Unit system having multiplicity of means for dispensing useful agent

• US 4,304,232 A
• Filed: 01/28/1980
• Issued: 12/08/1981
• Est. Priority Date: 03/14/1979
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Michaels, Alan S.
• Primary Examiner(s): Michell, Robert W.
• Assistant Examiner(s): Wallen, T. J.
• Application Number:
  US06/115,750
• Time in Patent Office: 680 Days
• Field of Search: 128/260, 128/270, 128/272, 128/268, 128/213 R, 128/213 A, 128/296, 128/271
• US Class Current: 604/892.1
• CPC Class Codes: A61J 3/07 into the form of capsules or similar small containers for oral use
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas

Abstract

A system is disclosed for dispensing an useful agent. The system comprises (1) means for storing an agent, (2) an agent stored in the means, (3) means for releasing agent from the system, (4) means for absorbing fluid into the system surrounding the storing means, and (5) means for admitting fluid into the system. In operation fluid is admitted into the system by the admitting means cooperating with the absorbing means, causing it to increase in dimensions and apply force against the storing means, which force urges the storing means to decrease its dimensions and correspondingly dispense agent through the releasing means from the system. Laminates are disclosed useful for manufacturing the system.

Claims

1. An agent dispensing device comprising:

(a) a container for storing a beneficial agent, said container formed of an elastomeric polymer that is changeable from an agent storing capacity to a substantially emptied capacity over time;

(b) a wall surrounding and defining an internal space that houses the container, the wall formed of a material selected from the group consisting of a semipermeable and microporous polymer that have selective fluid permeability and governs the passage of fluid into the device at a controlled rate, maintains the physical integrity of the device, and lets pressure be exerted against it, thereby assuring that pressure generated in the device is applied inwardly against the container;

(c) a passageway communicating with the container and the exterior of the device for dispensing agent from the device, said passageway having internal dimensions that assist in governing the rate of release of agent from the device;

(d) a lamina positioned between the wall and the container in the device, said lamina surrounding the container and formed of a material that absorbs and retains an exterior fluid admitted into the device, and is capable of changing in size at a controlled rate in response to absorbed and retained fluid; and

(e) wherein, when the device is in operation, fluid is admitted into the device at a rate controlled by the wall acting in cooperation with the lamina that absorbs and retains the fluid, causing the lamina to increase in size at a controlled rate and apply pressure against the container, which urges the container to squeeze inwardly at a corresponding rate and dispense agent through the passageway to the exterior of the device at a combined rate governed by the wall, lamina, container and the internal dimensions of the passageway.

2. The agent dispensing device according to claim 1, wherein, the wall is formed of member selected from the group consisting of cellulose acylate, cellulose diacylate and cellulose triacylate.

3. The agent dispensing device according to claim 1, wherein, the device is sized, shaped and adapted for use in the rectal passageway.

4. The agent dispensing device according to claim 1, wherein, the lamina for absorbing and retaining fluid is a swellable, hydrophilic, cross-linked polymer.

5. The agent dispensing device according to claim 1, wherein, the lamina for absorbing and retaining fluid is formed of a member selected from the group consisting of lightly cross-linked poly(hydroxyalkyl methacrylate), poly(acrylamide), poly(methacrylamide), poly(N-vinyl-2-pyrrolidone), anionic and cationic hydrogels, poly(electrolytes) and protein polymers.

6. The agent dispensing device according to claim 1, wherein, the container houses an agent that is a drug, which drug is present in solution, in semi-solid, or in a thixotropic formulation.

7. The agent dispensing device according to claim 1, wherein, the container is formed of a member selected from the group consisting of natural rubber, gutta percha, cyclized rubber, silicone rubber isoprene rubber, butadiene rubber, styrene-butadiene rubber, nitrile rubber, chloroprene rubber, ethylene-butylene rubber, and butyl rubber.

8. The agent dispensing device according to claim 1, wherein, the container is formed with the passageway, and the lamina for absorbing and retaining fluid is a swellable, hydrophilic polymer and has a surface in contact with the container.

9. The agent dispensing device according to claim 1, wherein, the container houses an agent that is a drug, said drug a member selected from the group consisting of locally and systemically acting drugs.

10. The agent dispensing device according to claim 1, wherein, the device is sized, shaped and adapted for oral use and the dispensing of agent in the gastrointestinal tact.

11. The agent dispensing device according to claim 1, wherein, the passageway is connected to a conduit to transport dispensed agent to a receptor distant from the device.

12. The agent dispensing device according to claim 1, wherein, the device is sized, shaped and adapted for dispensing agent in a vagina.

13. The agent dispensing device according to claim 1, wherein, the device is sized, shaped and adapted for uses as an implant.