Flushable disposable polymeric products

• US 6,592,892 B1
• Filed: 08/29/2000
• Issued: 07/15/2003
• Est. Priority Date: 08/30/1999
• Status: Expired due to Term

• Current Assignee: Tepha Incorporated (Becton, Dickinson & Co)
• Original Assignee: Tepha Incorporated (Becton, Dickinson & Co)
• Inventors: Williams, Simon F.
• Primary Examiner(s): Dodson, Shelley A.
• Application Number:
  US09/649,978
• Time in Patent Office: 1,050 Days
• Field of Search: 424/448, 424/449, 424/78.02, 424/78.08
• US Class Current: 424/449
• CPC Class Codes: A61K 9/0034 Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants
• CPC Class Codes: A61K 9/006 Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
• CPC Class Codes: A61K 9/7023 Transdermal patches and similar drug-containing composite devices, e.g. cataplasms galenical aspects of iontophoretic devices A61K9/0009; microneedle arrays A61K9/0021; buccal patches A61K9/006
• CPC Class Codes: A61L 15/26 Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds; Derivatives thereof A61L15/225 takes precedence
• CPC Class Codes: A61L 15/62 Compostable, hydrosoluble or hydrodegradable materials
• CPC Class Codes: A61P 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: B09B 2101/68 Transdermal patches
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

Materials suitable for preparing components of flushable drug delivery systems are described. These components include drug impermeable and drug permeable materials, including materials that can be used to control the rate of release of drugs from the device, and pressure sensitive adhesive compositions which are drug compatible. Methods for fabricating these devices, including transdermal drug delivery patches, are described.

Claims

1. A flushable drug delivery device or bandage which degrades in an aqueous environment or sewage within one year, wherein the device or bandage comprises as a structural or adhesive component a polyhydroxyalkanoate.

2. The device of claim 1 wherein the device is manufactured in a form suitable for use as a device selected from the group consisting of a transdermal delivery patch, a buccal delivery device, a vaginal delivery device, an ophthalmic delivery device.

3. The device of claim 1 wherein the polyhydroxyalkanoate forms a laminate or barrier in the device which breaks down within six to twelve months in an aqueous environment.

4. The device of claim 1 wherein the polyhydroxyalkanoate forms a woven or non-woven fibrous material which breaks down within six to twelve months in an aqueous environment.

5. The device of claim 1 comprising a biodegradable adhesive.

6. The device of claim 5 wherein the adhesive is pressure sensitive.

7. The device of claim 5 wherein the device is an adhesive bandage.

8. The device of claim 5 wherein the adhesive is compatible with a drug or active agent.

9. The device of claim 8 wherein the adhesive can be used to control the rate of release of a drug incorporated into the device.

10. The device of claim 3 wherein the polyhydroxyalkanoate forms a drug impermeable membrane.

11. The device of claim 3 wherein the polyhydoxyalkanoate comprises a drug permeable membrane.

12. The device of claim 11 wherein the membrane can control the rate of drug release from the device.

13. The device of claim 1 wherein the polyhydroxyalkanoate is a copolymer or blend with a polymer selected from the group consisting of polyesters, polyurethanes, polyorthoesters, polyanhydrides, polyvinylacetate, cellulose acetate, polycarbonate, polysaccharides, polyamino acids, polyethylene oxide, and polyvinylalcohol.

14. The device of claim 2, further comprising an electrotransport system.

15. The device of claim 14 wherein the electrotransport system can be removed prior to flushing the drug delivery component of the transdermal patch.

16. The device of claim 1 further comprising a prophylactic, therapeutic or diagnostic agent.

17. The device of claim 16 wherein the agent is selected from the group consisting of proteins and peptides, sugars and polysaccharides, nucleic acid molecules, and synthetic drugs.

26. The method of claim 1 wherein the polyhydroxyalkanoate is a copolymer or blend with a polymer selected from the group consisting of polyesters, polyurethanes, polyorthoesters, polyanhydrides, polyvinylacetate, cellulose acetate, polycarbonate, polysaccharides, polyamino acids, polyethylene oxide, and polyvinylalcohol.

18. A method for drug delivery or to protect a wound comprising providing to a patient in need thereof a flushable drug delivery device or bandage which degrades in an aqueous environment or sewage within one year, wherein the device or bandage comprises as a structural or adhesive component a polyhydroxyalkanoate.

19. The method of claim 18 wherein the device is manufactured in a form suitable for use as a device selected from the group consisting of a transdermal delivery patch, a buccal delivery device, a vaginal delivery device, and an ophthalmic delivery device.

20. The method of claim 18 wherein the polyhydroxyalkanoate forms a laminate or barrier in the device which breaks down within six to twelve months in an aqueous environment.

21. The method of claim 18 wherein the polyhydroxyalkanoate forms a woven or non-woven fibrous material which breaks down within six to twelve months in an aqueous environment.

22. The method of claim 18 wherein the device is an adhesive bandage.

23. The method of claim 18 wherein the adhesive can be used to control the rate of release of a drug incorporated into the device.

24. The method of claim 20 wherein the polyhydroxyalkanoate forms a drug impermeable membrane.

25. The method of claim 20 wherein the polyhydoxyalkanoate comprises a drug permeable membrane, that can be used to control the rate of drug release from the device.

27. The method of claim 18, wherein the device is applied for drug delivery and comprises an electrotransport system that can be removed prior to flushing the drug delivery component of the transdermal patch.

28. The method of claim 18 further comprising administering in the device a prophylactic, therapeutic or diagnostic agent.