HOMOARGININE PRODRUGS AND/OR CONJUGATES OF AMPHETAMINE AND OTHER STIMULANTS AND PROCESSES FOR MAKING AND USING THE SAME
Disclosed are homoarginine amphetamine prodrug and/or conjugate compositions, salts thereof, or a combination thereof that can reduce or prevent amphetamine side effects in a human subject, and methods to reduce or prevent amphetamine side effects in a human subject.
1 . A method of reducing or preventing amphetamine or amphetamine derivative side effects in a human comprising the step of orally administering at least one thin film or strip comprising a dose of at least one homoarginine amphetamine dihydrochloride prodrug or homoarginine amphetamine derivative dihydrochloride prodrug, or a combination thereof, wherein the dose is equivalent to amphetamine freebase in the range of about 5 mg to about 40 mg, and wherein the prodrug is below the limit of quantitation in the bloodstream of the human following the oral administration step.
2 . The method of claim 1 , wherein the prodrug is below the level of 1.00 ng/mL in the bloodstream of the human following the oral administration step.
3 . The method of claim 1 , wherein the dose is equivalent to amphetamine freebase in the range of about 9 mg to about 30 mg.
4 . A composition for reducing or preventing amphetamine or amphetamine derivative side effects in a human, the composition comprising at least one orally administered homoarginine-amphetamine prodrug or salt thereof, or at least one homoarginine-amphetamine derivative prodrug or a salt thereof, wherein either of the prodrugs or salts thereof are present in the composition in an amount equivalent to amphetamine freebase in the range of about 5 mg to about 40 mg, and wherein either of the prodrugs or salts thereof are below the limit of quantitation in the bloodstream of the human following oral administration.
5 . The composition of claim 4 , wherein either of the prodrugs or salts thereof are below the level of 1.00 ng/mL in the bloodstream of the human following oral administration.
6 . The composition of claim 4 , wherein either of the prodrugs or salts thereof are provided in a thin film or strip dosage form.
7 . The composition of claim 4 , wherein the homoarginine-amphetamine prodrug is homoarginine amphetamine dihydrochloride.
8 . The composition of claim 4 , wherein the homoarginine-amphetamine derivative prodrug is homoarginine amphetamine derivative dihydrochloride.
9 . The composition of claim 4 , wherein the amount of the prodrug or salt thereof is equivalent to amphetamine freebase in the range of about 9 mg to about 30 mg.
10 . A method of reducing or preventing amphetamine or amphetamine derivative side effects in a human comprising the step of orally administering to a human at least one thin film or strip comprising a dose of at least one homoarginine-amphetamine conjugate or salt thereof, or at least one homoarginine-amphetamine derivative conjugate or a salt thereof, wherein the dose is equivalent to amphetamine freebase in the range of about 5 mg to about 40 mg, and wherein the conjugate is below the limit of quantitation in the bloodstream of the human following the oral administration step.
11 . A composition for reducing or preventing amphetamine or amphetamine derivative side effects in a human, the composition comprising at least one orally administered homoarginine-amphetamine conjugate or salt thereof, or at least one homoarginine-amphetamine derivative conjugate or a salt thereof, wherein either of the conjugates or salts thereof are present in the composition in an amount equivalent to amphetamine freebase in the range of about 5 mg to about 40 mg, and wherein either of the conjugates or salts thereof are below the limit of quantitation in the bloodstream of the human following oral administration.
12 . The composition of claim 11 , wherein either of the conjugates or salts thereof are below the level of 1.00 ng/mL in the bloodstream of the human following oral administration.
13 . The composition of claim 11 , wherein either of the conjugates or salts thereof are provided in a thin film or strip dosage form.
14 . The composition of claim 11 , wherein the homoarginine-amphetamine conjugate is homoarginine amphetamine dihydrochloride.
15 . The composition of claim 11 , wherein the homoarginine-amphetamine derivative conjugate is homoarginine amphetamine derivative dihydrochloride.
16 . The composition of claim 11 , wherein the amount of the conjugate or salt thereof is equivalent to amphetamine freebase in the range of about 9 mg to about 30 mg.
17 . A method of reducing or preventing ADD, ADHD, or CNS diseases or disorders in a human comprising the step of orally administering at least one thin film or strip comprising a dose of at least one homoarginine amphetamine dihydrochloride prodrug or homoarginine amphetamine derivative dihydrochloride prodrug, or a combination thereof, wherein the dose is equivalent to amphetamine freebase in the range of about 5 mg to about 40 mg, and wherein the prodrug is below the limit of quantitation in the bloodstream of the human following the oral administration step.
18 . A composition for reducing or preventing ADD, ADHD, or negative CNS stimulation side effects, or psychostimulant side effects, diseases or disorders in a human, the composition comprising at least one orally administered homoarginine-amphetamine prodrug or salt thereof, or at least one homoarginine-amphetamine derivative prodrug or a salt thereof, wherein either of the prodrugs or salts thereof are present in the composition in an amount equivalent to amphetamine freebase in the range of about 5 mg to about 40 mg, and wherein either of the prodrugs or salts thereof are below the limit of quantitation in the bloodstream of the human following oral administration.
19 . A method of reducing or preventing ADD, ADHD, or negative CNS side effects in a human comprising the step of orally administering to a human at least one thin film or strip comprising a dose of at least one homoarginine-amphetamine conjugate or salt thereof, or at least one homoarginine-amphetamine derivative conjugate or a salt thereof, wherein the dose is equivalent to amphetamine freebase in the range of about 5 mg to about 40 mg, and wherein the conjugate is below the limit of quantitation in the bloodstream of the human following the oral administration step.
20 . A composition for reducing or preventing stimulant side effects in a human, the composition comprising at least one orally administered homoarginine-amphetamine conjugate or salt thereof, or at least one homoarginine-amphetamine derivative conjugate or a salt thereof, wherein either of the conjugates or salts thereof are present in the composition in an amount equivalent to amphetamine freebase in the range of about 5 mg to about 40 mg, and wherein either of the conjugates or salts thereof are below the limit of quantitation in the bloodstream of the human following oral administration.