Li-3124-SOT19.pdf

SOT 2019 - Clonidine is approved for therapy of attention-deficit hyperactivity disorder (ADHD) that is one of the most common neurobehavioral problems mainly afflicting children and youth between 6 and 17 years of age with a high modality from 2% to 18% in USA. Current ordinary tablets may produce a burst release after oral administration, leading to a high drug concentration and subsequently severe adverse reactions. Sustained-release formulations are preferred and orthodontic retainers have the advantage of convenient administration and termination. However, the drug release profiles need to be optimized to ensure suitable exposure in the human body. The purpose of this portion of the work was to use physiologically based pharmacokinetic (PBPK) modeling to predict the pharmacokinetic profiles for these formulations to assist selection of an ideal formulation with a long duration sustained release.