Development and in vivo evaluation of atomoxetine hydrochloride ODMTs in a nicotine-induced attention deficit hyperactivity disorder (ADHD) model in rats

Abstract

Abstract The study aimed to evaluate in vitro and in vivo oral rapid mini tablets containing atomoxetine hydrochloride (ATO), developed for children with Attention Deficit and Hyperactivity (ADHD). An inclusion complex of ATO with β-cyclodextrin (β-CD) was prepared to mask the bitter taste of ATO and make it suitable for oral administration to children. ODMTs were administered to ADHD mice born from nicotine-administered mother mice during pregnancy and lactation, allowing the assessment of their efficacy in vivo setting. Results obtained from the open field test, new object recognition test, and Barnes maze test revealed that the ODMT formulation containing ATO-β-CD inclusion complexes exhibited potential as an alternative to the capsule form of ATO. As a conclusion, factorial experimental design was employed in the preparation of ATO-β-CD complexes and ODMTs, and the experimental animals were subjected to hyperactivity induced by nicotine, thereby providing a distinct context in which the developed ODMT formulation was evaluated.