would have been predicted by combining the activity of each individual compound.
 
“To prepare our Parkinson’s disease formulations for human clinical trials, we wanted the ease-of-use offered by Zydis ODTs for our Parkinson’s patients, many of whom may have difficulties in swallowing. Catalent’s proprietary delivery method also potentially offers consistent dosing for our complex cannabinoid- and terpenoid-containing APIs,” said Dr. Andrea Small-Howard, chief science officer of GB Sciences. “The creation of GB Sciences’ proprietary APIs in Zydis ODT formulations is a very important step towards readying them for our Exploratory IND filing and planned phase zero human trial for patients with mild to moderate Parkinson’s disease.”
 
Jonathan Arnold, president of oral drug delivery at Catalent, added, “Dissolving rapidly in the mouth, ODTs are convenient and ease administration, offering an alternate dosage form for patients who have difficulty swallowing, as is sometimes the case with Parkinson’s disease, as well as with geriatric or pediatric patients.”
 
GB Sciences selected Catalent as its development partner due to its expertise in formulation challenges and ability to achieve the stability and dosing necessary for novel complex mixtures. Catalent may also provide early development and oral drug delivery solutions available for the efficient delivery of GB Sciences’ APIs.