Oral pulsed dose drug delivery system

Abstract

A multiple pulsed dose drug delivery system for pharmaceutically active amphetamine salts, comprising an immediate-release component and an enteric delayed-release component wherein (1) the enteric release coating has a defined minimum thickness and/or (2) there is a protective layer between the pharmaceutically active amphetamine salt and the enteric release coating and/or (3) there is a protective layer over the enteric release coating. 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 . A pharmaceutical composition for enteric delivery of one or more pharmaceutically active amphetamine salts comprising: 
 (a) one or more pharmaceutically active amphetamine salts covered with an immediate release coating; and    (b) one or more pharmaceutically active amphetamine salts that are covered with an enteric release coating that provides for pulsed enteric release wherein the enteric release coating has a thickness of at least 25μ.    
     
     
         2 . The pharmaceutical composition of  claim 1  wherein the one or more pharmaceutically active amphetamine salts are coated onto a core.  
     
     
         3 . The pharmaceutical composition of  claim 1  wherein the one or more pharmaceutically active amphetamine salts are incorporated into a core.  
     
     
         4 . The pharmaceutical composition of  claim 1 , wherein the immediate release and enteric release portions of the composition are present on a single core.  
     
     
         5 . The pharmaceutical composition of  claim 1 , wherein the immediate release and enteric release components are present on different cores.  
     
     
         6 . A pharmaceutical composition for enteric delivery of one or more pharmaceutically active amphetamine salts comprising: 
 (a) one or more pharmaceutically active amphetamine salts covered with an immediate release coating;    (b) one or more pharmaceutically active amphetamine salts that are covered with an enteric release coating that provides for pulsed enteric release; and    (c) a protective layer between the at least one pharmaceutically active amphetamine salt and the enteric release coating.    
     
     
         7 . The pharmaceutical composition of  claim 6  wherein the one or more pharmaceutically active amphetamine salts are coated onto a core.  
     
     
         8 . The pharmaceutical composition of  claim 6  wherein the one or more pharmaceutically active amphetamine salts are incorporated into a core.  
     
     
         9 . The pharmaceutical composition of  claim 6  wherein the enteric release coating has a minimum thickness of 25μ.  
     
     
         10 . A pharmaceutical composition for delivering one or more pharmaceutically active amphetamine salts comprising: 
 (a) one or more pharmaceutically active amphetamine salts covered with an immediate release coating;    (b) one or more pharmaceutically active amphetamine salts that are covered with an enteric release coating that provides for pulsed enteric release; and    (c) a protective layer over the enteric release coating.    
     
     
         11 . The pharmaceutical composition of  claim 10  wherein the one or more pharmaceutically active amphetamine salts are coated onto a core.  
     
     
         12 . The pharmaceutical composition of  claim 10  wherein the one or more pharmaceutically active amphetamine salts are incorporated into a core.  
     
     
         13 . The pharmaceutical composition of  claim 10 , wherein the immediate release and enteric release portions of the composition are present on a single core.  
     
     
         14 . The pharmaceutical composition of  claim 10 , wherein the immediate release and enteric release components are present on different cores.  
     
     
         15 . A pharmaceutical composition for delivery of at least one amphetamine salt, comprising: 
 (a) at least one pharmaceutically active amphetamine salt covered with an immediate release coating; and    (b) at least one pharmaceutically active amphetamine salt covered with an enteric release coating, said component (a) providing for an immediate release of amphetamine salt to provide a first blood level of amphetamine salt and component (b) providing a delayed pulsed-release of amphetamine salt that increases the blood level of amphetamine salt to a second level that is greater than the first level provided by component (a).    
     
     
         16 . The pharmaceutical composition of  claim 15  wherein the enteric release coating has a minimum thickness of 25 microns.  
     
     
         17 . The pharmaceutical composition of  claim 15  wherein the delayed pulsed-release is from 4 to 6 hours after administration of the pharmaceutical composition.  
     
     
         18 . The pharmaceutical composition of  claim 15  wherein the delayed pulsed-release, releases the amphetamine salt in about 30 to 60 minutes after initiation of the release.