| Autor: |
Gomeni, R, Bressolle‐Gomeni, FMM, Spencer, TJ, Faraone, SV, Fang, L, Babiskin, A |
| Předmět: |
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| Zdroj: |
Clinical Pharmacology & Therapeutics; Dec2017, Vol. 102 Issue 6, p951-960, 10p |
| Abstrakt: |
Methylphenidate (MPH) is currently used to treat children with attention deficit hyperactivity disorder (ADHD). Several extended-release (ER) formulations characterized by a dual release process were developed to improve efficacy over an extended duration. In this study, a model-based approach using literature data was developed to: 1) evaluate the most efficient pharmacokinetic (PK) model to characterize the complex PK profile of MPH ER formulations; 2) provide PK endpoint metrics for comparing ER formulations; 3) define criteria for optimizing development of ER formulations using a convolution-based model linking in vitro release, in vivo release, and hour-by-hour behavioral ratings of ADHD symptoms; and 4) define an optimized trial design for assessing the activity of MPH in pediatric populations. The convolution-based model accurately described the complex PK profiles of a variety of ER MPH products, providing a natural framework for establishing an in vitro/ in vivo correlation and for defining criteria for assessing comparative bioequivalence of MPH ER products. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
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