Controlled dose drug delivery system

Abstract

A multiple pulsed dose drug delivery system for pharmaceutically active amphetamine salts, comprising a pharmaceutically active amphetamine salt covered with an immediate-release coating and a pharmaceutically active amphetamine salt covered with an enteric coating wherein the immediate release coating and the enteric coating provide for multiple pulsed dose delivery of the pharmaceutically active amphetamine salt. The product can be composed of either one or a number of beads in a dosage form, including either capsule, tablet, or sachet method for administering the beads.

1 - 32 . (canceled) 
     
     
         33 . A pharmaceutical composition comprising:
 at least one amphetamine salt and a pharmaceutically acceptable carrier;   wherein the composition provides an about bioequivalent plasma level of amphetamine in a patient compared to an equivalent amount of at least one amphetamine salt contained in the combination of ADDERALL® and an immediate release amphetamine salt composition when the immediate release composition is administered to the patient about 8 hours after the ADDERALL®.   
     
     
         34 . The composition of  claim 33 , wherein the composition provides an about bioequivalent plasma level of d-amphetamine in the patient compared to an equivalent amount of at least one amphetamine salt contained in the combination of ADDERALL® and an immediate release amphetamine salt composition when the immediate release composition is administered to the patient about 8 hours after the ADDERALL®. 
     
     
         35 . The composition of  claim 33 , wherein the composition provides an about bioequivalent plasma level of l-amphetamine in the patient compared to an equivalent amount of at least one amphetamine salt contained in the combination of ADDERALL® and an immediate; release amphetamine salt composition when the immediate release composition is administered to the patient about 8 hours after the ADDERALL®. 
     
     
         36 . (canceled) 
     
     
         37 . A sustained release pharmaceutical composition comprising:
 (a) at least one amphetamine salt,   (b) a sustained release coating, and   (c) a delayed release coating,   
       wherein the at least one amphetamine salt is released about 4 to about 6 hours after oral administration to a patient. 
     
     
         38 . The pharmaceutical composition of  claim 37 , wherein the sustained release coating is external to the delayed release coating. 
     
     
         39 . The pharmaceutical composition of  claim 37 , wherein about 50% of the at least one amphetamine salt is released at about six hours at a pH of about 7.5. 
     
     
         40 . The pharmaceutical composition of  claim 37 , comprising:
 (a) at least one amphetamine salt layered onto a core,   (b) a delayed release coating layered onto the at least one amphetamine salt;   (c) a sustained release coating layered onto the delayed release coating, and   (d) a protective coating layered onto the sustained release coating.   
     
     
         41 . The pharmaceutical composition of  claim 37 , wherein the at least one amphetamine salt comprises dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine aspartate monohydrate, amphetamine sulfate, and mixtures thereof. 
     
     
         42 . The pharmaceutical composition of  claim 37 , wherein the delayed release coating is selected from the group consisting of: cellulose acetate phthalate; cellulose acetate trimellitate; hydroxypropyl methylcellulose phthalate; polyvinyl acetate phthalate; carboxymethylethylcellulose; co-polymerized methacrylic acid/methacrylic acid methyl esters, EUDRAGIT® L12.5, L100; EUDRAGIT® S12.5, S100; and EUDRAGIT® FS30 D. 
     
     
         43 . The pharmaceutical composition of  claim 37 , wherein the sustained release coating is selected from the group consisting of: polyvinyl acetate, cellulose acetate, cellulose acetate butyrate, cellulose acetate propionate, ethyl cellulose, fatty acids and esters thereof, alkyl alcohols, waxes, zein (prolamine from corn), EUDRAGIT® RS and RL30D, EUDRAGIT® NE30D, AQUACOAT®, SURELEASE®, KOLLICOAT® SR30D, and cellulose acetate latex. 
     
     
         44 . The pharmaceutical composition of  claim 42 , wherein the delayed release coating is EUDRAGIT® FS-30D. 
     
     
         45 . The pharmaceutical composition of  claim 43 , wherein the sustained release coating is SURELEASE®. 
     
     
         46 . The pharmaceutical composition of  claim 37 , comprising 12.5 mg of the at least one amphetamine salt; wherein the composition has an d-amphetamine AUC (0-inf) of about 367 ng·hr/mL. 
     
     
         47 . The pharmaceutical composition of  claim 37 , comprising 12.5 mg of the at least one amphetamine salt; wherein the composition has an l-amphetamine AUC (0-inf) of about 125 ng·hr/mL. 
     
     
         48 . The pharmaceutical composition of  claim 37 , wherein the composition comprises 18.75 mg, 25 mg, 31.25 mg, 37.5 mg, or 50 mg of at least one amphetamine salt and has an AUC (0-inf) that is linearly proportional to the AUC (0-inf) for a 12.5 mg at least one amphetamine salt composition. 
     
     
         49 . The pharmaceutical composition of  claim 37 , comprising 12.5 mg of the at least one amphetamine salt; wherein the composition has an d-amphetamine Cmax of about 18.67 ng/mL. 
     
     
         50 . The pharmaceutical composition of  claim 37 , comprising 12.5 mg of the at least one amphetamine salt; wherein the composition has an l-amphetamine Cmax of about 5.64 ng/mL. 
     
     
         51 . The pharmaceutical composition of  claim 37 , wherein the composition comprises 18.75 mg, 25 mg, 37.5 mg, or 50 mg of at least one amphetamine salt and has a Cmax that is linearly proportional to the Cmax for a 12.5 mg at least one amphetamine salt composition. 
     
     
         52 . The pharmaceutical composition of  claim 37 , comprising 12.5 mg of the at least one amphetamine salt; wherein the composition has an d-amphetamine Tmax of about 8.83 hours. 
     
     
         53 - 58 . (canceled)