Water-based personal moisturizers and lubricants, in particular vaginal lubricants, and uses thereof

• US 20060204557A1
• Filed: 03/01/2006
• Published: 09/14/2006
• Est. Priority Date: 03/02/2005
• Status: Active Grant

• Current Assignee: Mancini Holdings Pty Ltd.
• Original Assignee: Aquatrove Biosciences, Inc. (SASMAR Pharmaceuticals SPRL)
• Inventors: Gupta, Vibha, Nikolic, Boris, Gupta, Vineet
• Granted Patent: US 8,703,198 B2
• Time in Patent Office: Days
• US Class Current: 424/443
• CPC Class Codes: A61K 31/355 Tocopherols, e.g. vitamin E
• CPC Class Codes: A61K 33/06 Aluminium, calcium or magnesium; Compounds thereof , e.g. clay
• CPC Class Codes: A61K 33/14 Alkali metal chlorides; Alkaline earth metal chlorides
• 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 47/38 Cellulose; Derivatives thereof
• CPC Class Codes: A61K 8/31 Hydrocarbons
• CPC Class Codes: A61K 8/345 containing more than one hydroxy group
• CPC Class Codes: A61K 8/731 Cellulose; Quaternized cellulose derivatives
• CPC Class Codes: A61K 8/735 Mucopolysaccharides, e.g. hyaluronic acid; Derivatives thereof
• CPC Class Codes: A61K 9/0034 Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
• CPC Class Codes: A61K 9/06 Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels composition of ointments, creams or gels A61K47/00
• CPC Class Codes: A61P 15/00 Drugs for genital or sexual disorders for disorders of sex hormones A61P5/24; Contraceptives
• CPC Class Codes: A61P 15/08 for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
• CPC Class Codes: A61Q 19/00 Preparations for care of the skin

Abstract

There is a need for water-based sperm- and egg-friendly vaginal lubricant. We describe novel water-based nature-friendly personal moisturizers and lubricants that relive vaginal dryness. In addition to being non-spermicidal, sperm- and egg-friendly and biological-fluids mimicking, these personal moisturizers and lubricants also enhance sperm survival and motility, promote binding of sperm to eggs and facilitate the process of fertilization. Novel articles, and systems as well as methods of preparation and use of the novel compositions are also provided.

Claims

1. A topical lubricant composition, wherein the composition comprises:

a. a non-spermicidal aqueous lubricant base for topically lubricating reproductive tissue, and

b. a viability maintaining agent for maintaining or increasing the viability of reproductive tissue, cells or both.

4. A composition according to claims 1-3, where the aqueous lubricant base of the non-spermicidal aqueous topical lubricant comprises:

a. a lubricious agent selected from the group consisting of glycerol, hispagel, dextran, polyacrylic acid, carbomer, polyethylene glycol, polyethylene oxide, methylcellulose, hydroxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl methylcellulose, trehalose, polyethylene glycol, propylene glycol, pluronic-127, proteins, nucleic acids, petroleum jelly, and

b. an aqueous salt solution with balanced pH and osmolality.

5. A composition according to claims 1-3, where the aqueous lubricant base of the non-spermicidal aqueous topical lubricant comprises:

a. a lubricious agent that is a non-saccharide,

b. a lubricious agent selected from the group consisting of glycerol, hydroxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl methylcellulose, polyethylene glycol, propylene glycol, and

c. an aqueous salt solution with balanced pH and osmolality.

6. A composition according to claims 1, 2, 4 and 5, where the viability maintaining agent in the non-spermicidal aqueous topical lubricant is selected from the group consisting of calcium ions, sodium ions, potassium ions, magnesium ions, calcium salts, sodium salts, potassium salts, magnesium salts, other ions, salts, lipids, small molecules, carbon monoxide, carbon dioxide, nitric oxide, nucleosides, nucleotides, sugars, peptides and proteins.

14. A composition according to claims 1-12, where the non-spermicidal aqueous topical lubricant composition is devoid of preservatives and that the omitted preservative is EDTA.

15. A non-spermicidal aqueous topical lubricant composition according to claims 1-14, further comprising certain preservatives that are selected from the group consisting of boric acid, ascorbic acid, borate salts and methyl paraben.

16. A composition according to claims 1-15, wherein the non-spermicidal aqueous topical lubricant composition further comprises certain pharmaceutically useful substances that are selected from the group consisting of anti-itch agents, anesthetic agents, estrogenic agents, antibiotic agents, antiviral agents, anti-fungal agents, steroids, therapeutic drugs and drug delivery vehicles.

