Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
AssigneeOrexo AB
InventorAndreas Fischer
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Abstract
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.
Claims11
A method of treatment of opioid dependence in a subject, which method comprises:
- providing a sublingual tablet comprising
- (i) a dosage amount of buprenorphine or a pharmaceutically-acceptable salt thereof (calculated as the free base) that is 11.4 mg (±2%), 8.6 mg (±2%), 5.7 mg (±2%), 2.9 mg (±2%), or 1.4 mg (±2%);
- (ii) a dosage amount of naloxone or a pharmaceutically-acceptable salt thereof (calculated as the free base) that is about ¼ of the above doses of buprenorphine or salt thereof;
- and
- (iii) citric acid;
- and
- (iv) a disintegrant,
- which tablet is prepared according to a process comprising:
- (a) associatively admixing microparticles of buprenorphine or pharmaceutically-acceptable salt thereof with particles of citric acid by a process of simple mixing and/or granulation, to form an associative admixture between the microparticles of buprenorphine or salt thereof and the particles of citric acid;
- (b) mixing the associative admixture obtained in step (a) with particles comprising naloxone or pharmaceutically-acceptable salt thereof;
- and
- (c) compressing the mixture obtained in step (b) to produce said tablet;
- and
- sublingually administering the tablet to a subject in need of treatment of opioid dependence.
Dependencies are inferred from the claim text.