title: Formulation and evaluation of clozapine orally disintegrating tablets prepared by direct compression.
abstract: In this study, clozapine orally disintegrating tablets (ODTs) were prepared by direct compression method. Disintegration time, resistance to crushing of tablets, porosity, friability, dissolution tests were performed and dissolution profiles of ODTs were investigated. Morphological and interaction studies were also performed. Friability values were found to be less than 1%. All tablet formulations disintegrated within 1 min and fulfilled the 3 min disintegration time required for ODTs given in the European Pharmacopoeia. More than 85% of the labeled amount of clozapine was dissolved in 15 min from the ODTs. No interaction or changes were found between active substance and excipients. As a result of the studies, ODT formulations developed in this study can be suggested as promising formulations, which assist development and manufacturing a generic product of clozapine.
authors.affiliation: Department of Pharmaceutical Technology, Faculty of Pharmacy, Hacettepe University, Ankara, Turkey.
authors.forename: S S
authors.initials: SS
authors.lastname: Olmez
authors.forename: I
authors.initials: I
authors.lastname: Vural
authors.forename: S
authors.initials: S
authors.lastname: Sahin
authors.forename: A
authors.initials: A
authors.lastname: Ertugrul
authors.forename: Y
authors.initials: Y
authors.lastname: Capan
mesh_terms: D014150:Antipsychotic Agents / Q000008:administration & dosage* / Q000737:chemistry*; D002152:Calorimetry, Differential Scanning; D002266:Carboxymethylcellulose Sodium; D002626:Chemistry, Pharmaceutical; D003024:Clozapine / Q000008:administration & dosage* / Q000737:chemistry*; D004339:Drug Compounding; D005079:Excipients; D006245:Hardness Tests; D007700:Kinetics; D008855:Microscopy, Electron, Scanning; D016062:Porosity; D011205:Povidone; D012995:Solubility; D017550:Spectroscopy, Fourier Transform Infrared; D013213:Starch; D013607:Tablets; D014961:X-Ray Diffraction
chemical_list: D014150:Antipsychotic Agents; D005079:Excipients; D013607:Tablets; D013213:Starch; D011205:Povidone; D003024:Clozapine; D002266:Carboxymethylcellulose Sodium