Methods and compositions for deterring abuse
View Patent ↗Effective methods and compositions to deter abuse of pharmaceutical products (e.g., orally administered pharmaceutical products) including but not limited to immediate release, sustained or extended release and delayed release formulations for drugs subject to abuse comprising at least 10% by weight hydroxypropylcellulose; polyethylene oxide; and a disintegrant selected from the group consisting of crospovidone, sodium starch glycolate and croscarmellose sodium; wherein the ratio of hydroxypropylcellulose to polyethylene oxide on a weight basis is between about 10:1 and 1:10.
1. A therapeutic composition comprising:
pseudoephedrine or a salt thereof;
at least 10% by weight hydroxypropylcellulose;
about 1% to about 10% by weight polyethylene oxide; and
a disintegrant selected from the group consisting of crospovidone, sodium starch glycolate and croscarmellose sodium;
wherein the ratio of hydroxypropylcellulose to polyethylene oxide on a weight basis is between about 10:1 and 1:10.
2. The therapeutic composition of claim 1 , wherein the composition comprises an immediate release formulation.
3. The therapeutic composition of claim 1 , wherein the hydroxypropylcellulose has a viscosity of about 1,500 mPa·s to about 3,000 mPa·s at 1%.
4. The therapeutic composition of claim 1 , wherein the hydroxypropylcellulose has a molecular weight of about 1,150,000 Da.
5. The therapeutic composition of claim 1 , comprising ethylcellulose.
6. The therapeutic composition of claim 5 , wherein the ethylcellulose includes an ethoxyl content of about 45% to about 52%.
7. The therapeutic composition of claim 1 , wherein the crospovidone is present in an amount of about 15 wt % to about 25 wt %.
8. The therapeutic composition of claim 1 , wherein the crospovidone is present in an amount of about 18 wt % to about 22 wt %.
9. The therapeutic composition of claim 1 , wherein the crospovidone is present in an amount of about 20.41 wt %.
10. The therapeutic composition of claim 1 , further comprising a glidant.
11. The therapeutic composition of claim 9 , wherein the glidant comprises colloidal silicon dioxide.
12. The therapeutic composition of claim 1 , further comprising a lubricant.
13. The therapeutic composition of claim 11 , wherein the lubricant comprises magnesium stearate.
14. The therapeutic composition of claim 1 , wherein the composition is a suppository, capsule, caplet, pill, gel, soft gelatin capsule, or compressed tablet form.
15. The therapeutic composition of claim 1 , wherein the composition is in unit dose form.
16. The therapeutic composition of claim 1 , wherein the composition is an extended release formulation.
17. The therapeutic composition of claim 2 , wherein the composition is an analgesic.
18. The therapeutic composition of claim 17 , wherein the composition is in unit dose form.
19. The therapeutic composition of claim 18 , wherein the unit dose form is a powder.