title: High resolution particle characterization to expedite development and regulatory acceptance of nanomedicines.
abstract: The pharmaceutical industry as well as European and US governing agencies have indicated the need for more accurate, high resolution, characterization of complex drug materials, nanomedicines, to facilitate their development and eventual approval. In particular, accurately measuring the size, zeta-potential, and concentration of nanomedicines is desired. Herein we demonstrate the comprehensive and high resolution analysis capabilities of tunable resistive pulse sensing (TRPS) on the most widely approved nanomedicines to-date, liposomal particles. The number-based size distribution, concentration and volume fraction of liposomes formed by extrusion through a 100 nm or 200 nm Nucleopore filter membrane are shown as well as how freeze-thaw aggregation changes individual liposomes and the overall size distribution. In addition, the simultaneous size and zeta-potential analysis capabilities of TRPS is used to characterize the homogeneity and difference between liposomes made with and without the addition of PEGylated phospholipids.
authors.affiliation: Izon Science US Ltd, 85 Bolton Street, Cambridge, MA, USA. darby@izon.com.
authors.forename: Darby
authors.initials: D
authors.lastname: Kozak
authors.forename: Murray
authors.initials: M
authors.lastname: Broom
authors.forename: Robert
authors.initials: R
authors.lastname: Vogel
mesh_terms: D002626:Chemistry, Pharmaceutical; D017277:Drug Approval; D008081:Liposomes; D050997:Nanomedicine / Q000379:methods* / Q000592:standards; D053758:Nanoparticles; D010316:Particle Size; D010743:Phospholipids / Q000737:chemistry* / Q000592:standards; D011092:Polyethylene Glycols / Q000737:chemistry* / Q000592:standards; D011786:Quality Control; D013499:Surface Properties; D013678:Technology, Pharmaceutical / Q000379:methods* / Q000592:standards
chemical_list: D008081:Liposomes; D010743:Phospholipids; D011092:Polyethylene Glycols