Pharmaceutical compositions resistant to abuse
View Patent ↗The present invention provides immediate release pharmaceutical compositions for Oral administration that are resistant to abuse.
1. An abuse-resistant pharmaceutical composition comprising a shell resistant to physical tampering, the shell comprising an outer shell wall having an inner surface and an outer surface, the outer surface being a double curved surface,
wherein the shell extends from a first end to a second end, the shell having a length in the range of from 4 mm to 20 mm,
wherein the outer shell wall has a first opening at the first end and a second opening at the second end, the first opening and the second opening having an area in the range of from about 1 mm 2 to about 100 mm 2 , and
wherein the outer shell wall is of varying thickness and has a maximum thickness in a range of from 1 mm to about 10 mm, the outer shell wall being impermeable to water.
2. The pharmaceutical composition according to claim 1 , wherein the shell comprises one or more reinforcement elements extending from the inner surface of the outer shell wall.
3. The pharmaceutical composition according to claim 2 , wherein the one or more reinforcement elements comprises a first reinforcement wall.
4. The pharmaceutical composition according to claim 3 , wherein the first reinforcement wall is a plane wall.
5. The pharmaceutical composition according to claim 3 , wherein the first reinforcement wall is perpendicular to a first axis from the first end to the second end.
6. The pharmaceutical composition according to claim 3 , wherein the first reinforcement wall is parallel to a first axis extending from the first end to the second end.
7. The pharmaceutical composition according to claim 3 , wherein the first reinforcement wall has a thickness in a range of from 0.2 mm to 2 mm.
8. The pharmaceutical composition according to claim 3 , wherein the first reinforcement wall has one or more openings.
9. The pharmaceutical composition according to claim 2 , wherein the one or more reinforcement elements comprises a second reinforcement wall.
10. The pharmaceutical composition according to claim 9 , wherein the second reinforcement wall is a plane wall.
11. The pharmaceutical composition according to claim 9 , wherein the second reinforcement wall is perpendicular to a first axis extending from the first end to the second end.
12. The pharmaceutical composition according to claim 9 , wherein the second reinforcement wall is parallel to a first axis extending from the first end to the second end.
13. The pharmaceutical composition according to claim 9 , wherein the second reinforcement wall has a thickness in the range of from 0.2 mm to 2 mm.
14. The pharmaceutical composition according to claim 9 , wherein the first reinforcement wall and the second reinforcement wall are parallel.
15. The pharmaceutical composition according to claim 14 , wherein the first reinforcement wall and the second reinforcement wall extend in the same plane.
16. The pharmaceutical composition according to claim 9 , wherein the first reinforcement wall intersects the second reinforcement wall forming an angle between the first reinforcement wall and the second reinforcement wall.
17. The pharmaceutical composition according to claim 1 , wherein the shell defines a cavity extending from the first end to the second end.
18. The pharmaceutical composition according to claim 1 , wherein the shell defines a plurality of separated cavities extending from the first end to the second end.
19. The pharmaceutical composition according to claim 18 , wherein one or more of the cavities has a circular cross section perpendicular to a first axis extending from the first end to the second end.
20. The pharmaceutical composition according to claim 18 , wherein one or more of the cavities has an elliptical cross section perpendicular to a first axis extending from the first end to the second end.
21. The pharmaceutical composition according to claim 1 , wherein the outer surface of the shell has an elliptical cross section perpendicular to a first axis extending from the first end to the second end.
22. The pharmaceutical composition according to claim 1 , wherein the outer surface of the shell forms an arc, such as a circular arc, from the first end to the second end in a cross section along a first axis extending from the first end to the second end.
23. The pharmaceutical composition according to claim 1 , wherein the shell is made of a material comprising polylactic acid, and wherein the concentration of the polylactic acid is at least 50% w/w.
24. The pharmaceutical composition according to claim 1 , wherein the shell is made of a material comprising one or more of the following polymers: ethyl cellulose grade 20 and 100, cornpack 200, polycaprolactone, PEO 7000000, and/or polyhydroxybuturate.
25. The pharmaceutical composition according to claim 1 , wherein the shell is made of a material comprising one or more of the following plasticizers: cetostearyl alcohol, castor oil, dibutyl sebacate, polyethylene oxide, and/or poloxamer.
26. The pharmaceutical composition according to claim 1 , wherein the shell is made of a material comprising one polymer and the concentration of the polymer is from 5 to 100% w/w.
27. The pharmaceutical composition according to claim 1 , wherein the shell comprises a mixture of polymers and the total concentration of polymers included in the shell is from 70 to 100% w/w.
28. The pharmaceutical composition according to claim 1 , wherein the maximum length of the outer shell wall is 16 mm.