sodium-stearyl-fumarate and calcium-phosphate--dibasic--anhydrous

To develop a model linking in vitro and in vivo erosion of extended release tablets under fasting and postprandial status.. A nonlinear mixed-effects model was developed from the in vitro erosion profiles of four hydroxypropyl methylcellulose (HPMC) matrix tablets studied under a range of experimental conditions. The model was used to predict in vivo erosion of the HPMC matrix tablets in different locations of the gastrointestinal tract, determined by magnetic marker monitoring. In each gastrointestinal segment the pH was set to physiological values and mechanical stress was estimated in USP2 apparatus rotation speed equivalent.. Erosion was best described by a Michaelis-Menten type model. The maximal HPMC release rate (V. The in silico model accurately predicted the erosion profiles of HPMC matrix tablets under fasting and postprandial status and can be used to facilitate future development of extended release tablets.

Topics: Adult; Calcium Phosphates; Chemistry, Pharmaceutical; Colon; Computer Simulation; Delayed-Action Preparations; Fasting; Ferric Compounds; Fumarates; Gastric Mucosa; Gastrointestinal Tract; Humans; Hydrogen-Ion Concentration; Hypromellose Derivatives; Intestine, Small; Male; Postprandial Period; Solubility; Stress, Mechanical; Tablets