Delivery devices with pulsatile effect

• US 5,456,679 A
• Filed: 12/07/1994
• Issued: 10/10/1995
• Est. Priority Date: 02/18/1992
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Pike, James B., Baile, Clifton A., Smith, Jonathan P., Balaban, Stephen M.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): SMITH, CHALIN A
• Application Number:
  US08/352,268
• Time in Patent Office: 307 Days
• Field of Search: 604/19-22, 604/890.1, 604/891.1, 604/892.1, 604/143, 424/422
• US Class Current: 604/892.1
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• CPC Class Codes: A61M 2005/14513 with secondary fluid driving or regulating the infusion
• CPC Class Codes: A61M 2206/10 Flow characteristics
• CPC Class Codes: A61M 5/14526 the piston being actuated by fluid pressure

Abstract

Delivery devices which include a beneficial agent and an activating mechanism in separate compartments separated by a moveable partition are designed to deliver the beneficial agent in a pulsatile manner through an orifice. The pulsatile delivery is achieved by a band of resilient material which is placed over the orifice. The resilient material is sufficiently tight to substantially seal the orifice when the pressure within the device is below a threshold level while at the same time being capable of being stretched when the internal pressure exceeds the threshold.

Claims

1. A delivery device for placement in an environment of use for the pulsatile delivery of a beneficial agent to said environment, the device comprising:

an enclosure, the enclosure defining an orifice therein;

activating means within said enclosure for generating a pressure within said enclosure;

a beneficial agent contained within said enclosure; and

resilient sealing means for sealing said orifice, said resilient means being displaced from a first position sealing said orifice to a second position opening said orifice when said pressure within said enclosure, generated by said activating means, exceeds a predetermined pressure, said resilient means returning to said first position sealing said orifice when said pressure within said enclosure fails below said threshold pressure.

2. A delivery device in accordance with claim 1 wherein said resilient means for sealing said orifice is selected from elastomeric compounds.

3. A delivery device in accordance with claim 1 wherein said resilient means for sealing said orifice is selected from injection-moldable elastomeric compounds.

4. A delivery device in accordance with claim 1 wherein said activating means is selected from the group consisting of an osmotic engine, a thermal system, a mechanical system, a system dependent on vapor pressure of fluid, a system dependent on chemical or electrochemical reactions, an elastomeric system, a spring-loaded chamber or piston, and a system dependent on gravity.

5. A delivery device in accordance with claim 1 wherein said environment of use is an aqueous environment, at least a portion of said enclosure of said device is permeable to moisture, and said activating means includes an osmotic engine, said activating means within said portion of said enclosure permeable to moisture.

6. A delivery device in accordance with claim 5 which further comprises a partition, said partition movable from a first position to a second position within said interior, said partition dividing said interior into a first compartment and a second compartment, said beneficial agent in said first compartment and wherein said activating means includes at least one osmotically active agent in said second compartment, and in which said resilient means for sealing said orifice and said orifice are constructed such that continuous absorption of fluid from said aqueous environment causes said resilient means to be displaced from a first position sealing said orifice to a second position opening said orifice when said pressure within said enclosure, generated by said activating means, exceeds a predetermined pressure, said resilient means returning to said first position sealing said orifice when said pressure within said enclosure falls below said threshold pressure.

7. A delivery device in accordance with claim 1 which further comprises a capacitance means within said enclosure.

8. A delivery device in accordance with claim 1 which further comprises a density element.

9. A device for providing delivery of a beneficial agent in a pulsatile manner to an environment of use, the device comprising:

an enclosure having first and second ends and an orifice at or near said first end;

a partition dividing the interior of said enclosure into a first compartment for containing a beneficial agent and a second compartment for containing an activating mechanism, said first and second compartments being adjacent to said first and second ends, respectively, said partition being capable of moving within said enclosure;

a beneficial agent in said first compartment; and

a band of resilient material sealing said orifice on the exterior of said enclosure and covering said orifice, said means for resiliently sealing said orifice being sufficiently tight to seal or substantially seal said orifice but capable of being displaced from a first position sealing said orifice to a second position opening said orifice when said pressure within said enclosure, generated by said activating means, exceeds a predetermined pressure, said resilient means returning to said first position sealing said orifice when said pressure within said enclosure falls below said threshold pressure.

10. A method in accordance with claim 9 wherein said means for resiliently sealing said orifice is selected from elastomeric compounds.

11. A method in accordance with claim 9 wherein said means for resiliently sealing said orifice is selected from injection-moldable elastomeric compounds.

12. A method in accordance with claim 9 wherein said activating mechanism is selected from the group consisting of an osmotic engine, a thermal system, a mechanical system, a system dependent on vapor pressure of fluid, a system dependent on chemical or electrochemical reactions, an elastomeric system, a spring-loaded chamber or piston, and a system dependent on gravity.

13. A method in accordance with claim 9 wherein said environment of use is an aqueous environment, at least a portion of said enclosure of said device adjacent to said second end is permeable to moisture, said activating mechanism is an osmotically active agent or a mixture of osmotically active agents, and said activating mechanism is activated by allowing said device to imbibe fluid from said aqueous environment through said moisture-permeable enclosure to activate said osmotically active agent or agents.

14. A method in accordance with claim 9 wherein said delivery device further comprises a capacitance means in said second compartment.

15. A method in accordance with claim 9 wherein said delivery device further comprises a density element.