Intravaginal devices for controlled delivery of lubricants

Patent metadata

Field	Value
Publication number	US-9226894-B2
Application number	US-201514709138-A
Country	US
Kind code	B2
Filing date	May 11, 2015
Priority date	Nov 12, 2010
Publication date	Jan 5, 2016
Grant date	Jan 5, 2016

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.

First claim

What is claimed is:

1. An intravaginal device comprising:
a first segment comprising:
an outer surface and
a lumen containing an aqueous lubricant,

wherein the first segment comprises a water-swellable, hydrophilic polyether polyurethane and is configured to deliver the contents of the lumen to the outer surface by diffusion.

2. The intravaginal device of claim 1 wherein the aqueous lubricant has a pH of about 3 to about 6.

3. The intravaginal device of claim 1 wherein the aqueous lubricant comprises one or more salts, nonaqueous solvents, C1-8 carboxylic acids, glucose, antioxidants, preservatives, surfactants, fragrance, flavoring agents, colors, or sweeteners.

4. The intravaginal device of claim 3 where the aqueous lubricant has a pH from 3 to 6.

5. The intravaginal device of claim 1 wherein the aqueous lubricant comprises one or more salts, propylene glycol, glycerol, lactic acid, acetic acid, glucose, BHT, ascorbic acid, sorbital, sorbic acid, parabens, EDTA, sodium benzoate, tocopherol, polysorbate 20, polysorbate 60, sorbate salts, saccharine, or aspartamate.

6. The intravaginal device of claim 1 wherein the aqueous lubricant is buffered at an acidic pH to promote the natural acidity of the vagina.

7. The intravaginal device of claim 1 wherein the aqueous lubricant comprises vaginal fluid simulant, about 5 to about 50 mM lactic acid, an acetic acid buffer at a pH of about 3.5 to about 5.0, and optionally about 5 to about 50 mM glucose.

8. The intravaginal device of claim 1 wherein the aqueous lubricant comprises from 4 wt % to 90 wt % glycerol.

9. The intravaginal device of claim 1 wherein the aqueous lubricant comprises from 60 wt % to 95 wt % glycerol.

10. The intravaginal device of claim 1 further comprising an agent selected from the group consisting of drugs and probiotics.

11. The intravaginal device of claim 10 wherein the agent is a probiotic selected from the group consisting of Lactobacillus , vitamins, and minerals.

12. 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.

13. The intravaginal device of claim 12 wherein the polymer of the one or more additional segments is a hydrophobic elastomer.

14. The intravaginal device of claim 12 wherein the hydrophobic elastomer is silicone, silicone polyurethane, polyurethane, or ethylene-vinyl acetate copolymer.

15. The intravaginal device of claim 1 wherein the device is refillable with aqueous lubricant.

16. The intravaginal device of claim 1 wherein the device is a intravaginal ring.

17. The intravaginal device of claim 16 further comprising a spring configured to support the ring or any part thereof.

18. The intravaginal device of claim 16 wherein the spring is embedded in the ring and encircles at least one lumen of the ring.

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

20. The method of claim 19 wherein the device delivers 0.001-1000 mg of aqueous lubricant to the outer surface of the device per day.

21. The method of claim 19 wherein the lubricant is delivered over a period of time ranging from 1 hour to 1 month.

22. The method of claim 19 wherein the intravaginal device is administered to the female to relieve vaginal dryness from vaginitis, inflammation of the vagina due to the thinning and shrinking of the tissues, decreased lubrication, sexual arousal disorder, menopause, drug-induced vaginal dryness, dyspareunia, sexual pain disorder, menopause, pregnancy, hormone imbalance, anxiety and diabetes, or other related disorders.

23. The method of claim 19 wherein the aqueous lubricant is water, hypo-osmolar solution, iso-osmotic solution, hyper-osmotic solution, or gel.

24. The method of claim 19 wherein the aqueous lubricant comprises one or more salts, nonaqueous solvents, C1-8 carboxylic acids, glucose, antioxidants, preservatives, surfactants, fragrance, flavoring agents, colors, or sweeteners.

25. The method of claim 19 wherein the aqueous lubricant comprises from 4 wt % to 90 wt % glycerol.

26. The intravaginal device of claim 1 wherein the first segment is configured to deliver 0.1-1000 mg of aqueous lubricant to the outer surface of the device per day.

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

28. The method of claim 20 wherein the device delivers 0.1-1000 mg of aqueous lubricant to the outer surface of the device per day.

29. The method of claim 20 wherein the device delivers 1-1000 mg of aqueous lubricant to the outer surface of the device per day.

Assignees

• Univ Utah Res Found

Inventors

• Kiser Patrick F
• Mccabe R Tyler
• Kiser Margaret N
• Albright Theodore Henry

Classifications

• A61M31/002

  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) · CPC title

• A61K9/0092

  Hollow drug-filled fibres, tubes of the core-shell type, coated fibres, coated rods, microtubules or nanotubes · CPC title

• A61K9/0036 Primary

  Devices retained in the vagina or cervix for a prolonged period, e.g. intravaginal rings, medicated tampons, medicated diaphragms · CPC title

• A61F13/20

  Tampons, e.g. catamenial tampons; Accessories therefor · CPC title

• A61M3/02 Primary

  Enemata; Irrigators · CPC title