Abuse-resistant pharmaceutical composition for the treatment of opioid dependence

摘要

There is provided pharmaceutical compositions for the treatment of e.g. opioid dependency comprising microparticles of a pharmacologically-effective amount of buprenorphine, or a pharmaceutically-acceptable salt thereof, in associative admixture with particles comprising a weak acid, or particles comprising weakly-acidic buffer forming materials. The composition may further comprise a disintegrant and/or particles of a pharmacologically-effective amount of naloxone, or a pharmaceutically-acceptable salt thereof. The compositions are useful in the treatment of opioid dependency/addiction and/or pain.

主权项

1. A pharmaceutical composition in the form of a tablet suitable for sublingual administration comprising:
buprenorphine, or a pharmaceutically acceptable salt thereof, provided in the form of microparticles, a weak acid, provided in the form of particles, which particles are separate from the microparticles of buprenorphine, or a pharmaceutically acceptable salt thereof, a disintegrant, and naloxone or a pharmaceutically acceptable salt thereof,wherein the per tablet dosage of buprenorphine (calculated as the free base) is 11.4 mg, 8.6 mg, 5.7 mg, 2.9 mg, or 1.4 mg; andwherein the per tablet dosage ratio of buprenorphine:naloxone dose (calculated as free bases) is about 4:1.