Tamper-resistant pharmaceutical compositions of opioids and other drugs
AssigneeCollegium Pharmaceutical, Inc.
InventorsRoman V. Rariy, Alison FLEMING, Jane C. HIRSH, Said SAIM, Ravi K. VARANASI
Life of this patent
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Abstract
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.
Claims18
-49. (canceled)
A tamper resistant pharmaceutical composition comprising a plurality of solid particles each particle comprising:
- (a) one or more drugs prone to abuse;
- (b) one or more waxes, wax-like substances or mixtures thereof;
- and
- (c) one or more fatty acids;
- wherein the particles have a median particle size (D[0.5]) between about 200 microns and about 400 microns;
- wherein the molar ratio of fatty acid to drug is about 6:1 to about 15:1;
- wherein the drug is oxycodone or a pharmaceutically acceptable salt thereof and after oral administration as directed a therapeutically effective amount of drug is released over a period of 6-24 hours;
- and
- wherein the composition maintains a slow release of composition even if the particles are crushed with a mortar an pestle and snorted.
A method of treating pain comprising administering to a human subject in need thereof, a therapeutically effective amount of a tamper resistant pharmaceutical composition comprising a plurality of particles, each particle comprising:
- (a) one or more drugs prone to abuse;
- (b) one or more waxes, wax-like substances or mixtures thereof;
- and
- (c) one or more fatty acids;
- wherein the drug is present as a solid dispersion or solid solution within the particles and wherein the particles have a median particle size (D[0.5]) between about 200 microns and about 400 microns;
- wherein the molar ratio of fatty acid to drug is about 6:1 to about 15:1;
- wherein the drug is oxycodone or a pharmaceutically acceptable salt thereof and after oral administration as directed a therapeutically effective amount of drug is released over a period of 6-24 hours;
- and
- the composition maintains a slow release of drug even if the particles are crushed with a mortar and pestle and snorted.
Dependencies are inferred from the claim text.