Noramco and SPI Pharma announced they have completed work on an excipient compatibility study examining a range of options for the development of cannabidiol (CBD) solid oral dosage forms, including orally-disintegrating tablets (ODT), orally-disintegrating powders (ODP) and sublingual tablets (SLT). This study was part of a series of proof-of-concept (POC) exercises to enable the creation of finished drug products in patient-friendly dosage forms, which will be out-licensed to customers for immediate scale-up, registration, and market launch. The companies have a phased development approach and they expect to offer the first generation of new formulations in late 2019 followed by full implementation of highly efficacious and patient-friendly dosage forms by 2020. Knowledge and experience gained during CBD dosage form development could be applied outside of the pharmaceutical sector to such areas as nutritional supplements, functional foods, beverage, personal care, and other consumer product group applications.
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"Compatibility studies like this one are complex, expensive and labor-intensive. But even more important, they are time-consuming. Conducting them requires, at minimum, a Schedule 1 DEA license, access to a pure form of an API, and reliable, sensitive and selective analytical methodologies," Josh Hoerner, Managing Director & Senior Director, Innovation & Product Development for Noramco said. "The high quality of work should be an asset to companies looking to develop finished dosage forms on their own to address unmet patient needs and achieve speed-to-market."
Cannabidiol, particularly in solid dosage forms, is among a number of substances known to have low bioavailability due to the first pass effect, where much of the compound is metabolized in the digestive system prior to entry into the bloodstream. APIs with high first pass effect need a considerably higher drug loading than those that avoid first pass, like sublingual or parenteral doses. The recent study examined more than 75 samples of high-purity CBD with various inactive ingredients by stressing samples and measuring chemical decomposition over time to specifically address these challenges as part of the development strategy.
"These comprehensive formulation packages offer Noramco and SPI's global customers the opportunity to achieve speed-to-market, a reduction in trial-and-error, product differentiation, life-cycle management through IP from both the API and delivery platforms, and critical technical/regulatory support", Sarath Chandar, Chief Scientific Officer of SPI Pharma said. "Our customers will benefit from the strong track record of success in 505b(2) and NDA application that this partnership brings.”