Active agent dosage form comprising a matrix and at least two insoluble bands

• US 5,534,263 A
• Filed: 02/24/1995
• Issued: 07/09/1996
• Est. Priority Date: 02/24/1995
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Edgren, David E., Wong, Patrick S.-L., Dong, Liang C., Ferrari, Vincent J.
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): WEBBER, PAMELA S
• Application Number:
  US08/394,074
• Time in Patent Office: 501 Days
• Field of Search: 424/484, 424/467, 424/468, 424/471, 424/474, 424/473, 424/486
• 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

Abstract

The present invention is directed to an active agent dosage form 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 two or more insoluble bands. The invention is also directed to the method for making the active agent dosage form.

Claims

1. An active agent dosage form for the prolonged delivery of an active agent formulation to a fluid environment of use, the dosage form comprising an active agent formulation matrix with at least two insoluble bands positioned in spaced relationship on the surface of the active agent formulation matrix with the surface of the matrix on both sides of each band exposed to the fluid environment of use.

2. The dosage form of claim 1 wherein the bands are placed on the surface of the active agent formulation matrix.

3. The dosage form of claim 2 wherein the bands drop off as the matrix erodes.

4. The dosage form of claim 1 wherein the bands are printed onto the surface of the active agent formulation matrix.

5. The dosage form of claim 1 wherein the dosage form is cylindrical in shape and the insoluble bands concentrically surround the active agent formulation matrix.

6. The active agent dosage form of claim 1 wherein the active agent formulation comprises a drug.

7. The active agent dosage form of claim 1 wherein the active agent formulation comprises a drug and the dosage form is administered orally.

8. The active agent dosage form of claim 1 wherein the active agent formulation matrix comprises an active agent formulation and a hydrophilic polymeric material.

10. The active agent dosage form of claim 1, wherein delivery of the active agent formulation lasts for up to about 20 hours.

11. The active agent dosage form of claim 1 wherein the insoluble bands are between about 0.5 and 8 mm in width.

12. The active agent dosage form of claim 1 wherein the total number of insoluble bands is between 2 and 10.

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

a first active agent formulation matrix and at least two insoluble bands positioned in spaced relationship on the surface of the first active agent formulation matrix with the surface of the first active agent formulation matrix on both sides of each band exposed to the fluid environment of use, and a second active agent formulation matrix, the first active agent formulation matrix providing for the prolonged delivery of a first active agent and the second active agent formulation matrix providing an initial pulse of a second active agent, the second active agent being the same as or different than the first active agent.

13. A method for making an active agent dosage form for the prolonged release of an active agent to a fluid environment of use, the method comprising:

(a) preparing an active agent formulation matrix; and

(b) applying an insoluble material onto the active agent formulation matrix to form at least two insoluble bands on the surface of the active agent formulation matrix.

14. The method of claim 13 wherein, in step (b), applying the insoluble material is done by printing the insoluble material onto the active agent formulation matrix.

15. A method for delivering an active agent to a fluid environment of use over a prolonged period of time, said method comprising the steps of:

a. placing an active agent formulation matrix into the fluid environment of use, the matrix having at least two insoluble bands positioned in spaced relationship on its surface with the surface of the active agent formulation matrix on both sides of the each band exposed to the fluid environment of use;

b. allowing the matrix to erode in the fluid environment of use; and

c. allowing the bands to drop off the matrix and expose the surface of the matrix to the fluid environment of use.

16. A method for delivering an active agent to a fluid environment of use over a prolonged period of time, said method comprising the steps of:

a. placing an active agent formulation matrix into the fluid environment of use, said matrix having at least two insoluble bands positioned in spaced relationship on its surface with the surface of the active agent formulation matrix on both sides of each band exposed to the fluid environment of use; and

b. allowing the matrix to erode in the fluid environment of use while the bands remain positioned on the surface of the active agent formulation matrix;

wherein the surface area of the matrix not covered by the bands increases with time.

17. A method for delivering a first and second active agent to a fluid environment of use, said method comprising the steps of:

a. placing a first active agent formulation matrix into the fluid environment of use, said matrix comprising a first active agent and having at least two insoluble bands positioned in spaced relationship on its surface with the surface of the active agent formulation matrix on both sides of each band exposed to the fluid environment of use;

b. placing a second active agent formulation matrix comprising a second active agent into the fluid environment of use;

c. allowing the first active agent formulation matrix to erode in the fluid environment of use to provide prolonged delivery of said first active agent; and

d. allowing the second active agent matrix to erode in the fluid environment of use to provide an initial pulse of second active agent;

wherein the first and second active agents may be the same or different.

18. The method of claim 17 wherein the bands drop off the surface of the first active agent formulation matrix as the matrix erodes in the fluid environment of use.

19. The method of claim 17 wherein the bands remain positioned on the surface of the first active agent formulation matrix as the matrix erodes in the fluid environment of use.