Delivery device providing beneficial agent stability

• US 5,861,166 A
• Filed: 09/30/1993
• Issued: 01/19/1999
• Est. Priority Date: 03/12/1991
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Eckenhoff, James B.
• Primary Examiner(s): Bawa, Raj
• Application Number:
  US08/129,558
• Time in Patent Office: 1,937 Days
• Field of Search: 424/422, 424/438, 424/423, 424/427, 424/430, 424/434
• US Class Current: 424/422
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas

Abstract

This invention relates to fluid-imbibing delivery devices for delivering a beneficial agent to a biological environment of use. In particular, the devices include a rigid housing defining an internal compartment comprising a substantially impermeable first wall section and a second wall section permeable to fluid in the environment of use. The first wall section may be shape-retaining, with exit means and an open end, and extend for at least 85% of the entire length of the device to define the internal compartment.

Claims

1. A fluid-imbibing delivery device for delivering a beneficial agent to a biological environment of use, the delivery device comprising:

(a) a rigid housing defining an internal compartment, the housing comprising

(i) a first wall section having either an osmotic permeability coefficient less than about 3.7×

10^-7 cm.mil/atm.hr or a water vapor transmission rate less than about 11 g.mil/100 in² /24 hr at 38°

C., having an open end;

(ii) a second wall section permeable to fluid in the environment of use, the second wall section surrounding at lease a portion of the first wall section in spaced apart relationship thereto and enclosing the open end thereof, the second wall section being in sealing relationship around the periphery of the first wall section at a location distal to the open end thereof; and

(iii) exit means providing fluid communication between the environment of use and the portion of the compartment within the first wall section distal to the open end;

(b) a fluid swellable driving member in the space between the first and second wall sections and in communication with the open end; and

(c) a beneficial agent formulation in the internal compartment adjacent to the exit means.

2. A delivery device according to claim 1, wherein at least one-half of a length of the first wall section is surrounded by the fluid swellable driving member and the second wall section.

4. A delivery device according to claim 1 further including a fluid-impermeable partition layer between the beneficial agent formulation and the expandable driving member.

5. A delivery device according to claim 1 wherein the expandable driving member surrounds at least two-thirds of the length of the first wall section.

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

7. A delivery device according to claim 6 wherein the animal is a swine or a bovine.

8. A delivery device according to claim 1 wherein the beneficial agent is a hormone.

9. A delivery device according to claim 1 wherein the beneficial agent is a somatotropin or a somatotropin analogue.

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

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

12. A delivery device according to claim 11 wherein the means for closing the exit passageway is a material which is discharged, leaches or erodes.

13. A delivery device according to claim 1 wherein the driving member comprises an osmagent or an osmopolymer together with an osmagent.

14. A delivery device according to claim 10 wherein the beneficial agent is a somatotropin or a somatotropin analogue, and the fluid swellable driving member comprises and osmagent or an osmopolymer together with an osmagent.

3. A fluid-imbibing delivery device for delivering a beneficial agent to a biological environment of use, the delivery device comprising:

(a) a rigid housing enclosing an internal compartment, the housing having

(i) a shape-retaining first wall section, wherein said first wall section has either an osmotic permeability coefficient less than about 3.7×

10^-7 cm.mil/atm.hr or a water vapor transmission rate less than about 11 g.mil/100 in² /24 hr at 38°

C., having exit means and an open end, the first wall section defining the internal compartment;

(ii) an osmotically active expandable driving member surrounding at least about one-half of the vertical sides of the first wall section and enclosing said open end; and

(iii) a fluid-permeable second wall section surrounding and enclosing the expandable driving member; and

(b) a beneficial agent formulation in a portion of the internal compartment adjacent to the exit means.