Delivery device providing beneficial agent stability

• US 5,137,727 A
• Filed: 06/12/1991
• Issued: 08/11/1992
• Est. Priority Date: 06/12/1991
• Status: Expired

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Eckenhoff, James B.
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): Bawa, Raj
• Application Number:
  US07/714,415
• Time in Patent Office: 426 Days
• Field of Search: 424/422, 424/438, 424/473
• US Class Current: 424/422
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas

Abstract

The present invention is directed to an improved fluid-imbibing dispensing device for delivering a beneficial agent to a biological environment of use, the dispensing device being of the type having a housing which includes a fluid-impermeable first wall section with an open end and a fluid-permeable second wall section with an open end, an internal compartment formed by the first and second wall sections, exit means in the housing, a beneficial agent in that portion of the compartment formed by the first wall section, expandable driving means in that portion of the compartment formed by the second wall section, and a partition layer between the beneficial agent and the expandable driving means; wherein the improvement comprises the first wall section being comprised of an extremely fluid-impermeable material and the open end of each of the first wall section and the second wall section having reciprocally tapered edges one with the other to form a tapered lap joint for mating engagement, the tapered lap joints being bonded together with a pressure-sensitive contact adhesive to form the housing.

Claims

1. An improved fluid-imbibing delivery device for delivering a beneficial agent to a biological environment of use, the dispensing device having a housing which includes a fluid-impermeable first wall section with an open end and a fluid-permeable second wall section with an open end, an internal compartment formed by the first and second wall sections, exit means in the housing, a fluid-sensitive beneficial agent formulation in that portion of the compartment formed by the first wall section, expandable driving means in that portion of the compartment formed by the second wall section, and a partition layer between the beneficial agent formulation and the expandable driving means;

wherein the improvement comprises the first wall section being comprised of an extremely fluid-impermeable material and the open end of each of the first wall section and the second wall section having reciprocally tapered edges one with the other to form a tapered lap joint for mating engagement, the tapered lap joints being bonded together with a pressure-sensitive contact adhesive to form the housing.

2. A delivery device according to claim 1 wherein the first wall section is comprised of a polyolefinic material.

3. A delivery device according to claim 1 wherein the environment of use is an animal.

4. A delivery device according to claim 3 wherein the animal is a swine or a bovine.

5. A delivery device according to claim 1 wherein the beneficial agent formulation comprises a hormone.

6. A delivery device according to claim 1 wherein the first wall section comprises a polyolefinic material, and the beneficial agent formulation comprises a somatotropin, a somatotropin derivative or a somatotropin analogue.

7. A delivery device according to claim 1 wherein the device is an implant.

8. A delivery device according to claim 1 wherein the exit means comprises an exit passageway and means for closing the exit passageway.

9. A delivery device according to claim 8 wherein the means for closing the exit passageway is a material which is discharged, leaches or erodes.

10. A method for delivering a fluid-sensitive beneficial agent to an animal, wherein the method comprises:

(1) admitting into the animal an improved fluid-imbibing delivery device having a housing which includes a fluid-impermeable first wall section with an open end and a fluid-permeable second wall section with an open end, an internal compartment formed by the first and second wall sections, exit means in the housing, a fluid-sensitive beneficial agent formulation in that portion of the compartment formed by the first wall section, expandable driving means in that portion of the compartment formed by the second wall section, and a partition layer between the beneficial agent formulation and the expandable driving means;

wherein the improvement comprises the first wall section being comprised of an extremely fluid-impermeable material and the open end of each of the first wall section and the second wall section having reciprocally tapered edges one with the other to form a tapered lap joint for mating engagement, the tapered lap joints being bonded together with a pressure-sensitive contact adhesive to form the housing;

(2) allowing fluid to be imbibed through the fluid-permeable second wall section of the dispenser for causing the expandable driving member to increase in volume; and

(3) delivering beneficial agent to the animal by the driving member increasing in volume and occupying space in the internal compartment comprising the first wall section, thereby pushing the beneficial agent formulation through the exit means to the animal.

11. A method according to claim 10 wherein the first wall section comprises a polyolefinic material.

12. A method according to claim 10 wherein the animal is a swine or a bovine.

13. A method according to claim 10 wherein the beneficial agent formulation comprises a hormone.

14. A method according to claim 10 wherein the first wall section comprises a polyolefinic material, and the beneficial agent formulation comprises a somatotropin, a somatotropin derivative or a somatotropin analogue.

15. A method according to claim 10 wherein the device is an implant.

16. A method according to claim 10 wherein the exit means comprises an exit passageway and means for closing the exit passageway.

17. A method according to claim 16 wherein the means for closing the exit passageway is a material which is discharged, leaches or erodes.

18. A method for providing improved stability for a fluid-sensitive beneficial agent formulation in a fluid environment of use, which method comprises:

(1) admitting into the environment of use an improved fluid-imbibing delivery device having a housing which includes a fluid-impermeable first wall section with an open end and a fluid-permeable second wall section with an open end, an internal compartment formed by the first and second wall sections, exit means in the housing, a fluid-sensitive beneficial agent formulation in that portion of the compartment formed by the first wall section, expandable driving means in that portion of the compartment formed by the second wall section, and a partition layer between the beneficial agent formulation and the expandable driving means;

wherein the improvement comprises the first wall section being comprised of an extremely fluid-impermeable material and the open end of each of the first wall section and the second wall section having reciprocally tapered edges one with the other to form a tapered lap joint for mating engagement, the tapered lap joints being bonded together with a pressure-sensitive contact adhesive to form the housing;

(2) allowing fluid to be imbibed through the fluid-permeable second wall section of the dispenser for causing the expandable driving member to increase in volume; and

(3) delivering beneficial agent to the animal by the driving member increasing in volume and occupying space in the internal compartment comprising the first wall section, thereby pushing the beneficial agent formulation through the exit means to the animal.

19. A method according to claim 18 wherein the first wall section comprises a polyolefinic material.

20. A method according to claim 18 wherein the beneficial agent is a somatotropin, a somatotropin derivative or a somatotropin analogue.

21. A method according to claim 18 wherein the environment of use is an animal, and the animal is a swine or a bovine.

22. A method according to claim 18 wherein the device is an implant.