Methylphenidate Extended-Release Capsules With Multilayer Beads: A New Once Daily Product for ADHD

Marcia L. Buck, PharmD, FCCP, FPPAG


Pediatr Pharm. 2015;21(8) 

In This Article

Abstract and Introduction


It is estimated that 5 to 7% of children and adolescents worldwide meet the criteria for attention deficit hyperactivity disorder (ADHD), with symptoms persisting into adulthood for more than 50%.[1] Current treatment guidelines focus on a multimodal treatment approach, with behavioral and educational interventions and pharmacologic therapy when appropriate. Prior to the approval of Concerta® in 2000, management of ADHD in older children and adolescents often required the administration of a stimulant multiple times during the day. The introduction of a preparation that provided symptom control for 12 hours from a single dose ushered in a new era in treatment.[2]

Since the approval of Concerta®, an extended-release tablet formulated using osmotic-release oral system (OROS) technology, several other once-daily products have entered the market in the United States. Two capsule formulations containing extended-release beads, Metadate CD® and Ritalin LA®, were approved in 2001 and 2002, respectively, and an extended-release oral liquid, Quillivant XR®, was approved in 2012. On April 17, 2015, the Food and Drug Administration (FDA) approved Aptensio XRTM, an extended-release methylphenidate capsule containing multilayered beads (MPH-MLR) that provides up to 12 hours of ADHD symptom control for patients 6 years of age and older.[3–8]