title: Preparation and physicochemical characterization of matrix pellets containing APIs with different solubility via extrusion process.
abstract: In this study, a multiparticulate matrix system was produced, containing two different active pharmaceutical ingredients (APIs): enalapril-maleate and hydrochlorothiazide. The critical control points of the process were investigated by means of factorial design. Beside the generally used microcrystalline cellulose, ethylcellulose was used as matrix former to achieve modified drug release ensured by diffusion. The matrix pellets were made by extrusion-spheronization using a twin-screw extruder. Some pellet properties (aspect ratio, 10% interval fraction, hardness, deformation process) were determined. The aim of our study was to investigate how the two different APIs with different solubility and particle size influence the process. The amount of the granulation liquid plays a key role in the pellet shaping. A higher liquid feed rate is preferred in the pelletization process.
authors.affiliation: a Institute of Pharmaceutical Technology and Regulatory Affairs , University of Szeged , Szeged , Hungary.|b Gedeon Richter Ltd. , Budapest , Hungary.
authors.forename: Diána
authors.initials: D
authors.lastname: Hegyesi
authors.affiliation: c Department of Biochemical and Chemical Engineering, Chair of Solids Process Engineering , Technical University Dortmund , Dortmund , Germany.
authors.forename: Markus
authors.initials: M
authors.lastname: Thommes
authors.affiliation: d Institute of Pharmaceutics and Biopharmaceutics , Heinrich Heine University , Düsseldorf , Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Kleinebudde
authors.affiliation: a Institute of Pharmaceutical Technology and Regulatory Affairs , University of Szeged , Szeged , Hungary.
authors.forename: Tamás
authors.initials: T
authors.lastname: Sovány
authors.affiliation: e Evonik Nutrition & Care GmbH Magyarországi Fióktelepe , Budapest , Hungary.
authors.forename: Péter
authors.initials: P
authors.lastname: Kása
authors.affiliation: f Department of Applied Informatics , University of Szeged , Szeged , Hungary.
authors.forename: András
authors.initials: A
authors.lastname: Kelemen
authors.affiliation: a Institute of Pharmaceutical Technology and Regulatory Affairs , University of Szeged , Szeged , Hungary.
authors.forename: Klára
authors.initials: K
authors.lastname: Pintye-Hódi
authors.affiliation: a Institute of Pharmaceutical Technology and Regulatory Affairs , University of Szeged , Szeged , Hungary.
authors.forename: Géza
authors.initials: G
authors.lastname: Regdon
mesh_terms: D055598:Chemical Phenomena; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D004343:Drug Implants / Q000138:chemical synthesis* / Q000378:metabolism; D012995:Solubility
chemical_list: D004343:Drug Implants
keywords: Enalapril-maleate; extrusion; hydrochlorothiazide; multiparticulate matrix system; pellets; spheronization