GB Sciences has selected Catalent to provide oral delivery systems, formulation development, and clinical-scale oral dose manufacturing of GB Sciences’ proprietary active pharmaceutical ingredients (“APIs”) for its Parkinson’s disease therapies. A proof of concept study will be conducted by Catalent at its Swindon, U.K. facility to evaluate GB Sciences’ clinical candidates GBS101, GBS102, and GBS103 using Catalent’s proprietary Zydis Orally Disintegrating Tablet (ODT) technology.
GB Sciences’ three patent-pending 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,” explained 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 tackling formulation challenges, and ability to achieve the stability and dosing necessary for these novel complex mixtures. In addition to its Zydis technology, Catalent has early development and oral drug delivery solutions available for the efficient delivery of GB Sciences’ proprietary APIs.
(Source: GB Sciences, Inc.)
