Lecithin Reverse Micelle System is Promising in Constructing Carrier Particles for Protein Drugs Encapsulated Pressurized Metered‐Dose Inhalers

Abstract

AbstractProtein drugs contained within pressurized metered dose inhalers (pMDIs) show immense potential for fundamental research and industrial applications, owing to their high bioavailability, convenient administration, and cost‐effectiveness. To deliver protein drugs efficiently, researchers have reached a consensus on the use of carrier particles. However, the main obstacle impeding the commercial availability of pMDI carrier particles is their low stability. This instability is primarily attributed to particle aggregation caused by the Ostwald ripening phenomenon and chemical degradation by water sensitivity of protein drugs. This study proposes the utilization of lecithin, a carrier material possessing an amphiphilic structure, to overcome this bottleneck. By constructing lecithin‐based reverse micelle systems with protein drugs encapsulated within the high‐polarity microdomain, this work anticipates an improvement in the stability of carrier particles within pMDIs. Specifically, the formation of crystalline phases in the reverse micelle systems can control carrier particle size through crystalline self‐limiting effect, preventing particle aggregation. Additionally, the low‐polarity microdomain of the carrier serves as a hydrophobic barrier, shielding protein drugs from water and preventing chemical degradation. Consequently, this work believes that the lecithin‐based reverse micelle system holds significant potential in providing new theoretical insights and experimental support for the advancement of pMDIs containing protein drugs.