Title:  AIDS prophylactic lubricating composition and devices for its use

United States Patent:  6,624,198

Issued:  September 23, 2003

Inventors:  Porat; Michael (Afeka, IL)

Assignee:  Medgreen, Inc. (Fairfield, NJ)

Appl. No.:  978671

Filed:  November 7, 1994

PCT Filed:  February 5, 1993

PCT NO:  PCT/US93/00826

PCT PUB.NO.:  WO93/15728

PCT PUB. Date:  August 19, 1993

Abstract

A prophylactic spermicidal lubricant composition and method for its use in safe sexual relations, including prevention of infection by HIV and other viruses. The composition contains: a) a cosmetically acceptable lubricant effective to reduce friction, thereby reducing the rupture of blood vessels during sexual relations; b) an effective amount of chlorhexidine salt active against HIV and other, viruses, the chlorhexidine salt immobilizing sperm and reacting with vaginal mucosa to form a barrier to the penetration of sperm calls into the uterus, but also destroying natural flora in the vagina and thereby permitting growth of fungi which causes ulceration; and c) an effective amount of a cosmetically acceptable fungicide to prevent the growth of fungi in the vagina in the absence of natural bacterial flora, destroyed by the chlorhexidine salt.

DETAILED DESCRIPTION OF THE INVENTION

In accordance with the present invention, there is provided a prophylactic lubricant composition for use during sexual relations, comprising an effective lubricant and an antiseptic compound effective in destroying the human immunodeficiency virus and other viruses, said antiseptic compound being a spermacide, which also reacts with the vaginal mucosa to form a barrier to the penetration of sperm cells into the uterus, said composition having no substantial detrimental side effects. In a preferred embodiment, the prophylactic lubricant composition also contains a fungicide, a preferred fungicide being methylparaben.

The lubricant may be any effective lubricant or combination of lubricants acceptable for cosmetic applications.

The antiseptic compounds in accordance with this invention are preferably chlorhexidine and its salts, particularly the gluconate or digluconate salts.

Chlorhexidine and its salts are well described in the medical literature as effective against a wide range of viruses and bacteria and have been used in the form of antiseptic solutions, creams and gels for topically disinfecting wounds, skin, mouth, urethra and other parts of the body. Chlorhexidine is known not to accumulate in the blood and does not enter the mammalian cells. When applied to the human genitals in concentrations even up to 4%, it did not produce any undesirable side effects.

During ovulation, the female body produces a mucous in the cervix which selectively allows sperm cells to penetrate to the uterus. At all other times, the cervix does not allow penetration of sperm cells or semen into the uterus. Chlorhexidine, on the other hand, diffuses into the cervical mucous, creating a suspension. This suspension restricts the penetration of sperm cells during ovulation and causes them to rapidly lose their mobility. This occurs at concentrations of chlorhexidine in excess of 0.1%. Thus, by using chlorhexidine as the active antiseptic compound in accordance with the present invention, the chlorhexidine diffuses into the cervical mucous prior to the ejection of semen and in effect creates the "sealed bag" of the vagina, which will retain all the body secretions including the semen. Any viruses present will be destroyed by the chlorhexidine.

Chlorhexidine, in concentrations above 0.1%, effectively destroys the envelope of thee virus and in so doing prevents the virus from penetrating the human cell. The present invention is premised on the discovery that when selected antiseptically active materials are incorporated in lubricants for use in sexual relations, a number of advantages are obtained which make the sexual relations safe and worry-free, both from the fear of contracting a serious viral disease such as the HIV, and the fear of becoming pregnant. The antiseptic material for use in this invention must be effective in concentrations that are safe and acceptable for use in contact with sexual organs. It must have the ability to kill bacteria and viruses at such concentration levels. It must have spermacidal properties and furthermore must have the additional feature of reaction with vaginal mucosa to seal the cervical passage against penetration of any residual or surviving sperm cells.

