Extended release opioid 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) sorbitan monoester at about 1 to 10 percent by weight.
2. The therapeutic pharmaceutical composition of claim 1 , wherein the gel-forming polymer is polyethylene oxide.
3. The therapeutic pharmaceutical composition of claim 2 , wherein the polyethylene oxide has an average molecular weight ranging from 300,000 to about 5,000,000.
4. The therapeutic pharmaceutical composition of claim 1 , wherein the sorbitan monoester is present in an amount of about 1 to about 3 percent by weight.
5. The therapeutic pharmaceutical composition of claim 1 , wherein the disintegrant comprises croscarmellose sodium.
6. The therapeutic pharmaceutical composition of claim 1 , further comprising microcrystalline cellulose.
7. The therapeutic pharmaceutical composition of claim 1 , further comprising polyethylene glycol.
8. The therapeutic pharmaceutical composition of claim 1 , wherein the pharmaceutical composition is in unit dose form.
9. 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.
10. A therapeutic pharmaceutical composition comprising: a mixture including
(a) a water soluble drug susceptible to abuse;
(b) a gel-forming polymer in an amount of about 3 to about 40 wt %;
(c) a disintegrant; and
(d) a surfactant;
wherein the disintegrant is present in an amount sufficient to cause the pharmaceutical composition to exhibit an immediate release profile.
11. The therapeutic pharmaceutical composition of claim 10 , wherein the pharmaceutical composition is in unit dose form.
12. The therapeutic pharmaceutical composition of claim 10 , wherein the pharmaceutical composition is in suppository, capsule, caplet, pill, gel, soft gelatin capsule, or compressed tablet form.
13. The therapeutic pharmaceutical composition of claim 10 , wherein the water soluble drug susceptible to abuse is present in an amount of 0.5 to about 25 wt % of the composition.
14. The therapeutic pharmaceutical composition of claim 10 , wherein the disintegrant is present in an amount of about 2 to about 25 wt % of the composition.
15. The therapeutic pharmaceutical composition of claim 10 , wherein the surfactant is present in an amount of about 1 to about 10 wt % of the composition.
16. The therapeutic pharmaceutical composition of claim 10 , wherein the gel-forming polymer is present in an amount of about 3 to about 40 wt % of the composition.
17. The therapeutic pharmaceutical composition of claim 10 , wherein the disintegrant is selected from the group consisting of sodium starch glycolate, crospovidone, and croscarmellose sodium.