Compositions comprising methylphenidate complexed with ion-exchange resin particles

  • US 9,089,496 B2
  • Filed: 07/22/2013
  • Issued: 07/28/2015
  • Est. Priority Date: 06/28/2011
  • Status: Active Grant
First Claim
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1. A pharmaceutical composition comprising an ADHD effective agent complexed with ion-exchange resin particles to form drug-resin particles,wherein said ADHD effective agent is methylphenidate,wherein said composition comprises a first plurality of drug-resin particles that provide for immediate release of said ADHD effective agent and a second plurality of drug-resin particles that are coated with a delayed release coating, said drug-resin particles of said second plurality being coated with a triggered-release coating triggered by a pH change and a diffusion barrier coating,wherein 20%-30% by weight of said methylphenidate is present-in the first plurality of drug-resin particles and 70-80% by weight of said methylphenidate is present in the second plurality of drug-resin particles, andwherein administration of the composition to a human produces a mean plasma concentration profile for d-methylphenidate in human subjects which has one or more parameters selected from the group consisting of AUC0-3, AUC0-5, AUC0-Tmax, AUC5-12, AUC5-24, AUCTmax-24, AUCTmax-12, AUC5-t, AUCTmax-t, AUC0-24, and AUC0-∞

  • which is substantially similar to those parameters of at least one of the in vivo serum profiles of the compositions comprising methylphenidate-containing drug-resin particles shown in FIG. 20A.

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