Delivery devices with pulsatile effect

• US 5,308,348 A
• Filed: 05/05/1993
• Issued: 05/03/1994
• Est. Priority Date: 02/18/1992
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Baile, Clifton A., Smith, Jonathan P., Pike, James B., Balaban, Stephen M.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): SMITH, CHALIN A
• Application Number:
  US08/058,151
• Time in Patent Office: 363 Days
• Field of Search: 604/19-22, 604/890.1, 604/891.1, 604/892.1, 424/438, 424/422, 424/424, 424/473
• 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 pulsate delivery of a beneficial agent to said environment, 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 retaining a beneficial agent and a second compartment for retaining 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 band of resilient material on the exterior of said enclosure and covering said orifice, said resilient material being sufficiently tight to seal or substantially seal said orifice while at the same time being capable of being stretched in response to pressure generated by said activating mechanism; and

a trough formed in the outer surface of the side wall of said enclosure near said first end and encircling said enclosure, wherein said orifice is located inside said trough and said band of resilient material is seated inside said trough.

2. A delivery device in accordance with claim 1 wherein said resilient material is selected from elastomeric compounds.

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

4. A delivery device in accordance with claim 1 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.

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 adjacent to said second end is permeable to moisture, and said activating mechanism is an osmotic engine.

6. A delivery device in accordance with claim 5 which further comprises a beneficial agent in said first compartment and an osmotically active agent or mixture of osmotically active agents in said second compartment, and in which said band of resilient material and said orifice are constructed such that continuous absorption of fluid from said aqueous environment causes said band to be stretched away from said orifice to release said beneficial agent intermittently.

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

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

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

1) placing into said environment a delivery device, said 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 retaining a beneficial agent and a second compartment for retaining 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;

a band of resilient material on the exterior of said enclosure and covering said orifice, said resilient material being sufficiently tight to seal or substantially seal said orifice while at the same time being capable of being stretched in response to pressure generated by said activating mechanism; and

a trough formed in the outer surface of the side wall of said enclosure near said first end and encircling said enclosure, wherein said orifice is located inside said trough and said band of resilient material is seated inside said trough; and

2) activating said activating mechanism in said device to cause said activating mechanism to generate a pressure differential within said enclosure to cause said band of resilient material to be stretched away from said orifice to release said beneficial agent intermittently.

10. A method in accordance with claim 9 wherein said resilient material is selected from elastomeric compounds.

11. A method in accordance with claim 9 wherein said resilient material 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.