Extended-Release Methylphenidate Orally Disintegrating Tablets

Marcia L. Buck, PharmD, FCCP, FPPAG, BCPPS


Pediatr Pharm. 2017;23(8) 

In This Article

Abstract and Introduction


The options for management of attention deficit/hyperactivity disorder (ADHD) continue to grow. Over the last five years, nearly a dozen extended-release formulations of methylphenidate and amphetamine salts have been introduced onto the market in the United States.[1] These products include traditional tablets and capsules, as well as liquids, chewable tablets, and more recently, orally disintegrating tablets (ODTs). In June 2016, Neos Therapeutics received approval from the Food and Drug Administration for their mixed amphetamine salts ODT (Adzenys XR-ODTTM). Their extended-release ODT formulation of methylphenidate, Cotempla XR-ODT®, was approved on June 20, 2017 for the management of ADHD in children and adolescents from 6 to 17 years of age.[2]

As with other extended-release methylphenidate products, the ODT formulation provides 12 hours of symptom control, giving patients a once-daily dosing in a formulation that does not require swallowing a large tablet or capsule. Orally disintegrating tablets, introduced in the 1980s, have become a very popular dosage form worldwide.[3,4] While first used for immediate-release medications such as antihistamines, new technologies have led to the ability to create extended-release products and widened the market for this dosage form.