PhD US Food and Drug Administration Silver Spring, Maryland
Spray-dried phospholipid porous particles (PPPs) are increasingly used in orally inhaled drug products (OIDPs) such as dry powder inhalers (DPls) and meter-dosed inhalers (MDls). PPPs exhibit ultra-low density due to nano-sized pore structure and enable higher drug loading, improved dose uniformity and lung deposition as compared to OIDPs formulated as drug-excipient (e.g., lactose) mixture. This study aims at evaluating morphological and physicochemical characteristics of OIDPs containing PPPs using various analytical techniques to evaluate product performance. Multiple commercially available OIDPs containing PPPs were used as model drug products. Methods for powder collection were developed using MDRS and DUSA. SEM was used for morphological evaluation of the powders. Physicochemical characterization methods including DSC, TGA, DVS, and XRD were also developed, and the results were compared among products. Sample preparation technique was identified as a potential factor impacting the degree of powder aggregation and different manufacturing processes may affect API crystallinity.
Learning Objectives:
Upon completion, participant will be able to understand FDA's current thinking on potential methods for evaluating OIDPs containing spray-dried phospholipid porous particles (PPPs).
Upon completion, participant will be able to understand what solid-state properties of the PPP formulation will affect product quality.
Upon completion, participant will be able to understand how manufacturing process may affect product quality.