Innovation in formulation and delivery
The To the Airways and Beyond session was divided into two sections, with the first addressing delivery to the lungs and the second devoted to nasal delivery. Michelle Dawson of Fortrea, chairing the first part, noted the continuing trend toward the use of the pulmonary route for systemic delivery and explained that the session was designed to address technologic innovations designed to facilitate that type of therapy.
The session started with a talk by Dave Farrow of Aptar Pharma on formulation of biologics as dry powders for inhalation. Among many challenges, Farrow noted that such formulations may require delivery of high loads, and his talk was followed by a presentation from Baudouin Géraud of Phillips-Medisize on “Powder Deagglomeration in a Chaotic Flow: An Introduction to the O1 High Payload DPI Device,” describing a concept blister-based device for payloads up to 100 mg.
While few podium presentations or posters at DDL 2025 described the use of artificial intelligence / machine learning for specific development purposes; one that did was a lecture by Sarah Zellnitz-Neugebauer of the Research Center Pharmaceutical Engineering titled, “From Prediction to Performance: ML-Guided Co-Amorphous Rifampicin Formulations for Inhalation Therapy in Tuberculosis.” Zellnitz-Neugebauer described a basic machine learning screening tool to select the best candidates to form co-amorphous systems with rifampicin, with a goal of saving time and money in development.
A presentation by Pete Lambert of Monash University titled, “Inhaled Oxytocin (IHO): Adventures in Pharmacokinetics and Bioanalysis to Save Mothers’ Lives” offered a case study that fit neatly into the theme of barriers to innovation. Development of the oxytocin DPI has been ongoing for over a dozen years and has received support over the years from a number of organizations, including the Gates Foundation, GSK, and Johnson & Johnson.
The project has worked with Vectura for early development of the DPI and after using a modified Rotahaler device for at Phase 1/2 clinical trial, worked with Iconovo for delivery of the dry powder formulation via the ICOone single-use inhaler. According to Lambert, the development hit a snag when the initial Phase 1/2 trial failed to detect plasma concentrations. He recounted how the researchers were finally able to get PK data thanks to work at Johnson & Johnson to develop a new analytical method.
With the switch to the ICOone device, which is about 25% more efficient at delivering the oxytocin formulation than the Rotahaler was, Lamber said, the project is “now in a good position to go forward.” Unfortunately, he reported, the project now has little to no funding at this time, and development cost is a major barrier.
