Design and statistical optimization of circadian rhythm based press-coated tablets of Atomoxetine hydrochloride

Attention-deficit/hyperactivity disorder (ADHD) is a common neurological disease affecting 5-8 percent of school going children with symptoms persuading into adulthood in about 60 percent of cases. ADHD severity correlates positively with circadian delay i.e. retarded sleep timing and day time sleepiness, suggesting that treatment interventions focussed at advancing circadian phase may make better day time sleepiness. Hence, the present research work aimed to formulate circadian rhythm based press-coated tablets of atomoxetine hydrochloride in morning hours by increasing adrenal hormones in the brain. The core tablets formulated by direct compression and press coated with HPMC K100M and MCC and the release compared with natural polymers Guar gum (6000 cps) and Xanthan gum (1800 cps). The three level two factorial design and one-way Anova employed to evaluate the effect of natural and synthetic polymers on drug release and lag time. IR spectrophotometer study showed that all the excipients were compatible with the drug. The stability study carried out for the desired optimized formulation for a period of 3 months and showed insignificant difference.

Author(s): AkilaRamanathan and Chandran Palanisamy

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