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Details for Patent: 7,108,865

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Details for Patent: 7,108,865

Title:Controlled-release dosage forms of azithromycin
Abstract: A controlled-release dosage form of azithromycin having an improved side effect profile; a process for preparing the dosage form; and a method of treating a microbial infection, comprising administering azithromycin in such a controlled-release dosage form to a mammal, including a human patient, in need of such treatment.
Inventor(s): Curatolo; William J. (Niantic, CT), Friedman; Hylar L. (Brattleboro, VT), Korsmeyer; Richard W. (Old Lyme, CT), LeMott; Steven R. (East Lyme, CT)
Assignee: Pfizer Inc (New York, NY)
Filing Date:Mar 09, 2001
Application Number:09/803,628
Claims:1. A controlled release dosage form for oral administration to a human comprising a therapeutically effective amount of azithromycin and one or more additional components, said dosage form controlling the azithromycin release rate into the gastrointestinal tract of said human, thereby decreasing the incidence or severity of gastrointestinal side effects, said dosage form releasing the bulk of its azithromycin in a portion of the gastrointestinal tract distal to the duodenum.

2. The controlled release dosage form of claim 1 that releases 80% or more of the azithromycin in the portion of the gastrointestinal tract distal to the duodenum.

3. The dosage form of claim 2 that release no more than about 10% of the azithromycin in the stomach.

4. The dosage form of claim 2 comprising a plurality of particles, said particles having a diameter of from about 50 micrometers to about 3 millimeters.

5. The dosage form of claim 4 wherein said particles comprise azithromycin and a pharmaceutically acceptable carrier or diluent.

6. The dosage form of claim 3 comprising a plurality of particles, said particles having a diameter of from about 50 micrometers to about 400 micrometers.

7. The dosage form of claim 3 comprising a plurality of particles, said particles having a diameter of from about 50 micrometers to about 3 millimeters.

8. The dosage form of claim 2 in the form of a capsule, a tablet, a suspension or a sachet.

9. The dosage form of claim 4 in the form of a sachet.

10. The dosage form of claim 4 wherein said particles further comprise a matrix material.

11. The dosage form of claim 10 wherein said matrix material is selected from the group consisting of waxes, cellulose and derivatives thereof, polymers; and mixtures thereof.

12. The dosage form of claim 11 further comprising a release-modifying agent.

13. The dosage form of claim 3 comprising a hydrogel.

14. The dosage form of claim 1 or 2 comprising a plurality of particles, said particles having a diameter of from about 50 micrometers to about 3 millimeters and said particles further comprising a core, said core having a first surface coating thereon.

15. The dosage form of claim 14 wherein said core comprises azithromycin and a pharmaceutically acceptable vehicle, carrier or diluent.

16. The dosage form of claim 14 wherein said first surface coating comprises a sustained release coating.

17. The dosage form of claim 14 further comprising a second surface coating on said core.

18. The dosage form of claim 17 wherein said second surface coating comprises a sustained release coating.

19. The dosage form of claim 17 wherein said second surface coating comprises an enteric coating.

20. The dosage form of claim 1 comprising a matrix multiparticulate.

21. The dosage form of claim 20 wherein said matrix multiparticulate comprises a plurality of azithromycin-containing particles, each particle comprising a mixture of azithromycin with one or more excipients, said mixture forming the matrix limiting the release rate of the azithromycin into the gastrointestinal tract.

22. The dosage form of claim 20 wherein said release rate is such that no more than 70% of the azithromycin is released within about one-half hour from time of ingestion.

23. The dosage form of claim 1 wherein the azithromycin is in the form of a pharmaceutically acceptable salt.

24. The dosage form of claim 1 wherein the azithromycin is in an anhydrous form.

25. The dosage form of claim 1 wherein the azithromycin is in a hydrated form.

26. The dosage form of claim 23 wherein the azithromycin is in a dihydrate form.

27. The dosage form of claim 1 wherein said azithromycin is present in an amount of from about 1 gram to about 7 grams.

28. The dosage form of claim 25 wherein said azithromycin is present in an amount of from about 1.5 grams to about 4 grams.
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