title: An empirical model for dissolution profile and its application to floating dosage forms.
abstract: A sum of two inverse Gaussian functions is proposed as a highly flexible empirical model for fitting of in vitro dissolution profiles. The model was applied to quantitatively describe theophylline release from effervescent multi-layer coated floating tablets containing different amounts of the anti-tacking agents talc or glyceryl monostearate. Model parameters were estimated by nonlinear regression (mixed-effects modeling). The estimated parameters were used to determine the mean dissolution time, as well as to reconstruct the time course of release rate for each formulation, whereby the fractional release rate can serve as a diagnostic tool for classification of dissolution processes. The approach allows quantification of dissolution behavior and could provide additional insights into the underlying processes.
authors.affiliation: Department of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand; Department of Pharmacology, Martin Luther University Halle-Wittenberg, Halle, Germany. Electronic address: michael.weiss@medizin.uni-halle.de.
authors.forename: Michael
authors.initials: M
authors.lastname: Weiss
authors.affiliation: Department of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand.
authors.forename: Worawut
authors.initials: W
authors.lastname: Kriangkrai
authors.affiliation: Department of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand.
authors.forename: Srisagul
authors.initials: S
authors.lastname: Sungthongjeen
mesh_terms: D003692:Delayed-Action Preparations / Q000737:chemistry; D005989:Glycerides / Q000737:chemistry; D008956:Models, Chemical; D012995:Solubility; D013607:Tablets; D013627:Talc / Q000737:chemistry; D013806:Theophylline / Q000737:chemistry*
chemical_list: D003692:Delayed-Action Preparations; D005989:Glycerides; D013607:Tablets; D013627:Talc; C048159:glyceryl monostearate; D013806:Theophylline
keywords: Anti-tacking agents; Dissolution model; Floating tablets; Inverse Gaussian distribution; Sustained release