Controlled release device and method

• US 5,980,508 A
• Filed: 04/30/1997
• Issued: 11/09/1999
• Est. Priority Date: 06/22/1994
• Status: Expired due to Fees

• Current Assignee: Controlled Release Technologies Pty. Ltd.
• Original Assignee: Controlled Release Technologies Pty. Ltd.
• Inventors: Bentley, Herbert William, Cardamone, Michael
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US08/750,894
• Time in Patent Office: 923 Days
• Field of Search: 604/892.1, 604/890.1, 604/891.1, 424/449, 424/473
• US Class Current: 604/890.1
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• 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

A device for dispensing one or more active agents, the device including: a housing (112) having an opening; at least one active agent (118) located within the housing; a driving means (124) located within, or at the closed end of the housing, including an expandable material; and one or more permeable fluid conveying passage(s) adapted to convey fluid from outside the housing to the driving means.

Claims

1. A device for dispensing one or more active agents, the device including:

a housing having one or more openings;

an active agent or agents located within the housing;

a driving means located within, or at a closed end of, the housing, said driving means including an expandable material; and

one or more fluid conveying passages adapted to convey fluid from outside the housing to the driving means;

wherein said passages allow restricted but controlled conveyance of fluid, such as body fluid, to the expandable material but not so restricted as to provide semi-permeable flow and further wherein in use said fluid leads to expansion of said expandable material with subsequent displacement of said active agent or agents and thus subsequent dispensing of said agent or agents.

2. A device according to claim 1 wherein the driving means includes an expandable layer of a passive or active agent and/or a liquid imbibing swellable material of an active agent.

3. A device according to claim 1 wherein the active agent is in a dosage form.

4. A device according to claim 1 wherein the device is adapted to provide continuous or pulsatile release, the housing is elongate and includes a multiplicity of layers arranged lengthwise therein with one or more layers being an expandable or non-expandable layer and one or more layers containing the active agent.

5. A device according to claim 4, wherein each active layer includes a protective skin or coating.

6. A device according to claim 1 wherein the housing is formed from a substantially liquid impermeable polymer selected from the group consisting of non-porous polyethylene, polycarbonate, polypropylene, polyvinyl chloride, polytetrafluoroethylene (PTFE), fluoroethylenepropylene (FEP), polyvinylidene fluoride (PVDF), polyvinylacetate, polystyrene, ethylene vinylacetate, nylon, polyurethane, a polyhydroxy alkoanate, silicone rubber, polysiloxane, polybutadiene, polyisoprene, poly(lactic acid), poly(glycolic acid), poly(alkyl 2-cyanoacrylates), polyanhydrides and polyorthoesters and mixtures thereof.

7. A device according to claim 6 wherein the housing of the device is formed from a hydrophobic biocompatible material and the internal walls of the housing or the fluid conveying passages are treated to render them hydrophilic.

8. A device according to claim 1 wherein the opening of the device is closed by an occlusion means formed of a material which is discharged, leached or eroded by the environment in which the device is to be used.

9. A device according to claim 1 wherein the driving means is a swellable hydrophilic polymer or hydrogel.

10. A device according to claim 9 wherein the driving means is selected from the group consisting of polyacrylates, poly(hydroxyalkyl methacrylates), polyvinyl alcohol, poly(N-vinyl-2-pyrrolidone), poly(vinyl acetate), poly(hydroxyethyl methacrylate), alginates, polyacrylamide, cellulose acetate phthalate, hydroxypropyl cellulose, carboxymethyl cellulose, ethyl cellulose, methyl cellulose, collagen, zein, gelatin, agarose, DEAE, Sephadex T, natural rubber, guar gum, gum agar, curdland or other schleroglucans, hydroxymethyl cellulose, albumin and mixtures thereof.

11. A device according to claim 1 wherein the fluid conveying passages permit blood vessels to infiltrate.

12. A device according to claim 1 wherein the fluid conveying passages have outlets which are located at one end of the housing adjacent to the expandable material.

13. A dispensing device for dispensing one or more active agents, the device including:

a housing having one or more openings;

an active agent or agents located within the housing;

a driving means located within or at a closed end of the housing, said driving means including an expandable material; and

one or more capillary passages adapted to convey fluid from outside the housing to the driving means;

wherein said passages allow restricted but controlled conveyance of fluid, such as body fluid, to the expandable material but not so restricted as to provide semi-permeable flow and further wherein in use said fluid leads to expansion of said expandable material with subsequent displacement of said active agent or agents and thus subsequent dispensing of said agent or agents.

14. A device according to claim 13 wherein the device is adapted to provide pulsatile or continuous release including a multiplicity of layers arranged lengthwise in the housing with one or more layers being an expandable or non-expandable layer and one or more layers containing the active agent;

and the capillary passages have outlets which are located against one or more of the expandable or non-expandable layers.

15. A device according to claim 14 wherein said expandable layers are formed with a radial skin which is relatively impervious to body fluid.

