Paneled capsule shells for release of pharmaceutical compositions

• US 20090110721A1
• Filed: 10/15/2008
• Published: 04/30/2009
• Est. Priority Date: 10/15/2007
• Status: Active Grant

• Current Assignee: Capsugel Belgium NV (Lonza Group AG)
• Original Assignee: Capsugel Belgium NV (Lonza Group AG)
• Inventors: McAllister, Stephen Mark
• Granted Patent: US 8,454,992 B2
• Time in Patent Office: Days
• US Class Current: 424/451
• CPC Class Codes: A61J 3/071 into the form of telescopically engaged two-piece capsules
• CPC Class Codes: A61J 3/077 Manufacturing capsule shells
• CPC Class Codes: A61K 9/4808 characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release capsules filled with granules or microparticles A61K9/16; filled with microcapsules or coated microparticles A61K9/50; with mixture of different granules, microcapsules, (coated) microparticles A61K9/5084

Abstract

Capsule shells for use in multi-part dosage forms have generally cylindrical shell members with a snap fit component on an interior surface adjacent an open end, for connection to a linker part of the dosage form. The shell member also has a plurality of spaced apart integrally formed thin (relative to circumferentially adjacent shell member portions) panels located adjacent a closed shell member end, for preferential dissolution and release of pharmaceutical compositions from the shell member interior. The ratio of the thickness of the panels to the thickness of the shell member ranges from about 0.2 to about 0.6. The panels can be integrally formed together with the shell member as reliefs or depressions on the inner surface of the shell member by injection molding, and panel thicknesses as thin as about 0.1 mm can be achieved,

Claims

1. Capsule shell for connection to a linker in multipart dosage form, the capsule shell comprising:

a generally cylindrical shell member having an interior, a longitudinal axis, an outer surface, a closed end, and an open end, the open end being configured to connect to the linker, and the closed end being generally rounded; and

one or more panels adjacent the closed end and circumferentially spaced apart about the axis, each of the panels being integral with the shell member and configured to have a thickness thinner than a thickness of an adjacent shell member portion.

2. The capsule shell as in claim 1, wherein at least one of the panels has a circumferential width that decreasingly tapers in the longitudinal direction toward the closed end.

3. The capsule shell as in claim 1, wherein at least one of the panels extends along only a part of a longitudinal length of the shell member.

4. The capsule shell as in claim 1, having three or more panels.

5. The capsule shell as in claim 1, wherein at least one of the panels is configured to provide preferential dissolution relative to the adjacent shell member portion, to release a substance from the shell member interior past the outer surface.

6. The capsule shell as in claim 1 having a plurality of panels circumferentially spaced equidistantly apart about the axis.

7. The capsule shell as in claim 1, wherein at least one of the panels has a generally trapezoidal shape.

8. The capsule shell as in claim 7, wherein the at least one trapezoidal panel has curved major and minor base edges, and axially tapered opposing side edges.

9. The capsule shell as in claim 1, wherein at least one panel has a generally triangular shape.

10. The capsule shell as in claim 1, wherein the shell member and panels are formed of the same material.

12. The capsule shell as in claim 1, wherein the shell member and panels are formed simultaneously by molding.

13. The capsule shell as in claim 12, wherein the shell member and panels are injection molded.

14. The capsule shell of as in claim 13, wherein the shell member and panels are configured for release from a mold along the axial direction.

15. The capsule shell as in claim 1, wherein the shell member further includes a protuberance on an inner shell member surface at the closed end, and wherein the panels terminate adjacent the protuberance.

16. The capsule shell as in claim 1, wherein one or more snap fit elements are provided on an inner shell member surface adjacent the open end, said snap fit elements for engaging complementary snap fit elements on the linker.

17. The capsule shell as in claim 16, wherein the snap fit elements are selected from circumferential grooves, ridges, groove segments, and ridge segments.

18. The capsule shell as in claim 1, wherein at least one of the panels is positioned substantially entirely at the shell rounded end.

19. The capsule shell as in claim 1, wherein at least one of the panels has a top surface substantially continuous with the shell member outer surface.

20. The capsule shell as in claim 1, wherein at least one of the panels is a relief or depression formed in an inner surface of the shell member.

21. The capsule shell as in claim 1, wherein a ratio of the panel thickness to the adjacent shell member portion thickness is in a range of about 0.2 to about 0.6.

22. The capsule shell as in claim 1, wherein the shell member and integral panels are formed by injection molding, wherein a thickness of the adjacent shell member portions is about 0.5 mm.

23. The capsule shell as in claim 1, wherein the shell member and integral panels are formed by injection molding, and wherein the thickness of at least one of the panels is about 0.1 mm.

24. The capsule shell as in claim 22, wherein the shell member and integral panels are formed by injection molding, and wherein the thickness of at least one of the panels is about 0.2-0.3 mm.

25. The capsule shell as in claim 22, wherein the shell member and integral panels are formed by injection molding, and wherein the thickness of at least one of the panels is about 0.1 mm.

11. The capsule shell as in claim 11, wherein the material is selected from the group consisting of hydroxypropyl cellulose, hydroxypropyl methylcellulose acetate succinate, polyvinyl alcohol, hydroxypropyl methyl cellulose, and acrylic or methacrylic acid-based polymers.

26. An injection molded capsule shell for use as part of a dosage form, the capsule shell comprising:

a generally cylindrical shell member having an interior, a longitudinal axis, an inner surface, an outer surface, a closed end, and an open end, the open end being configured to connect to another part of the dosage form, and the closed end being generally rounded; and

one or more panels positioned within the rounded closed end and circumferentially spaced apart about the axis, the panels comprising reliefs or depressions in the inner surface, the panels being formed by injection molding with the shell member and configured to have a thickness thinner than a thickness of a circumferentially adjacent shell member portion.

27. The injection molded capsule shell as in claim 26, wherein the panel thickness is greater than or equal to about 0.1 mm.

28. The injection molded capsule shell as in claim 26, wherein the panels each terminate at a location proximate an entry point of the capsule shell material into the mold cavity.

29. The injection molded capsule shell as in claim 27, wherein the thickness of the shell member is about 0.5 mm.

30. The injection molded capsule shell as in claim 26, further including a protuberance positioned on the inner shell member surface at a juncture of the axis and the closed end, the thickened portion interconnecting adjacent shell member portions.

31. The injection molded capsule shell as in claim 26 wherein the other dosage form part is a linker part.

32. The injection molded capsule shell as in claim 26 having a linker part of the dosage form attached to the open end.