title: Modeling accelerated and decelerated drug release in terms of fractional release rate.
abstract: The model of a proportional change in fractional dissolution rate was used to quantify influences on the vitro dissolution process. After fitting the original dissolution profile with an empirical model (inverse Gaussian distribution), acceleration and deceleration effects due to dissolution conditions or formulation parameters could be described by one parameter only. Acceleration of dissolution due to elevated temperature and deceleration by increasing the content of glyceryl monostearate in theophylline tablets are presented as examples. Likewise, this approach was applied to in vitro-in vivo correlation (IVIVC). It is shown that the model is appropriate when the plot of the in vivo versus in vivo times is nonlinear and can be described by a power function. The results demonstrate the utility of the model in dissolution testing and IVIVC assessment.
authors.affiliation: Department of Pharmacology, Martin Luther University Halle-Wittenberg, D-06112 Halle (Saale), Germany. Electronic address: michael.weiss@medizin.uni-halle.de.
authors.forename: Michael
authors.initials: M
authors.lastname: Weiss
mesh_terms: D065546:Drug Liberation; D008962:Models, Theoretical; D004364:Pharmaceutical Preparations / Q000737:chemistry / Q000378:metabolism; D020156:Salicylic Acid / Q000737:chemistry; D012995:Solubility; D013806:Theophylline / Q000737:chemistry
chemical_list: D004364:Pharmaceutical Preparations; D013806:Theophylline; D020156:Salicylic Acid
keywords: Accelerated drug release; Dissolution testing; In vitro–in vivo correlation (IVIVC); Time scaling