17. A method of making a non-spermicidal aqueous topical lubricating composition according to claims 1-16, wherein the method of making comprises adding two or more of the following components:

a. a non-spermicidal aqueous lubricant base for topically lubricating reproductive tissue,

b. a non-saccharide containing viability maintaining agent for maintaining or increasing the viability of reproductive tissue, cells or both,

c. an agent that enhances physiological function for improving the potential of reproductive tissue, cells or both to perform their natural function.

18. A composition according to claims 1-16, where the non-spermicidal aqueous topical lubricant composition is in the form of a solution, a gel, a jelly, a foam, a cream, a pessary, a sponge, a suppository, a liquid douche, a tampon, a film, a controlled delivery device or a lubricant on an article, including a condom or a modified condom.

19. A lubricating system for topically lubricating a substrate, wherein the system comprises:

a. a non-spermicidal aqueous topical lubricant composition according to claims 1-16 and 18, and

b. an article for topical delivery of lubricant composition.

20. A lubricating method for topically lubricating a substrate, wherein the method comprises:

a. a non-spermicidal aqueous topical lubricant composition according to claims 1-16 and 18, and

b. an article for application of lubricant composition, and

c. using article and composition for promoting lubrication of substrate.

21. A lubricating system for facilitating fertilization, wherein the system comprises:

a. a non-spermicidal aqueous topical lubricant composition according to claims 1-16 and 18, and

b. an article for topical delivery of lubricant composition.

22. A lubricating method for facilitating fertilization, wherein the method comprises:

a. a non-spermicidal aqueous topical lubricant composition according to claims 1-16 and 18, and

b. an article for application of lubricant composition, and

c. using article and composition for promoting a fertilization process.

23. A method of imparting lubrication to a substrate in need thereof, comprising the steps selected from the group consisting of:

a. contacting the substrate of said human or other animal with a non-spermicidal aqueous topical lubricant composition according to claims 1-16 and 18 in an amount sufficient to achieve an acceptable degree of lubrication on the contacted substrate; and

b. allowing the lubricant composition to remain in contact with and coat the substrate for sufficient time and in sufficient amount so as to cause the substrate of the human or other animal to have lubrication imparted thereto.

24. A method of imparting lubrication to an article in need thereof, comprising the steps selected from the group consisting of:

a. contacting the said article with a non-spermicidal aqueous topical lubricant composition according to claims 1-16 and 18 in an amount sufficient to achieve an acceptable degree of lubrication on the surface of the contacted article; and

b. allowing the lubricant composition to remain in contact with and coat the article for sufficient time and in sufficient amount so as to cause the article to have lubrication imparted thereto.

25. A composition according to claims 1-16 and 18, where the non-spermicidal aqueous topical lubricant composition is employed for topically lubricating a substrate, where the substrate is selected from a group consisting of skin, reproductive tissue and mucous membranes, among others, of human or other animal.

26. A lubricating method for topically lubricating a substrate according to claims 23 and 25, wherein the substrate is selected from the group consisting of hand, fingers, skin, reproductive tissue and mucous membranes, among others, of human or other animal.

27. A lubricating method for topically lubricating an article according to claim 24, wherein the article is selected from the group that includes glove, condom, a modified condom, polymers, and medical and diagnostic device, among others.

28. A composition according to claims 1-16 and 18, where the non-spermicidal aqueous topical lubricant composition is employed for topically lubricating reproductive tissue, where the reproductive tissue is selected from the group including mucous, vaginal, urethral, and penal tissue, and skin surrounding vaginal and penal tissue, among others.

29. A method of manufacturing a lubricated condom, said method comprising the steps of:

a. fabricating a condom, and

b. depositing an aliquot of the lubricant composition of claims 1-16 and 18 on the surface of the condom, and

c. sealing the said condom in a container.

40. A composition according to claims 1-16, 18 and 30-39, where the non-spermicidal aqueous composition is employed for facilitating fertilization of reproductive cells during various steps of assisted reproduction technique (ART) procedures in human and other animal, wherein the ART procedure includes artificial insemination and in vitro fertilization, among others, and wherein various steps of ART procedures include semen collection, sperm collection, oocyte collection, sperm washing, oocyte washing, sperm isolation, oocyte isolation, fertilization, embryo isolation, and a transfer of embryo to female human and other animal, among others.

