Hydrogel containing envelopes

• US 5,147,646 A
• Filed: 09/16/1991
• Issued: 09/15/1992
• Est. Priority Date: 03/02/1983
• Status: Expired due to Fees

• Current Assignee: British Technology Group Ltd.
• Original Assignee: National Research Development Corporation
• Inventors: Graham, Neil B.
• Primary Examiner(s): Nutter, Nathan M.
• Application Number:
  US07/759,623
• Time in Patent Office: 365 Days
• Field of Search: 424/14, 424/16, 424/19, 424/20, 424/22, 424/424, 424/425, 424/426, 424/443, 424/469, 424/470, 210/633, 210/635, 210/642, 210/634, 604/372, 604/374, 604/375, 604/369, 604/892
• US Class Current: 424/424
• CPC Class Codes: A61K 9/009 Sachets, pouches characterised by the material or function of the envelope with gastric retention A61K9/0065; sachets which are not administered but function merely as a container are classified according to the content, e.g. sachets comprising powder for reconstitution of a drink A61K9/0095
• 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: C02F 1/265 Desalination
• 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

An envelope having flexible water-permeable or porous walls contains a quantity of particulate water-insoluble hydrogel. The quantity of hydrogel in the envelope is such that, when the hydrogel is fully swollen at 20° C., its volume is at least 66%, preferably at least 100%, of the maximum non-stretched internal volume of the envelope. Thus, the envelope according to the invention is limp and floppy under dry conditions but in a wet environment the hydrogel absorbs water and swells accordingly causing the envelope to swell and take on a more rigid configuration. The envelope is particularly useful for the administration of sustained release pharmaceutically or veterinarily active ingredients. Thus the limp dry envelope may for example be rolled up for introduction through the throat but will swell up and therefore be retained in the stomach for sustained release of the active ingredient therein.

Claims

1. A method of treating animals which method comprises administering to the animal an envelope having flexible water-permeable or porous walls and a given maximum non-stretched internal volume and containing a quantity of particulate water-insoluble hydrogel and a veterinarily active ingredient in sustained release form in the closed envelope wherein the volume of the quantity of hydrogel when fully swollen at 20°

C. amounts to at least 66% of the given maximum non-stretched internal volume but is insufficient when fully swollen at 20°

C. to rupture the envelope.

2. A method according to claim 1 wherein the animal is a ruminant.

3. A method of treating a human patient which method comprises administering to the patient an envelope having flexible water-permeable or porous walls and a given maximum non-stretched internal volume and containing a quantity of particulate water-insoluble hydrogel and a pharmaceutically active ingredient in sustained release form in the closed envelope wherein the volume of the quantity of hydrogel when fully swollen at 20°

C. amounts to at least 66% of the given maximum non-stretched internal volume but is insufficient when fully swollen at 20°

C. to rupture the envelope.

4. A device for sustained release of an active ingredient in the stomach of a human or animal, which device comprises an envelope having flexible water-permeable and porous walls of perforated plastic, knitted, braid or woven material, the envelope containing particulate water-insoluble hydrogel in a pharmaceutically, veterinarily or biologically active ingredient in sustained release form in the closed envelope wherein the volume of the hydrogel when fully swollen in water at 20°

C. amounts to at least 66% of the maximum non-stretched internal volume of the envelope and is sufficient to retain the device within the stomach of the human or animal during the sustained release of the active ingredient but is insufficient when fully swollen in water at 20°

C. to rupture the envelope.

5. The envelope according to claim 4, wherein the quantity of hydrogel when fully swollen in water at 20°

C. amounts to at least 100% of the given maximum non-stretched internal volume.

6. The envelope according to claim 4, wherein the hydrogel is a crosslinked polyethylene glycol.

7. The envelope according to claim 4, which contains a mixture of hydrogel particles and particles of active ingredient in sustained release form.

8. The envelope according to claim 4, wherein the active ingredient in sustained release form is contained in the hydrogel particles.

9. The envelope according to claim 4, wherein the quantity of hydrogel when fully swollen in water at 20°

C. ranges from 90 to 110% of the given maximum non-stretched internal volume of the envelope.

10. The envelope according to claim 4, wherein the average particle size of the hydrogel particles is at least 1% larger than the pores of the surrounding envelope.

11. The envelope according to claim 10, wherein said average particle size is at least twice the size of the pores of the surrounding envelope.

12. The envelope according to claim 4, wherein the hydrogel is one that upon swelling absorbs more than 40% of its dry weight of water without dissolution.

13. The envelope according to claim 12, wherein the degree of swelling of the hydrogel ranges between 150 and 1000% by weight.

14. The envelope according to claim 4, which is in the form of a toroid.