Abuse deterrent immediate release formulations comprising non-cellulose polysaccharides
The present disclosure provides pharmaceutical compositions that provide immediate release of active ingredients and have abuse deterrent properties. In particular, the pharmaceutical compositions comprise at least one pharmaceutically active ingredient, at least one non-cellulose polysaccharide, at least one hydrophilic gelling polymer, and an effervescent system.
1. An abuse deterrent solid dosage form comprising a mixture of at least one active pharmaceutical ingredient (API) susceptible to abuse or a pharmaceutically acceptable salt thereof, about 10% w/w to about 25% w/w of at least one natural gum comprising glucomannan, about 25% w/w to about 35% w/w of a combination of hydrophilic gelling polymers comprising (i) at least one cellulose ether, (ii) a polyethylene oxide having an average molecular weight of about 100,000, and (iii) a polyethylene oxide having an average molecular weight of about 4,000,000, and about 40% w/w to about 50% w/w of an effervescent system, wherein the abuse deterrent solid dosage form provides immediate release of the at least one API.
2. The abuse deterrent solid dosage form of claim 1 , wherein the at least one cellulose ether is hydroxypropylmethylcellulose, hydroxypropylcellulose, sodium carboxymethylcellulose, or a combination thereof; and the effervescent system comprises an organic acid and an alkali metal bicarbonate.
3. The abuse deterrent solid dosage form of claim 1 , wherein the at least one API is an opioid or a combination of an opioid and a non-opioid analgesic, and the opioid is oxycodone, oxymorphone, hydrocodone, hydromorphone, codeine, or morphine.
4. The abuse deterrent solid dosage form of claim 1 , wherein the at least one API is oxycodone.
5. The abuse deterrent solid dosage form of claim 1 , wherein the at least one natural gum comprises glucomannan and xanthan gum, the at least one cellulose ether is hydroxypropylmethylcellulose and sodium carboxymethylcellulose; the effervescent system comprises (i) tartaric and/or citric acid and (ii) sodium bicarbonate; and the at least one API is oxycodone, oxymorphone, hydrocodone, hydromorphone, codeine, or morphine.
6. The abuse deterrent solid dosage form of claim 1 , which deters abuse by forming a viscous mixture or gel when mixed with about 3 mL to about 15 mL of an aqueous solvent.
7. The abuse deterrent solid dosage form of claim 1 , wherein at least about 70% of the at least one API is released within about 45 minutes when dissolution is measured using an USP-approved in vitro release procedure.
8. The abuse deterrent solid dosage form of claim 7 , wherein at least about 80% of the at least one API is released within about 30 minutes.
9. The abuse deterrent solid dosage form of claim 1 , wherein the abuse deterrent solid dosage form is a tablet.
10. The abuse deterrent solid dosage form of claim 1 , which deters abuse by breaking into a plurality of particles having an average diameter greater than about 250 microns when crushed, ground, or pulverized.
11. The abuse deterrent solid dosage form of claim 1 , which deters abuse by releasing less than about 35% of the at least one API when extracted with about 5 mL to about 10 mL of an aqueous solvent.
12. The abuse deterrent solid dosage form of claim 1 , which deters abuse by (i) breaking into a plurality of particles having an average diameter of greater than about 250 microns when crushed, ground, or pulverized, (ii) forming a viscous mixture or gel when in contact with about 3 mL to about 10 mL of an aqueous solvent, and (iii) releasing less than about 35% of the at least one API when extracted with about 5 mL to about 10 mL of an aqueous solvent.
13. The abuse deterrent solid dosage form of claim 5 , further comprising at least one lubricant, at least one preservative, or a combination thereof.
14. The abuse deterrent solid dosage form of claim 5 , further comprising a water-soluble film coating.
15. The abuse deterrent solid dosage form of claim 5 , which deters abuse by breaking into a plurality of particles having an average diameter greater than about 250 microns when crushed, ground, or pulverized.
16. The abuse deterrent solid dosage form of claim 5 , which deters abuse by forming a viscous mixture or gel when mixed with about 3 mL to about 15 mL of an aqueous solvent.
17. The abuse deterrent solid dosage form of claim 5 , which deters abuse by releasing less than about 35% of the at least one API when extracted with about 5 mL to about 10 mL of an aqueous solvent.
18. The abuse deterrent solid dosage form of claim 5 , which deters abuse by (i) breaking into a plurality of particles having an average diameter of greater than about 250 microns when crushed, ground, or pulverized, (ii) forming a viscous mixture or gel when in contact with about 3 mL to about 10 mL of an aqueous solvent, and (iii) releasing less than about 35% of the at least one API when extracted with about 5 mL to about 10 mL of an aqueous solvent.
19. The abuse deterrent solid dosage form of claim 5 , wherein at least about 70% of the at least one API is released within about 45 minutes when dissolution is measured using an USP-approved in vitro release procedure.
20. The abuse deterrent solid dosage form of claim 5 , wherein at least about 80% of the at least one API is released within about 30 minutes when dissolution is measured using an USP-approved in vitro release procedure.