US2009234018A1PendingUtilityA1

Non-Standard Amino Acid Conjugates of Amphetamine and Processes for Making and Using the Same

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Individually held — no corporate assignee on recordPriority: Dec 11, 2006Filed: May 28, 2009Published: Sep 17, 2009
Est. expiryDec 11, 2026(~0.4 yrs left)· nominal 20-yr term from priority
Inventors:Travis Mickle
A61K 31/135A61P 3/04A61P 25/24A61P 25/28A61K 47/542A61K 31/198A61P 25/00A61P 25/22
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Claims

Abstract

Disclosed are amphetamine prodrug compositions comprising at least one non-standard amino acid conjugate of amphetamine, a salt thereof, a derivative thereof, or a combination thereof. Methods of making and using the same are also disclosed.

Claims

exact text as granted — not AI-modified
1 . A composition for treating a human or animal patient having a disorder or condition requiring the stimulation of the central nervous system of the patient, comprising at least one conjugate of amphetamine with ornithine or homoarginine, a salt thereof, a derivative thereof, or a combination thereof. 
   
   
       2 . The composition of  claim 1 , wherein at least one conjugate of amphetamine is l-ornithine-d-amphetamine. 
   
   
       3 . The composition of  claim 1 , wherein at least one conjugate of amphetamine is l-homoarginine-d-amphetamine. 
   
   
       4 . The composition of  claim 1 , wherein the composition having a reduced or prevented pharmacological activity when administered by parenteral routes. 
   
   
       5 . The composition of  claim 1 , wherein the salt of the conjugate of amphetamine is a mesylate, a hydrochloride salt, a sulfate, an oxalate, a triflate, a citrate, a malate, a tartrate, a phosphate, a nitrate, a benzoate, or a mixture thereof. 
   
   
       6 . The composition of  claim 1 , wherein the composition is in the form of a tablet, a capsule, a caplet, a troche, a lozenge, an oral powder, a solution, a oral film, a thin strip, or a suspension. 
   
   
       7 . The composition of  claim 6 , wherein the tablet, troche, or lozenge is chewable. 
   
   
       8 . The composition of  claim 1 , wherein at least one conjugate of amphetamine, the salt thereof, derivative thereof, or the combination thereof is present in the amount of from about 1 mg to about 500 mg. 
   
   
       9 . The composition of  claim 1 , wherein at least one conjugate of amphetamine, the salt thereof, derivatives thereof, or the combination thereof is present in the amount of from about 5 mg to about 250 mg. 
   
   
       10 . The composition of  claim 1 , wherein at least one conjugate of amphetamine, the salt thereof, derivatives thereof, or the combination thereof is present in the amount of from about 10 mg to about 100 mg. 
   
   
       11 . The composition of  claim 1 , wherein at least one conjugate of amphetamine, the salt thereof, the derivative thereof, or the combination thereof is in an amount sufficient to provide a therapeutically bioequivalent AUC when compared to amphetamine alone, but does not provide a C max  spike. 
   
   
       12 . The composition of  claim 1 , wherein at least one conjugate of amphetamine, the salt thereof, the derivative thereof, or the combination thereof is in an amount sufficient to provide a therapeutically bioequivalent AUC when compared to amphetamine alone, but does not provide an equivalent C max . 
   
   
       13 . A method for treating a patient having a disorder or condition requiring the stimulation of the central nervous system of the patient, comprising orally administering to the patient a pharmaceutically effective amount of at least one conjugate of amphetamine with ornithine or homoarginine, a salt thereof, a derivative thereof, or a combination thereof. 
   
   
       14 . The composition of  claim 13 , wherein at least one conjugate of amphetamine is l-ornithine-d-amphetamine. 
   
   
       15 . The composition of  claim 13 , wherein at least one conjugate of amphetamine is l-homoarginine-d-amphetamine. 
   
   
       16 . The method of  claim 13 , wherein said step of orally administering comprises administering a tablet, a capsule, a caplet, a troche, a lozenge, an oral powder, an oral solution, an oral film, a thin strip, or an oral suspension. 
   
   
       17 . The method of  claim 13 , wherein the conjugate of amphetamine is administered in the form of a salt. 
   
   
       18 . The method of  17 , wherein the salt is a mesylate, a hydrochloride salt, a sulfate, an oxalate, a triflate, a citrate, a malate, a tartrate, a phosphate, a nitrate, a benzoate, or a mixture thereof. 
   
   
       19 . The method of  claim 13 , comprising administering a dosage form containing from about 1 mg to about 500 mg of the at least one conjugate of amphetamine, the salt thereof, the derivative thereof, or the combination thereof. 
   
   
       20 . The method of  claim 13 , comprising administering a dosage form containing from about 5 mg to about 250 mg of the at least one conjugate of amphetamine, the salt thereof, or the combination thereof. 
   
   
       21 . The method of  claim 13 , comprising administering a dosage form containing from about 10 mg to about 100 mg of the at least one conjugate of amphetamine, the salt thereof, or the combination thereof. 
   
   
       22 . The method of  claim 13 , wherein at least one conjugate of amphetamine, the salt thereof, or the combination thereof is in an amount sufficient to provide a therapeutically bioequivalent AUC when compared to amphetamine alone, but does not provide a C max  spike. 
   
   
       23 . The method of  claim 13 , wherein the at least one conjugate of amphetamine, the salt thereof, or the combination thereof is in an amount sufficient to provide a therapeutically bioequivalent AUC when compared to amphetamine alone, but does not provide an equivalent C max . 
   
   
       24 . The method of  claim 13 , wherein the disorder or condition is attention deficit hyperactivity disorder, attention deficit disorder, obesity, narcolepsy, appetite suppression, depression, anxiety, wakefulness, or a combination thereof. 
   
   
       25 . The method of  claim 24 , wherein the disorder or condition is attention deficit hyperactivity disorder. 
   
   
       26 . The method of  claim 24 , wherein the disorder or condition is attention deficit disorder. 
   
   
       27 . The method of  claim 24 , wherein the disorder or condition is obesity. 
   
   
       28 . The method of  claim 24 , wherein the disorder or condition is appetite suppression. 
   
   
       29 . The method of  claim 24 , wherein the disorder or condition is depression. 
   
   
       30 . The method of  claim 24 , wherein the disorder or condition is narcolepsy.

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