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Last Updated: October 31, 2020

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Claims for Patent: 9,173,857

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Summary for Patent: 9,173,857
Title: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.
Inventor(s): Shojaei; Amir (Phoenixville, PA), Read; Stephanie (Philadelphia, PA), Couch; Richard A. (Bryn Mawr, PA), Hodgkins; Paul (Exton, PA)
Assignee: Shire LLC (Florence, KY)
Application Number:14/498,130
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,173,857
Patent Claims: 1. A method for treating attention deficit hyperactivity disorder (ADHD) which comprises: administering to a patient in need thereof, a pharmaceutical composition comprising: (a) an immediate release bead comprising at least one amphetamine salt; (b) a first delayed release bead comprising at least one amphetamine salt; and (c) a second delayed release bead comprising at least one amphetamine salt; wherein the first delayed release bead provides pulsed release of the at least one amphetamine salt and the second delayed release bead provides sustained release of the at least one amphetamine salt; wherein the second delayed release bead comprises at least one amphetamine salt layered onto or incorporated into a core; a delayed release coating layered onto the amphetamine core; and a sustained release coating layered onto the delayed release coating, wherein the sustained release coating is pH-independent; and wherein the first delayed release bead and the second delayed release bead comprise an enteric coating.

2. The method of claim 1, wherein the enteric coating is pH dependent.

3. The method of claim 1, wherein the first delayed release bead and the second delayed release bead comprise different enteric coatings.

4. The method of claim 1, wherein the first delayed release bead and the second delayed release bead comprise the same enteric coating.

5. The method of claim 1, wherein administration of a 37.5 mg dose of the pharmaceutical composition to a human patient results in a d-amphetamine C.sub.max of about 50 ng/ml.

6. The method of claim 1, wherein the d-amphetamine area under the curve from time 0 to the last measured time (AUC.sub.0-last) after administration of a 37.5 mg dose of the pharmaceutical composition to a human patient is about 1058 nghr/ml.

7. The method of claim 1, wherein the d-amphetamine area under the curve from time 0 to time infinity (AUC.sub.0-inf) after administration of a 37.5 mg dose of the pharmaceutical composition to a human patient is about 1085 nghr/ml.

8. The method of claim 1, wherein the d-amphetamine T.sub.max is about 8.2 hours after administration of a 37.5 mg dose of the pharmaceutical composition to a human patient.

9. The method of claim 1, wherein the l-amphetamine C.sub.max after administration of a 37.5 mg dose of the pharmaceutical composition to a human patient is about 15 ng/ml.

10. The method of claim 1, wherein the l-amphetamine area under the curve from time 0 to the last measured time (AUC.sub.0-last) after administration of a 37.5 mg dose of the pharmaceutical composition to a human patient is about 354 nghr/ml.

11. The method of claim 1, wherein the l-amphetamine area under the curve from time 0 to time infinity (AUC.sub.0-inf) after administration of a 37.5 mg dose of the pharmaceutical composition to a human patient is about 373 nghr/ml.

12. The method of claim 1, wherein the l-amphetamine T.sub.max is about 8.4 hours after administration of a 37.5 mg dose of the pharmaceutical composition to a human patient.

13. The method of claim 1, wherein the at least one amphetamine salt is coated onto a core.

14. The method of claim 1, wherein the at least one amphetamine salt is incorporated into a core.

15. The method of claim 1, which further comprises a protective layer over at least one enteric coating.

16. The method of claim 1, which further comprises a protective layer between the amphetamine salt and at least one enteric coating.

17. The method of claim 1, wherein the at least one amphetamine salt is selected from the group consisting of dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine aspartate monohydrate, amphetamine sulfate, and mixtures thereof.

18. The method of claim 17, wherein the at least one amphetamine salt is a mixture of dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine aspartate monohydrate, and amphetamine sulfate.

19. The method of claim 1, wherein the composition does not exhibit a food effect.

20. The method of claim 1, wherein the amount of at least one amphetamine salt is about 12.5 mg.

21. The method of claim 1, wherein the amount of at least one amphetamine salt is about 18.75 mg.

22. The method of claim 1, wherein the amount of at least one amphetamine salt is about 25 mg.

23. The method of claim 1, wherein the amount of at least one amphetamine salt is about 31.25 mg.

24. The method of claim 1, wherein the amount of at least one amphetamine salt is about 37.5 mg.

25. The method of claim 1, wherein the amount of at least one amphetamine salt is about 43.75 mg.

26. The method of claim 1, wherein the amount of at least one amphetamine salt is about 50 mg.

27. The method of claim 1, wherein the amount of at least one amphetamine salt is about 62.5 mg.

28. The method of claim 1, wherein the amount of at least one amphetamine salt is about 75 mg.

29. The method of claim 1, wherein a protective coating is layered between the delayed release coating and the sustained release coating.

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