Osmotic delivery system with membrane plug retention mechanism

• US 6,270,787 B1
• Filed: 12/22/1998
• Issued: 08/07/2001
• Est. Priority Date: 12/29/1997
• Status: Expired due to Term

• Current Assignee: Intarcia Therapeutics, Inc.
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Ayer, Rupal
• Primary Examiner(s): Dudash, Diana
• Assistant Examiner(s): SHARAREH, SHAHNAM J
• Application Number:
  US09/217,823
• Time in Patent Office: 959 Days
• Field of Search: 604/892.1, 604/890.1, 604/891.1, 424/457, 424/468, 424/422, 424/423, 424/424, 424/425
• US Class Current: 424/423
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas

Abstract

An osmotic delivery system has a membrane plug retention mechanism which can also be used to control the delivery rate of a beneficial agent from the osmotic delivery system. The osmotic delivery device includes an implant capsule containing a beneficial agent and an osmotic agent. Holes are formed along a side wall of the implant capsule at an open end of the capsule. When the membrane plug is inserted into the open end of the capsule the membrane material swells into the holes in the capsule side wall creating a large frictional force which prevents expulsion of the membrane plug. A beneficial agent delivery rate of the osmotic delivery system is controllable by varying the size and number of the holes to change the amount of exposed surface area of the membrane plug. An increase in the surface area of the membrane plug exposed to the exterior environment causes a corresponding increase in the liquid permeation rate of the membrane and thus, increases the beneficial agent delivery rate.

Claims

1. An osmotic delivery device comprising:

a delivery device capsule having a substantially cylindrical side wall, a first end having a beneficial agent delivery orifice, and a second open end;

a separating member positioned within the delivery device capsule and movable in a longitudinal direction within the delivery device capsule to dispense the beneficial agent;

an osmotic engine positioned adjacent one side of the separating member;

a plurality of openings in the substantially cylindrical side wall adjacent the second open end of the delivery device capsule; and

a membrane plug positioned within the second open end of the delivery device capsule and covering each of the plurality of openings in the substantially cylindrical side wall and retained in the capsule by the plurality of openings.

2. The osmotic delivery device according to claim 1, wherein the membrane plug is formed of a material which swells causing a portion of the membrane plug to extend into the openings in the side wall increasing friction between the membrane plug and the delivery device capsule and preventing expulsion of the membrane plug from the delivery device capsule.

3. The osmotic delivery device according to claim 1, wherein the openings in the side wall are through holes allowing fluid to pass through the openings into the membrane plug and into the osmotic engine within the delivery device capsule.

4. The osmotic delivery device according to claim 1, wherein the openings are cylindrical bores spaced in an annular manner around the side wall.

5. The osmotic delivery device according to claim 1, wherein the substantially cylindrical side wall includes an inwardly directed annular lip at the open end of the delivery device casing which provides additional retention of the membrane in the second open end of the delivery device casing.

6. The osmotic delivery device according to claim 1, wherein the separating member is movable longitudinally in a direction defined by a longitudinal axis passing through the first end and the second open end of the delivery device capsule.

7. The osmotic delivery device according to claim 1, wherein the membrane plug is formed of a semipermeable composition.

8. The osmotic delivery device according to claim 1, wherein the membrane plug provides a semipermeable closure of the second open end of the delivery device capsule, the membrane plug allowing fluid to pass into the osmotic engine and preventing the osmotic engine from passing out of the capsule.

9. An osmotic delivery device comprising:

a delivery device capsule having a substantial cylindrical side wall, a first end having a beneficial agent delivery orifice, and a second open end;

a separating member positioned within the delivery device capsule and movable in a longitudinal direction within the delivery device capsule to dispense the beneficial agent;

an osmotic engine positioned adjacent one side of the separating member;

a plurality of openings in the substantially cylindrical side wall adjacent the second open end of the delivery device capsule; and

a membrane plug secured in the second open end of the delivery device capsule and allowing external liquids to pass through the membrane plug into the delivery device capsule, the membrane plug secured in the second open end of the delivery device capsule by the plurality of openings formed in the delivery device capsule, the membrane plug expandable to extend into the plurality of openings to prevent expulsion of the membrane plug from the delivery device capsule.

10. The osmotic delivery device according to claim 9, wherein the openings in the side wall are through holes allowing fluid to pass through the openings into the membrane plug and into the osmotic engine within the delivery device capsule.

11. The osmotic delivery device according to claim 9, wherein the openings are cylindrical bores spaced in an annular manner around the side wall.

12. The osmotic delivery device according to claim 9, wherein the membrane plug is formed of a semipermeable composition.