43. A composition according to claims 1-16, 18 and 30-39, where the non-spermicidal aqueous composition is employed for facilitating fertilization of cells during various steps of stem cell generation, development, culture, extension, transportation and storage.

46. An article according to claim 44, where the article is lubricated with a non-spermicidal aqueous lubricant composition according to claims 1-16 and 18.

48. A method of manufacturing an article according to claims 44-47, said method comprising the steps of:

a. fabricating a condom, and

b. depositing an aliquot of the lubricant composition of claims 1-16 and 18 on the surface of the condom, and

c. sealing the said condom in a container.

49. A system for facilitating pregnancy in human and other animals, wherein the system comprises:

a. a non-spermicidal aqueous topical lubricant composition according to claims 1-16 and 18, and

b. an article for delivery of lubricant composition.

50. A system for facilitating pregnancy in human and other animals, wherein the system comprises:

a. a non-spermicidal aqueous topical lubricant composition according to claims 1-16 and 18, and

b. an article according to claims 44-48 for delivery of lubricant composition.

51. A method for facilitating pregnancy in human and other animals, wherein the method comprises:

a. non-spermicidal aqueous fertilization media composition according to claims 1-16 and 18, and

b. an article according to claims 44-48 an article for delivery of lubricant composition, and

c. employing article and composition for promoting pregnancy in human and other animals.

52. A method for facilitating pregnancy in human and other animals, wherein the method comprises:

a. non-spermicidal aqueous fertilization media composition according to claims 1-16 and 18, and

b. an article according to claims 44-48 an article for delivery of lubricant composition, and

c. employing article and composition for promoting pregnancy in human and other animals.

53. A kit to facilitate fertilization comprising:

a. a non-spermicidal aqueous topical lubricant composition according to claims 1-16 and 18, and

b. an instruction booklet outlining instructions on how to use the fertility kit along with dietary and lifestyle recommendations known to enhance fertility potential.

54. A kit to facilitate pregnancy comprising:

a. a non-spermicidal aqueous topical lubricant composition according to claims 1-16 and 18, and

b. an article according to claims 44-48, and

c. an instruction manual outlining instructions on how to use the fertility kit along with dietary and lifestyle compositions or recommendations or both that are known to improve the pregnancy potential.

55. A composition according to claims 1-16, 18 and 30-39, where the aqueous composition is employed for collection, maintaining or increasing viability, maintaining or enhancing physiological function, culture, extension, transplantation, use, transport, and storage, among other things, from human and other animal of various biological samples, including tissue, cerebrospinal fluid, biopsy cells, biopsy tissue, cysts, tumors, saliva, stool, buccal swab, tissue, cells, fluid, blood, or a mixture thereof.

56. A composition according to claims 1-16, 18 and 30-39, where the aqueous composition is employed for collection, maintaining or increasing viability, maintaining or enhancing physiological function, reducing rate of rejection upon employment, culture, extension, transplantation, use, transport, and storage, among other things, from human and other animal of various organs, including vagina, penus, kidney, lung, heart, liver, bone, skin and the like or a mixture thereof.

57. A composition according to claims 1-16, 18 and 30-39, where the aqueous composition is employed for use during medical procedures and treatments in human and other animals for, such as, without limit, wounds, rashes, burns, bruises, transplants and the like.

58. A composition according to claims 1-16, 18 and 30-39, where the aqueous composition is employed for collection, maintaining or increasing viability, maintaining or enhancing physiological function, culture, extension, transplantation, use, transport, and storage, among other things, of various microbiological flora (including, bacteria, fungi, and virus, among other things) from various human and other animal biological samples, including tissue, organ, cerebrospinal fluid, biopsy cells, biopsy tissue, cysts, tumors, saliva, stool, buccal swab, tissue, cells, fluid, blood, or a mixture thereof.

2. A topical lubricant composition, wherein the composition comprises:

a. a non-spermicidal aqueous lubricant base for topically lubricating reproductive tissue, and

b. a viability maintaining agent for maintaining or increasing the viability of reproductive tissue, cells or both, and

c. an agent that enhances physiological function for improving the potential of reproductive tissue, cells or both to perform their natural function.

7. A composition according to claims 2, 3, 4 and 5 where the non-spermicidal aqueous topical lubricant composition comprises an agent that enhances physiological function and the said agent is selected from the group consisting of:

a. sperm activation agent,

b. energy-boosting agent,

c. free-radical scavenger agent,

d. fertilization facilitator agent, and

e. embryo implantation facilitator agent.

