title: Spherical agglomerates of lactose with enhanced mechanical properties.
abstract: The aim of this study was to prepare spherical agglomerates of lactose and to evaluate their physicochemical properties, flow properties, particle friability and compaction properties, and to compare them to commercially available types of lactose for direct compression (spray-dried, granulated and anhydrous β-lactose). Porous spherical agglomerates of α-lactose monohydrate with radially arranged prism-like primary particles were prepared exhibiting a high specific surface area. All types of lactose analysed had passable or better flow properties, except for anhydrous β-lactose, which had poor flowability. Particle friability was more pronounced in larger granulated lactose particles; however, particle structure was retained in all samples analysed. The mechanical properties of spherical agglomerates of lactose, in terms of compressibility, established with Walker analysis, and compactibility, established with a compactibility profile, were found to be superior to any commercially available types of lactose. Higher compactibility of spherical agglomerates of lactose is ascribed to significantly higher particle surface area due to a unique internal structure with higher susceptibility to fragmentation.
authors.affiliation: Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Ljubljana, Aškerčeva cesta 7, 1000 Ljubljana, Slovenia. Electronic address: dejan.lamesic@ffa.uni-lj.si.
authors.forename: Dejan
authors.initials: D
authors.lastname: Lamešić
authors.affiliation: Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Ljubljana, Aškerčeva cesta 7, 1000 Ljubljana, Slovenia.
authors.forename: Odon
authors.initials: O
authors.lastname: Planinšek
authors.affiliation: Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Ljubljana, Aškerčeva cesta 7, 1000 Ljubljana, Slovenia.
authors.forename: Zoran
authors.initials: Z
authors.lastname: Lavrič
authors.affiliation: Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Ljubljana, Aškerčeva cesta 7, 1000 Ljubljana, Slovenia.
authors.forename: Ilija
authors.initials: I
authors.lastname: Ilić
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000379:methods*; D005079:Excipients / Q000737:chemistry*; D007785:Lactose / Q000737:chemistry*; D016062:Porosity; D013499:Surface Properties
chemical_list: D005079:Excipients; D007785:Lactose
keywords: Compactibility; Compressibility; Lactose; Spherical agglomerates; Spherical crystallization