AIDS prophylactic lubricating composition and devices for...

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Nitrogen containing other than solely as a nitrogen in an...

Reexamination Certificate

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Reexamination Certificate

active

06624198

ABSTRACT:

This application is a 371 of PCT/US93/00826 filed Feb. 5, 1993 which claims priority from Israel Patent Application 100881 filed Feb. 6, 1992.
FIELD OF THE INVENTION
The present invention relates to an antiseptic lubricant composition for use in sexual relations. The lubricant composition of this invention reduces the risk of infection by lethal viruses such as herpes simplex (HSC), cytomegalovirus (CMB), influenza A, parainfluenza, hepatitis B (HBV) and particularly human immunodeficiency virus (HIV). The lubricant composition of this invention, in addition to destroying bacteria and viruses, prevents pregnancy by destroying sperm cells and furthermore prevents any surviving sperm cells from entering the uterus. The present invention also relates to a method for reducing the risk of infection by lethal viruses during sexual relations and reducing the risk of pregnancy, and to devices containing antiseptic lubricant.
BACKGROUND OF THE INVENTION
In the last decade, the rapid spread of the HIV and the accompanying concern of its terrifying consequences for mankind, have created a sense of urgency to find both short and long term solutions for this modern plague. There are many ways in which the HIV and some other viruses are transmitted by people. One of the most common forms of transmission is by sexual contact. During intercourse, there are basically three ways in which the HIV can be transmitted from one person to another. One way is by the friction caused by a penis penetrating into the vagina, which is capable of tearing small and sometimes invisible blood vessels (capillary vessels) of both sexual partners. The blood from these vessels is consequently commingled and the HIV present in one partner is transferred via the blood to the other partner. As far as is known, the HIV develops mainly in the blood cells, although it is transferred and transmitted by body fluids. A second way for transmitting the HIV is through the body fluids which the body secretes during sexual relations. A third way is via the semen. It has been found that the HIV can reside in the spermatophore (sperm-liquid) or even on or in the spermatocide (sperm cell). Thus, the HIV which resides in the sperm may infect the other sexual partner.
HIV, herpes and similar viruses are surrounded by three envelopes. These envelopes are composed of the same material as that of the human cell walls. When the outside envelope of the virus comes into contact with the outer cell wall of humans, the human cell recognizes the virus as part of itself and absorbs it, and proceeds to produce more viruses until they overflow. The excess viruses are then expelled from the human cell and search for other host cells which will continue to produce more viruses.
The most common and so far most effective way of avoiding infection by HIV and other related viruses during sexual relations is by the use of a condom put on prior to copulation. The condom prevents direct contact between sexual organs and body fluids of the partners and also retains the sperm and prevents it from entering the vagina and eventually the uterus. As far as is known, the HIV cannot penetrate the rubber material from which condoms are made. Only if the condom is defective, for example perforated or otherwise damaged, can transmission of the virus occur. Many people, however, do not like using a condom, mainly because of the odd sensation of indirect contact with the sex partner, which in many cases interferes with and/or diminishes sexual satisfaction.
It is also known that to increase sexual satisfaction during intercourse, people avail themselves of lubricants which may be soluble, like K-Y (a Trademark product of Johnson & Johnson) or a non-soluble fatty lubricant, like soft paraffin. This is particularly the case with atrophy and in elderly people, who use lubricants to complement the diminished quantities of natural lubricants produced as compared with the situation in younger people.
Gels and foams for application before or during sexual intercourse are known, some of which contain spermicides, such as Nonoxynol-9. Many disinfectants are also known to be effective against viruses and are used as antiseptics in topical applications in concentrations that are not harmful to body tissues. Some compositions containing disinfectants are also known for use in disinfecting the sexual organs. These disinfectants, however, have never been used in concentrations sufficient to effectively kill viruses, specifically the HIV virus, in lubricant compositions for use in sexual relations. The disinfectant compositions are generally used as antiseptics and applied topically for destroying bacteria and/or viruses that already exist in the area to which they are applied and to maintain these areas free of such organisms, to prevent possible future infections such as in the treatment of wounds and burns. Among the known disinfectants are the previously mentioned Nonoxynol-9, Benzalkonium Chloride, Povidone Iodine, Nitrofurazone and chlorhexidine salt. These disinfectants, and others not mentioned but found in medical pharmacopoeias, have similar disinfecting characteristics, although they differ chemically and react differently to body tissues. Many of these disinfectants destroy bacteria as well as viruses. Most of them, however, do not destroy fungi. This presents a problem, since the flora of bacteria prevent the growth of fungi and with the destruction of the bacteria, there is a tendency for the fungi to develop.
One of the problems of using a disinfecting agent in the area of the female genitals is that the tissues in the vagina are normally regenerated frequently and antiseptic agents in general inhibit the vaginal tissues from regenerating.
It is the object of the present invention to provide a prophylactic lubricating composition for use in sexual relations.
It is a further object of the invention to enhance sexual satisfaction during intercourse, to solve the problem of infection, and to avoid pregnancy, by using a single prophylactic lubricating composition which will accomplish the following:
1. Provide proper lubrication.
2. Destroy bacteria and viruses.
3. Prevent the mobility of sperm cells.
4. Prevent the penetration of sperm cells into the uterus.
5. Prevent fungi from developing in the vagina.
6. Safe use without side effects.
Yet another object of the invention is to provide devices containing and dispensing a prophylactic lubricating composition and a method for using the same.
A still further object of the present invention is to provide a prophylactic method for protecting against the spread of infection from bacteria and viruses such as HIV during sexual relations, as well as avoid becoming pregnant, for people who do not use condoms or diaphragms during intercourse, or provide an additional prophylactic safety factor for those who do use them.
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

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