Abstract: Hypotonic microbicidal compositions including an antimicrobial, such as an antiviral compound, and a pharmaceutically acceptable carrier in a solution formulation having hypotonic osmolarity have been developed for administration rectally to the gastrointestinal mucosa. In a preferred embodiment for use in preventing or decreasing HIV infection, the microbiocidal is tenofovir, or a prodrug or derivative thereof. The formulations may include additional agents such as surfactants to enhance cleansing, buffers, or preservatives. Polymers may be included for osmolarity as well as comfort.

Abstract: Hypotonic formulations were evaluated for delivering water-soluble drugs and for drug delivery with muco-inert (that is, non-adhesive) mucus-penetrating nanoparticles (MPP). Hypotonic formulations markedly increased the rate at which drugs and MPP reached the epithelial surface, including deep into the vaginal folds. Minimally hypotonic formulations, preferably ranging from 20-220 mOsm/kg, provided rapid and uniform delivery of MPP to the entire vaginal surface, with minimal risk of epithelial toxicity. Data also show that there is a higher osmolality in the colon, such that vehicles with an osmolality above that of blood plasma (generally considered isotonic at ˜300 mOsm/kg), still lead to improvements in distribution in the colon due to rapid, osmotically-induced fluid absorption. The range for improved colon distribution with a hypotonic vehicle in the colon is ˜20 mOsm/kg-450 mOsm/kg.

Abstract: Hypotonic formulations were evaluated for delivering water-soluble drugs and for drug delivery with muco-inert (that is, non-adhesive) mucus-penetrating nanoparticles (MPP). Hypotonic formulations markedly increased the rate at which drugs and MPP reached the epithelial surface, including deep into the vaginal folds. Minimally hypotonic formulations, preferably ranging from 20-220 mOsm/kg, provided rapid and uniform delivery of MPP to the entire vaginal surface, with minimal risk of epithelial toxicity. Data also show that there is a higher osmolality in the colon, such that vehicles with an osmolality above that of blood plasma (generally considered isotonic at ˜300 mOsm/kg), still lead to improvements in distribution in the colon due to rapid, osmotically-induced fluid absorption. The range for improved colon distribution with a hypotonic vehicle in the colon is ˜20 mOsm/kg-450 mOsm/kg.

Abstract: Methods and materials for treating bacterial vaginosis (“BV”) are provided. Cervicovaginal secretions (“CVS”) from a woman with vaginal microbiota dominated (>50%) by one of the species of lactobacillus typically found in the human vagina, e.g. Lactobacillus crispatus, L. iners, L. gasseri, L jensenii, is transplanted to women with BV as a method for restoring beneficial vaginal microbial communities and/or increasing resistance to sexually transmitted disease. Efficacy can be enhanced, or the properties of the endogenous CVS improved, through administration of an acidifying agent such as lactic acid. The examples demonstrate the role of healthy CVS in disease resistance, and the effect of pH on CVS properties. The examples also describe the collection and transplantation of healthy beneficial CVS into women at risk for, or after treatment for, BV.

Abstract: Hypotonic formulations were evaluated for delivering water-soluble drugs and for drug delivery with muco-inert (that is, non-adhesive) mucus-penetrating nanoparticles (MPP). Hypotonic formulations markedly increased the rate at which drugs and MPP reached the epithelial surface, including deep into the vaginal folds. Minimally hypotonic formulations, preferably ranging from 20-220 mOsm/kg, provided rapid and uniform delivery of MPP to the entire vaginal surface, with minimal risk of epithelial toxicity. Data also show that there is a higher osmolality in the colon, such that vehicles with an osmolality above that of blood plasma (generally considered isotonic at ˜300 mOsm/kg), still lead to improvements in distribution in the colon due to rapid, osmotically-induced fluid absorption. The range for improved colon distribution with a hypotonic vehicle in the colon is ˜20 mOsm/kg-450 mOsm/kg.

