Minimally compliant, volume efficient piston for osmotic drug delivery systems

• US 6,939,556 B2
• Filed: 06/25/2003
• Issued: 09/06/2005
• Est. Priority Date: 06/26/2002
• Status: Active Grant

• Current Assignee: Intarcia Therapeutics, Inc.
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Lautenbach, Scott D.
• Primary Examiner(s): KENNEDY, SHARON E
• Application Number:
  US10/606,407
• Publication Number:
  US 20040019345A1
• Time in Patent Office: 804 Days
• Field of Search: 604/892.1, 604/890.1, 424/438, 424/424, 424/452, 424/423, 424/433, 424/436, 424/422, 424/425
• US Class Current: 424/424
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• CPC Class Codes: A61K 9/48 Preparations in capsules, e.g. of gelatin, of chocolate A61K9/0004 takes precedence; bite capsules A61K9/0056
• CPC Class Codes: A61M 2005/14513 with secondary fluid driving or regulating the infusion
• 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

An osmotic pump having a minimally compliant, volume-efficient piston positioned within a capsule is provided. The capsule has an interior surface, a beneficial agent, and an osmotic agent. The piston is movable with respect to an interior surface of the capsule, and defines a movable seal with the interior surface of the capsule. The movable seal separates the osmotic agent from the beneficial agent. The piston has a length-to-total-diameter ratio of about 1.1:1 and a core-diameter-to-total-diameter ratio of about 0.9:1. The piston enables greater beneficial agent and/or osmotic agent payload without increasing the size of the capsule. The osmotic agent imbibes liquid from a surrounding environment through a semipermeable body to cause the piston to move and, in turn, cause delivery of the beneficial agent from the capsule.

Claims

1. An osmotic delivery system comprising:

a capsule, said capsule having an interior for holding a beneficial agent, said interior having an interior surface;

an osmotic agent located in said interior;

a semipermeable body in liquid communication with said capsule for permitting liquid to permeate through said semipermeable body to said osmotic agent; and

a piston having a length to total diameter ratio of about 1.1;

1 and a core-diameter-to-overall-diameter ratio of about 0.9;

1 located within said interior of said capsule, being movable with respect to said interior surface of said capsule, defining a movable seal with said interior surface of said capsule that separates said osmotic agent from said beneficial agent;

said osmotic agent located between said piston and said semipermeable body, said osmotic agent for imbibing fluid from a surrounding environment through said semipermeable body to cause said piston to move and, in turn, cause delivery of said beneficial agent from said capsule.

2. The osmotic delivery system according to claim 1, wherein said piston includes one or a plurality of ribs for effecting said movable seal with said interior surface.

3. The osmotic delivery system according to claim 1, wherein said capsule includes a cylindrical tube.

4. The osmotic delivery system according to claim 3, wherein said cylindrical tube includes an opening and said semipermeable body includes a semipermeable plug, said semipermeable plug located within said opening.

5. The osmotic delivery system according to claim 1, wherein said osmotic agent includes a tablet.

6. An osmotic delivery system comprising:

a piston having a length-to-overall-diameter ratio of about 1.1;

1 and a core-diameter-to-overall-diameter ratio of about 0.9;

1;

an osmotic agent; and

an enclosure having an interior holding said piston and said osmotic agent, said piston being movable with respect to said enclosure, and said enclosure having a semipermeable body in liquid communication with said osmotic agent for permitting liquid to permeate through said semipermeable body to said osmotic agent, said osmotic agent for imbibing fluid from a surrounding environment and causing said piston to move.

7. The osmotic delivery system according to claim 6, wherein said interior of said enclosure includes an interior surface, said piston abutting against said interior surface.

8. The osmotic delivery system according to claim 6, wherein said semipermeable body is located within said interior of said enclosure.

9. The osmotic delivery system according to claim 6, wherein said enclosure is fluid impermeable.

10. The osmotic delivery system according to claim 6, wherein said osmotic agent is located between said semipermeable body and said piston.

11. The osmotic delivery system according to claim 6, further comprising a beneficial agent located in said interior of said enclosure, said beneficial agent being delivered from said enclosure when said piston moves.

12. The osmotic delivery system according to claim 6, wherein said piston is fluid impermeable.

13. The osmotic delivery system according to claim 6, wherein said piston includes at least one rib for effecting a movable seal with said enclosure.

14. The osmotic delivery system according to claim 6, further comprising a beneficial agent located in said interior of said enclosure, said piston defining a movable seal that separates said osmotic agent from said beneficial agent.

15. An osmotic delivery system comprising:

a capsule having a tubular interior, said tubular interior having an interior surface;

a semipermeable body located at least partially within said tubular interior;

an osmotic agent located between said semipermeable body and a piston;

a beneficial agent located within said tubular interior; and

said piston located within said tubular interior, said piston having a length-to-overall-diameter ratio of about 1.1;

1 and a core-diameter-to-overall-diameter ratio of about 0.9;

1, said piston separating said beneficial agent from said osmotic agent, and being movable with respect to said interior surface of said tubular interior and with respect to said semipermeable body.

16. The osmotic delivery system according to claim 15, wherein said piston includes at least one rib.