Device having variable volume chamber for dispensing useful agent

• US 4,203,440 A
• Filed: 10/23/1978
• Issued: 05/20/1980
• Est. Priority Date: 10/23/1978
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Theeuwes, Felix
• Primary Examiner(s): Michell, Robert W.
• Assistant Examiner(s): Rosenbaum, C. F.
• Application Number:
  US05/953,489
• Time in Patent Office: 575 Days
• Field of Search: 128/213 R, 128/232, 128/260, 128/261-262, 128/271, 424/14, 424/25, 424/27, 222/386.5
• US Class Current: 604/892.1
• CPC Class Codes: A61K 9/009 Sachets, pouches characterised by the material or function of the envelope with gastric retention A61K9/0065; sachets which are not administered but function merely as a container are classified according to the content, e.g. sachets comprising powder for reconstitution of a drink A61K9/0095

Abstract

A self-powered device is disclosed for delivering a useful agent. The device comprises (1) a housing member, (2) a variable volume chamber storing a useful agent and having a passageway for delivering the agent in the housing, and (3) a pressure generating member comprising a semipermeable polymer having a cross-linked hydrophilic polymer dispersed therein positioned between the housing and the chamber. In operation, when the device is in a fluid environment, fluid from the environment enters the housing and is imbibed by the hydrophilic polymer into the generator, causing the generator to enlarge and apply pressure against the chamber, thereby decreasing the volume of the chamber and simultaneously dispensing agent through the passageway from the device at a controlled rate over a prolonged period of time. An article of manufacture also is disclosed which consists of a pressure generating member manufactured as a film useful for making a dispensing device.

Claims

1. A device for delivering a useful agent to an environment of use, comprising:

(a) a useful agent;

(b) a housing having a shape retaining wall defining an internal space, the housing having at least one opening connecting the space with the exterior of the device;

(c) a variable volume chamber in the housing, said chamber comprising a flexible wall surrounding a reservoir for storing the agent, and a passageway for delivering the agent from the chamber to the exterior of the device;

(d) a pressure generating member in the housing positioned between the housing and the chamber, said member formed of a semipermeable polymer having therein a swellable, insoluble hydrophilic polymer; and

,

(e) wherein, in operation when the device is in the environment of use, the member imbibes fluid admitted into the device, causing the member to expand, generate and exert pressure on the chamber which decreases the volume of the chamber thereby delivering agent through the passageway from the device at a controlled rate over a prolonged period of time.

2. The device for delivering the useful agent to an environment of use according to claim 1, wherein the passageway of the variable volume chamber extends through the opening in the housing to the exterior of the device.

3. The device for delivering the useful agent to an environment of use according to claim 1, wherein the swellable hydrophilic polymer, is an ion exchange resin.

4. The device for delivering the useful agent to an environment of use according to claim 1, wherein the housing has an opening for the passageway and at least an additional opening for letting fluid into the housing.

5. The device for delivering the useful agent according to claim 1, wherein the housing is manufactured from a microporous polymer.

6. The device for delivering the useful agent to an environment of use according to claim 1, wherein the chamber is formed of a member selected from the group consisting of natural rubber, gutta percha, cyclised rubber, isoprene rubber, butadiene rubber, styrene-butadiene copolymeric rubber, nitrile rubber, chloroprene rubber and ethylenepropylene copolymeric rubber.

7. The device for delivering the useful agent to an environment of use according to claim 1, wherein the housing is formed of a member selected from the group consisting essentially of polyolefin, polyethylene, polypropylene, polytetrafluoroethylene, polyamide, polyformaldehyde, polystyrene, polycarbonate, polyacrylate, polymethacrylate, polyacrylonitrile, and polyvinyl chloride.

8. The device for delivering the useful agent to an environment of use according to claim 1, wherein the agent is a drug.

9. The device for delivering the useful agent according to claim 1, wherein the environment is a biological environment, and the agent is a drug selected from the group consisting of locally and systemically acting gastrointestinal, central nervous system, hypnotic, sedative, psychic energizer, tranquilizer, anticonvulsant, antiparkinson, muscle relaxant, analgesic, antipyretic, anti-inflammatory, anesthetic, antispasmodic, antimicrobial, antiviral, antiulcer, hormonal, sympathomimetic, diuretic, hypoglycemic and anticontraceptive drugs.

10. The device for delivering the useful agent according to claim 1, wherein the agent in the chamber is a drug mixed with a pharmaceutically acceptable carrier.

11. The device for delivering the useful agent according to claim 1, wherein the passageway is projected through the opening in the housing, with said passageway formed by the wall of the chamber.

12. The device for delivering the useful agent according to claim 1, wherein the passageway is connected to a tube that extends through the opening in the housing for delivering agent from the device.

13. The device for delivering the useful agent according to claim 1, wherein the pressure-generating member comprises a semipermeable polymer selected from the group consisting of a cellulose ester, cellulose ether, cellulose acylate, cellulose diacylate, cellulose triacylate, and polyurethane, having dispersed therein particles of a member selected from the group consisting of a cross-linked anion and cation resins.

14. The device for delivering the useful agent according to claim 1, wherein the swellable, insoluble hydrophilic polymer is an ion exchange resin selected from the group consisting essentially of cross-linked styrene-divinylbenzene copolymer, cross-linked basic acidic cation resin, cross-linked basic anion resin, anion resin--C₆ H₄ --CH₂ N(CH₃)₃ Cl, anion resin--C₆ H₄ --CH₂ N(CH₃)₃ (C₂ H₅ --OH)Cl, cation resin--C₆ H₄ --SO₃ H, and acid cation resin--C₆ H₄ --CH₂ N(CH₂ COOH)₂.

15. The device for the delivery of the useful agent according to claim 1, wherein the swellable, insoluble hydrophilic polymer is present in the form of particles and the particles are bead and spherical shaped.

16. The device for delivery of the useful agent according to claim 13 wherein the semipermeable polymer contains a plasticizer.

17. The device for delivering the useful agent to an environment of use according to claim 1, wherein the swellable, insoluble polymer is lightly cross-linked.