| 摘要 |
Disclosed herein is a pharmaceutical composition comprising a plurality of timed pulsatile release and rapid release particles, wherein: the timed pulsatile release particles each comprise a core coated with a timed pulsatile release layer; the core comprises a weakly basic, poorly soluble drug and a pharmaceutically acceptable organic acid separated from each other by a sustained release layer; the rapid release particles each comprise the weakly basic, poorly soluble drug, and release at least about 80 wt.% of the weakly basic, poorly soluble drug in about 15 minutes when dissolution tested using United States Pharmacopoeia (USP) dissolution methodology (Apparatus 2 - paddles@ 50 RPM and a two-stage dissolution medium at 37ºC (first 2 hours in 0.1N HCl followed by testing in a buffer at pH 6.8).
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