Fiber-reinforced composite rings for intravaginal controlled drug delivery

• US 8,404,272 B2
• Filed: 06/03/2004
• Issued: 03/26/2013
• Est. Priority Date: 06/26/2003
• Status: Active Grant

• Current Assignee: Poly-Med, Inc.
• Original Assignee: Poly-Med, Inc.
• Inventors: Shalaby, Shalaby W.
• Primary Examiner(s): Wax, Robert A
• Assistant Examiner(s): Palenik, Jeffrey T
• Application Number:
  US10/860,677
• Publication Number:
  US 20040265355A1
• Time in Patent Office: 3,218 Days
• Field of Search: 424/423, 424/426, 424/430, 424/431, 424/432, 424/433, 424/434, 424/444, 424/449, 424/473, 424/484, 424/486, 424/488, 514/15, 514/236.2, 514/415, 514/613, 514/650, 514/718, 514/772.3, 514/843, 623/2.36
• US Class Current: 424/432
• 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 47/32 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 47/34 Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers A61K47/10 takes precedence
• CPC Class Codes: A61L 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 31/129 containing macromolecular fillers
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

A fiber-reinforced composite ring for the controlled release of at least one bioactive agent includes a biocompatible matrix reinforced with absorbable/biodegradable fibers capable of providing the mechanical properties needed for inserting and maintaining the ring in a body cavity for a desired period of time. Such ring system as can be used for the intravaginal, intraperitoneal, and subcutaneous delivery of at least one bioactive agent, including those used as contraceptives, antimicrobial agents, and/or antiviral agents, as well as those for the treatment of cancer.

Claims

1. An intravaginal ring for the controlled delivery of a bioactive agent, said ring comprising a) a biocompatible matrix and b) a reinforcing, absorbable biodegradable fiber construct within said biocompatible matrix, wherein said biocompatible matrix further comprises an absorbable microparticulate polymer and a bioactive agent contained within said matrix, wherein said reinforcing, absorbable biodegradable fiber construct is formed from at least one cyclic monomer selected from the group consisting of glycolide, l-lactide, ε

-caprolactone, p-dioxanone and trimethylene carbonate.

2. The intravaginal ring of claim 1 wherein said microparticulate polymer comprises poly-glycolide.

3. The intravaginal ring of claim 1 wherein said reinforcing, absorbable fiber construct is a multifilament fiber.

4. The intravaginal ring of claim 1 wherein said biocompatible matrix comprises a poly dimethylsiloxane.

5. The intravaginal ring of claim 1 wherein said bioactive agent is a viscosity modifier of the vaginal mucus.

6. The intravaginal ring of claim 1 wherein said bioactive agent is ascorbic acid.

7. The intravaginal ring of claim 1 wherein said bioactive agent is a spermiostatic agent.

8. The intravaginal ring of claim 7 wherein said spermiostatic agent is ferrous gluconate.

9. The intravaginal ring of claim 1 wherein said bioactive agent is for intravaginal and transvaginal prevention or treatment of an infection selected from bacterial infections, fungal infections, viral infections and parasitic infections.

10. The intravaginal ring of claim 1 wherein said bioactive agent is the treatment of cervical or ovarian cancer.

11. The intravaginal ring of claim 1 wherein said bioactive agent provides hormone replacement therapy.

12. The intravaginal ring of claim 1 wherein said bioactive agent aids in achieving contraception.

13. The intravaginal ring of claim 1 wherein said bioactive agent provides treatment for infertility, enhancing fertility.

14. The intravaginal ring of claim 1 wherein said bioactive agent provides treatment for gynecological infectious diseases.

15. The intravaginal ring of claim 1 wherein said bioactive agent provides treatment in gynecological cancer.

16. The intravaginal ring of claim 1 wherein said bioactive agent is selected from the group consisting of antifertility drugs, testosterone, testosterone precursurs, spermicidal agents, sperm immobilizers and bisphosphonate.

17. The intravaginal ring of claim 1 wherein said bioactive agent is selected from the group consisting of anti-progestinic agents, anesthetic agents, analgesic agents, anti-inflammatory agents, antimicrobial agents, antiviral agents and antipsychotic agents.

18. The intravaginal ring of claim 1 wherein said bioactive agent is selected from the group consisting of monoclonal antibodies, recombinant immunomodulator vaccines and hematopoietic growth factors.