Intravesical drug delivery system

• US 6,039,967 A
• Filed: 04/02/1998
• Issued: 03/21/2000
• Est. Priority Date: 04/03/1997
• Status: Expired due to Fees

• Current Assignee: POINT Biomedical Corporation
• Original Assignee: POINT Biomedical Corporation
• Inventors: Yamamoto, Ronald K., Conston, Stanley R., Ottoboni, Thomas B.
• Primary Examiner(s): AZPURU, CARLOS A
• Application Number:
  US09/054,154
• Time in Patent Office: 719 Days
• Field of Search: 424/426, 424/430, 514/772.3
• US Class Current: 424/426
• CPC Class Codes: A61K 47/10 Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
• CPC Class Codes: A61K 47/12 Carboxylic acids; Salts or anhydrides thereof
• CPC Class Codes: A61K 47/26 Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
• CPC Class Codes: A61K 47/32 Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers , poly(meth)acrylates, or polyvinyl pyrrolidone
• CPC Class Codes: A61K 47/36 Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
• CPC Class Codes: A61K 47/44 Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin synthetic glycerides, e.g. medium-chain triglycerides, A61K47/14
• CPC Class Codes: A61K 9/0034 Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
• CPC Class Codes: A61K 9/1647 Polyesters, e.g. poly(lactide-co-glycolide)
• CPC Class Codes: A61K 9/70 Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug hollow drug-filled fibres A61K9/0092
• CPC Class Codes: A61P 13/00 Drugs for disorders of the urinary system
• CPC Class Codes: A61P 13/10 of the bladder
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 35/00 Antineoplastic agents

Abstract

Bioerodible, sustained release preparations are provided for placement into the bladder through the urethra which provide sustained release of drugs. Configurations are provided which are insertable through a catheter, such as a coiled filament, patch or a flowable gel. The device is bioeroded during or after the sustained release of the drug such that there is no blockage of the urinary tract while the device is in place within the bladder.

Claims

1. A bioerodible, sustained-release preparation for placement into the bladder through the urethra,

comprising a pharmaceutically active ingredient and a bioerodible pharmaceutically acceptable carrier;

said carrier being capable of sustained delivery within the bladder of said active ingredient and said carrier being excretable through the urinary tract after bioerosion.

2. A preparation according to claim 1 wherein said preparation has a specific gravity less than about 1.005 at 25°

C.

3. A preparation according to claim 1 wherein said active ingredient is selected from the group consisting of oxybutynin, doxorubicin, imipramine, dicyclomine, desmopressin, estrogen, terodiline, propantheline, doxepin, and flavoxate.

4. A preparation according to claim 1 wherein said active ingredient comprises oxybutynin.

5. A preparation according to claim 1 further comprising a mucoadhesive surface adherable to the endothelium of the bladder.

6. A preparation according to claim 5 wherein said preparation comprises a patch.

7. A preparation according to claim 5 wherein said preparation comprises a tablet.

8. A preparation according to claim 1 comprising an expandable filament which in unexpanded form is passable through the urethra for insertion and in expanded form is retained within the bladder.

9. A preparation according to claim 8 wherein said filament comprises a coil.

10. A preparation according to claim 8 wherein said filament comprises a hoop.

11. A preparation according to claim 9 wherein said filament comprises a random coil.

12. A preparation according to claim 8 wherein said filament comprises a spherical cage wherein the filaments meet at poles of the sphere.

13. A preparation according to claim 8 wherein said filament is progressively degradable from its ends.

14. A preparation according to claim 8 wherein said filament is progressively degradable in discrete segments.

15. The preparation according to claim 8 wherein said filament forms a porous open cell foam.

16. A preparation according to claim 1 further comprising a reservoir from which said active ingredient is controllably released.

17. A preparation according to claim 1 comprising a gel.

18. A preparation according to claim 17 wherein said gel is formed upon contact with urine in said bladder.

19. A preparation according to claim 17 wherein said gel is mucoadhesive.

20. A preparation according to claim 18 wherein said gel has a density less than urine.

21. A preparation according to claim 17 wherein said active ingredient is in a carrier dispersed in said gel.

22. A preparation according to claim 21 wherein said carrier comprises microspheres, liposomes or an emulsion.

23. A preparation according to claim 1 wherein said active ingredient is released from said carrier before said carrier is completely bioeroded.

24. A preparation according to claim 1 wherein said active ingredient is controllably released as said carrier is bioeroded.

25. A preparation according to claim 1 wherein said active ingredient is for treatment of interstitial cystitis.

26. A preparation according to claim 1 wherein said active ingredient is for treatment of cancer.

27. A preparation according to claim 1 wherein said active ingredient is for treatment of incontinence.

28. A preparation according to claim 1 wherein said active ingredient is for treatment of inflammation.

29. A preparation according to claim 1 wherein said active ingredient is for treatment of infection.