8. A composition according to claims 2, 3, 4, 5 and 7, where the non-spermicidal aqueous topical lubricant composition comprises a sperm activation agent as an agent that enhances function and that the sperm activation agent is selected from the group consisting of calcium ions, sodium ions, magnesium ions, manganese ions, bicarbonate ions, calcium salts, sodium salts, magnesium salts, manganese salts, bicarbonate salts, peptides, nucleosides, nucleotides, cyclic adenosine monophosphate, small molecules, proteins, antibodies, chemokine, cytokines, prostaglandins, caffeine, aspirin, carbon monoxide, carbon dioxide and nitric oxide.

9. A composition according to claims 2, 3, 4, 5 and 7, where the non-spermicidal aqueous topical lubricant composition comprises an energy-boosting agent as an agent that enhances physiological function and that the energy-boosting agent is selected from the group consisting of adenosine triphosphate, glucose, fructose, lactose, pyruvate, pyruvate salts, lactate, lactate salts, oxalate, oxalate salts, lipids, peptides, proteins, and carnitine.

10. A composition according to claims 2, 3, 4, 5 and 7, where the non-spermicidal aqueous topical lubricant composition comprises a free-radical scavenger agent as an agent that enhances physiological function and that the free-radical scavenger agent is selected from the group consisting of vitamin E, vitamin C, niacin, riboflavin, niacinamide, glutathione, NADH, and other anti-oxidants.

11. A composition according to claims 2, 3, 4, 5 and 7, where the non-spermicidal aqueous topical lubricant composition comprises a fertilization facilitator agent as an agent that enhances physiological function and that the fertilization facilitator agent is selected from the group consisting of magnesium ions, manganese ions, bicarbonate ions, magnesium salts, manganese salts, bicarbonate salts, zinc ions, zinc salts, hyaluronidase (such as PH-20), albumin, high-density lipoprotein, progesterone, panthenol, caffeine, L-carnitine, cyclic-AMP, aspirin, activators of CD9 protein, and other activators of integrins.

12. A composition according to claims 2, 3, 4, 5 and 7, where the non-spermicidal aqueous topical lubricant composition comprises an embryo implantation facilitator agent as an agent that enhances physiological function and that the embryo implantation facilitator agent is hyaluronan.

3. A topical lubricant composition, wherein the composition comprises:

a. a non-spermicidal aqueous lubricant base for topically lubricating reproductive tissue, and

b. an agent that enhances physiological function for improving the potential of reproductive tissue, cells or both to perform their natural function.

13. A composition for topically lubricating reproductive tissue, where the non-spermicidal aqueous topical lubricant composition is devoid of preservatives and that the omitted preservative is EDTA.

30. A fertilization media composition for facilitating fertilization, wherein the non-spermicidal aqueous fertilization media composition comprises:

a. a non-spermicidal aqueous salt solution base for culture and extension of reproductive tissue, cells, or both and

b. a viability maintaining agent for maintaining or increasing the viability of reproductive tissue, cells or both, and

c. an agent that enhances physiological function for improving the potential of reproductive tissue, cells or both to perform their natural function.

32. A composition according to claims 30-31, where the viability maintaining agent in the non-spermicidal aqueous media is selected from the group consisting of calcium ions, sodium ions, potassium ions, magnesium ions, calcium salts, sodium salts, potassium salts, magnesium salts, other ions, salts, lipids, small molecules, carbon monoxide, carbon dioxide, nitric oxide, nucleosides, nucleotides, sugars, peptides and proteins.

33. A composition according to claims 30-31, where the non-spermicidal aqueous media composition comprises an agent that enhances physiological function and the said agent is selected from the group consisting of:

a. sperm activation agent,

b. energy-boosting agent,

c. free-radical scavenger agent,

d. fertilization facilitator agent, and

e. embryo implantation facilitator agent.

34. A composition according to claims 30-33, where the non-spermicidal aqueous media composition comprises an energy-boosting agent as an agent that enhances physiological function and that the energy-boosting agent is selected from the group consisting of adenosine triphosphate, glucose, fructose, lactose, pyruvate, pyruvate salts, lactate, lactate salts, oxalate, oxalate salts, lipids, peptides, proteins, and carnitine.

