Intravaginal devices for controlled delivery of lubricants

• US 10,350,160 B2
• Filed: 10/27/2017
• Issued: 07/16/2019
• 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, Kiser, Margaret N., Albright, Theodore Henry
• Primary Examiner(s): Wax, Robert A
• Assistant Examiner(s): Mercier, Melissa S
• Application Number:
  US15/796,335
• Publication Number:
  US 20180104182A1
• Time in Patent Office: 627 Days
• Field of Search: None
• 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 comprises a water-swellable, hydrophilic polyether polyurethane and is configured to deliver the contents of the lumen to the outer surface by diffusion; and

the aqueous lubricant comprises water and about 60 wt % to about 95 wt % glycerol and has a pH of about 3 to about 6.

2. The intravaginal device of claim 1 wherein the aqueous lubricant has a pH of about 3.5 to about 4.5.

3. The intravaginal device of claim 1 wherein the aqueous lubricant further 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 wherein the aqueous lubricant further comprises ascorbic acid or citric acid.

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

6. The intravaginal device of claim 1 further comprising probiotics.

7. The intravaginal device of claim 1 wherein the aqueous lubricant further comprises vaginal fluid stimulant, 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. A method of lubrication comprising administering an intravaginal device of claim 1 to a female in need of vaginal lubrication.

9. The method of claim 8 wherein the device delivers 0.001-2000 mg of aqueous lubricant to the outer surface of the device per day.

10. The method of claim 8 wherein the lubricant is delivered over a period of time ranging from 1 day to 1 month.

11. The intravaginal device of claim 1, wherein the device is an intravaginal ring.

12. 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; and

the aqueous lubricant comprises water, glycerol and is buffered at an acidic pH to promote the natural acidity of the vagina.

13. The intravaginal device of claim 12, further comprising one or more additives selected from the group consisting of C1-8 carboxylic acids, sorbic acid, amino acids, and ascorbic acid.

14. The intravaginal device of claim 12, further comprising one or more additives selected from the group consisting of stearic acid, benzoic acid, sodium benzoate, boric acid, adipic acid, alkyl fumarate, aluminum sulfate, calcium acetate, calcium carbonate, calcium lactate, citric acid, acetic acid, glutamic acid, glycine, hydrochloric acid, lactic acid, methionine, nitric acid, phosphoric acid, potassium bitartrate, sodium dihydrogen citrate, sodium citrate, sodium dibasic phosphate, sodium carbonate, sodium bicarbonate, sodium hydroxide, sodium lactate, sodium monobasic phosphate, stannous chloride, succinic acid, and tartaric acid, ascorbic acid, sodium ascorbate, butylated hydroxyanisole, butylated hydroxytoluene, EDTA, and sodium metabisulfite.

15. The intravaginal device of claim 12, wherein the aqueous lubricant further comprises 60 wt % to 95 wt % glycerol.

16. The intravaginal device of claim 12, wherein the device is an intravaginal ring.

17. An intravaginal device comprising:

a first segment comprising;

an outer surface and

a lumen containing an aqueous lubricant,

wherein

the device is an intravaginal ring;

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; and

the aqueous lubricant comprises water, about 70 wt % to about 95 wt % glycerol and one or both of a pH modifying agent or probiotics.

18. The intravaginal device of claim 17 wherein the aqueous lubricant comprises a pH-modifying agent selected from the group consisting of adipic acid, alkyl fumarate, aluminum sulfate, calcium acetate, calcium carbonate, calcium lactate, citric acid, glacial acetic acid, glutamic acid, glycine, hydrochloric acid, lactic acid, methionine, nitric acid, phosphoric acid, potassium bitartrate, sodium dihydrogen citrate, sodium citrate, sodium dibasic phosphate, sodium carbonate, sodium bicarbonate, sodium hydroxide, sodium lactate, sodium monobasic phosphate, stannous chloride, succinic acid, ascorbic acid, sodium ascorbate, and tartaric acid.

19. The intravaginal device of claim 17, comprising one or more additives selected from the group consisting of one or more salts, C1-8 carboxylic acids, ascorbic acid, sodium ascorbate, and amino acids.

20. The intravaginal device of claim 17, comprising about 90% glycerol.

21. The intravaginal device of claim 17 wherein the aqueous lubricant comprises probiotics.

22. The intravaginal device of claim 21, wherein the probiotics comprise Lactobacillus.

23. The intravaginal device of claim 21, wherein the aqueous lubricant further comprises one or more salts, nonaqueous solvents, C1-8 carboxylic acids, glucose, antioxidants, preservatives, surfactants, fragrance, flavoring agents, colors, or sweeteners.

24. A method of lubrication comprising administering an intravaginal device of claim 21 to a female in need of vaginal lubrication.