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 process for preparing a solid dosage form, the process comprising:
(a) blending at least one active pharmaceutical ingredient (API) or 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 to form a mixture;
(b) compressing the mixture into a solid dosage unit; and
(c) heating the solid dosage unit at a temperature from about 50° C. to less than about 90° C. for 1 to 3 hours to form the solid dosage form;
wherein the solid dosage form deters abuse and provides immediate release of the at least one API.
2. The process 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.
3. The process of claim 1 , wherein the at least one natural gum comprising glucomannan further comprises xanthan gum.
4. The process of claim 1 , wherein the at least one cellulose ether is hydroxypropylmethylcellulose, hydroxypropylcellulose, sodium carboxymethylcellulose, or a combination thereof.
5. The process of claim 1 , wherein the effervescent system comprises a) an acid component chosen from an organic acid, an inorganic acid, or a combination thereof, and b) a base component chosen from an alkali metal bicarbonate, an alkaline earth metal bicarbonate, an alkali metal carbonate, an organic carbonate, or a combination thereof.
6. The process of claim 1 , wherein the mixture at step (a) further comprises a lubricant, and the lubricant is present in an amount of less than about 1% by weight of the solid dosage form.
7. The process of claim 1 , further comprising applying a film coating to the solid dosage unit before step (c) or applying a film coating to the solid dosage form after step (c).
8. The process of claim 1 , wherein the solid dosage form is a tablet, compact, pellet, caplet, or pill.