35. A composition according to claims 30-33, where the non-spermicidal aqueous media composition comprises a free-radical scavenger agent as an agent that enhances physiological function and that the free-radical scavenger agent is selected from the group consisting of vitamin E, vitamin C, niacin, riboflavin, niacinamide, glutathione, NADH, and other anti-oxidants.

36. A composition according to claims 30-33, where the non-spermicidal aqueous media composition comprises a fertilization facilitator agent as an agent that enhances physiological function and that the fertilization facilitator agent is selected from the group consisting of magnesium ions, manganese ions, bicarbonate ions, magnesium salts, manganese salts, bicarbonate salts, zinc ions, zinc salts, hyaluronidase (such as PH-20), albumin, high-density lipoprotein, progesterone, panthenol, caffeine, L-carnitine, cyclic-AMP, aspirin, activators of CD9 protein, and other activators of integrins.

37. A composition according to claims 30-33, where the non-spermicidal aqueous media composition comprises an embryo implantation facilitator agent as an agent that enhances physiological function and that the embryo implantation facilitator agent is hyaluronan.

38. A composition according to claims 30-37, where the non-spermicidal aqueous media composition is devoid of preservatives and that the omitted preservative is EDTA.

39. A composition according to claims 30-38, wherein the non-spermicidal aqueous media composition further comprises certain pharmaceutically useful substances that are selected from the group consisting of anti-itch agents, anesthetic agents, estrogenic agents, antibiotic agents, antiviral agents, anti-fungal agents, steroids, therapeutic drugs and drug delivery vehicles.

41. A fertilization media system for facilitating fertilization, wherein the system comprises:

a. a non-spermicidal aqueous fertilization media composition according to claims 30-39, and

b. an article for application or delivery of media composition.

42. A method for facilitating fertilization of reproductive cells, wherein the method comprises:

a. non-spermicidal aqueous fertilization media composition according to claims 30-39, and

b. an article for application or delivery of media composition, and

c. using article and composition for promoting fertilization of reproductive cells, for further growth of fertilized cells or both.

31. A storage media composition for facilitating fertilization, wherein the non-spermicidal aqueous storage media composition comprises:

a. a non-spermicidal aqueous salt solution base for culture and extension of reproductive tissue, cells, or both and

b. a viability maintaining agent for maintaining or increasing the viability of reproductive tissue, cells or both, and

c. an agent that enhances physiological function for improving the potential of reproductive tissue, cells or both to perform their natural function, and

d. an agent that enhances physiological function for improving the potential of reproductive tissue, cells or both to perform their natural function, and

e. a protective agent that reduces the loss of viable cells, tissues or organs during their storage in a controlled temperature, heated, refrigerated, frozen or vitrified state, wherein the protective agent is selected from a group including hydroxypropyl methylcellulose, DMSO, albumin, serum, glycerol, trehalose, carbon monoxide, carbon dioxide and glycoproteins, among others.

44. An article for facilitating fertilization in human and other animal, comprising a condom having an elongated tubular configuration in the middle and two ends, a back end and a front end, said back end having an opening for enclosing a male sexual organ, and:

a. said front end forming a generally cylindrical reservoir having one or more small holes to allow semen and/or sperm to escape post ejaculation, or

b. said front end forming a generally closed cylindrical reservoir and the elongated tubular portion in the middle having one or more small holes to allow semen and/or sperm to escape post ejaculation, or

c. said front end having one or more small holes to allow semen and/or sperm to escape post ejaculation and the elongated tubular portion in the middle having one or more small holes to allow semen and/or sperm to escape post ejaculation.

45. An article according to claim 44, where the article is lubricated with a non-spermicidal aqueous lubricant.

47. An article according to claims 44-46, where the article is enclosed in a sealed container.

59. A topical lubricant composition, wherein the composition comprises:

a. a non-spermicidal aqueous lubricant base for topically lubricating reproductive tissue, wherein the aqueous lubricant base of the non-spermicidal aqueous topical lubricant comprises

i. a lubricious agent that is a non-saccharide, and

ii. a lubricious agent selected from the group consisting of glycerol, hydroxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl methylcellulose, polyethylene glycol, propylene glycol, and

iii. an aqueous salt solution with balanced pH and osmolality, wherein the pH of the solution is between 7.2 and 8.5, and the osmolality of the solution is between 200 mOsm/kg and 500 mOsm/kg.

and

b. a viability maintaining agent for maintaining or increasing the viability of reproductive cells, wherein the first viability maintaining agent is calcium ions and the second viability maintaining agent is magnesium ions.