Abuse deterrent formulations of amphetamine
The present invention relates generally to abuse-deterrent formulations containing dextroamphetamine sulfate.
1. An abuse-deterrent formulation, comprising medicament, poloxamer, water-soluble anionic polysaccharide, and PEG ester;
wherein the medicament is
or a pharmaceutically acceptable salt thereof.
2. The abuse-deterrent formulation of claim 1 , wherein the poloxamer is poloxamer 124.
3. The abuse-deterrent formulation of claim 1 , wherein the water-soluble anionic polysaccharide is gellan gum.
4. The abuse-deterrent formulation of claim 1 , wherein the PEG ester is polyoxyl stearate.
5. The abuse-deterrent formulation of claim 1 , wherein the ratio of poloxamer:water-soluble anionic polysaccharide:PEG ester is about 40:30:30.
6. The abuse-deterrent formulation of claim 1 , comprising 33-43 wt % of poloxamer; 24-32 wt % of water-soluble anionic polysaccharide; and 24-32 wt % of PEG ester.
7. The abuse-deterrent formulation of claim 1 , wherein the poloxamer is poloxamer 124, the water-soluble anionic polysaccharide is gellan gum, and the PEG ester is polyoxyl stearate.
8. The abuse-deterrent formulation of claim 7 , wherein the ratio of poloxamer 124:gellan gum:polyoxyl stearate is about 40:30:30.
9. The abuse-deterrent formulation of claim 1 , wherein the poloxamer is Kollisolv P124, the water-soluble anionic polysaccharide is Kelcogel CGHA, and the PEG ester is Gelucire 48/16.
10. The abuse-deterrent formulation of claim 1 , wherein the medicament is the S enantiomer, or a pharmaceutically acceptable salt thereof.
11. The abuse-deterrent formulation of claim 1 , wherein the medicament is dextroamphetamine, or a pharmaceutically acceptable salt thereof.
12. The abuse-deterrent formulation of claim 1 , wherein the medicament is a sulfate salt.
13. The abuse-deterrent formulation of claim 1 , further comprising a capsule.
14. The abuse-deterrent formulation of claim 1 , comprising about 10 mg to about 50 mg of medicament.
15. An abuse-deterrent formulation, comprising medicament, poloxamer 124, gellan gum, and polyoxyl stearate;
wherein the ratio of poloxamer 124:gellan gum:polyoxyl stearate is about 40:30:30;
the medicament is
or a pharmaceutically acceptable salt thereof; and
wherein at least 80% of the medicament is released in solution within 45 minutes.
16. The abuse-deterrent formulation of claim 15 , wherein the medicament is the S enantiomer, or a pharmaceutically acceptable salt thereof.
17. The abuse-deterrent formulation of claim 15 , wherein the medicament is dextroamphetamine, or a pharmaceutically acceptable salt thereof.
18. The abuse-deterrent formulation of claim 15 , wherein the medicament is a sulfate salt.
19. The abuse-deterrent formulation of claim 15 , comprising about 10 mg to about 50 mg of medicament.
20. The abuse-deterrent formulation of claim 15 , wherein the poloxamer 124 is Kollisolv P124, the gellan gum is Kelcogel CGHA, and the polyoxyl stearate is Gelucire 48/16.