Active Ingredients in Freedom Pre-Fix Invisible Condom:

• SLS (Sodium Lauryl Sulphate) Clinically proven to kill the viruses that cause Herpes, HPV, HIV and Chlamidia.  Clinically proven to prevent the transmission of the Herpes Virus, and strongly suspected to prevent or lessen the risk of transmission of other STDs including HIV, HPV, and chlamidia.
• N-lauroylsarcosine - similar in effect to SLS.  Clinically proven to prevent Herpes transmission.
• A base of polyoxyethylene and polyoxypropylene thermoreversible gel.  Clinically proven to prevent STD transmission including Herpes, HIV, HPV, and chlamidia.

The base of Pre-fix Invisible Condom is a thermoreversible gel.  Below is some research information on this:

Thermoreversible Gel Formulation Shows Promise in Preventing HIV Infection

WESTPORT, CT (Reuters Health) - Polyoxyethylene and polyoxypropylene polymers form compounds that can change from a liquid to a gel at body temperature. A report published in the August issue of Sexually Transmitted Diseases suggests that these compounds could be used to create a topical microbicide to prevent HIV infection and other sexually transmitted diseases.

Dr. Michel G. Bergeron from the Centre Hospitalier Universitaire de Québec and colleagues from the Université Laval in Québec created a thermoreversible gel and tested its ability to prevent HIV-1 and herpes simplex virus (HSV)-2 infection in cell cultures. The gel was deposited on a membrane that was placed in close contact with the cell culture. The viral suspension was then placed on the gel.

The researchers found that the gel prevented HIV-1 and HSV-2 infection of susceptible cells. Coating the membrane with the gel produced a delay in HSV-2 transit time and only small amounts of the virus were detected during the first 4 hours of incubation. Electron microscopic analysis revealed that HSV-2 was either coated with the gel or trapped within gel micelles.

"The fluid state of these polymers at room temperature allows an easier application and a better distribution in the irregularities of the [vaginal] mucosa," the authors state. "Once the formulations gel at body temperature, they persist for a longer time in the vaginal cavity and could act as a physical barrier against pathogens," they add.

Thermoreversible gels "could be an ideal vehicle for the incorporation of microbicides," the investigators point out. At a meeting last year, Dr. Bergeron described the successful preventive effects of an agent created by incorporating sodium lauryl sulfate into the gel formulation (see Reuters Health report, March 15, 2000).

The gels "could prevent the sexual transmission of pathogens by physically blocking their interaction with the vaginal, cervical, and anorectal mucosae, whereas the microbicide could act chemically by destroying the infectious agent or pharmacologically by abrogating the process of entry and/or replication of pathogens in host cells," the authors conclude.

9/05/01

Sex Transm Dis 2001; 28:484-490.

Thermoreversible gel as a candidate barrier to prevent the transmission of HIV-1 and herpes simplex virus type 2.

Piret J; Gagne N; Perron S; Desormeaux A; Tremblay MJ; Gourde P; Omar RF; Bergeron AM

Sexually transmitted diseases., 2001 Aug, 28(8):484-91

BACKGROUND: Sexually transmitted diseases (STDs) caused by HIV, herpes simplex virus (HSV), and other pathogens are spreading dramatically. The need to develop active products and vehicles to reduce this epidemic is urgent. GOAL: The efficacy of a thermoreversible gel formulation as a possible barrier to prevent the transmission of pathogens causing STDs was evaluated. STUDY DESIGN: This evaluation investigated the ability of the gel formulation to prevent infection of susceptible cells by HIV-1 and HSV-2 in vitro, the diffusion of radiolabeled herpes virus and micelles of polymer through an insertion membrane, and the electron microscopic appearance of herpes virus and gel alone or mixed together. RESULTS: The gel formulation prevents infection of susceptible cells by HIV-1 and HSV-2. It acts as an effective artificial physical barrier against the herpes virus within the first 4 hours of incubation. Herpes virus is coated by the gel or entrapped within micelles of the gel, which could hinder its attachment to target cells and inhibit its infectivity. CONCLUSION: This thermoreversible gel formulation represents an attractive matrix for the incorporation of microbicides to prevent the spread of STDs.

WESTPORT, CT (Reuters Health) - Polyoxyethylene and polyoxypropylene polymers form compounds that can change from a liquid to a gel at body temperature. A report published in the August issue of Sexually Transmitted Diseases suggests that these compounds could be used to create a topical microbicide to prevent HIV infection and other sexually transmitted diseases.

Dr. Michel G. Bergeron from the Centre Hospitalier Universitaire de Québec and colleagues from the Université Laval in Québec created a thermoreversible gel and tested its ability to prevent HIV-1 and herpes simplex virus (HSV)-2 infection in cell cultures. The gel was deposited on a membrane that was placed in close contact with the cell culture. The viral suspension was then placed on the gel.