Abstract: Hypotonic formulations were evaluated for delivering water-soluble drugs and for drug delivery with muco-inert (that is, non-adhesive) mucus-penetrating nanoparticles (MPP). Hypotonic formulations markedly increased the rate at which drugs and MPP reached the epithelial surface, including deep into the vaginal folds. Minimally hypotonic formulations, preferably ranging from 20-220 mOsm/kg, provided rapid and uniform delivery of MPP to the entire vaginal surface, with minimal risk of epithelial toxicity. Data also show that there is a higher osmolality in the colon, such that vehicles with an osmolality above that of blood plasma (generally considered isotonic at ˜300 mOsm/kg), still lead to improvements in distribution in the colon due to rapid, osmotically-induced fluid absorption. The range for improved colon distribution with a hypotonic vehicle in the colon is ˜20 mOsm/kg-450 mOsm/kg.

Abstract: The presently-disclosed subject matter relates to antibodies, compositions, and methods for inhibiting and treating pathogen infection and providing contraception. In particular, the presently-disclosed subject matter relates to inhibiting and treating pathogen infection and providing contraception in a subject using compositions and antibodies capable of trapping pathogens or sperm in mucus, thereby inhibiting transport of pathogens or sperm across mucus secretions. The subject matter further relates to methods for monitoring the effectiveness of vaccines by detecting antibodies capable of trapping pathogens in mucus.

Abstract: The present disclosure includes compositions and methods of inactivating pathogens of a genital tract of a female. The compositions include L-lactic acid substantially free of D-lactic acid. In particular, an intravaginal ring for sustained release of L-lactic acid out of a reservoir containing multi-gram quantities of L-lactic acid, with minimal osmotically induced swelling or pressurization of the reservoir during prolonged use is provided.

Abstract: The present invention provides improved rim designs for diaphragms or any similar intravaginal device and methods for producing same. The rim designs of the present invention improve, among other characteristics of the rim, structural durability, manufacturability, ease of insertion, comfort in use, and ease of removal of intravaginal devices. These designs incorporate one or more recesses in the inner portion of a rim piece that provide an attachment site for a separate dome piece. Attachment within a recess shields the exposed outer edge of the dome material from contact with epithelial surfaces and improves comfort and safety. In certain embodiments of the invention, a thinned inner portion of the rim serves as a handle that can be easily grasped by a finger to remove the device from the vagina. These devices are useful in providing a protective cervical barrier for contraception and disease prevention, to deliver beneficial agents, and as a means to collect and remove substances from the vagina.

Abstract: The present invention reveals a device, a kit and a method for simultaneously delivering and distributing at least one beneficial agent to both the cervical and vaginal lumen sides of a vagina. The device is made of a flexible circular rim and a flexible dome. The device can exist in either a relaxed state or in a compressed state. In the compressed state, pouches are formed for carrying and delivering the beneficial agent to both the cervical and vaginal lumen sides of the vagina.

Abstract: The present invention provides improved rim designs for diaphragms or any similar intravaginal device and methods for producing same. The rim designs of the present invention improve, among other characteristics of the rim, structural durability, manufacturability, ease of insertion, comfort in use, and ease of removal of intravaginal devices. These designs incorporate one or more recesses in the inner portion of a rim piece that provide an attachment site for a separate dome piece. Attachment within a recess shields the exposed outer edge of the dome material from contact with epithelial surfaces and improves comfort and safety. In certain embodiments of the invention, a thinned inner portion of the rim serves as a handle that can be easily grasped by a finger to remove the device from the vagina. These devices are useful in providing a protective cervical barrier for contraception and disease prevention, to deliver beneficial agents, and as a means to collect and remove substances from the vagina.

Abstract: The present invention reveals a device, a kit and a method for simultaneously delivering and distributing at least one beneficial agent to both the cervical and vaginal lumen sides of a vagina. The device is made of a flexible circular rim and a flexible dome. The device can exist in either a relaxed state or in a compressed state. In the compressed state, pouches are formed for carrying and delivering the beneficial agent to both the cervical and vaginal lumen sides of the vagina.

