title: Applicability of sucrose laurate as surfactant in solid dispersions prepared by melt technology.
abstract: This study focused on an investigation of the applicability of sucrose laurate as surfactant in solid dispersions. Although this surfactant has a US Drug Master File, it has not been used so far in internal pharmaceutical products. High drug-loaded solid dispersion systems consisting of gemfibrozil as a model drug and PEG 6000 as a carrier, with or without sucrose laurate (D1216), were prepared by the melting method. Cytotoxicity studies on Caco-2 monolayer cells were also performed, in order to gain information on the applicability of D1216 in oral formulations. The results showed that the presence of the surface-active agent did not affect the solid-state characteristics of the model drug significantly. A markedly improved dissolution of gemfibrozil from the ternary solid dispersion systems was observed as compared with the binary solid dispersion systems. The optimum concentration range of the D1216 in the formulations was determined to be 5-10%. The effective final concentrations of D1216 in the dissolution experiments proved to be non-toxic towards CaCo-2 cells. The results suggest the potential use of D1216 in innovative internal pharmaceutical formulations.
authors.affiliation: Department of Pharmaceutical Technology, University of Szeged, H-6720 Szeged, Eötvös u. 6, Hungary.
authors.forename: Angéla
authors.initials: A
authors.lastname: Szuts
authors.forename: Péter
authors.initials: P
authors.lastname: Láng
authors.forename: Rita
authors.initials: R
authors.lastname: Ambrus
authors.forename: Lóránd
authors.initials: L
authors.lastname: Kiss
authors.forename: Mária A
authors.initials: MA
authors.lastname: Deli
authors.forename: Piroska
authors.initials: P
authors.lastname: Szabó-Révész
mesh_terms: D000284:Administration, Oral; D018938:Caco-2 Cells; D004337:Drug Carriers / Q000737:chemistry; D015248:Gemfibrozil / Q000008:administration & dosage* / Q000737:chemistry; D006801:Humans; D011092:Polyethylene Glycols / Q000737:chemistry*; D012995:Solubility; D013395:Sucrose / Q000031:analogs & derivatives* / Q000737:chemistry / Q000633:toxicity; D013501:Surface-Active Agents / Q000737:chemistry* / Q000633:toxicity; D013678:Technology, Pharmaceutical / Q000379:methods
chemical_list: D004337:Drug Carriers; D013501:Surface-Active Agents; C018152:sucrose monolaurate; D011092:Polyethylene Glycols; D013395:Sucrose; D015248:Gemfibrozil