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A Comparison of the Pharmacokinetics of Methylphenidate Extended‐Release Orally Disintegrating Tablets With a Reference Extended‐Release Formulation of Methylphenidate in Healthy Adults
Author(s) -
Childress Ann,
Stark Jeffrey G.,
McMahen Russ,
Engelking Dorothy,
Sikes Carolyn
Publication year - 2018
Publication title -
clinical pharmacology in drug development
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.711
H-Index - 22
eISSN - 2160-7648
pISSN - 2160-763X
DOI - 10.1002/cpdd.362
Subject(s) - methylphenidate , pharmacokinetics , medicine , bioavailability , extended release , pharmacology , adverse effect , immediate release , nausea , oral administration , bioequivalence , anesthesia , attention deficit hyperactivity disorder , psychiatry
Extended‐release (ER) methylphenidate (MPH) is a first‐line treatment for attention‐deficit/hyperactivity disorder. A methylphenidate extended‐release orally disintegrating tablet (MPH XR‐ODT) has recently been developed. This was a randomized, open‐label, 3‐period, 3‐treatment study comparing the bioavailability and absorption of 2 MPH XR‐ODT formulations with an MPH ER reference medication. Here we report the 2 treatments comparing the commercial MPH XR‐ODT formulation and reference medication. Following a ≥10‐hour fast, 42 healthy adults received 60 mg of reference medication or MPH XR‐ODT (2 × 30 mg). The following pharmacokinetic (PK) parameters were calculated for total methylphenidate ( d + l ): maximum plasma concentration (C max ), time to maximum plasma concentration (T max ), terminal half‐life (T 1/2 ), and areas under the concentration–time curve from time zero to the time of the last quantifiable concentration (AUC last ), and from time zero extrapolated to infinity (AUC inf ). Secondary PK end points included partial AUCs. Safety was also assessed. Overall systemic exposure to methylphenidate after MPH XR‐ODT administration was similar to that of the reference product, and the concentration–time profiles for MPH XR‐ODT and the reference drug were similar, although the C max was 25% higher for MPH XR‐ODT. The most common treatment‐emergent adverse events were nausea (6) and anxiety (4), which were similar across treatments.