ABSTRACT
Introduction: Since Ritalin® (Methylphenidate-Immediate release or MPH-IR) was introduced for the treatment of attention-deficit/hyperactivity disorder, multiple formulations of MPH have been developed. The specific formulation determines the pharmacokinetic (PK) profile and the onset and duration of action for the compound.
Areas covered: Aptensio XR® is a multilayer-release MPH (MPH-MLR) consisting of an MPH-IR layer (40%) and an extended-release (ER) portion of 60% of MPH. It has an initial maximum MPH concentration at about two hours (h) and a second concentration peak at approximately 8 h. This formulation allows for a rapid onset of effect by 1 h and a duration of action through 12 h after dosing. The chemistry, PK, efficacy and adverse event profile of MPH-MLR will be reviewed.
Expert commentary: Although the PK profile may prove beneficial to patients in the late afternoon and early evening, it is not clear if this is a significant advantage compared with other MPH-ER formulations.
Declaration of interest
A. Childress has acted as a consultant and speaker and has received research support from Shire, Novartis, Pfizer and Tris, and has acted as a consultant and received research support from NextWave, Neurovance, Neos and Ironshore, and has received research support from Lilly USA, LLC, Ortho-McNeil Janssen, Johnson & Johnson, Noven, Theravance, Forest, Ostuka, Sunovion, Rhodes, Akili, and Pearson. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.