Optimizing Amphotericin B Invasomes: Critical Quality Attributes using Plackett Burman Design

Priyank Kumar M. Patel, Mansiben M. Patel, Chainesh N. Shah, Umesh M. Upadhyay

Abstract: This study investigates the development and optimization of Amphotericin B loaded invasomes for enhanced transdermal drug delivery. Invasomes (IVS) are the novel vesicular carrier of drugs for transdermal delivery and enhanced penetration than conventional liposomes. IVS are flexible vesicles and composed of phospholipids, alcohol, and terpenes. Invasomes were prepared using the mechanical Dispersion method. Plackett - Burman design is used as screening method to identify the critical factors using 12 runs with 7 variables. Hence, critical quality attributes (CQAs) such as phospholipid concentration, terpene concentration, and sonication speed were identified and optimized to maximize entrapment efficiency and control vesicle size. Results showed that the entrapment efficiency (%) and vesicle size (nm) across the 12 batches ranged from 60.63 to 96.82% and 73 to 306 nm, respectively which demonstrated significant improvements in drug entrapment and vesicle size, offering a promising approach for effective transdermal delivery of Amphotericin B.

Keywords: Quality by Design, Invasomes, Amphotericin B, Topical Candidiasis, Mechanical Dispersion, Plackett Burman Design, Critical Quality Attributes, Critical Process Parameters, Critical Material Attributes