Extended release, abuse deterrent dosage forms
Extended release, abuse deterrent dosage forms comprising crush-resistant controlled-release particles that provide abuse deterrent properties to the dosage forms. The crush-resistant controlled-release particles, which comprise plastic/elastic polymers and at least one active pharmaceutical ingredient (API) or a pharmaceutically acceptable salt thereof, are prepared by a hot melt extrusion process.
1. An extended release, abuse deterrent dosage form comprising a plurality of particles and at least one pharmaceutically acceptable excipient, wherein the plurality of particles consists of at least two plastic/elastic polymers, an active pharmaceutical ingredient (API) susceptible to abuse or a pharmaceutically acceptable salt thereof, at least one plasticizer, at least one optional lubricant, at least one optional polyalkylene oxide, and at least one optional wetting agent,
wherein the D 50 of the particles is reduced by less than about 50% after milling or grinding for a period of time from about 15 seconds to about 10 minutes.
2. The extended release, abuse deterrent dosage form of claim 1 , wherein the D 50 of the particles is reduced by less than about 25% after milling or grinding for a period of time from about 15 seconds to about 10 minutes.
3. The extended release, abuse deterrent dosage form of claim 1 , wherein the D 50 of the particles is reduced by less than about 10% after milling or grinding for a period of time from about 15 seconds to about 10 minutes.
4. The extended release, abuse deterrent dosage form of claim 1 , wherein the at least one API is oxycodone, oxymorphone, hydrocodone, hydromorphone, codeine, or morphine.
5. The extended release, abuse deterrent dosage form of claim 1 , wherein the at least two plastic/elastic polymers comprise at least one polyvinyl ester and at least one poly-N-vinylamide.
6. The extended release, abuse deterrent dosage form of claim 5 , wherein the at least one polyvinyl ester is selected from the group consisting of polyvinyl acetate, polyvinyl propionate, and polyvinyl butyrate.
7. The extended release, abuse deterrent dosage form of claim 5 , wherein the at least one polyvinyl ester is polyvinyl acetate, copolymers thereof, or derivatives thereof.
8. The extended release, abuse deterrent dosage form of claim 5 , wherein the at least one poly-N-vinylamide is polyvinylpyrrolidone or polyvinyl caprolactam.
9. The extended release, abuse deterrent dosage form of claim 5 , wherein the at least one poly-N-vinylamide is polyvinylpyrrolidone or copolymers thereof.
10. An extended release, abuse deterrent dosage form comprising a plurality of particles and at least one pharmaceutically acceptable excipient, wherein the plurality of particles consists of at least two plastic/elastic polymers, an active pharmaceutical ingredient (API) susceptible to abuse or a pharmaceutically acceptable salt thereof, at least one plasticizer, at least one optional lubricant, at least one optional polyalkylene oxide, and at least one optional wetting agent, wherein no more than about 80% of the API is released within about 6 hours in vitro as measured in a USP approved Type 2 paddle apparatus at 50 rpm or 100 rpm at a constant temperature of 37±0.5° C.
11. The extended release, abuse deterrent dosage form of claim 10 , wherein no more than about 80% of the API is released within about 8 hours.
12. The extended release, abuse deterrent dosage form of claim 10 , wherein no more than about 80% of the API is released within about 12 hours.
13. The extended release, abuse deterrent dosage form of claim 10 , wherein no more than about 80% of the API is released within about 18 hours.
14. The extended release, abuse deterrent dosage form of claim 10 , wherein no more than about 80% of the API is released within about 24 hours.
15. The extended release, abuse deterrent dosage form of claim 10 , wherein the at least one API is oxycodone, oxymorphone, hydrocodone, hydromorphone, codeine, or morphine.
16. The extended release, abuse deterrent dosage form of claim 10 , wherein the at least two plastic/elastic polymers comprise at least one polyvinyl ester and at least one poly-N-vinylamide.
17. The extended release, abuse deterrent dosage form of claim 16 , wherein the at least one polyvinyl ester is selected from the group consisting of polyvinyl acetate, polyvinyl propionate, and polyvinyl butyrate.
18. The extended release, abuse deterrent dosage form of claim 16 , wherein the at least one polyvinyl ester is polyvinyl acetate, copolymers thereof, or derivatives thereof.
19. The extended release, abuse deterrent dosage form of claim 16 , wherein the at least one poly-N-vinylamide is polyvinylpyrrolidone or polyvinyl caprolactam.
20. The extended release, abuse deterrent dosage form of claim 16 , wherein the at least one poly-N-vinylamide is polyvinylpyrrolidone or copolymers thereof.