Abuse deterrent compositions and methods of making same
View Patent ↗This invention relates to an abuse deterrent dosage form of opioid analgesics, wherein an analgesically effective amount of opioid analgesic is combined with a polymer to form a matrix.
1. A therapeutic pharmaceutical composition comprising: a mixture including (a) a water soluble drug susceptible to abuse at about 0.5 to about 25 percent by weight; (b) gel-forming polymer at about 3 to about 40 percent by weight; (c) a disintegrant at about 2 to 25 percent by weight wherein the disintegrant is selected from the group consisting of crospovidone, sodium starch glycolate, and croscarmellose sodium; and (d) polysorbate 80 at about 1 to 10 percent by weight.
2. The therapeutic pharmaceutical composition of claim 1 , wherein the gel-forming polymer is hydroxypropyl methyl cellulose.
3. The therapeutic pharmaceutical composition of claim 2 , wherein the hydroxypropyl methyl cellulose has an average molecular weight ranging from about 10,000 to about 1,500,000.
4. The therapeutic pharmaceutical composition of claim 1 , wherein the disintegrant comprises croscarmellose sodium.
5. The therapeutic pharmaceutical composition of claim 1 , further comprising hydrogenated oil.
6. The therapeutic pharmaceutical composition of claim 1 , wherein the pharmaceutical composition is in unit dose form.
7. The therapeutic pharmaceutical composition of claim 1 , wherein the pharmaceutical composition is in suppository, capsule, caplet, pill, gel, soft gelatin capsule, or compressed tablet form.
8. A therapeutic pharmaceutical composition comprising: a mixture including (a) a water soluble drug susceptible to abuse at about 0.5 to about 25 percent by weight; (b) gel-forming polymer at about 3 to about 40 percent by weight; (c) a disintegrant at about 2 to 25 percent by weight wherein the disintegrant is selected from the group consisting of crospovidone, sodium starch glycolate, and croscarmellose sodium; (d) sorbitan monooleate at about 1 to 10 percent by weight; and (e) a lubricant including polyethylene glycol.
9. The therapeutic pharmaceutical composition of claim 8 , wherein the gel-forming polymer is hydroxypropyl methyl cellulose.
10. The therapeutic pharmaceutical composition of claim 9 , wherein the hydroxypropyl methyl cellulose has an average molecular weight ranging from about 10,000 to about 1,500,000.
11. The therapeutic pharmaceutical composition of claim 8 , wherein the disintegrant comprises croscarmellose sodium.
12. The therapeutic pharmaceutical composition of claim 8 , further comprising microcrystalline cellulose.
13. The therapeutic pharmaceutical composition of claim 8 , wherein the pharmaceutical composition is in unit dose form.
14. The therapeutic pharmaceutical composition of claim 8 , wherein the pharmaceutical composition is in suppository, capsule, caplet, pill, gel, soft gelatin capsule, or compressed tablet form.
15. The therapeutic pharmaceutical composition of claim 8 , the lubricant further comprising hydrogenated oil.
16. A therapeutic pharmaceutical composition comprising: a mixture including (a) a water soluble drug susceptible to abuse at about 0.5 to about 25 percent by weight; (b) gel-forming polymer at about 3 to about 40 percent by weight; (c) a disintegrant at about 2 to 25 percent by weight wherein the disintegrant is selected from the group consisting of crospovidone, sodium starch glycolate, and croscarmellose sodium; (d) polysorbate 80 at about 1 to 10 percent by weight; and (e) a lubricant including polyethylene glycol.
17. The therapeutic pharmaceutical composition of claim 16 , wherein the gel-forming polymer is hydroxypropyl methyl cellulose.
18. The therapeutic pharmaceutical composition of claim 17 , wherein the hydroxypropyl methyl cellulose has an average molecular weight ranging from about 10,000 to about 1,500,000.
19. The therapeutic pharmaceutical composition of claim 16 , wherein the disintegrant comprises croscarmellose sodium.
20. The therapeutic pharmaceutical composition of claim 16 , further comprising microcrystalline cellulose.
21. The therapeutic pharmaceutical composition of claim 16 , wherein the pharmaceutical composition is in unit dose form.
22. The therapeutic pharmaceutical composition of claim 16 , wherein the pharmaceutical composition is in suppository, capsule, caplet, pill, gel, soft gelatin capsule, or compressed tablet form.
23. The therapeutic pharmaceutical composition of claim 16 , the lubricant further comprising hydrogenated oil.
24. A therapeutic pharmaceutical composition comprising: a mixture including (a) a water soluble drug susceptible to abuse at about 0.5 to about 25 percent by weight; (b) gel-forming polymer at about 3 to about 40 percent by weight; (c) a disintegrant at about 2 to 25 percent by weight wherein the disintegrant is selected from the group consisting of crospovidone, sodium starch glycolate, and croscarmellose sodium; (d) sorbitan monooleate at about 1 to 10 percent by weight; and (e) microcrystalline cellulose.
25. The therapeutic pharmaceutical composition of claim 24 , wherein the gel-forming polymer is hydroxypropyl methyl cellulose.
26. The therapeutic pharmaceutical composition of claim 25 , wherein the hydroxypropyl methyl cellulose has an average molecular weight ranging from about 10,000 to about 1,500,000.
27. The therapeutic pharmaceutical composition of claim 24 , wherein the disintegrant comprises croscarmellose sodium.
28. The therapeutic pharmaceutical composition of claim 24 , further comprising hydrogenated oil.
29. The therapeutic pharmaceutical composition of claim 24 , wherein the pharmaceutical composition is in unit dose form.
30. The therapeutic pharmaceutical composition of claim 24 , wherein the pharmaceutical composition is in suppository, capsule, caplet, pill, gel, soft gelatin capsule, or compressed tablet form.
31. A therapeutic pharmaceutical composition comprising: a mixture including (a) a water soluble drug susceptible to abuse at about 0.5 to about 25 percent by weight; (b) gel-forming polymer at about 3 to about 40 percent by weight; (c) a disintegrant at about 2 to 25 percent by weight wherein the disintegrant is selected from the group consisting of crospovidone, sodium starch glycolate, and croscarmellose sodium; (d) polysorbate 80 at about 1 to 10 percent by weight; and (e) microcrystalline cellulose.
32. The therapeutic pharmaceutical composition of claim 31 , wherein the gel-forming polymer is hydroxypropyl methyl cellulose.
33. The therapeutic pharmaceutical composition of claim 32 , wherein the hydroxypropyl methyl cellulose has an average molecular weight ranging from about 10,000 to about 1,500,000.
34. The therapeutic pharmaceutical composition of claim 31 , wherein the disintegrant comprises croscarmellose sodium.
35. The therapeutic pharmaceutical composition of claim 31 , further comprising hydrogenated oil.
36. The therapeutic pharmaceutical composition of claim 31 , wherein the pharmaceutical composition is in unit dose form.
37. The therapeutic pharmaceutical composition of claim 31 , wherein the pharmaceutical composition is in suppository, capsule, caplet, pill, gel, soft gelatin capsule, or compressed tablet form.