Effectiveness of Extended Release Single Dose Suspension of Methylphenidate for ADHD

It’s clear that children and adolescents with attention-deficit/hyperactivity disorder (ADHD) have to stick to their medication regimens, but getting them to take pills a few times a day was difficult. In response, pharmaceutical companies developed once-daily extended release versions of the drugs, but even they could be a challenge for children and adolescents who would not, or could not, swallow pills.

But an extended-release suspension formulation could do the trick.

In a recent issue of Postgraduate Medicine, researchers from the Center for Psychiatry and Behavioral Medicine in Las Vegas reported that there were no age-related pharmacokinetic differences after oral administration of an extended release version of methylphenidate (NWP06) to children or adolescents in a small sample.

The researchers noted that currently, there is no extended-release liquid oral preparation of any stimulant, thus underscoring a medical need for a liquid extended-release preparation of methylphenidate for the management of ADHD in children who are unable or unwilling to swallow solid formulations.

For the study, the researchers evaluated the single-dose pharmacokinetics of an extended-release oral liquid formulation of methylphenidate (NWP06) in pediatric subjects with ADHD.

“Subjects with ADHD received a single oral dose of NWP06 20 or 60 mg. Serial blood samples were obtained before and after drug administration for determination of plasma methylphenidate concentrations and standard pharmacokinetic parameters. Dose- and weight-corrected pharmacokinetic parameters were presented by age group (9-12 years and 13-15 years),” they wrote in the study abstract.

The researchers enrolled a total of 14 youths (seven children aged nine-12 years and seven adolescents aged 13-15 years) and all completed the study. Their body mass index ranged from 12.08 to 34.08 kg/m(2).

“Mean values of dose and body weight-adjusted maximum plasma concentration (Cmax) (23.8, 22.3, 22.1, 25.7 [ng/mL]/mg) and area under the concentration-time curve (AUC) (208, 199, 239, 210 [hr•ng/mL]/[mg/kg]) were similar among all age/dose groups, suggesting dose proportionality and a similar rate and extent of absorption in children and adolescents,” the authors wrote.

Values for Cmax were observed between two and four hours after the dose, and the elimination half-life and body weight-adjusted clearance also appeared to be independent of dose and age. “NWP06 was well tolerated with no serious adverse events and no adverse event-related treatment discontinuations,” the researchers concluded.

SourceSingle-dose Pharmacokinetics of NWP06, an Extended-release Methylphenidate Suspension, in Children and Adolescents with ADHD [Postgraduate Medicine]