Composite dosage forms having an inlaid portion

• US 7,807,197 B2
• Filed: 09/28/2002
• Issued: 10/05/2010
• Est. Priority Date: 09/28/2002
• Status: Active Grant

• Current Assignee: Johnson & Johnson Consumer Inc. (Johnson & Johnson)
• Original Assignee: McNeil-PPC Incorporated (Johnson & Johnson)
• Inventors: Sowden, Harry S., Lee, Der-Yang, Thomas, Martin
• Primary Examiner(s): Hartley; Michael G
• Assistant Examiner(s): Ebrahim; Nabila G
• Application Number:
  US10/476,388
• Publication Number:
  US 20040156902A1
• Time in Patent Office: 2,929 Days
• Field of Search: 424/467
• US Class Current: 424/473
• CPC Class Codes: A61K 9/2072 characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms A61K9/0004, A61K9/0056, A61K9/0065 take precedence
• CPC Class Codes: A61K 9/2086 Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat active cores with a complete drug-free outer coat A61K9/28
• CPC Class Codes: A61K 9/209 containing drug in at least two layers or in the core and in at least one outer layer
• CPC Class Codes: A61K 9/2095 Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing mechanical aspects A61J3/00
• CPC Class Codes: A61K 9/2893 Tablet coating processes mechanical aspects A61J3/06
• CPC Class Codes: B30B 11/34 for coating articles, e.g. tablets
• CPC Class Codes: B30B 15/0082 Dust eliminating means; Mould or press ram cleaning means

Abstract

A dosage form comprises at least one active ingredient, a first portion which comprises an exterior surface and one or more cavities defining at least one interior surface having indentations and an exterior surface, and a second molded portion which is inlaid into the cavities of the first portion and has an exterior surface. The first and second portions are in contact at an interface, the second portion comprises a solidified thermoplastic material, and the second portion resides substantially conformally upon the indentations of the first portion. In another embodiment, a dosage form comprises at least one active ingredient, a core having an outer surface and a shell residing on at least a portion of the core outer surface, wherein the shell comprises a first shell portion and a second molded shell portion which is inlaid into the first shell portion. In another embodiment, a dosage form comprises at least one active ingredient, a core, and a shell having a first molded shell portion which is discontinuous, and a second molded shell portion which is continuous, such that the discontinuities of the first shell portion are due to the presence of the second molded shell portion, and the first and second shell portions are compositionally different.

Claims

1. A dosage form comprising at least one active ingredient, a first portion which comprises an exterior surface and one or more cavities defining at least one interior surface having indentations, and a second molded portion which is inlaid into the cavities of the first portion and has an exterior surface, wherein the first and second portions are in contact at an interface, the second portion comprises a solidified thermoplastic material, and the second portion resides substantially conformally upon the indentations.

2. The dosage form of claim 1, wherein the second molded portion is substantially free of pores having a diameter of 0.5 to 5.0 microns.

3. The dosage form of claim 1, wherein the first and second portions are in intimate contact at the interface.

4. The dosage form of claim 1, wherein the first portion is a compressed tablet.

5. The dosage form of claim 1, wherein the first portion is a molded tablet.

6. The dosage form of claim 1 wherein the first portion comprises an intagliation and the second portion resides in the intagliation.

7. The dosage form of claim 1 wherein the exterior surface of the second portion is flush with the exterior surface of the first portion.

8. The dosage form of claim 1 wherein the exterior surface of the second portion is raised with respect to the exterior surface of the first portion.

9. The dosage form of claim 1 wherein the first portion consists essentially of a single homogeneous layer.

10. The dosage form of claim 1, in which the second molded portion comprises at least one active ingredient.

11. The dosage form of claim 1, in which the first portion has a first color and the inlaid second portion has a second color.

12. The dosage form of claim 1, in which the first portion comprises a first active ingredient and the inlaid second portion comprises a second active ingredient which may be the same or different than the first active ingredient.

13. The dosage form of claim 1, in which the first and second portions together provide a prearranged pattern.

14. The dosage form of claim 1, in which the first portion comprises a microelectronic device.

15. The dosage form of claim 1, in which the interior surface of one or more cavities in the first portion has a draft angle having a value less than zero.

16. The dosage form of claim 1, in which the interface is substantially coextensive with the interior surface.

17. The dosage form of claim 1, in which the first portion is discontinuous and the second portion is continuous.

18. A dosage form comprising at least one active ingredient, a core having an outer surface and a shell residing on at least a portion of the core outer surface, wherein the shell comprises a first shell portion having one or more cavities with interior surfaces and a second molded shell portion which is inlaid into the one or more cavities in the first shell portion, and the first and second shell portions are in contact at an interface and in which the interior surface of one or more cavities in the first portion has a draft angle having a value less than zero.

19. The dosage form of claim 18, in which the shell has an outer surface and the second molded shell portion extends from the outer surface of the core to the outer surface of the shell.

20. The dosage form of claim 18, in which the first and second shell portions are discontinuous.

21. The dosage form of claim 18, in which the first shell portion has a first color and the second shell portion has a second color.

22. The dosage form of claim 18, in which the core comprises a compressed powder.

23. The dosage form of claim 18, in which the core comprises an insert.

24. The dosage form of claim 23, in which the insert comprises an active ingredient.

25. The dosage form of claim 24, in which one or more of the core, the inlaid portion or the insert comprise an active ingredient.

26. The dosage form of claim 18, in which the core comprises a microelectronic device.

27. The dosage form of claim 23, in which the insert comprises a microelectronic device.

28. The dosage form of claim 18, in which either the first shell portion, second shell portion, or both have a textured outer surface.

29. The dosage form of claim 18, in which the outer surface of the shell contains a prearranged pattern.

30. The dosage form of claim 18, in which the shell comprises one or more openings therein.

31. The dosage form of claim 18, in which the outer surface of the shell is substantially smooth.

32. The dosage form of claim 18, in which the shell contains indentations, letters, symbols or a pattern.

33. The dosage form of claim 18, in which the first shell portion contains indentations, letters, symbols or a pattern.

34. The dosage form of claim 18, in which the second shell portion contains indentations, letters, symbols or a pattern.

35. The dosage form of claim 18, in which the first shell portion, second shell portion or both contain raised protrusions in the form of letters, symbols or a pattern.

36. The dosage form of claim 18, in which the inlaid portion is substantially free of pores having a diameter of 0.5-5.0 microns.

40. The dosage form of claim 18, wherein the cavities define a plurality of side walls for receiving the inlaid portion, and the side walls have a draft angle less than zero.

41. The dosage form of claim 18, wherein the area of at least one cross-section of the second molded inlaid portion is greater than the cross-sectional area of the cavity at the surface of the first portion.

37. A dosage form comprising at least one active ingredient, a core, and a shell having a first molded shell portion which is discontinuous, and a second molded shell portion which is continuous, such that the discontinuities of the first shell portion are due to the presence of the second molded shell portion, and the first and second shell portions are compositionally different, in which the first molded shell portion and second molded shell portions are substantially free of pores having a diameter of 0.5-5.0 microns.

38. The dosage form of claim 37, wherein the first and second shell portions comprise a solidified thermoplastic material.

39. The dosage form claim 37, wherein the exterior surfaces of the first and second shell portions are coplanar.