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. A pharmaceutical composition comprising a mixture of an opioid, 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 pharmaceutical composition provides immediate release of the opioid and has abuse deterrent properties.
2. The pharmaceutical composition of claim 1 , wherein the opioid is oxycodone, oxymorphone, hydrocodone, hydromorphone, codeine, or morphine.
3. The pharmaceutical composition of claim 1 , wherein the at least one natural gum comprising glucomannan further comprises xanthan gum.
4. The pharmaceutical composition of claim 1 , wherein the at least one cellulose ether is hydroxypropylmethylcellulose, hydroxypropylcellulose, sodium carboxymethylcellulose, or a combination thereof.
5. The pharmaceutical composition of claim 1 , wherein the effervescent system comprises an organic acid and an alkali metal bicarbonate.
6. The pharmaceutical composition of claim 1 , further comprising at least one lubricant, at least one preservative, or a combination thereof.
7. The pharmaceutical composition of claim 1 , further comprising a water-soluble film coating.
8. The pharmaceutical composition of claim 1 , which is formulated as a solid dosage form.
9. The pharmaceutical composition of claim 8 , wherein the solid dosage form is a tablet.
10. The pharmaceutical composition of claim 1 , which releases at least about 75% of the opioid within about 30 minutes when measured using an USP-approved in vitro release procedure.
11. The pharmaceutical composition of claim 1 , which releases at least about 80% of the opioid within about 30 minutes when measured using an USP-approved in vitro release procedure.
12. The pharmaceutical composition of claim 1 , which deters abuse by breaking into a plurality of particles having an average diameter of greater than about 250 microns when crushed, ground, or pulverized.
13. The pharmaceutical composition of claim 1 , which deters abuse by forming a viscous mixture or gel when in contact with about 3 mL to about 10 mL of an aqueous solvent.
14. The pharmaceutical composition of claim 1 , which deters abuse by releasing less than about 35% of the opioid when extracted with about 5 mL to about 10 mL of an aqueous solvent.
15. The pharmaceutical composition of claim 1 , which deters abuse (i) by breaking into a plurality of particles having an average diameter of greater than about 250 microns when crushed, ground, or pulverized, (ii) by forming a viscous mixture or gel when in contact with about 3 mL to about 10 mL of an aqueous solvent, and (iii) by releasing less than about 35% of the opioid when extracted with about 5 mL to about 10 mL of an aqueous solvent.
16. The pharmaceutical composition of claim 1 , wherein the opioid is oxycodone or oxymorphone, the at least one natural gum comprises glucomannan and xanthan gum, the at least one cellulose ether is hydroxypropylmethylcellulose and sodium carboxymethylcellulose, and the effervescent system comprises (i) tartaric and/or citric acid and (ii) sodium bicarbonate.