发明名称 Compositions comprising methylphenidate complexed with ion-exchange resin particles
摘要 Pharmaceutical compositions of methylphenidate complexed with ion-exchange resin particles to form drug-resin particles are provided. The compositions have a first plurality of drug-resin particles that are uncoated and a second plurality of drug-resin particles that are coated with a delayed release coating. Preferably, the second plurality of drug-resin particles are coated with a triggered-release coating triggered by a pH change and a diffusion barrier coating.
申请公布号 US9072680(B2) 申请公布日期 2015.07.07
申请号 US201313844584 申请日期 2013.03.15
申请人 NEOS THERAPEUTICS, LLP 发明人 Tengler Mark;McMahen Russell
分类号 A61K31/4458;A61K9/14;A61K47/48;A61K9/50;C12N9/24;A61K9/00;A61K31/137 主分类号 A61K31/4458
代理机构 Hunton & Williams LLP 代理人 Hunton & Williams LLP
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 triggered-release coating triggered by a pH change and a diffusion barrier coating, 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.
地址 Grand Prairie TX US