Method of fabricating a banded prolonged release active agent dosage form

• US 20040067300A1
• Filed: 09/26/2003
• Published: 04/08/2004
• Est. Priority Date: 05/07/1998
• Status: Abandoned Application

• Current Assignee: David E. Edgren, Francisco Jao, Patrick S.-L. Wong, Yolanda M. Puga
• Original Assignee: David E. Edgren, Francisco Jao, Patrick S.-L. Wong, Yolanda M. Puga
• Inventors: Puga, Yolanda M., Edgren, David E., Wong, Patrick S.-L., Jao, Francisco
• Application Number:
  US10/672,791
• Publication Number:
  US 20040067300A1
• Time in Patent Office: Days
• US Class Current: 427/2.14
• 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 9/2095 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

Abstract

The present invention is directed to an active agent dosage form and methods of its fabrication which is useful for the prolonged delivery of an active agent formulation to a fluid environment of use. The active agent dosage form is a matrix that has on its surface one or more insoluble bands located in complementary grooves. The invention is also directed to articles of manufacture, methods and systems for fabricating the active agent dosage form.

Claims

1. A method of preparing an active agent dosage form for the prolonged delivery of the active agent, comprising:

forming a blank from an active agent formulation matrix so that the blank has a groove circumscribing a portion of the external surface of the blank; and

depositing insoluble material in the groove.

2. The method of claim 1, wherein said forming step comprises:

compressing the active agent formulation matrix; and

embossing the groove in the active agent formulation matrix so that it lies in a plane perpendicular to the longitudinal axis of the blank.

3. The method of claim 1, wherein said depositing step comprises:

using printing means to transfer insoluble material into the groove.

4. The method of claim 3, wherein the printing means comprises a rotatable wheel.

5. The method of claim 4, wherein the wheel has a substantially planar outer circumferential surface.

6. The method of claim 4, wherein the wheel has a concave outer circumferential surface.

7. The method of claim 1, wherein said depositing step is carried out so that the insoluble material does not extend above the external surface of the blank.

8. The method of claim 1, further comprising:

coating the blank with a water-soluble film.

9. A method for fabricating an active agent dosage form for the prolonged delivery of the active agent, comprising:

providing a blank, the blank comprising an active agent formulation matrix having a groove circumscribing a portion of the external surface of the blank;

orienting the blank with respect to a forming means for forming a band in the groove; and

forming the band in the groove using the forming means.

10. The method of claim 9, wherein said orienting step comprises:

registering the forming means with the groove.

11. The method of claim 10, wherein said registering step is carried out using a rotatable wheel.

12. The method of claim 9, wherein said forming step comprises:

using printing means to transfer insoluble material into the groove.

13. The method of claim 12, wherein the printing means comprises a rotatable wheel.

14. The method of claim 13, wherein the wheel has a substantially planar outer circumferential surface.

15. The method of claim 13, wherein the wheel has a concave outer circumferential surface.

16. The method of claim 9, wherein said forming step is carried out so that the band does not extend above the external surface of the blank.

17. The method of claim 9, further comprising:

coating the blank with a water-soluble film.

18. The method of claim 9, further comprising:

transporting the blank from a source of blanks to the forming means.

19. An active agent dosage form for the prolonged delivery of an active agent formulation to a fluid environment of use, comprising:

an active agent formulation matrix having a groove circumscribing a portion of the external surface thereof; and

an insoluble band disposed in said groove.

20. The active agent dosage form of claim 19, wherein said groove has a notch shape.

21. The active agent dosage form of claim 19, wherein said groove has a concave shape.

22. The active agent dosage form of claim 19, wherein the depth of said groove is between about 0.1 mm and about 3 mm.

23. The active agent dosage form of claim 19, wherein the width of said groove is between about 0.5 mm and 10 mm.

24. The active agent dosage form of claim 19, further comprising:

a water-soluble film coating.

25. The active agent dosage form of claim 19, wherein the dosage form comprises a plurality of grooves, each of said grooves circumscribing a portion of the external surface of the active agent formulation matrix.

26. The active agent dosage form of claim 25, wherein the dosage form comprises an insoluble band disposed in each of said grooves.

27. The active agent dosage form of claim 19, wherein said insoluble band comprises a latex of acrylate polymers.

28. The active agent dosage form of claim 27, wherein said acrylate polymers comprise copolymers of ethylacrylate and methylmethacrylate.

29. The active agent dosage form of claim 27, wherein said latex comprises an ethylacrylate methylmethacrylate 2:

1 copolymer latex.

30. A blank for formation of a pharmaceutical dosage form for controlled delivery of an active agent, comprising:

an active agent formulation matrix having a groove circumscribing a portion of the external surface of said matrix.

31. The blank of claim 30, wherein said groove has a notch shape.

32. The blank of claim 30, wherein said groove has a concave shape.

33. The blank of claim 30, wherein the depth of said groove is between about 0.1 mm and about 3 mm.

34. The blank of claim 30, wherein the width of said groove is between about 0.5 mm and 10 mm.

35. The blank of claim 30, wherein said active agent formulation matrix has a cylindrical shape, the ends of which are rounded and convex.

36. A system for fabricating an active agent dosage form for the prolonged delivery of the active agent, comprising:

forming means for forming a band in a groove circumscribed on the external surface of a blank; and

orienting means for orienting, by way of the groove, the blank with respect to said forming means.

37. The system of claim 36, wherein said orienting means comprises means registering with the groove on the blank.

38. The system of claim 37, wherein said means registering with the groove comprises a rotatable wheel.

39. The system of claim 36, wherein said forming means comprises:

a source of material for the band; and

a printing wheel.

40. A system for fabricating an active agent dosage form for the prolonged delivery of the active agent, comprising:

a source of blanks, each of said blanks having a groove circumscribing a portion of the external surface of the blank; and

a banding station that forms a band of insoluble material in the groove.

41. The system of claim 40, wherein said banding station comprises:

a printing means.

42. The system of claim 41, wherein said printing means comprises:

a source of insoluble material; and

a printing wheel.

43. The system of claim 42, wherein said printing wheel has a substantially planar outer circumferential surface.

44. The system of claim 42, wherein said printing wheel has a concave outer circumferential surface.

45. The system of claim 40, further comprising:

a transport mechanism that transports the blanks from said source to said banding station.

46. The system of claim 45, wherein said transport mechanism comprises:

a stationary table; and

a rotating transport table adapted to rotate over said stationary table.

47. The system of claim 46, wherein said rotating transport table defines a plurality of openings positioned linearly on respective radii, said openings adapted to receive blanks from said source.

48. The system of claim 40, further comprising:

a drying apparatus configured to dry the band.