16. A device according to claim 13 wherein the capillary passages permit blood vessels to infiltrate.

17. A device according to claim 13 wherein the capillary passages extend along part or all of the housing such that an end of the passage or passages is located inside or close to an opening in the housing for ingress of fluid and another end of the passage or passages is located adjacent to the driving means for egress of the fluid from the passage.

18. A device according to claim 17 wherein the device further includes a shield-tube of larger diameter than the housing positioned around an outer end of the device, with the capillary passages being positioned within or adjacent to the outer wall of the housing.

19. A device according to claim 13 wherein the capillary passages include hydrophilic fibrous, granular mat-form or molecular wick material which facilitates the transport of water and aqueous solutions therethrough.

20. A device according to claim 19 wherein the capillary passages are extruded, intertwined or woven fibrous material in the form of a rope, cord or the like, the spacing between the fibres forming the capillary passages.

21. A device according to claim 20 wherein the fibres are formed from a hydrophilic polymeric material or a hydrophobic polymeric material with the surface thereof being treated so as to be hydrophilic.

22. A device according to claim 21 wherein the polymer fibres are formed from polyethylene, polyetheretherketone, polyimide, polytetrafluoroethylene, polyvinylidene fluoride, propylene or fluoroethylenepropylene.

23. A device according to claim 14 wherein one or more capillary channels are formed on the inner surface of the housing.

24. A device for dispensing one or more active agents, the device including:

a housing having an opening and being formed at least in part from a substantially liquid impervious material;

an active agent or agents located within the liquid impervious housing;

a driving means located within, or at a closed end of, the housing, the driving means including an expandable material;

said housing including a portion having a plurality of pores formed therein to convey fluid from outside the housing to the driving means, wherein in use said fluid leads to expansion of said expandable material with subsequent displacement of said active agent or agents and thus subsequent dispensing of said agent or agents.

25. A device according to claim 24 wherein the housing includes a porous plug, cover or cap associated with the body of the housing.

26. A device according to claim 24 wherein the housing includes a water impermeable section with an open end and a porous section fabricated from a porous polymer forming a closed end of the device and surrounding an expandable driving system.

27. A device for dispensing one or more active agents, the device including:

a housing having an opening;

at least one active agent located within the housing;

a driving means located within, or at the closed end of, the housing, the driving means including an expandable material;

one or more fluid conveying passages formed on the inner surface of the housing adapted to convey fluid from the outside of the housing to the driving means; and

a constrained edge wick which extends the full length of the inner surface of the housing so that it contacts the edges of all layers in the stack loaded in the housing, the capacity of the edge wick to deliver water to each expanding layer being substantially less than the capacity of the layer to absorb water.

28. A device according to claim 27 wherein wick tracks are formed on the inner surface of the housing by printing a broad circumferential capillary band opposite each expandable active or spacer layer and by joining each band to the next by a fluid conveying passage.

29. A device according to claim 27 wherein said constrained edge wick extending the length of the inner surface of the housing is covered and enclosed with a layer of impermeable material so that it is adapted to convey water to only an end bearing a swellable agent.

30. A device according to claim 27 wherein said constrained edge wick extending the length of the inner surface of the housing is uncovered so that its inner face abuts the edges of the active layers when the housing is filled.

31. A device according to claim 27 wherein said constrained edge wick extending the length of the housing is left partially uncovered so that it abuts the edges of only selected layers.

32. A device according to claim 27 wherein said device includes a short wick formed in the inside of the outer end of the housing so as to contact and feed moisture to the edge of each expandable layer as it reaches the open end of the capsule.

33. A dispensing device for dispensing one or more active agents the device including:

a housing having an opening;

at least one active agent located within the housing;

a driving means located within or at the closed end of the housing, the driving means including an expandable material;

one or more capillary channels formed on the inner surface of the housing adapted to convey fluid from the outside of the housing to the driving means; and

a constrained edge wick which extends the full length of the inner surface of the housing so that it contacts the edges of all layers in the stack in the housing, the capacity of the constrained edge wick to deliver water to each expanding layer being substantially less than the capacity of the layer to absorb water.

34. A device according to claim 33 wherein wick tracks are formed on the inner surface of the housing by printing a broad circumferential capillary band opposite each expandable active or spaces layer and by joining each band by a capillary passage.

35. A device according to claim 33 wherein said constrained edge wick extending the length of the inner surface of the housing is covered and enclosed with a layer of impermeable material so that it is adapted to convey water to only an end bearing a swellable agent.

36. A device according to claim 33 wherein said constrained edge wick extending the length of the inner surface of the housing is uncovered so that its inner face abuts the edges of the active layers when the housing is filled.

37. A device according to claim 33 wherein said constrained edge wick which extends the full length of the housing is left partially uncovered so that it abuts the edges of only selected layers.

38. A device according to claim 33 wherein said device includes a short wick formed in the inside of the outer end of the housing so as to contact and feed moisture to the edge of each expandable layer as it reaches the open end of the capsule.