Abuse deterrent formulations of amphetamine
The present invention relates generally to abuse-deterrent formulations containing dextroamphetamine sulfate.
1. A method of deterring abuse of a medicament, comprising providing a formulation comprising the medicament, poloxamer, water-soluble anionic polysaccharide, and PEG ester;
wherein the medicament is
or a pharmaceutically acceptable salt thereof.
2. The method of claim 1 , wherein the abuse is abuse by insufflation.
3. The method of claim 1 , wherein the abuse is abuse by injection.
4. The method of claim 1 , wherein the ratio of poloxamer:water-soluble anionic polysaccharide:PEG ester is about 40:30:30.
5. The method of claim 1 ,
wherein the poloxamer is poloxamer 124;
wherein the water-soluble anionic polysaccharide is gellan gum;
wherein the PEG ester is polyoxyl stearate; and
wherein the ratio of poloxamer 124:gellan gum:polyoxyl stearate is about 40:30:30.
6. The method of claim 5 , wherein the formulation comprises about 10 mg to about 50 mg of the medicament.
7. The method of claim 5 , wherein the formulation 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 the medicament.
8. The method of claim 1 ,
wherein the poloxamer is poloxamer 124;
wherein the water-soluble anionic polysaccharide is Kelcogel CGHA;
wherein the PEG ester is Gelucire 48/16; and
wherein the ratio of poloxamer 124:gellan gum:polyoxyl stearate is about 40:30:30.
9. A method of treating attention-deficit/hyperactivity disorder (ADHD) in a subject by administering to the subject an abuse-deterrent formulation comprising a medicament, poloxamer, water-soluble anionic polysaccharide, and PEG ester;
wherein the medicament is
or a pharmaceutically acceptable salt thereof.
10. The method of claim 9 , wherein the ratio of poloxamer:water-soluble anionic polysaccharide:PEG ester is about 40:30:30.
11. The method of claim 9 ,
wherein the poloxamer is poloxamer 124;
wherein the water-soluble anionic polysaccharide is gellan gum;
wherein the PEG ester is polyoxyl stearate; and
wherein the ratio of poloxamer 124:gellan gum:polyoxyl stearate is about 40:30:30.
12. The method of claim 11 , wherein the formulation comprises about 10 mg to about 50 mg of the medicament.
13. The method of claim 11 , wherein the formulation 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 the medicament.
14. The method of claim 9 ,
wherein the poloxamer is poloxamer 124;
wherein the water-soluble anionic polysaccharide is Kelcogel CGHA;
wherein the PEG ester is Gelucire 48/16; and
wherein the ratio of poloxamer 124:gellan gum:polyoxyl stearate is about 40:30:30.