Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Implant or insert
Reexamination Certificate
2001-03-06
2004-03-16
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Implant or insert
C424S430000, C424S488000, C424S464000
Reexamination Certificate
active
06706276
ABSTRACT:
FIELD OF THE INVENTION
This invention generally relates to compositions and methods for preventing the transmission of sexually transmitted diseases (STDs) and/or reducing the rate of transmission of such sexually transmitted diseases in sexually active individuals. This invention also generally relates to compositions and methods for preventing conception and/or reducing the risk of conception in sexually active females. Although not wishing to be bound by theory, it is believed that the compositions of the present invention, when used within the vagina during sexual intercourse, tend to physically trap and inactivate pathogenic microbes associated with STDs as well as spermatozoa contained in ejaculate that may be deposited within the vagina. The present compositions and methods are especially effective for preventing, or reducing the likelihood of, conception in sexually active females and reducing the risk of being infected by, or of transmitting, sexually transmitted diseases during male/female sexual intercourse. It can, however, be used by heterosexual, homosexual, and bisexual individuals to reduce the risk of being infected by, or of transmitting, a sexually transmitted disease through sexual contact. The present method of this invention is especially effective when used in conjunction with so-called “safe sex” techniques.
The method of this invention generally comprises application of an effective amount of the trapping gel within the vagina. Although an applicator can be used to apply the trapping gel within the vagina, such an applicator would be removed before the sexual activity. Preferably, the trapping gel is applied before sexual activity. Although perhaps not as effective, it can also be applied after sexual activity; such delayed application should take place as soon as possible after the sexual activity. Increased protection can be obtained by application of the trapping gel both just before and just after the sexual activity. Although the present trapping gel is designed to provide anti-STD activity during heterosexual activity, it may also provide protection against STDs during other sexual activity (e.g., heterosexual or homosexual anal sex); throughout this specification, a reference to heterosexual intercourse is intended to include other forms of sexual activity.
The trapping gels of the present invention have both antimicrobial and contraceptive activities. The antimicrobial and contraceptive formulations of the present invention generally have fewer side effects than conventional vaginal contraceptives (e.g., nonoxynol-9). For example, the trapping gels useful in this invention are generally not toxic (or only slightly toxic) at their effective levels to natural and beneficial vaginal flora and, thus, do not significantly upset the local microbiological balance. Of course, inclusion of contraceptives such as nonoxynol-9 in the present trapping gels will increase the risk of side effects. Generally, however, such contraceptives can generally be added to the present compositions at lower levels than found in conventional vaginal contraceptives while maintaining their effectiveness. Furthermore, the present compositions are generally not cytotoxic (or at least only minimally so) and do not cause irritation or lesions of the vagina or cervix. In addition, the trapping gels of the present invention assist in maintaining the pH level within the vagina at natural acidic levels (generally about pH of about 3.5 to 4.5) and, therefore, provide even more protection. Maintaining the pH at such acidic levels reduces the risk of conception as well as infection by STD-causing microbes while maintaining local microbiological balance. Moreover, by reducing the risk of damage to the vaginal lining, the risk of infection by STDs, including HIV, is further reduced. Additionally, the trapping gels of this invention may be used to prevent and/or treat vaginitis and/or bacterial vaginosis.
When semen is ejaculated into the vagina, the trapping gel of the present invention causes thickening of the gel/semen mixture, forming a semisolid structure from which ejaculated pathogenic microbes (e.g., STD-causing microbes, including HIV) and spermatozoa cannot escape, or do so only slowly, thereby preventing or significantly reducing migration through the lower genital tract. The trapping gel also tends to harden cervical mucus, thereby preventing or decreasing sperm penetration of the vaginal mucus and obstructing passage through the cervical canal. Additional prevention of STD-infection by the trapping gel arises from the formation of a bio-adhesive, protective barrier over the vaginal lining (e.g., the stratified squamous epithelium) or over the rectal lining in the case of anal sex. To further increase the anti-STDs and/or contraceptive activity of the trapping gels of this invention, microbiocides and/or spermicides (e.g., nonoxynol-9 and others) can be included in the present formulations. It is expected that lower levels of such microbiocides and/or spermicides can be used in the present compositions and methods while maintaining high contraceptive activity, thereby reducing the side effects of such microbiocides and/or spermicides.
BACKGROUND OF THE INVENTION
In recent years, sexually transmitted diseases (STDs) have become an increasing medical problem and concern throughout the world. The HIV/AIDS epidemic over the last decade or so has significantly and dramatically underscored the threat of STDs to the human population. The best, and perhaps only realistic, approach to this increasing problem of STDs (especially HIV/AIDS) appears to be reducing the risk of transmission of STDs by pathogenic organisms and thus reducing the number of individuals who become newly infected. Even when treatments or cures become available, prevention of infections in the initial instance will likely remain as the first line of defense. For medical, psychological, and economic reasons, it is preferable to prevent the initial infection rather than treating, and even curing, individuals with STDs.
At present, education in regard to STDs, their modes of transmission, and so-called “safe-sex” techniques has, at least to some degree in the more developed countries, shown promise in reducing the risks of STD transmission through sexual activity. Screening of the blood supply has helped to reduce the risk of transmission of such STD-causing organisms via blood transfusions and related medical practices. Nonetheless, the spread of such STDs has not been halted to a satisfactory degree even in developed countries with active and progressive education programs. Even with their known effectiveness in preventing STDs, current safe-sex techniques are not always used, or are not always used properly, for many reasons (e.g. carelessness, lack of knowledge, improper techniques, cultural barriers, unplanned or spontaneous sexual activity, and the like). Moreover, even when used, safe-sex techniques (except perhaps abstinence) are not always effective. For example, condoms are generally only about 80 to about 90 percent effective in preventing conception when used alone; in the case of such failures, STD-causing organisms, if present, may pass from one sexual partner to the other.
Various birth control devices—including barrier methods and vaginal contraceptives—are currently available. Some of these may, in addition, also have at least some degree of anti-STD activity. For example, condoms can help prevent the transmission of STDs so long as they are properly used and/or they perform properly. Nonoxynol-9, currently one of the most widely used contraceptive agents, is reported, at least in some cases, to reduce the risk of transmission of some STDs. Nonoxynol-9, which is a nonionic detergent with strong surfactant properties, acts, like most other chemical-based contraceptives, by killing or otherwise immobilizing spermatozoa (e.g., spermicidal activity). Nonoxynol-9 is a potent cytotoxic agent which tends to nonspecifically disrupt cell membranes. These properties, however, give rise to some very significan
Anderson, Jr. Robert Anthony
Garg Sanjay
Waller Donald Paul
Zaneveld Lourens Jan Dirk
Joynes Robert M.
Page Thurman K.
Rush-Presbyterian-St. Luke's Medical Center
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