Orally Effective Methylphenidate Extended Release Powder and Aqueous Suspension Product

A powder which is reconstitutable into an aqueous oral suspension comprising (i) an immediate release methylphenidate component, (ii) a sustained release water-insoluble, water-permeable, pH-independent, barrier coated methylphenidate-ion exchange resin complex, and (iii) a buffering agent which adjusts the pH of the reconstituted oral aqueous suspension to a pH of about 4.2,

• wherein the reconstituted oral aqueous suspension comprises at least about 80% of water based on the total weight of the suspension,
• wherein the reconstituted oral aqueous suspension has less than about 1% threo-α-phenyl-2-piperidineacetic acid hydrochloride impurity after a period of about 1 month of storage at room temperature, and
• wherein following a single oral administration of an aqueous liquid suspension at a dose equivalent to 60 mg racemic methylphenidate HCl the reconstituted oral aqueous suspension has a pharmacokinetic profile in which the d-methylphenidate has
• an area under the curve (AUC)0-˜ of about 114 ng-hr/mL to about 180 ng-hr/mL in adults under fasted conditions,
• a Cmax of about 11 ng/mL to about 17 ng/mL in adults under fasted conditions, and
• a reduced Tmax in adults fed with a high-fat meal prior to administration compared to adult subjects in a fasted state prior to administration.