Method of fabricating a banded prolonged release active agent dosage form

• US 6,365,183 B1
• Filed: 03/23/1999
• Issued: 04/02/2002
• Est. Priority Date: 05/07/1998
• Status: Expired due to Fees

• Current Assignee: Encinal Pharmaceutical Investments, LLC
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Puga, Yolanda M., Edgren, David E., Wong, Patrick S.-L., Jao, Francisco
• Primary Examiner(s): Dees, Jose′ G.
• Assistant Examiner(s): George, Konata M.
• Application Number:
  US09/274,648
• Time in Patent Office: 1,106 Days
• Field of Search: 424/400, 424/464, 424/467, 424/468
• US Class Current: 424/468
• 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 an insoluble band in the groove, said orienting comprising registering the forming means with the groove; and

forming the insoluble band in the groove using the forming means.

10. The method of claim 9, wherein said registering step is carried out using a rotatable wheel.

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

using printing means to transfer insoluble material into the groove.

12. The method of claim 11, wherein the printing means comprises a rotatable wheel.

13. The method of claim 12, wherein the wheel has a substantially planar outer circumferential surface.

14. The method of claim 12, wherein the wheel has a concave outer circumferential surface.

15. 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.

16. The method of claim 9, further comprising:

coating the blank with a water-soluble film.

17. The method of claim 9, further comprising:

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

18. 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.

19. The active agent dosage form of claim 18, wherein said groove has a notch shape.

20. The active agent dosage form of claim 18, wherein said groove has a concave shape.

21. The active agent dosage form of claim 18, wherein the depth of said groove is between about 0.1 mm and about 3 mm.

22. The active agent dosage form of claim 18, wherein the width of said groove is between about 0.5 mm and 10 mm.

23. The active agent dosage form of claim 18, further comprising:

a water-soluble film coating.

24. The active agent dosage form of claim 18, 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.

25. The active agent dosage form of claim 24, wherein the dosage form comprises an insoluble band disposed in each of said grooves.

26. The active agent dosage form of claim 18, wherein said insoluble band comprises a latex of acrylate polymers.

27. The active agent dosage form of claim 26, wherein said acrylate polymers comprise copolymers of ethylacrylate and methylmethacrylate.

28. The active agent dosage form of claim 26, wherein said latex comprises an ethylacrylate methylmethacrylate 2:

1 copolymer latex.

29. The active agent dosage form of claim 18, wherein said active agent formulation matrix has a cylindrical shape.

30. The active agent dosage form of claim 29, wherein each end of said active agent formulation matrix is rounded and convex.