| 主权项 |
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, and wherein 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. |
