title: Prediction of oral disintegration time of fast disintegrating tablets using texture analyzer and computational optimization.
abstract: One of the promising approaches to predict in vivo disintegration time of orally disintegrating tablets (ODT) is the use of texture analyzer instrument. Once the method is able to provide good in vitro in vivo correlation (IVIVC) in the case of different tablets, it might be able to predict the oral disintegration time of similar products. However, there are many tablet parameters that influence the in vivo and the in vitro disintegration time of ODT products. Therefore, the measured in vitro and in vivo disintegration times can occasionally differ, even if they coincide in most cases of the investigated products and the in vivo disintegration times may also change if the aimed patient group is suffering from a special illness. If the method is no longer able to provide good IVIVC, then the modification of a single instrumental parameter may not be successful and the in vitro method must be re-set in a complex manner in order to provide satisfactory results. In the present experiment, an optimization process was developed based on texture analysis measurements using five different tablets in order to predict their in vivo disintegration times, and the optimized texture analysis method was evaluated using independent tablets.
authors.affiliation: Gedeon Richter Plc., Formulation R&D, Gyömrői Str. 19-21, 1103 Budapest, Hungary.
authors.forename: G
authors.initials: G
authors.lastname: Szakonyi
authors.forename: R
authors.initials: R
authors.lastname: Zelkó
mesh_terms: D000284:Administration, Oral; D002626:Chemistry, Pharmaceutical / Q000295:instrumentation / Q000379:methods*; D004339:Drug Compounding / Q000295:instrumentation / Q000379:methods*; D005079:Excipients / Q000737:chemistry; D004364:Pharmaceutical Preparations / Q000008:administration & dosage / Q000737:chemistry*; D013607:Tablets; D013997:Time Factors
chemical_list: D005079:Excipients; D004364:Pharmaceutical Preparations; D013607:Tablets