Dexmethylphenidate extended-release capsules for the treatment of attention deficit hyperactivity disorder.
Dexmethylphenidate is a chirally pure d-isomer of the racemic mixture of methylphenidate. The extended-release form of this compound was developed using proprietary Spheroidal Oral Drug Absorption System technology. The product is approved for the treatment of attention deficit hyperactivity disorder in individuals as young as 6 years old. It represents the first methylphenidate product approved for use in adults. The agent's delivery system is designed to provide an initial release of medication immediately after dosing, with a second release approximately 4 h later. Blood levels first peak at approximately 1.5 h, and the second peak is noted at an average of 6.5 h post-dose. Laboratory classroom studies have demonstrated clinically and statistically meaningful efficacy throughout a 12-h day. Pharmacokinetics, safety and efficacy data are reviewed.
Kowalik
Sharon
S
New York University School of Medicine, New York, USA.
Minami
Haruka
H
Silva
Raul
R
D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy* / Q000378:metabolism / Q000523:psychology; D002214:Capsules; D003692:Delayed-Action Preparations / Q000008:administration & dosage / Q000737:chemistry / Q000493:pharmacokinetics; D064699:Dexmethylphenidate Hydrochloride; D006801:Humans; D008774:Methylphenidate / Q000008:administration & dosage* / Q000737:chemistry* / Q000493:pharmacokinetics; D013237:Stereoisomerism
D002214:Capsules; D003692:Delayed-Action Preparations; D064699:Dexmethylphenidate Hydrochloride; D008774:Methylphenidate