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Last Updated: November 30, 2020

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Claims for Patent: 9,682,075

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Summary for Patent: 9,682,075
Title:Tamper-resistant pharmaceutical compositions of opioids and other drugs
Abstract: Tamper-resistance 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.
Inventor(s): Rariy; Roman (Philadelphia, PA), Fleming; Alison (Mansfield, MA), Hirsh; Jane C. (Wellesley, MA), Saim; Said (New Milford, CT), Varanasi; Ravi K. (Cumberland, RI)
Assignee: COLLEGIUM PHARMACEUTICAL, INC. (Canton, MA)
Application Number:14/320,086
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,682,075
Patent Claims: 1. 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 present at 42%-69% by weight of the particle wherein the particles have a median particle size (D[0.5]) between about 200 microns and about 400 microns; and 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 swallowed.

2. The composition of claim 1, wherein the particles are substantially spherical.

3. The composition of claim 1, wherein the drug and the one or more fatty acids interact ionically.

4. The composition of claim 1, wherein the fatty acids are selected from the group consisting of linoleic acid, octanoic acid, capric acid, lauric acid, myristic acid, palmitic acid, stearic acid, oleic acid.

5. The composition of claim 4, wherein the fatty acid is myristic acid.

6. The composition of claim 1, wherein the one or more wax or wax-like substances are selected from the group consisting of beeswax, glycowax, castor wax, carnauba wax, paraffins, microcrystalline wax, and candelilla wax.

7. The composition of claim 6, wherein the wax or wax-like substances are beeswax and carnauba wax.

8. The composition of claim 7, wherein the drug prone to abuse is oxycodone, the wax or wax-like substances are beeswax and carnauba wax, and the fatty acid is myristic acid.

9. 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 present at 42%-69% by weight of the particle 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; and 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 swallowed.

10. A method of making the tamper resistant pharmaceutical composition of claim 1, comprising: (a) dispersing or dissolving a drug prone to abuse in a mixture comprising one or more waxes, wax-like substances or mixtures thereof; and (b) forming a plurality of particles 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.

11. The method of claim 10, wherein said process comprises a spinning disc atomization process.

12. The composition of claim 1, wherein the particles have a median particle size (D[0.5]) between about 250 microns and about 400 microns.

13. The method of claim 9, wherein the particles have a median particle size (D[0.5]) between about 250 microns and about 400 microns.

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