Formulation development and evaluation of taste-masked atomoxetine hydrochloride orally disintegrating tablets (ODTs)

Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor used for the treatment of attention deficit/hyperactivity disorder. Atomoxetine hydrochloride is available in the form of capsules and oral solutions, yet it has no orally disintegrating form due to its bitter taste. ODTs are formulated to disintegrate rapidly upon contact with saliva and enable oral administration without water or chewing and offer improved patient compliance and ease of administration. Appropriate taste masking has great importance for ODTs. In this study, developing a taste-masked ODT formulation containing atomoxetine hydrochloride produced using the wet granulation method was aimed. Formulations were designed by changing the granulation agent (Hydroxypropylmethylcellulose (HPMC), Gellan gum, Veegum, Polyethylene glycol (PEG) 20000P) and active substance to granulation agent ratio (1:2, 1:3, 1:4). Each formulation was tested physically and chemically. According to the results, it was concluded that Gellan gum is more appropriate for use in ODTs for taste masking.