Method for treating ADD or ADHD comprising administering amphetamine complexed with ion-exchange resin particles
Inventors
Tengler, Mark • McMahen, Russell
Assignees
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Publication Number
US-9839619-B2
Publication Date
2017-12-12
Expiration Date
Abstract
The invention relates to dosage forms that provide prolonged therapy. In particular, the invention relates to dosage forms including various pluralities of drug-containing resin particles. The invention also relates to methods of making these dosage forms and methods of treating using these dosage forms.
Core Innovation
The invention provides a method for treating Attention-Deficit Disorder or Attention-Deficit Hyperactivity Disorder in a subject substantially contemporaneously exposed to ethanol. The method administers a pharmaceutical composition comprising an ADHD effective agent complexed with ion-exchange resin particles to form drug-resin particles, wherein the ADHD effective agent is amphetamine.
The composition comprises a first plurality of drug-resin particles for immediate release and a second plurality of drug-resin particles coated with a delayed release coating. The amount of ADHD effective agent released from the composition in up to 20% ethanol is substantially similar to the amount released in the absence of ethanol.
The disclosure further describes controlled-release oral formulations, including oral controlled-release amphetamine and methylphenidate formulations, resin-based suspensions, orally disintegrating tablets, and other oral controlled-release dosage forms. It also describes pharmacokinetic performance characteristics, including serum or plasma profiles, exposure metrics, food effects, alcohol effects, and age-related pharmacokinetic and clearance/volume targets in children with ADHD.
Claims Coverage
The provided content identifies one independent claim directed to treating ADHD or ADHD/ADD in a subject substantially contemporaneously exposed to ethanol using an amphetamine ion-exchange resin drug-resin system with immediate and delayed release components, while making release in up to 20% ethanol substantially similar to release in the absence of ethanol. Three inventive features are identified.
Ethanol-exposed ADHD treatment with amphetamine ion-exchange drug-resin particles
A method for treating Attention-Deficit Disorder or Attention-Deficit Hyperactivity Disorder in a subject substantially contemporaneously exposed to ethanol by administering a pharmaceutical composition comprising an ADHD effective agent complexed with ion-exchange resin particles to form drug-resin particles, wherein the ADHD effective agent is amphetamine.
Immediate and delayed release pluralities from coated resin particles
The composition comprises a first plurality of drug-resin particles for immediate release and a second plurality of drug-resin particles coated with a delayed release coating.
Substantially ethanol-similar release up to 20% ethanol
The amount of ADHD effective agent released from the composition in up to 20% ethanol is substantially similar to the amount released in the absence of ethanol.
The claim coverage centers on amphetamine ion-exchange drug-resin particles that combine immediate-release and delayed-release components, while maintaining substantially similar release in up to 20% ethanol compared with the absence of ethanol.
Stated Advantages
Release of the ADHD effective agent in up to 20% ethanol is substantially similar to release in the absence of ethanol.
Food effects show exposure metrics within predefined bioequivalence ranges for d- and l-amphetamine and methylphenidate, while T_max may differ.
Alcohol effects show no significant change in the rate and extent of amphetamine absorption.
Reported pharmacokinetic parameters for children with ADHD are within specified clearance/volume targets.
The delayed release coating provides delayed release of the ADHD effective agent from the second plurality.
In vivo pharmacokinetic parameters show 90% confidence interval upper and lower bounds within a specified range relative to a bioequivalent reference composition.
Documented Applications
Treating Attention-Deficit Disorder or Attention-Deficit Hyperactivity Disorder in a subject substantially contemporaneously exposed to ethanol.
Evaluating oral controlled-release amphetamine and methylphenidate formulations in human studies, including food effects and alcohol effects.
Comparing resin-based suspensions versus ADDERALL XR with respect to early exposure and early-onset effect when taken with meals.
Assessing pharmacokinetics and clearance/volume targets in children with ADHD after administration of the described compositions.
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