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Claims for Patent: 6,984,403

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Claims for Patent: 6,984,403

Title:Azithromycin dosage forms with reduced side effects
Abstract:The present invention is related to an oral dosage form comprising an effective amount of an alkalizing agent and an azithromycin multiparticulate wherein said multiparticulate comprises azithromycin, a glyceride which comprises glyceryl monobehenate, glyceryl dibehenate, glyceryl tribehenate, or a mixture thereof and a poloxamer. Typically, the oral dosage form includes any suitable oral dosing means such as a powder for oral suspension, a unit dose packet or sachet, a tablet or a capsule.
Inventor(s): Hagen; Timothy A. (East Lyme, CT), Lo; Julian B. (Old Lyme, CT), Thombre; Avinash G. (East Lyme, CT), Herbig; Scott M. (East Lyme, CT), Appel; Leah Elizabeth (Bend, OR), Crew; Marshall David (Bend, OR), Friesen; Dwayne Thomas (Bend, OR), Lyon; David Keith (Bend, OR), McCray; Scott Baldwin (Bend, OR), West; James Blair (Bend, OR)
Assignee: Pfizer Inc. (New York, NY)
Application Number:10/763,340
Patent Claims: 1. An oral dosage form comprising: (a) an effective amount of an alkalizing agent; and (b) multiparticulates wherein said multiparticulates comprise (i) about 20% to about 75% azithromycin, and (ii) about 25% to about 80% of a glyceride which comprises glyceryl monobehenate, glyceryl dibehenate, glyceryl tribehenate or a mixture thereof; and (iii) a poloxamer.

2. An oral dosage form of claim 1 wherein the poloxamer comprises poloxamer 407.

3. An oral dosage form of claim 1 wherein the alkalizing agent comprises a bicarbonate, a phosphate, a metal hydroxide, a metal oxide or a combination thereof.

4. An oral dosage form of claim 3 wherein the alkalizing agent comprises tribasic sodium phosphate and magnesium hydroxide.

5. An oral dosage form of claim 3 further comprising about 250 mgA to about 7 gA of azithromycin.

6. An oral dosage form of claim 5 further comprising about 1.5 gA to about 4 gA of azithromycin.

7. An oral dosage form of claim 5 further comprising 1.8 to 2.2 gA of azithromycin.

8. An azithromycin oral dosage form, comprising: (a) at least about 200 mg of tribasic sodium phosphate; and (b) multiparticulates, wherein said multiparticulates comprise (i) azithromycin, (ii) a mixture of glyceryl monobehenate, glyceryl dibehenate and glyceryl tribehenate, and (iii) poloxamer 407, and wherein said dosage form contains about 1.5 gA to about 4 gA of azithromycin.

9. An oral dosage form of claim 8, further comprising at least about 100 mg of magnesium oxide.

10. An oral dosage form of claim 8, comprising: (a) 300 mg to 400 mg of tribasic sodium phosphate; (b) 200 mg to 300 mg of magnesium hydroxide; and (c) multiparticulates, wherein said multiparticulates comprise (i) azithromycin, (ii) a mixture of glyceryl monobehenate, glyceryl dibehenate and glyceryl tribehenate, and (iii) poloxamer 407, and wherein said dosage form contains about 1.5 gA to about 4 gA of azithromycin.

11. An oral dosage form of claim 8 further comprising 1.8 to 2.2 gA of azithromycin.

12. An oral dosage form of claim 11 wherein said azithromycin is azithromycin dihydrate.

13. An oral dosage form of claim 1 wherein said azithromycin is azithromycin dihydrate.

14. An oral dosage form of claim 3 wherein said azithromycin is at least 70 wt % crystalline.

15. An oral dosage form of claim 3 wherein said oral dosage form is a powder for oral suspension, a unit dose packet, an oral suspension, a tablet or a capsule.

16. A method for reducing the frequency of gastrointestinal side effects, associated with administering azithromycin to a mammal, comprising contiguously administering oral dosage form of claim 1 to said mammal wherein the frequency of gastrointestinal side effects is reduced as compared to the frequency experienced when administering an equal dose of azithromycin without said alkalizing agent.

17. A method of claim 16 wherein said mammal is a human.

18. A method of claim 17 further comprising administering between about 250 mgA and about 7 gA of azithromycin to said human.

19. A method of claim 18 wherein the azithromycin is administered in a single dose.

20. A method of claim 19 further comprising administering between about 1.5 and about 4 gA of azithromycin.

21. A method of claim 19 further comprising administering between about 1.5 and about 3 gA of azithromycin.

22. A method of claim 19 further comprising administering between 1.8 and 2.2 gA of azithromycin to said human in a single dose.

23. A method of claim 17 further comprising administering between 30 mgA/kg and 90 mgA/kg of azithromycin to a human, wherein said human is a child weighing 30 kg or less.

24. A method of claim 23 wherein the azithromycin is administered in a single dose.

25. A method of claim 24 further comprising administering between 45 mgA/kg and 75 mgA/kg of azithromycin to a child weighing 30 kg or less.

26. A method of claim 24 further comprising administering about 60 mgA/kg of azithromycin to a child weighing 30 kg or less.

27. A method of claim 16 wherein the alkalizing agent further comprises a bicarbonate, a phosphate, a metal hydroxide, a metal oxide, or a combination thereof.

28. A method of claim 27 wherein the alkalizing agent comprises tribasic sodium phosphate and magnesium hydroxide.

29. A method of claim 27 wherein said azithromycin comprises an immediate release form of azithromycin.

30. A method of claim 27 wherein said azithromycin comprises a sustained release form of azithromycin.

31. A method of claim 27 wherein said azithromycin comprises azithromycin multiparticulates.

32. A method of claim 31 wherein said azithromycin multiparticulates comprise: (a) azithromycin; and (b) a pharmaceutically acceptable carrier.

33. A method of treating a bacterial or protozoal infection in a mammal in need thereof comprising administering to said mammal a single dose of an oral dosage form of claim 1.

34. A method of claim 33 wherein said mammal is a human.

35. A method of claim 34 further comprising administering between about 250 mgA and about 7 gA of azithromycin to said human.

36. A method of claim 35 wherein the azithromycin is administered in a single dose.

37. A method of claim 36 further comprising administering between about 1.5 and about 4 gA of azithromycin to said human.

38. A method of claim 36 further comprising administering between about 1.5 and about 3 gA of azithromycin to said human.

39. A method of claim 36 further comprising administering 1.8 gA to 2.2 gA of azithromycin to said human.

40. A method of claim 34 further comprising administering between 30 mgA/kg and 90 mgA/kg of azithromycin to said human, wherein said human is a child weighing 30 kg or less.

41. A method of claim 34 wherein the azithromycin is administered in a single dose.

42. A method of claim 41 further comprising administering between 45 mgA/kg and 75 mgA/kg of azithromycin to a child weighing 30 kg or less.

43. A method of claim 41 further comprising administering 60 mgA/kg of azithromycin to a child weighing 30 kg or less.

44. A method of claim 33 wherein the alkalizing agent comprises a bicarbonate, a phosphate, a metal hydroxide, a metal oxide, or a combination thereof.

45. A method of claim 44 wherein the alkalizing agent comprises tribasic sodium phosphate.

46. A method of claim 45 wherein the alkalizing agent further comprises magnesium hydroxide.

47. A method of claim 44 wherein said azithromycin comprises an immediate release form of azithromycin.

48. A method of claim 44 wherein said azithromycin comprises a sustained release form of azithromycin.
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