QuilliChew extended-release chewable tablets for the treatment of ADHD in patients ages 6 years old and above

ABSTRACT

Introduction: Attention-deficit/hyperactivity disorder (ADHD) is a common neurobehavioral disorder affecting as many as 6.4 million children and adolescents in the United States. Since amphetamine (AMPH) and methylphenidate (MPH) were found to be effective more than 60 years ago, numerous formulations of these compounds have been developed. New preparations have focused on convenience, with extended-release (ER) drugs allowing once-daily dosing. Multiple ER formulations do not require patients to swallow a tablet or capsule. Recent ER preparations include liquids, oral disintegrating tablets, and chewable tablets. Several new formulations use ion exchange technology containing both immediate-release and ER components.

Areas covered: Quillichew ER^TM (MPH-ERCT) is an ER methylphenidate designed to be chewed before swallowing. The technology and pharmacokinetics, along with efficacy and safety data, are presented.

Expert opinion: Extensive safety and efficacy data exist for MPH. ER formulations can be distinguished by preparation (tablet, capsule, liquid) and onset and duration of effect, but efficacy is similar for all ER MPH products. Each formulation has attributes, such as ease of titration, portability, and taste, that make it more acceptable for certain patients. Because AMPH and MPH are so effective, current technology research is focused on improving safety, convenience, and onset and duration of effect.

KEYWORDS:

• Attention-deficit/hyperactivity disorder
• ADHD
• methylphenidate
• Quillichew ER

Article Highlights

• Quillichew ER™ is an extended-release (ER) methylphenidate (MPH-ERCT) product in which MPH is ionically bound to polystyrene sulfonate particles which are covered by coatings of various thickness

• MPH-ERCT retains its ER properties when chewed

• Pharmacokinetic studies indicated that MPH-ERCT chewed is bioequivalent to MPH-ERCT swallowed whole

• MPH-ERCT is effective from 2 to 8 h after dosing

• Absorption of MPH-ERCT is not pH dependent

This box summarizes key points contained in the article.

Disclosure statement

A Childress has received grant support from the U.S. Food and Drug Administration and served on advisory boards for Akili, Ironshore, Neos, Neurovance, NLS, Noven, Otsuka, Pfizer, Rhodes, Shire, Sunovion, Supernus and Tris. She is a consultant for Shire, Akili, Arbor, Ironshore, KemPharm, Neos, Neurovance, Purdue, Rhodes, Sunovion, Supernus and Tris. She is a speaker for Arbor, Neos, Pfizer, Shire and Tris. She has received research support from Alcobra, Akili, Arbor, Eli Lilly,Ironshore, KemPharm, Lundbeck, Neos, Neurovance, Noven, Otsuka, Pearson, Pfizer, Purdue, Rhodes, Shire, Sunovion and Supernus. She has received writing support from Arbor, Ironshore, Neos, Pfizer, Rhodes, Shire, Sunovion and Tris. B Ponce De Leon has no disclosures. M Owens has served as an advisory board member for Sunovion and on the speakers bureaus for Arbor, Neos, Pfizer, Shire, Sunovion and Tris. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose

Additional information

Funding

This paper was not funded.