title: Bio-dis and the paddle dissolution apparatuses applied to the release characterization of ketoprofen from hypromellose matrices.
abstract: The purposes of this work were: (1) to comparatively evaluate the effects of hypromellose viscosity grade and content on ketoprofen release from matrix tablets, using Bio-Dis and the paddle apparatuses, (2) to investigate the influence of the pH of the dissolution medium on drug release. Furthermore, since direct compression had not shown to be appropriate to obtain the matrices under study, it was also an objective (3) to evaluate the impact of granulation on drug release process. Six formulations of ketoprofen matrix tablets were obtained by compression, with or without previous granulation, varying the content and viscosity grade of hypromellose. Dissolution tests were carried out at a fixed pH, in each experiment, with the paddle method (pH 4.5, 6.0, 6.8, or 7.2), while a pH gradient was used in Bio-Dis (pH 1.2 to 7.2). The higher the hypromellose viscosity grade and content were, the lower the amount of ketoprofen released was in both apparatuses, the content effect being more expressive. Drug dissolution enhanced with the increase of the pH of the medium due to its pH-dependent solubility. Granulation caused an increase in drug dissolution and modified the mechanism of the release process.
authors.affiliation: Departamento de Farmácia, Universidade da Região de Joinville, Bairro Bom Retiro, Joinville, Santa Catarina, Brasil. bianca.ramos@univille.net
authors.forename: Bianca
authors.initials: B
authors.lastname: Ramos Pezzini
authors.forename: Humberto
authors.initials: H
authors.lastname: Gomes Ferraz
mesh_terms: D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000032:analysis*; D002626:Chemistry, Pharmaceutical / Q000295:instrumentation*; D004337:Drug Carriers; D004339:Drug Compounding; D006863:Hydrogen-Ion Concentration; D065347:Hypromellose Derivatives; D007660:Ketoprofen / Q000008:administration & dosage / Q000032:analysis*; D008747:Methylcellulose / Q000031:analogs & derivatives* / Q000737:chemistry; D015233:Models, Statistical; D011208:Powders; D012995:Solubility; D013607:Tablets; D014783:Viscosity
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D004337:Drug Carriers; D011208:Powders; D013607:Tablets; D065347:Hypromellose Derivatives; D008747:Methylcellulose; D007660:Ketoprofen