Intravaginal devices for controlled delivery of lubricants

• US 9,078,813 B2
• Filed: 11/11/2011
• Issued: 07/14/2015
• Est. Priority Date: 11/12/2010
• Status: Active Grant

• Current Assignee: University of Utah Research Foundation (State of Utah)
• Original Assignee: University of Utah Research Foundation (State of Utah)
• Inventors: Kiser, Patrick F., McCabe, R. Tyler, Albright, Theodore Henry, Kiser, Margaret N.
• Primary Examiner(s): Desai, Anand
• Assistant Examiner(s): MERCIER, MELISSA S
• Application Number:
  US13/884,936
• Publication Number:
  US 20140074067A1
• Time in Patent Office: 1,341 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61K 2035/115 Probiotics
• CPC Class Codes: A61K 35/747 Lactobacilli, e.g. L. acidophilus or L. brevis
• CPC Class Codes: A61K 9/0036 Devices retained in the vagina or cervix for a prolonged period, e.g. intravaginal rings, medicated tampons, medicated diaphragms
• 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: 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

Abstract

The present technology provides intravaginal devices designed to deliver lubricants to the vagina for a sustained period of time. The intravaginal devices include a first segment comprising an outer surface and a lumen containing a lubricant, wherein the first segment is configured to deliver the contents of the lumen to the outer surface, and the first segment comprises a polymer selected from the group consisting of a hydrophilic, semi-permeable elastomer and a hydrophobic elastomer. The lubricant may be an aqueous lubricant. The present technology further provides an intravaginal device including a solid first segment that includes a hydrophilic semi-permeable elastomer, an outer surface and an aqueous lubricant, wherein the first segment is configured to deliver the aqueous lubricant to the outer surface.

Claims

1. An intravaginal device comprising:

a first segment comprising;

an outer surface and

a lumen containing an aqueous lubricant,

wherein

the first segment is configured to deliver the contents of the lumen to the outer surface, and

the first segment comprises a hydrophilic, semi-permeable elastomer.

3. The intravaginal device of claim 1 that is an intravaginal ring or a tampon-shaped device.

4. The intravaginal device of claim 1 wherein the hydrophilic, semi-permeable elastomer is water-swellable.

5. The intravaginal device of claim 4 wherein the hydrophilic, semi-permeable elastomer can swell from about 20 wt % to about 500 wt % over its dry weight.

6. The intravaginal device of claim 1 wherein the hydrophilic, semi-permeable elastomer is selected from the group consisting of hydrophilic polyurethane, hydrophilic silicone polyurethane copolymer, and hydrophilic polyether polyamide.

7. The intravaginal device of claim 6 wherein the hydrophilic polyurethane is selected from the group consisting of TECOPHILIC, HYDROTHANE, DRYFLEX, and HYDROMED 640.

8. The intravaginal device of claim 1 wherein the aqueous lubricant is water, aqueous solution, hypo-osmolar solution, iso-osmotic solution, hyper-osmotic solution, or gel.

9. The intravaginal device of claim 1 wherein the aqueous lubricant has a pH of about 3 to about 8.

10. The intravaginal device of claim 1 wherein the aqueous lubricant is a hyper-osmotic solution comprising glycerol.

11. The intravaginal device of claim 1 wherein the hyper-osmotic solution comprises about 4 wt % glycerol to 99 wt % glycerol.

12. The intravaginal device of claim 1 wherein the aqueous lubricant is free of steroids.

13. The intravaginal device of claim 1 wherein the aqueous lubricant comprises water and one or more additives selected from the group consisting of salt, nonaqueous solvents, C1-8 carboxylic acids, glucose, antioxidants, preservatives, surfactant, flavoring agents, and sweeteners.

14. The intravaginal device of claim 1 wherein the first segment is configured to deliver 0.001-1000 mg of aqueous lubricant to the outer surface of the device per day.

15. The intravaginal device of claim 1 further comprising one or more additional segments, each of which comprises a polymer, an outer surface and optionally a lumen.

16. The intravaginal device of claim 15 wherein each additional segment is separated from any adjacent segment by a polymer plug.

17. The intravaginal device of claim 1 comprising a segment containing a hyper-osmotic solution comprising glycerol and a segment containing a different aqueous lubricant.

18. The intravaginal device of claim 15 comprising a segment containing an aqueous gel lubricant and a segment containing or comprising an aqueous solution lubricant.

19. The intravaginal device of claim 18 wherein the aqueous gel comprises water and one or more additives selected from the group consisting of nonaqueous solvents, C1-8 carboxylic acids, glucose, antioxidants, viscosifying agents, preservatives, moisturizers, surfactant, flavoring agents, and sweeteners.

20. The intravaginal device of claim 15 wherein the polymer of the first segment is different from the polymer of at least one additional segment.

21. The intravaginal device of claim 20 wherein the polymer of the first segment is a hydrophilic, semi-permeable elastomer and the polymer of at least one additional segment is a hydrophobic elastomer.

22. The intravaginal device of claim 20 wherein the polymer of the first segment is a hydrophilic, semi-permeable elastomer and the polymer of at least one additional segment is a different hydrophilic elastomer.

23. The intravaginal device of claim 1 wherein the device is an intravaginal ring and the ring has an outer diameter ranging from about 40 mm to about 80 mm.

24. The intravaginal device of claim 1 wherein the device is an intravaginal ring and the ring has a cross-sectional diameter ranging from about 3 mm to about 12 mm.

25. The intravaginal device of claim 1 wherein the device is an intravaginal ring and a force of not less than 0.15 N and not more than 10 N is sufficient to compress the ring by 10%.

26. The intravaginal device of claim 1 wherein the device is an intravaginal ring and further comprises a spring configured to support the ring or any part thereof.

29. A method of lubrication comprising administering an intravaginal device of claim 1 to a female in need of vaginal lubrication.

30. A method of lubrication comprising delivering an aqueous lubricant or lubricant to vaginal tissue of a female by delivering the aqueous lubricant to the surface of the intravaginal device of claim 1, wherein the intravaginal device resides in the female vagina.

2. An intravaginal device comprising:

a solid first segment comprising;

a hydrophilic semi-permeable elastomer,

an outer surface and

an aqueous lubricant,

wherein

the first segment is configured to deliver the aqueous lubricant to the outer surface.

27. An intravaginal device comprising:

a first segment comprising;

an outer surface and

a lumen containing a lubricant,

wherein

the first segment is configured to deliver the contents of the lumen to the outer surface, and

the first segment comprises a hydrophilic, semi-permeable elastomer.

28. An intravaginal device comprising:

a solid first segment comprising;

a hydrophilic semi-permeable elastomer,

an outer surface and

a lubricant,

wherein

the first segment is configured to deliver the lubricant to the outer surface.