title: Asymmetric flow field-flow fractionation (AF4) for the quantification of nanoparticle release from tablets during dissolution testing.
abstract: Nanoparticles composed of poly(DL-lactide-co-glycolide) (PLGA) represent promising colloidal drug carriers for improved drug targeting. Although most research activities are focused on intravenous application of these carriers the peroral administration is described to improve bioavailability of poorly soluble drugs. Based on these insights the manuscript describes a model tablet formulation for PLGA-nanoparticles and especially its analytical characterisation with regard to a nanosized drug carrier. Besides physico-chemical tablet characterisation according to pharmacopoeias the main goal of the study was the development of a suitable analytical method for the quantification of nanoparticle release from tablets. An analytical flow field-flow fractionation (AF4) method was established and validated which enables determination of nanoparticle content in solid dosage forms as well as quantification of particle release during dissolution testing. For particle detection a multi-angle light scattering (MALS) detector was coupled to the AF4-system. After dissolution testing, the presence of unaltered PLGA-nanoparticles was successfully proved by dynamic light scattering and scanning electron microscopy.
authors.affiliation: Institute of Pharmaceutical Technology and Biopharmacy, University of Muenster, Corrensstraße 48, 48149 Münster, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Engel
authors.affiliation: Institute of Pharmaceutical Technology and Biopharmacy, University of Muenster, Corrensstraße 48, 48149 Münster, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Plöger
authors.affiliation: Institute of Pharmaceutical Technology and Biopharmacy, University of Muenster, Corrensstraße 48, 48149 Münster, Germany.
authors.forename: D
authors.initials: D
authors.lastname: Mulac
authors.affiliation: Institute of Pharmaceutical Technology and Biopharmacy, University of Muenster, Corrensstraße 48, 48149 Münster, Germany. Electronic address: k.langer@uni-muenster.de.
authors.forename: K
authors.initials: K
authors.lastname: Langer
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000379:methods; D004337:Drug Carriers / Q000737:chemistry*; D031521:Fractionation, Field Flow / Q000379:methods*; D019344:Lactic Acid / Q000737:chemistry*; D008027:Light; D008855:Microscopy, Electron, Scanning; D053758:Nanoparticles; D010316:Particle Size; D011100:Polyglycolic Acid / Q000737:chemistry*; D000077182:Polylactic Acid-Polyglycolic Acid Copolymer; D012542:Scattering, Radiation; D012995:Solubility; D013607:Tablets
chemical_list: D004337:Drug Carriers; D013607:Tablets; D000077182:Polylactic Acid-Polyglycolic Acid Copolymer; D011100:Polyglycolic Acid; D019344:Lactic Acid
keywords: Asymmetric flow field-flow fractionation (AF4); Dissolution testing; Drug release; Multi-angle light scattering (MALS); PLGA-nanoparticles; Tablets