Abstract: The present invention reveals a device, a kit and a method for simultaneously delivering and distributing at least one beneficial agent to both the cervical and vaginal lumen sides of a vagina. The device is made of a flexible circular rim and a flexible dome. The device can exist in either a relaxed state or in a compressed state. In the compressed state, pouches are formed for carrying and delivering the beneficial agent to both the cervical and vaginal lumen sides of the vagina.

Abstract: Certain antibody molecules are so stable and so potent at immobilizing sperm as well as the pathogens for sexually transmitted diseases (STDs) that they make possible new prophylactic contraceptive methods: (a) for men, a skin lotion containing antibodies against sperm and against STD pathogens to be applied to the penis and external genitals during sexual activity, thereby delivering prophylactically effective doses of antibodies to virtually all areas of skin and epithelia across which most STDs, including AIDS, are usually transmitted, and, during vaginal intercourse, the penis will deliver a contraceptively reliable dose of the antibodies to the cervical region of the vagina; and (b) for women, intrauterine devices (IUDs) and intravaginal devices (IVDS) that release antibodies into the uterus or into the vagina to provide continuous protection against pregnancy and STDs for periods of months to years.

Abstract: The present invention reveals a device, a kit and a method for simultaneously delivering and distributing at least one beneficial agent to both the cervical and vaginal lumen sides of a vagina. The device is made of a flexible circular rim and a flexible dome. The device can exist in either a relaxed state or in a compressed state. In the compressed state, pouches are formed for carrying and delivering the beneficial agent to both the cervical and vaginal lumen sides of the vagina.

Abstract: The present invention reveals a device, a kit and a method for simultaneously delivering and distributing at least one beneficial agent to both the cervical and vaginal lumen sides of a vagina. The device is made of a flexible circular rim and a flexible dome. The device can exist in either a relaxed state or in a compressed state. In the compressed state, pouches are formed for carrying and delivering the beneficial agent to both the cervical and vaginal lumen sides of the vagina.

Abstract: Certain antibody molecules are so stable and so potent at immobilizing sperm as well as the pathogens for sexually transmitted diseases (STDs) that they make possible new prophylactic contraceptive methods: (a) for men, a skin lotion containing antibodies against sperm and against STD pathogens to be applied to the penis and external genitals during sexual activity, thereby delivering prophylactically effective doses of antibodies to virtually all areas of skin and epithelia across which most STDs, including AIDS, are usually transmitted, and, during vaginal intercourse, the penis will deliver a contraceptively reliable dose of the antibodies to the cervical region of the vagina; and (b) for women, intrauterine devices (IUDs) and intravaginal devices (IVDs) that release antibodies into the uterus or into the vagina to provide continuous protection against pregnancy and STDs for periods of months to years.

Abstract: The present invention is for a device and a gel method for controlling pH by acidic buffering. The device is made of a flexible dome, a flexible circular rim and an absorbent acidic buffer. The flexible dome is attached a its margin to the circular rim and the absorbent acidic buffer is contained within the device. The absorbent acidic buffer can control or maintain pH within physiological ranges. The gel method for controlling pH by acidic buffering is accomplished by applying a gel to an area where the pH is to be controlled. The gel includes an acidic buffering polymer which can control or maintain the pH of the area within the range of about 3 to about 5.

Abstract: The present invention is for a device and a gel method for controlling pH by acidic buffering. The device is made of a flexible dome, a flexible circular rim and an absorbent acidic buffer. The flexible dome is attached at its margin to the circular rim and the absorbent acidic buffer is contained within the device. The absorbent acidic buffer can control or maintain pH within physiological ranges. The gel method for controlling pH by acidic buffering is accomplished by applying a gel to an area where the pH is to be controlled. The gel includes an acidic buffering polymer which can control or maintain the pH of the area within the range of about 3 to about 5.