Orally disintegrating tablet compositions comprising combinations of non-opioid and opioid analgesics

摘要

The present invention is directed to pharmaceutical compositions comprising a plurality of taste-masked non-opioid analgesic/opioid analgesic drug-containing microparticles, dosage forms comprising such pharmaceutical compositions (such as an orally disintegrating tablet), and methods of making the pharmaceutical compositions and dosage forms of the present invention. Dosage forms comprising the pharmaceutical compositions of the present invention are improved homogeneous blends of non-opioid and opioid analgesics which provide for more convenient and palatable administration of drug combinations, for example for treating pain.

主权项

1. A pharmaceutical composition comprising a first population of non-opioid analgesic/opioid analgesic drug-containing microparticles, wherein the drug-containing microparticles comprise:
(a) a first core comprising a non-opioid analgesic drug; (b) a first coating disposed over the first core, comprising an opioid analgesic drug; and (c) a second coating disposed over the first core, comprising a water-insoluble polymer; and further comprising a second population of non-opioid analgesic drug-containing particles, wherein the second population of non-opioid analgesic drug-containing particles comprise: (i) a second core comprising the non-opioid analgesic drug; and (ii) a third coating comprising a water-insoluble polymer disposed over the second core, wherein the water-insoluble polymer of the third coating is the same as or different from the water-insoluble polymer of the second coating.