Controlled release device

• US 4,814,182 A
• Filed: 04/15/1987
• Issued: 03/21/1989
• Est. Priority Date: 07/22/1983
• Status: Expired due to Term

• Current Assignee: British Technology Group Ltd.
• Original Assignee: National Research Development Corporation
• Inventors: Wood, David A., Graham, Neil B., McNeill, Marion E.
• Primary Examiner(s): GRIFFIN, RONALD
• Application Number:
  US07/039,805
• Time in Patent Office: 706 Days
• Field of Search: 424/425, 424/484, 424/486
• US Class Current: 424/484
• CPC Class Codes: A61K 9/0092 Hollow drug-filled fibres, tubes of the core-shell type, coated fibres, coated rods, microtubules or nanotubes
• CPC Class Codes: A61K 9/2027 obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
• CPC Class Codes: A61K 9/2031 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
• 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
• CPC Class Codes: C08G 18/4833 Polyethers containing oxyethylene units
• CPC Class Codes: C08G 18/6677 having at least three hydroxy groups
• CPC Class Codes: C08G 2210/00 Compositions for preparing hydrogels

Abstract

A controlled release device which comprises:

(i) a hydrogel; and incorporated therewith

(ii) an active substance,

at least part of at least one surface of the device comprising

(iii) a layer which is impermeable to aqueous media.

Claims

1. A controlled release device, which comprises:

(i) a hydrogel; and

incorporated therewith

(ii) an active substance which is released

through the hydrogel, with at least part of at least one surface of the device comprising

(iii) a layer which is impermeable to aqueous media and to said active substance thereby providing control of release of active substance from said device to the extent that at least functionally effective amounts of said active substance are released.

2. The controlled release device according to claim 1 wherein the hydrogel (i) comprises a hydrophilic homo- or copolymer comprising residues derivable from at least one of the following monomer classes:

(a) (meth)acrylic acid, (meth)acrylamide or an unsubstituted or hydroxy-substituted alkyl (meth)acrylate or a poly(oxyethylene)(meth)acrylate;

(b) a substituted or unsubstituted cyclic mono or poly ether having from 3 to 6 ring atoms or cyclic imine having 3 ring atoms;

or

(c) a substituted or unsubstituted vinyl alcohol, aldehyde, ether, acetal, ketone, ester, anhydride or substituted or unsubstituted N- or C- vinyl heterocyclic compound.

3. The controlled release device according to claim 1 or 2 wherein the hydrogel (i) comprises a homo- or copoly(alkylene oxide).

4. The controlled release device according to claim 3 wherein the hydrogel (i) comprises a poly(ethylene oxide).

5. The controlled release device according to claim 3 wherein the poly(alkylene oxide) is cross-linked through reaction with isocyanate or unsaturated cyclic ether groups.

6. The controlled release device according to claim 1 wherein the active substance (ii) comprises a lithium salt.

7. The controlled release device according to claim 1 wherein the active substance (ii) comprises a prostaglandin.

8. The controlled release device according to claim 1 wherein the active substance (ii) is homogeneously dispersed throughout the hydrogel (i).

9. The controlled release device according to claim 1 wherein the active substance (ii) is contained in a reservoir within the hydrogel (i).

10. The controlled release device according to claim 1 which is formed as a rod, slab, film hemisphere and/or is of hollow or sinusoidal profile.

11. The controlled release device according to claim 1 wherein the impermeable layer (iii) is hydrophobic.

12. The controlled release device according to claim 1 where the impermeable layer (iii) covers all of at least one surface of the device thereby defining at least one orifice thereon through which the hydrogel (i) is contactable by aqueous media.

13. The controlled release device according to claim 1 which comprises a rod, slab or film of hydrogel (i) wherein the impermeable layer (iii) covers all of the surfaces except one or both end profiles.

14. The controlled release device according to claim 1 wherein the rod or slab of hydrogel (i) is formed with a single or bis-sinusoidal profile along its length.

15. The controlled release according to claim 1 which comprises a hemisphere of hydrogel (i) wherein the impermeable layer (iii) covers all of the surfaces except a polar orifice.

16. The controlled release device according to claim 1 which comprises a ring of hydrogel (i) wherein the impermeable layer (iii) covers all of the external surfaces.

17. The controlled release device according to claim 1, which contains a plurality of orifices which provide access to the hydrogel component through said impermeable layer.

18. The controlled release device according to claim 1, wherein the active substance (ii) is inhomogeneously dispersed throughout the hydrogel (i).

19. A controlled release device, which comprises:

(i) a hydrogel, and incorporated therewith;

(ii) an active substance which is released

through the hydrogel, with at least one surface of the device comprising

(iii) a layer which is impermeable to aqueous media and to said active substance, said layer having at least one orifice therein which provides access to said hydrogel component by said aqueous media and control of release of said active substance from said device.

20. A controlled release device, which comprises:

(i) a hydrogel of a substituted or unsubstituted cyclic mono- or polyether having from 3 to 6 ring atoms; and

incorporated therewith

(ii) a lithium salt as an active substance which is released through the hydrogel, with at least a portion of at least one surface of the device comprising

(iii) a layer which is impermeable to aqueous media and to said active substance thereby providing control of release of active substance from said device to the extent that at least therapeutically effective amounts of said lithium salt are released.