Medical and pharmaceutical studies have shown that the HIV develops mainly in the blood cells and is carried by various body fluids to other cells. When the antiseptic lubricant of this invention is applied to the sex organs, a number of advantages are obtained. The lubricant reduces the friction between the penis and the vaginal wall, thus reducing the rupture of blood cells which might otherwise occur and therefore reducing the amount of blood that is commingled. Any blood that does appear is immediately disinfected by the active antiseptic ingredient. Furthermore, the antiseptic compound also kills any bacteria and viruses in the body fluids which are present or are generated during intercourse. The selected antiseptic compound, being a spermacide as well, destroys the sperm and any virus it may carry inside the vagina, and last but not least, the antiseptic compound reacts with the mucosa to create a barrier in the cervix, preventing any surviving sperm from entering the uterus. Thus, in accordance with the present invention, the vagina is converted into a "sealed bag" by creating a barrier which prevents sperm from passing through the cervix and any viruses present in the sealed vagina will subsequently be destroyed.

The tissues in the vagina are normally regenerated frequently and antiseptic agents are known to often inhibit the vaginal tissues from regenerating. Therefore lubricating compositions for use in the area of the vagina should have the same pH as the vagina itself, in order to eliminate this problem. The antiseptic lubricant composition of this invention should also preferably contain an alcohol or mixtures of alcohols, to enhance the activity of the disinfectant. Preferably water soluble lubricants are used, since any stains that they may form on clothing or sheets are readily washed out with water and their use is particularly recommended when rubber or latex prophylactics are used, such as condoms or diaphragms. The preferred lubricant is propylene glycol, but other water soluble lubricating materials, as known in the art, such as glycerine, may also be used, alone or in combination. Although water soluble lubricants are preferred, fatty lubricants like soft paraffin may also be used if desired. The antiseptic lubricant composition preferably contains a fungicide such as methylparaben. This particular fungicide is body friendly, does not harm tissues and destroys fungi which develop in the absence of bacterial flora. However, other known and approved fungicides may also be used. In the case where the active antiseptic compound also is a fungicide, it is not required to include a separate fungicide in the lubricant composition.

Compositions for use by people having oral sex can also be prepared by adding a flavour, such as menthol, lemon, cherry or other desired flavour.

A preferred antiseptic lubricant composition in accordance with this invention comprises a mixture of propylene glycol or glycerine, or both, with water, mixed with carbomethyl cellulose (CMC) or hydroxyethyl cellulose (HEC) or both. These are formulated with chlorhexidine gluconate or digluconate and methylparaben. Such a composition can have the following concentrations:

A preferred lubricant composition has the following concentration of ingredients:

The lubricant composition should be easy to apply and should not disturb the sexual act, without diminishing the antiseptic potency. (Most disinfectants are sensitive to light and should be packaged in sealed containers protected from light and air). It is therefore suggested to package the lubricant in a single use disposable sterile sealed packet. Sterilization can take place by heating the sealed packet for ten hours at 70^oC. to give a S.A.L. of 10^-10.

Claim 1 of 13 Claims

What is claimed is:

1. A method for reducing vaginal ulcer facilitated HIV transmission and providing for safe sexual relations with protection comprising applying to the sexual organs prior to sexual relations a paraben based fungicide containing spermicidal lubricant to prophylactically treat chlorohexidine inducted fungal vaginal ulcers comprising

a) a cosmetically acceptable lubricant effective to reduce friction, thereby reducing the rupture of blood vessels during sexual relations;

b) an effective amount of chlorhexidine salt active against HIV and other viruses, said chlorhexidine salt immobilizing sperm and reacting with vaginal mucosa to form a barrier to the penetration of sperm cells into the uterus, said chlorhexidine salt destroying the natural flora in the vagina, thereby permitting growth of fungi which causes ulceration of the vagina creating a source for HIV penetration into the bloodstream; and

c) an effective amount of a cosmetically acceptable fungicide to prevent,the growth of fungi in the vagina in the absence of natural bacterial flora destroyed by the chlorhexidine salt;

said composition having no substantial side effects.

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