Self-monitored device for releasing agent at functional rate

• US 3,944,064 A
• Filed: 10/26/1973
• Issued: 03/16/1976
• Est. Priority Date: 10/26/1973
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Zaffaroni, Alejandro, Michaels, Alan S., Bashaw, John D.
• Primary Examiner(s): Price, William
• Assistant Examiner(s): Moy, Joseph M.
• Application Number:
  US05/410,244
• Time in Patent Office: 872 Days
• Field of Search: 206/.5, 206/522, 206/437, 206/DIG. 30, 424/15, 424/19, 424/14, 128/2 R, 128/260, 128/214 F, 222/386.5
• US Class Current: 206/.5
• CPC Class Codes: A61K 9/0065 Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus
• CPC Class Codes: A61K 9/4808 characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release capsules filled with granules or microparticles A61K9/16; filled with microcapsules or coated microparticles A61K9/50; with mixture of different granules, microcapsules, (coated) microparticles A61K9/5084
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50

Abstract

A delivery device for the controlled and continuous release of a useful agent at a functional rate is comprised of an erodible capsule housing a self monitored delivery device attached to a collapsed support. The device is comprised of a hollow container having a wall formed of a self-monitored release rate controlling material permeable to the passage of the agent by diffusion, or the wall is formed of a microporous material whose micropores are a means for holding a self-monitored release rate controlling medium permeable to the passage of the agent by diffusion. The device on its release from the bioerodible capsule in the environment of use releases an effective amount of agent at a functional rate over a prolonged and continuous period of time.

Claims

1. A device for the controlled and continuous release of a useful agent to an environment of use wherein the device is comprised of a container having a wall enclosing a hollow area, a reservoir formed by the container wall'"'"'s inner surface as a means for storing the agent, the container wall additionally formed in at least a part of a self-monitored release rate controlling essentially imperforate homogenous material permeable to the passage of the agent by diffusion for releasing agent from the reservoir, a support member for carrying the container with the wall of the container covering at least a portion of the surface of the support and suitably fixed thereto, said support member movable from a collapsed position to an expanded position and movable from an expanded position to a collapsed position after a period of agent release time, and wherein agent is metered from the reservoir through the wall in a useful amount for a prolonged period of time when the device is in the selected environment of use.

2. A device for the controlled and continuous release of a useful agent according to claim 1 wherein a part of the wall of the container is a part of the support member.

3. A useful device for the release of a useful agent, wherein the device is comprised of a container having a wall enclosing a hollow area, a reservoir formed by the container wall'"'"'s inner surface as a means for storing the agent, said container wall defining the reservoir formed in at least a part of a microporous material whose micropores contain an agent release rate controlling medium permeable to the passage of the agent at a predetermined rate by diffusion, a support member for carrying the container with a wall of the container covering at least a portion of the support and suitably united thereto, with the support member movable from a collapsed position to an expanded position and returnable to a collapsed position after a period of agent release time, and wherein agent is metered from the reservoir by passage through a medium housed in the micropores of the wall of the container in an effective amount for a prolonged period of time when the device is placed in the environment of use.

4. A device for the controlled and continuous release of a useful agent according to claim 3 wherein a part of the wall of the container is a part of the support member.

5. A delivery device for the controlled and continuous release of a beneficial agent, the device comprising in combination,

a. a bioerodible capsule providing an internal space therein,

b. a delivery device housed in the capsules, the device comprising,

c. a container with an internal space for containing a beneficial agent, said container having a wall formed of a release rate controlling imperforate polymeric material permeable to the passage of the agent by diffusion, or a wall of microporous material whose micropores are a means for containing a liquid release rate controlling medium permeable to the passage of the agent by diffusion,

d. a reservoir defined by the container'"'"'s internal space as means for containing beneficial agent that is released from the device by passage through the release rate controlling wall or through a release rate controlling medium in the micropores of the microporous material, the container joined to,

e. a hollow deformable closed support member, said member movable from a collapsed position to an expanded position on release of the device from the capsule and movable from an expanded position to a collapsed position after a period of time,

f. and wherein agent is metered from the container through the wall in a therapeutically effective amount for a prolonged period of time on release of the device from the capsule in the environment of use.

6. A delivery device for the controlled and continuous release of agent according to claim 5 where the hollow deformable member is provided with a bioerodible plug that on bioerosion in a physiologic environment vents the interior of the member to its exterior.

7. A delivery device for the controlled and continuous release of agent according to claim 5 wherein the hollow deformable member is formed of an elastic material permeable to a gas that slowly diffuses through the material to move the member from an expanded position to a collapsed position.

8. A delivery device for the controlled and continuous release of agent according to claim 5 wherein the hollow deformable member contains a liquid means for producing a gas that has a vapor pressure above one atmosphere or physiological temperature.

9. A delivery device for the controlled and continuous release of an agent according to claim 5 wherein the container contains an agent that produces a local or systemic effect on its release from the container by diffusion in a biological environment.

10. A delivery device for the controlled and continuous administration of an agent according to claim 5 wherein the hollow deformable member is formed of a material that bioerodes at a physiological temperature in the physiological environment.