Oral pulsed dose drug delivery system
DC CAFCFirst Claim
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1. A pharmaceutical composition for 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 delayed pulsed enteric release, wherein said enteric release coating releases essentially all of said one or more pharmaceutically active amphetamine salts coated with said enteric coating within about 60 minutes after initiation of said delayed pulsed enteric release release;
wherein the pharmaceutically active amphetamine salts in (a) and (b) comprise mixed amphetamine salts.
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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 of a number of beads in a dosage form, including either capsule, tablet, or sachet method for administering the beads.
47 Citations
25 Claims
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1. A pharmaceutical composition for delivery of one or more pharmaceutically active amphetamine salts, comprising:
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(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 delayed pulsed enteric release, wherein said enteric release coating releases essentially all of said one or more pharmaceutically active amphetamine salts coated with said enteric coating within about 60 minutes after initiation of said delayed pulsed enteric release release;
wherein the pharmaceutically active amphetamine salts in (a) and (b) comprise mixed amphetamine salts. - View Dependent Claims (2, 3, 4, 5, 6, 7)
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8. A pharmaceutical composition for delivery of at least one amphetamine salt, comprising:
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(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 pulse enteric 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), wherein said enteric release coating releases essentially all of said one or more pharmaceutically active amphetamine salts coated with said enteric coating within about 60 minutes after initiation of said delayed pulsed enteric release;
wherein the pharmaceutically active amphetamine salts comprise mixed amphetamine salts in (a) and (b) comprise mixed amphetamine salts. - View Dependent Claims (9, 10, 11, 12)
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13. A pharmaceutical composition for delivering one or more pharmaceutically active amphetamine salts comprising:
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(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 delayed pulsed enteric release, wherein said enteric release coating releases essentially all of said one or more pharmaceutically active amphetamine salts coated with said enteric coating within about 60 minutes after initiation of said delayed pulsed enteric release; and
(c) a protective layer over the enteric release coating. - View Dependent Claims (14, 15, 16, 17, 25)
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18. A pharmaceutical composition for delivery of one or more pharmaceutically active amphetamine salts comprising:
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(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 delayed pulsed enteric release, wherein said enteric release coating releases said one or more pharmaceutically active amphetamine salts coated with said enteric coating within about 60 minutes after initiation of said delayed pulsed enteric release; and
(c) a protective layer between the at least one pharmaceutically active amphetamine salt and the enteric release coating. - View Dependent Claims (19, 20, 21, 22, 23, 24)
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Specification