The researchers found that the gel prevented HIV-1 and HSV-2 infection of susceptible cells. Coating the membrane with the gel produced a delay in HSV-2 transit time and only small amounts of the virus were detected during the first 4 hours of incubation. Electron microscopic analysis revealed that HSV-2 was either coated with the gel or trapped within gel micelles.

"The fluid state of these polymers at room temperature allows an easier application and a better distribution in the irregularities of the [vaginal] mucosa," the authors state. "Once the formulations gel at body temperature, they persist for a longer time in the vaginal cavity and could act as a physical barrier against pathogens," they add.

Thermoreversible gels "could be an ideal vehicle for the incorporation of microbicides," the investigators point out. At a meeting last year, Dr. Bergeron described the successful preventive effects of an agent created by incorporating sodium lauryl sulfate into the gel formulation (see Reuters Health report, March 15, 2000).

The gels "could prevent the sexual transmission of pathogens by physically blocking their interaction with the vaginal, cervical, and anorectal mucosae, whereas the microbicide could act chemically by destroying the infectious agent or pharmacologically by abrogating the process of entry and/or replication of pathogens in host cells," the authors conclude.

9/05/01

Sex Transm Dis 2001; 28:484-490.

Pre-fix includes SDS for addes anti-microbial effectiveness.  Below is some relevant research:

Common Soap Kills AIDS, Herpes, Human Wart Viruses

Reuters NewMedia - Sunday February 14, 1999
Maggie Fox, Health and Science Correspondent



WASHINGTON (Reuters) - A common detergent found in shampoo and toothpaste can kill not only the AIDS virus but the viruses that cause cervical cancer and herpes infection, researchers said Friday.

The compound, sodium dodecyl sulfate or SDS, can also kill the bacteria that cause chlamydia, the most commonly sexually transmitted disease, said Mary K. Howett and colleagues at Penn State University medical center in Hershey, Pa. While the researchers are trying to play down premature excitement about the compound, it is the first to work against not only the HIV virus that causes AIDS, herpes and chlamydia, but also the human wart virus blamed for cervical cancer.

If the compound could be developed into a product that women could use to protect themselves from these sexually transmitted diseases, millions could escape lingering deaths, the researchers said.

Toothpaste in particular contains high levels of SDS, but Howett said women seeking to protect themselves from disease should not try to use toothpaste or shampoo.

"Products on the market now are not formulated for the genital tract, won't stay in the genital tract," she said.

"This has to be formulated into a gel or a cream," added Dr. Penny Hitchcock of the National Institute of Allergy and Infectious Diseases, whose office helped fund the study. "It would be six to 12 months before it could be tested in women."

Experts say a microbicide would be the answer for people whose partners will not use condoms, and is vital for women in developing countries especially. "For the third world, this is the answer because they are not going to get retrovirus combination therapy (the drugs that keep AIDS at bay) and they are not going to get a vaccine for a long time," Howett said in a telephone interview.

Hitchcock said it was especially important that SDS could kill the wart virus, known as human papilloma virus or HPV.

HPV is blamed for virtually all cases of cervical cancer, which kills 250,000 women globally every year.

"HPV is so prevalent that in one study we did with the University of Washington, in the first year of sexual activity, one out of four women became infected with HPV," Hitchcock said in a telephone interview.

The women had, on average, only 1.2 sexual partners, which means most of them had only had sex with one man -- yet they became infected with an incurable virus.

Women with HPV infection often have abnormal Pap smears -- the check used to detect developing cervical cancer. If caught by a Pap smear cervical cancer is one of the most treatable cancers, but Hitchcock said many women in developing countries do not get Pap smears.

She estimated that since the start of the AIDS epidemic, five million women have died of cervical cancer. Fourteen million people have died of AIDS.

It is also important that the compound works against herpes, she said. "We now estimate about 60 million Americans have genital herpes," Hitchcock said. "There's been a 30 percent increase since the start of the AIDS epidemic, and that increasingly has been in adolescents, particularly white adolescent males. I don't want to diminish the HIV but these other two viruses are really important."

Writing in the journal Antimicrobial Agents and Chemotherapy, Howett, who worked with teams at several other universities including the University of North Carolina, said SDS killed the three viruses and the chlamydia bacteria, did not irritate the vaginas of rabbits and in general seemed non-toxic to animals. It is less toxic, she said, than nonoxynol-9, a widely used spermicide that can also kill viruses in test tubes but which has not been proved to kill HIV when used in animals. And nonoxynol-9 does not touch HPV.

She said SDS is widely used in laboratories to pull apart viruses that scientists want to study. "That's what made us think about it," she said. 
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