Abuse deterrent formulations of amphetamine
The present invention relates generally to abuse-deterrent formulations containing dextroamphetamine sulfate.
1. An abuse-deterrent formulation, comprising medicament, PEG ester, poloxamer, and water-soluble anionic polysaccharide,
wherein the PEG ester is polvoxyl stearate, the poloxamer is poloxamer 124, the water-soluble anionic polysaccharide is gellan gum, wherein the medicament is the formula
or a pharmaceutically acceptable salt thereof,
wherein the ratio of poloxamer:polysaccharide:PEG ester is about 40:30:30, and
wherein the medicament comprises about 10 mg to about 50 mg of medicament.
2. The abuse-deterrent formulation of claim 1 , wherein the PEG ester is Gelucire 48/16; poloxamer is Kollisolv P124; and the water-soluble anionic polysaccharide is Kelcogel CGHA.
3. The abuse-deterrent formulation of claim 1 , wherein the medicament is the S enantiomer.
4. The abuse-deterrent formulation of claim 1 , wherein the formulation further comprises a capsule.
5. The abuse-deterrent formulation of claim 1 , wherein the medicament is a sulfate salt.
6. The abuse-deterrent formulation of claim 4 , wherein the capsule comprises gelatin.
7. An abuse-deterrent formulation, comprising medicament, PEG ester, poloxamer, and water-soluble anionic polysaccharide,
wherein the PEG ester is polyoxyl stearate, the poloxamer is poloxamer 124, the water-soluble anionic polysaccharide is gellan gum, wherein the medicament is the formula
or a pharmaceutically acceptable salt thereof,
wherein the ratio of poloxamer:polysaccharide:PEG ester is about 40:30:30, and
wherein the medicament comprises a unit dose of 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, 40 mg, 45 mg, or 50 mg of medicament.
8. The abuse-deterrent formulation of claim 7 , wherein the PEG ester is Gelucire 48/16; the poloxamer is Kollisolv P124; and the water-soluble anionic polysaccharide is Kelcogel CGHA.
9. The abuse-deterrent formulation of claim 7 , wherein the medicament is the S enantiomer.
10. The abuse-deterrent formulation of claim 7 , wherein the medicament is a sulfate salt.
11. The abuse-deterrent formulation of claim 7 , wherein the formulation further comprises a capsule.
12. The abuse-deterrent formulation of claim 11 , wherein the capsule comprises gelatin.