Darren Quinn began this presentation by introducing BDD Pharma, a company that has been around for 25 years, originating as a spin-out from the University of Strathclyde. Initially focused on gamma scintigraphic clinical imaging, BDD evolved to offer a full range of CRO and CDMO services under the concept of lean clinical development.
Quinn explained that gamma scintigraphy, a non-invasive clinical imaging technique, allowed BDD to visualise and quantify the performance of drug delivery systems in real-time. This technique is particularly useful for understanding the behaviour of formulations in the human body, including gastric emptying, GI transit, and food effects. Scintigraphic images can be useful to correlate with pharmacokinetics data to optimise drug delivery strategies.
The presentation then focused on OralogiK, BDD’s patented modified release technology. OralogiK uses an erosion-based timed drug delivery system, which works independently of gastrointestinal variables such as pH and agitation. This allows for unparalleled control over the site and time of drug release. Quinn emphasised the simplicity and modularity of OralogiK, which can be tailored to specific therapeutic profiles by adjusting the ratio of excipients and the thickness of the erodible barrier layer.
Quinn provided a case study involving Synchronicity Pharma, where OralogiK was used to develop a fixed-dose combination of melatonin and clonidine for children with autism spectrum disorder causing sleep disturbance. The study demonstrated the effectiveness of OralogiK in achieving the desired pharmacokinetic profiles and improving patient compliance. The proof-of-concept clinical study, conducted in healthy volunteers, showcased the precise control of drug release and the correlation between scintigraphic images and pharmacokinetics.
In conclusion, Quinn highlighted the versatility and scalability of OralogiK, which has been successfully manufactured at a commercial scale. The technology’s ability to deliver drugs in a controlled manner makes it suitable for various therapeutic areas and molecule types. Quinn’s presentation underscored BDD’s commitment to innovation and its expertise in drug delivery and clinical development.
