Accelerating Nasal Dosage Form Development From Early-Phase To Clinical Trial Manufacture

This on-demand webinar delves into the development of nasal dosage forms and the critical success factors for rapid prototype selection, enabling efficient progression to clinical evaluation. Led by Dr. Richard Johnson, Chief Scientific Officer, the 40-minute session covers the five key stages of the UpperNose development platform, highlighting the significance of target product selection and its influence on formulation and clinical outcomes. Key topics include an overview of nasal drug delivery devices, strategies for accelerating to clinical trial manufacturing, and the development of a Target Product Profile (TPP) to guide device and formulation choices.

The webinar further explores formulation development, focusing on excipient selection and how data is utilized in IMPD/IND submissions, along with setting up technical batches and conducting stability studies to support clinical development. Attendees will also learn about manufacturing for Phase 1 clinical trial batches, adhering to ICH stability guidelines, and the importance of release testing to ensure product quality. Additionally, the session covers strategies for scaling up to Phase II/III production and the role of spray drying in particle engineering. A specific case study demonstrates the successful use of spray drying for a Liposomal Vaccine, and the Alberta Idealized Nasal Inlet (AINI) is discussed as a tool for evaluating formulation and device performance. Register for this webinar to gain valuable insights into the development of nasal dosage forms and the rapid selection of prototypes for clinical and commercial success.