Release rate adjustment of osmotic or diffusional delivery devices

• US 4,865,845 A
• Filed: 08/28/1987
• Issued: 09/12/1989
• Est. Priority Date: 03/21/1986
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Urquhart, John, Eckenhoff, James B.
• Primary Examiner(s): Swisher, Nancy A. B.
• Application Number:
  US07/090,720
• Time in Patent Office: 746 Days
• Field of Search: 424/422, 424/424, 424/468, 424/471, 604/892.1, 604/57
• US Class Current: 424/424
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas

Abstract

A sleeve shaped structure covers a portion of the transport area of a diffusional or osmotic delivery device. The structure is durable and inert to the use environment. Markings on the structure indicate where breaking or cutting will produce a predictable alteration in delivery rate. Among other attachment means, a water soluble adhesive maintains the structure on the delivery device.

Claims

1. A device for increasing and delivering duration of an osmotic or diffusional delivery device of a predetermined configuration, said delivery device having an external surface which acts as a transport area through which fluid passes to activate said delivery device, comprising:

a preformed integral sleeve impermeable to the passage of fluid, having a configuration substantially similar to said external surface and adapted to cover a portion of said surface;

whereby osmotic or diffusional fluid is prevented from contacting the covered portion; and

a means for precisely controlling the portion of transport area covered by said sleeve comprising markings on said sleeve having at least one weakened zone.

2. The device of claim 1 which further comprises:

a means for adjusting the size of said sleeve.

3. The device of claim 2 wherein said means for adjusting comprises at least one score line disposed about said sleeve.

4. The device of claim 1 wherein said sleeve comprises a plurality of weakened zones each having a predetermined relationship to the delivering duration of said osmotic or diffusional device.

5. The device of claim 1 which further comprises:

a means for attaching said sleeve to the delivery device.

6. The device of claim 5 wherein said means for attaching comprises a fluid permeable adhesive.

7. The device of claim 6 wherein said adhesive contains an ester.

8. The device of claim 6 wherein said adhesive is at least as fluid permeable as the transport area.

9. The device of claim 7 wherein said adhesive contains cellulose ester.

10. The device of claim 1 wherein said sleeve has the form of a cylinder, closed at one end.

11. The device of claim 1 wherein said sleeve is formed from polymethylmethacrylate, which is impermeable to said osmotic or diffusional fluid.

12. The device of claim 1 wherein said sleeve is formed from a styrene butadiene block copolymer, which is impermeable to said osmotic or diffusional fluid.

13. The device of claim 1 wherein said sleeve is formed from polysulfone, which is impermeable to said osmotic or diffusional fluid.

14. The device of claim 1 wherein said sleeve is formed from polycarbonate, which is impermeable to said osmotic or diffusional fluid.

15. The device of claim 1 wherein said sleeve is formed from polyethylene, which is impermeable to said osmotic or diffusional fluid.

16. A method of prolonging the delivering rate of diffusional or osmotic delivery devices of a predetermined configuration having an external surface which acts as a transport area through which fluid passes to activate said device, for a predetermined length of time, comprising the steps of:

forming a sleeve impermeable to the passage of fluid, sized to cover a portion of the transport area and having at least one weakened zone;

removing a portion of the sleeve at said weakened zone;

inserting the delivery device into the sleeve; and

attaching the sleeve to the delivery device;

wherein the assemblage thus formed is exposed to the osmotic or diffusional fluid to commence delivering.

17. The method of claim 16 wherein said forming step further comprises:

forming a sleeve comprised of a plurality of weakened zones each having a predetermined relationship to the delivering duration of said osmotic or diffusional device.

18. The method of claim 16 wherein said attaching step further comprises:

disposing a measured amount of a fluid permeable adhesive in the sleeve.

19. The method of claim 16 wherein said attaching step further comprises:

disposing a measured amount of a fluid permeable adhesive on the transport area.

20. The method of claim 16 which further comprises the steps of:

inserting a supporting mandrel into the sleeve; and

cutting the sleeve along the weakened zone.

21. The method of claim 16 which further comprises the step of:

marking the sleeve to determine at least two separate portions.

22. The method of claim 21 which further comprises the steps of:

inserting a supporting mandrel into the sleeve; and

cutting the sleeve along the marked zone.