Extended release, abuse deterrent pharmaceutical compositions
Pharmaceutical compositions comprising at least one active pharmaceutical ingredient or a pharmaceutically acceptable salt thereof, at least one hydrophilic plastomer, at least one hydrophilic elastomer, and at least one deliquescent plasticizer, wherein the pharmaceutical compositions provide extended release of the API and have abuse deterrent properties. Methods for preparing the pharmaceutical compositions in which the components of the composition are humidified such that the deliquescent plasticizer deliquesces, thereby plasticizing the hydrophilic polymers.
1. An abuse deterrent solid dosage form comprising at least one active pharmaceutical ingredient (API) having a potential for abuse or a pharmaceutically acceptable salt thereof, at least one hydrophilic plastomer having a molecular weight from 20,000 daltons to 2,000,000 daltons, a carbomer, and a deliquescent plasticizer comprising an organic acid and a sugar alcohol, wherein the solid dosage form is humidified in a relative humidity of about 65% to about 85% at about 25° C. and is heated to a temperature from about 60° C. to about 90° C. for about one to three hours, and wherein the solid dosage form provides extended release of the at least one API.
2. The abuse deterrent solid dosage form of claim 1 , wherein the at least one hydrophilic plastomer is a combination of hydroxypropyl cellulose, hydroxypropylmethyl cellulose, and polyethylene oxide.
3. The abuse deterrent solid dosage form of claim 1 , wherein the at least one hydrophilic plastomer is present in an amount from 30% to about 80% by weight of the solid dosage form.
4. The abuse deterrent solid dosage form of claim 1 , wherein the carbomer is present in an amount from about 0.5% to about 10% by weight of the solid dosage form.
5. The abuse deterrent solid dosage form of claim 1 , wherein the organic acid is citric acid, glutaric acid, malic acid, tartaric acid, or combination thereof; and the sugar alcohol is sorbitol, xylitol, maltitol, or combination thereof.
6. The abuse deterrent solid dosage form of claim 1 , wherein the deliquescent plasticizer is present in an amount from about 10% to about 30% by weight of the solid dosage form.
7. 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.
8. The abuse deterrent solid dosage form of claim 7 , wherein the opioid is oxycodone, oxymorphone, hydrocodone, hydromorphone, codeine, or morphine.
9. The abuse deterrent solid dosage form of claim 1 , which further comprises at least one lubricant.
10. The abuse deterrent solid dosage form of claim 1 , which further comprises a film coating.
11. The abuse deterrent solid dosage form of claim 1 , which has an in vitro release of no more than about 80% of the API within about 6 hours.
12. The abuse deterrent solid dosage form 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 abuse deterrent solid dosage form of claim 1 , which deters abuse by forming a viscous mixture or gel when contacted with from about 1 mL to about 10 mL of an aqueous solvent.
14. The abuse deterrent solid dosage form of claim 1 , wherein the at least one API is oxycodone, oxymorphone, hydrocodone, hydromorphone, codeine, or morphine; the at least one hydrophilic plastomer is a combination of hydroxypropyl cellulose, hydroxypropylmethyl cellulose, and polyethylene oxide; and the deliquescent plasticizer comprises citric acid and sorbitol.
15. The abuse deterrent solid dosage form of claim 14 , wherein the least one hydrophilic plastomer is present in an amount from 30% to about 80% by weight of the solid dosage form; the carbomer is present in an amount from about 0.5% to about 10% by weight of the solid dosage form; and the deliquescent plasticizer is present in an amount from about 10% to about 30% by weight of the solid dosage form.