Abuse-resistant pharmaceutical composition for the treatment of opioid dependence

A method of treatment of opioid dependency and/or addiction, which method comprises administration of at least one unit dose of a tablet composition to a person suffering from, or susceptible to, opioid dependency and/or addiction, which tablet composition is suitable for sublingual administration and comprises:

• (a) microparticles of a pharmacologically-effective amount of buprenorphine, or a pharmaceutically-acceptable salt thereof in associative admixture with particles comprising citric acid;
• (b) a pharmacologically-effective amount of naloxone, or a pharmaceutically-acceptable salt thereof;
• and
• (c) a disintegrant selected from the group croscarmellose sodium, sodium starch glycolate, crosslinked polyvinylpyrrolidone and mixtures thereof,
• (d) a buprenorphine to naloxone dose ratio in the tablet composition of about 4:1 (calculated as free bases),
• (e) a dose of both buprenorphine and naloxone in the tablet composition, which is about 75% of a dose of buprenorphine and naloxone, respectively, present in a random mixture compressed tablet comprising buprenorphine hydrochloride, naloxone hydrochloride dihydrate, lactose monohydrate, mannitol, maize starch, povidone K30, citric acid, sodium citrate, flavoring, acesulfame potassium, and magnesium stearate, wherein the random mixture compressed tablet was approved under NDA No. 20-733 in 2 mg and 8 mg buprenorphine doses on Oct. 8, 2002 and
• which method achieves, after an initial administration of said unit dose of said tablet composition, plasma-concentration time profiles for both buprenorphine and naloxone that are essentially equivalent to plasma-concentration time profiles for buprenorphine and naloxone, respectively, exhibited by said random mixture compressed tablet, where the plasma-concentration time profiles are measured as (i) a maximum plasma concentration (Cmax), (ii) total area under the plasma concentration-time curve from time zero to the time of a last measured plasma concentration (AUCt), or (iii) area under the plasma concentration-time curve from time zero to a last measured plasma concentration extrapolated to infinity based on an elimination rate constant (AUCint).