Tamper-resistant pharmaceutical compositions of opioids and other drugs
Tamper-resistant pharmaceutical compositions have been developed to reduce the likelihood of improper administration of drugs, especially drugs such as opioids. The tamper-resistant compositions retard the release of drug, even if the physical integrity of the formulation is compromised (for example, by chopping with a blade or crushing) and the resulting material is placed in water, snorted, or swallowed. However, when administered as directed, the drug is slowly released from the composition as the composition is passes through the GI tract.
1. A pharmaceutical composition comprising a plurality of solid particles each particle comprising:
(a) oxycodone;
(b) myristic acid;
(c) beeswax; and
(d) carnauba wax,
wherein the oxycodone is in the form of a myristic acid salt, and the particles have a D[0.50] from 200 microns to 400 microns and a D[0.90] from 400 microns to 700 microns.
2. The composition of claim 1 , wherein the particles are substantially spherical.
3. The composition of claim 1 , wherein the particles have a D[0.10] from 50 microns to 250 microns.
4. The composition of claim 1 , wherein the myristic acid and oxycodone have a molar ratio of about 6:1 to about 15:1.
5. The composition of claim 4 , wherein the myristic acid and oxycodone have a molar ratio of about 6:1 to about 10:1.
6. The composition of claim 5 , wherein the myristic acid and oxycodone have a molar ratio of about 7:1 to about 10:1.
7. A method of treating pain comprising administering to a human subject in need thereof, a therapeutically effective amount of the composition of claim 1 .
8. A method of treating pain comprising administering to a human subject in need thereof, a therapeutically effective amount of the composition of claim 2 .
9. A method of treating pain comprising administering to a human subject in need thereof, a therapeutically effective amount of the composition of claim 5 .
10. A method of treating pain comprising administering to a human subject in need thereof, a therapeutically effective amount of the composition of claim 6 .
11. A method of making the pharmaceutical composition of claim 1 , comprising:
(a) dissolving oxycodone in a mixture comprising myristic acid, beeswax, and carnauba wax; and
(b) forming a plurality of particles wherein the drug is present as a solid solution within the particles and wherein the particles have a D[0.5] between 200 microns and 400 microns and a D[0.90] between 400 microns to 700 microns.
12. The method of claim 11 , wherein said process comprises a spinning disc atomization process.
13. The method of claim 11 , wherein the particles are substantially spherical.
14. The method of claim 11 , wherein the particles have a D[0.10] from 50 microns to 250 microns.
15. The method of claim 11 , wherein the myristic acid and oxycodone have a molar ratio of about 6:1 to about 15:1.
16. The method of claim 11 , wherein the myristic acid and oxycodone have a molar ratio of about 6:1 to about 10:1.
17. The method of claim 11 , wherein the myristic acid and oxycodone have a molar ratio of about 7:1 to about 10:1.