Abuse-deterrent controlled release formulations
View Patent ↗Described herein are abuse deterrent controlled release oral pharmaceutical compositions comprising and methods for making the same. In particular, an abuse deterrent controlled release oral pharmaceutical composition comprising a soft capsule and an abuse deterrent controlled release matrix comprising an active pharmaceutical ingredient are described.
1. An abuse deterrent tamper resistant oral pharmaceutical dosage form comprising a soft capsule shell encapsulating a tamper resistant matrix comprising:
(a) about 45% to about 52% by mass soybean oil;
(b) about 1.8% to about 4% by mass polyethylene glycol glyceride ester;
(c) about 1.8% to about 4% by mass bee's wax;
(d) about 5% to about 15% by mass of a polyethylene oxide having a molecular weight of about 100,000;
(e) about 0.5% to about 4% by mass carboxypolymethylene;
(f) about 2% to about 8% by mass dimethylaminoethyl methacrylate copolymer;
(g) about 0.5% to about 5% by mass fumed silica; and
(h) about 5% to about 30% by mass tapentadol hydrochloride.
2. An abuse deterrent oral pharmaceutical dosage form comprising a soft capsule shell encapsulating a tamper resistant matrix comprising:
(a) about 45% to about 52% by mass soybean oil;
(b) about 1.5% to about 5% by mass polyethylene glycol glyceride ester;
(c) about 1.8% to about 4% by mass bee's wax;
(d) about 2% to about 8% by mass polyvinylpyrrolidone 90 ;
(e) about 0.5% to about 4% by mass carbomer polymer;
(f) about 2% to about 8% by mass dimethylaminoethyl methacrylate copolymer;
(g) about 0.5% to about 5% by mass fumed silica; and
(h) about 5% to about 30% by mass tapentadol hydrochloride.
3. The composition of claim 1 , wherein the soft capsule shell comprises:
(a) about 25-50% by mass of at least one film-forming polymer;
(b) about 15-25% by mass of at least one plasticizer; and
(c) about 20-40% by mass of a solvent.
4. The composition of claim 2 , wherein the soft capsule shell comprises:
(a) about 25-50% by mass of at least one film-forming polymer;
(b) about 15-25% by mass of at least one plasticizer; and
(c) about 20-40% by mass of a solvent.