Establishment of Virtual Bioequivalence via DoE-PBBM Model: A Donepezil Case Study

Conference: PAGE
Software: GastroPlus®
Division: Simulations Plus


Donepezil (DZP) is a medication used to treat Alzheimer’s disease. It works by inhibiting the breakdown of acetylcholine in the brain, which is a neurotransmitter important for memory and cognitive function. The immediate release (IR) tablets of donepezil (Aricept) were approved by the Food and Drug Administration in 1996, and an extended release (SR) formulation was approved in 2010. The SR tablet is different from the IR formulation in that it has a slower time to peak concentration following oral ingestion. One way to deliver drugs over an extended period through oral consumption is to use hydrophilic matrix tablets, which are made by incorporating water-swellable polymers that quickly expand and form a gel layer around the dry core, regulating the rate of drug release as it moves through the gastrointestinal tract.

By Frederico S. Martins, Renê Oliveira do Couto, Grace Fraczkiewicz, Osvaldo Freritas