Intravaginal devices for controlled delivery of lubricants

• US 9,642,795 B2
• Filed: 01/04/2016
• Issued: 05/09/2017
• 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:
  US14/987,306
• Publication Number:
  US 20160113866A1
• Time in Patent Office: 491 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 3 wt % to about 99 wt % propylene glycol.

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 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 where the aqueous lubricant has a pH from 3 to 6.

5. The intravaginal device of claim 1 wherein the aqueous lubricant further 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 aspartame.

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 further 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. 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 device delivers from 0.001-1000 mg of aqueous lubricant to the outer surface of the device per day.

11. The intravaginal device of claim 1, wherein the aqueous lubricant further comprises one or more of benzalkonium chloride, benzethonium chloride, benzoic acid, benzyl alcohol, boric acid, calcium lactate, glycerin, glacial acetic acid, hibitane acetate, methyl paraben, phenylethyl alcohol, potassium sorbate, propylene glycol, propyl paraben, sodium benzoate, sodium ethyl paraben, sodium propionate, sorbic acid, sorbital, or tocopherol.

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 one or more of pyridine, squalene, urea, complex alcohols, aldehydes, ketones, stearic acid, stearate, isopropyl palmitate, petrolatum, Aloe Vera, cucumus sativus extract, helianthus annulus seed oil, soybean sterol, vitamin E acetate, vitamin A palmitate, provitamin B5, sodium acrylate/acryloyldimethyl taurate copolymer, dimethicone, glyceryl stearate, cetyl alcohol, lecithin, mineral water, sodium PCA, potassium lactate, collagen, amino acids, triethanolamine, DMDM, hydantoin, iodopropynyl, butylcarbamate, disodium EDTA, or titanium dioxide.

13. The intravaginal device of claim 12, wherein the aqueous lubricant further comprises one or more of agarose, aluminum magnesium silicate, carbomer, carbopol, carrageenans, dermatan sulfate, ethyl cellulose, silicon dioxide, guar gum, hydroxyethyl cellulose, hydroxyethyl methacrylate, hydroxymethyl cellulose, hydroxypropyl cellulose, hydroxypropylmethyl cellulose, maltodextran, polyacrylamide, polycarbophil, polyethylene glycol, polyethylene oxide, pluronic/poloxamer, polyvinyl alcohol, sodium alginate, sodium carboxymethyl cellulose, sodium hyaluronate, sucrose, or xanthan gum.

14. The intravaginal device of claim 12, wherein the aqueous lubricant further comprises one or more of adipic acid, alkyl fumarate, aluminium 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 bitartarate, sodium dihydrogen citrate, sodium citrate, sodium dibasic phosphate, sodium carbonate, sodium bicarbonate, sodium hydroxide, sodium lactate, sodium monobasic phosphate, stannous chloride, succinic acid, or tartaric acid.

15. The intravaginal device of claim 12, wherein the aqueous lubricant further comprises one or more of benzyl alcohol, beta cyclodextrin, polyoxyethylene 20 cetyl ether, cremophor, piperazine hexahydrate, pluronic /poloxamer, polyoxyethylene lauryl ether, polyoxyethylene stearate, polysorbates, polyvinyl alcohol, silicone, sodium cetearyl sulfate, sodium lauryl sulfate, sorbate salts, or sorbitan esters.

16. The intravaginal device of claim 12, wherein the aqueous lubricant further comprises one omr more of ascorbic acid, butylated hydroxyanisole, butylated hydroxytoluene, citric acid, phosphoric acid, sodium ascorbate, sodium metabisulfite, tartaric acid, or tertiary butyl hydroquinone.

17. The intravaginal device of claim 12, wherein the aqueous lubricant further comprises one or more of acacia, allantoin, aluminium magnesium silicate, bentonite, bleached bees'"'"' wax, carbomer, polyoxyethylene 20 cetyl ether, cetostearyl alcohol, cetyl esters wax, cetyl palmitate, cholesterol, choleth, colloidal silicon dioxide, cremophor, diglycol stearate, glycerin, glyceryl monostearate, guar gum, hydrous lanolin, hydroxypropyl cellulose, hydroxypropylmethyl cellulose, isopropyl myristate, lactose, lanolin, methyl cellulose, mineral oil, palm oil, polyoxyethylene lauryl ether, polyoxyethylene stearates, polyethylene glycol, pluronic/poloxamer, polysorbates, propylene glycol monostearate, octyl dodecanol, sodium carboxymethyl cellulose, sodium lauryl sulfate, sodium monobasic phosphate, sorbitan esters, spermaceti wax, stearyl alcohol, or triethanolamine.

18. The intravaginal device of claim 12, wherein the aqueous lubricant further comprises one or more of aspartame, dextrose, maltose, mannitol, saccharine, or xylitol.

19. A method of lubrication comprising administering an intravaginal device of claim 12 to a female in need of vaginal lubrication.

20. The method of claim 19 wherein the device delivers 0.001-2000 mg of aqueous lubricant to the outer surface of the device per day.