Glucomannan containing pharmaceutical compositions with extended release and abuse deterrent properties
View Patent ↗A pharmaceutical composition comprising at least one active pharmaceutical ingredient (API) or a pharmaceutically acceptable salt thereof, a glucomannan, a first polyalkylene oxide having an average molecular weight of no more than 300,000, and a second polyalkylene oxide having an average molecular weight of at least 1,000,000 and methods of making. The pharmaceutical composition provides extended release of the API and has abuse deterrent features.
1. A solid dosage form comprising an opioid or a pharmaceutically acceptable salt thereof, about 20-30% w/w of a glucomannan, about 35-45% w/w of a first polyethylene oxide having an average molecular weight of 100,000, about 18-24% w/w of a second polyethylene oxide having an average molecular weight of 2,000,000, about 0.01-0.3% w/w of an antioxidant, about 1-3% w/w of a lubricant, and an optional film coating.
2. The solid dosage form of claim 1 , wherein the solid dosage form releases no more than about 80% of the opioid within about 6 hours using an USP in vitro release procedure.
3. The solid dosage form of claim 1 , wherein the solid dosage form has abuse deterrent properties.
4. The solid dosage form of claim 3 , wherein the solid dosage form deters abuse by breaking into a plurality of particles having an average diameter of greater than about 250 microns when crushed, ground, or pulverized.
5. The solid dosage form of claim 3 , wherein the solid dosage form deters abuse by forming a viscous gel upon contact with about 10 mL or less of an aqueous solution.
6. The solid dosage form of claim 1 , wherein the opioid is oxycodone, oxymorphone, hydrocodone, hydromorphone, codeine, or morphine.
7. A solid dosage form comprising an opiate or a pharmaceutically acceptable salt thereof, about 10-20% w/w of a glucomannan, about 30-50% w/w of a first polyethylene oxide having an average molecular weight of 100,000, about 18-24% w/w of a second polyethylene oxide having an average molecular weight of 7,000,000, about 5-20% w/w of a hydrophilic gelling polymer other than a polyalkylene oxide, about 0.02-0.3% w/w of an antioxidant, about 1-3% w/w of a lubricant, and an optional film coating.
8. The solid dosage form of claim 7 , wherein the solid dosage form releases no more than about 80% of the opioid within about 6 hours using an USP in vitro release procedure.
9. The solid dosage form of claim 7 , wherein the solid dosage form has abuse deterrent properties.
10. The solid dosage form of claim 9 , wherein the solid dosage form deters abuse by breaking into a plurality of particles having an average diameter of greater than about 250 microns when crushed, ground, or pulverized.
11. The solid dosage form of claim 9 , wherein the solid dosage form deters abuse by forming a viscous gel upon contact with about 10 mL or less of an aqueous solution.
12. The solid dosage form of claim 7 , wherein the opioid is oxycodone, oxymorphone, hydrocodone, hydromorphone, codeine, or morphine.
13. A solid dosage form comprising an opiate or a pharmaceutically acceptable salt thereof, about 20-30% w/w of a glucomannan, about 30-50% w/w of a first polyethylene oxide having an average molecular weight of 100,000, about 9-11% A w/w of a second polyethylene oxide having an average molecular weight of 2,000,000, about 1-3% w/w of a plasticizer chosen from vitamin E succinate or vitamin E palmitate, about 1-3% w/w of a lubricant, and an optional film coating.
14. The solid dosage form of claim 13 , wherein the solid dosage form releases no more than about 80% of the opioid within about 6 hours using an USP in vitro release procedure.
15. The solid dosage form of claim 13 , wherein the solid dosage form has abuse deterrent properties.
16. The solid dosage form of claim 15 , wherein the solid dosage form deters abuse by breaking into a plurality of particles having an average diameter of greater than about 250 microns when crushed, ground, or pulverized.
17. The solid dosage form of claim 15 , wherein the solid dosage form deters abuse by forming a viscous gel upon contact with about 10 mL or less of an aqueous solution.
18. The solid dosage form of claim 13 , wherein the opioid is oxycodone, oxymorphone, hydrocodone, hydromorphone, codeine, or morphine.