Modified Release Famciclovir Compositions

• US 20100136106A1
• Filed: 06/07/2006
• Published: 06/03/2010
• Est. Priority Date: 06/08/2005
• Status: Abandoned Application

• Current Assignee: Elan Pharma International Limited (Perrigo Company PLC)
• Original Assignee: Elan Pharma International Limited (Perrigo Company PLC)
• Inventors: Devane, John G., Fanning, Niall, Rekhi, Gurvinder Singh, Stark, Paul, Liversidge, Gary, Jenkins, Scott
• Application Number:
  US11/568,891
• Publication Number:
  US 20100136106A1
• Time in Patent Office: Days
• US Class Current: 424/456
• CPC Class Codes: A61K 9/5026 obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
• CPC Class Codes: A61K 9/5078 with drug-free core
• CPC Class Codes: A61K 9/5084 Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs tablets containing such a mixture A61K9/2077
• CPC Class Codes: A61P 31/20 for DNA viruses
• CPC Class Codes: A61P 31/22 for herpes viruses

Abstract

The invention relates to a multiparticulate modified release composition that, upon administration to a patient, delivers famciclovir in a bimodal, multimodal or continuous manner. The multiparticulate modified release composition comprises a first component and at least one subsequent component, the first component comprising a first population of active ingredient containing particles and the at least one subsequent component comprising a second population of active ingredient containing particles. The invention also relates to a solid oral dosage form containing such a multiparticulate modified release composition, and to a method for the treatment or suppression of viral infections.

Claims

1. A pharmaceutical composition comprising a first component of active ingredient-containing particles and at least one subsequent component of active ingredient-containing particles, wherein at least one of said components comprises famciclovir and at least one of said components further comprises a modified release coating, a modified release matrix material, or both, such that the composition, following oral delivery to a subject, delivers the active ingredient in a bimodal or multimodal manner.

2. The composition of claim 1 wherein each component comprises famciclovir-containing particles.

3. The composition of claim 1 wherein the composition comprises a first component of famciclovir-containing particles and one subsequent component of famciclovir-containing particles.

4. The composition of claim 3, wherein the first component comprises an immediate release component and the second component comprises a modified release component.

5. The composition of claim 1, wherein the active ingredient-containing particles are erodable.

6. The composition of claim 1, wherein at least one of said components further comprises a modified-release coating.

7. The composition of claim 1, wherein at least one of said components further comprises a modified-release matrix material.

8. The composition of claim 7, wherein said modified release matrix material is selected from the group consisting of hydrophilic polymers, hydrophobic polymers, natural polymers, synthetic polymers and mixtures thereof.

9. The composition of claim 8 wherein the famciclovir is released to the surrounding environment by erosion.

10. The composition of claim 9 wherein said composition further comprises an enhancer.

11. The composition of claim 8 comprising from about 0.1 mg to about 1 g of famciclovir.

23. A dosage form comprising the composition of claim 1.

24. The dosage form of claim 23 comprising a blend of active ingredient-containing particles contained within a hard gelatin or soft gelatin capsule.

25. The dosage form of claim 24, wherein the active ingredient-containing particles are in the form of mini-tablets and the capsule contains a mixture of said mini-tablets.

26. The dosage form of claim 25 in the form of tablet.

27. The dosage form of claim 26 wherein the famciclovir-containing particles are provided in a rapidly dissolving dosage form.

28. The dosage form of claim 26 wherein the tablet is a fast-melt tablet.

35. A method for treating a viral infection comprising the step of administering a therapeutically effective amount of the composition of claim 1.

36. The method of claim 35, wherein said virus is selected from the group consisting of HSV-1, HSV-2, VZV, hepatitis B, and Epstein Barr.

39. The composition of claim 1 wherein the modified-release coating comprises a pH-dependent polymer coating for releasing a pulse of the active ingredient in said patient following a time delay of about 6 to about 12 hours after administration of said composition to said patient.

40. The composition according to claim 39, wherein said polymer coating comprises methacrylate copolymers.

41. The composition according to claim 39, wherein the polymer coating comprises a mixture of methacrylate and ammoniomethacrylate copolymers in a ratio sufficient to achieve a pulse of the active ingredient following a time delay of at least about 6 hours.

42. The composition according to claim 41, wherein the ratio of methacrylate to ammonio methacrylate copolymers is approximately 1:

1.

12. A pharmaceutical composition comprising a first component of active ingredient-containing particles and at least one subsequent component of active ingredient-containing particles, wherein at least one of said components comprises famciclovir and at least one of said components further comprises a modified release coating, a modified release matrix material, or both, such that the composition, following oral delivery to a subject, delivers the active ingredient in a continuous manner.

13. The composition of claim 12 wherein each component comprises famciclovir-containing particles.

14. The composition of claim 12 wherein the composition comprises a first component of famciclovir-containing particles and one subsequent component of famciclovir-containing particles.

15. The composition of claim 14, wherein the first component comprises an immediate release component and the second component comprises a modified release component.

16. The composition of claim 12, wherein the active ingredient-containing particles are erodable.

17. The composition of claim 12, wherein at least one of said components further comprises a modified-release coating.

18. The composition of claim 12, wherein at least one of said components further comprises a modified-release matrix material.

19. The composition of claim 18, wherein said modified release matrix material is selected from the group consisting of hydrophilic polymers, hydrophobic polymers, natural polymers, synthetic polymers and mixtures thereof.

20. The composition of claim 19 wherein the famciclovir is released to the surrounding environment by erosion.

21. The composition of claim 20 wherein said composition further comprises an enhancer.

22. The composition of claim 19 comprising from about 0.1 mg to about 1 g of famciclovir.

29. A dosage form comprising the composition of claim 12.

30. The dosage form of claim 29 comprising a blend of active ingredient-containing particles contained within a hard gelatin or soft gelatin capsule.

31. The dosage form of claim 30, wherein the active ingredient-containing particles are in the form of mini-tablets and the capsule contains a mixture of said mini-tablets.

32. The dosage form of claim 31 in the form of tablet.

33. The dosage form of claim 32 wherein the famciclovir-containing particles are provided in a rapidly dissolving dosage form.

34. The dosage form of claim 32 wherein the tablet is a fast-melt tablet.

37. A method for treating a viral infection comprising the step of administering a therapeutically effective amount of the composition of claim 12.

38. The method of claim 37, wherein said virus is selected from the group consisting of HSV-1, HSV-2 and VZV, hepatitis B, and Epstein Barr.