Abstract: The present invention provides a non-toxic diagnostic composition for intravaginal monitoring of vaginal infections. The present invention further provides a diagnostic article for intravaginal monitoring of vaginal infections with the article including an absorbent material for absorbing vaginal secretions and a composition suitable for identification of the pH or the buffer capacities associated with vaginal secretions. The diagnostic composition provides a visible indication of vaginal infections, such as bacterial vaginosis.

Abstract: Provided are articles containing a solid surface material with an antimicrobial agent in a thermoset and/or thermoplastic resin matrix, wherein the antimicrobial agent comprises a chitosan-metal complex.

Abstract: A preparation for vaginal and rectal use comprising hyaluronic acid, with an average particle size comprised between about 50 micrometers and about 200 micrometers and a molecular weight comprised between about 1,000,000 Da and about 1,800,000 Da.

Abstract: An applicator having an enhanced grip portion. The applicator can include a barrel portion having an insertion end, a withdrawal end, and a barrel exterior surface, the barrel exterior surface being a barrel color, a grip portion positioned opposite the insertion end having a grip exterior surface, and a plunger having a plunger exterior surface. The applicator can further include gripping indicia disposed substantially on the grip exterior surface. The gripping indicia can include visual indicia and/or tactile indicia.

Abstract: Certain embodiments disclosed relate to compositions, including therapeutic compositions, methods, articles of manufacture, systems, and devices. Certain embodiments relate to anti-viral compositions, methods, articles of manufacture, systems and devices.

Abstract: The invention relates to a therapeutic device for the delivery of therapeutic agents, e.g. a peptide such as leuprolide, via the vagina to a female mammal. In some embodiments, the invention also relates to methods for the treatment of obesity and eating disorders, diabetes, multiple sclerosis (MS), endometriosis, uterine fibroids, polycystic ovarian disease, various cancers such as breast cancer, acne, hirsutism, microbial or fungal or viral infections such as bacterial vaginosis or AIDS/HIV, and chronic diseases using a disclosed vaginal device.

Abstract: Methods and implant materials are provided for treating urinary incontinence. The methods may include providing a composition that includes at least one pharmaceutically active formulation capable of retropubic fat dissolution; and introducing the composition into the retropubic space, preferably via a minimally invasive procedure, to contact adjacent tissue and promote dissolution of retropubic fat therein and consequent induction of adhesions. The implant material for treating urinary incontinence may include at least one pharmaceutically active detergent for promoting retropubic fat dissolution; and a biodegradable carrier material, wherein the implant material is sized and shaped for placement within a patient's retropubic space. The implant material may further include an auxiliary adhesion-promoting material.

Abstract: The present invention is directed to methods of reducing symptoms associated with an abrupt reduction in an endogenous or exogenous chemical in subjects, the methods comprising: (a) administering to the subject a single dosage form comprising an active agent, wherein the release rate of the active agent from the single dosage form tapers throughout the administration; and (b) removing the single dosage form from the subjects after the release rate of the active agent is at or below a terminal symptom threshold level.

Abstract: A method for inducing Fallopian tube blockage as a means for female contraception comprises contacting the inner surface tissue of a Fallopian tube with a silver nitrate bearing substrate and delivering an amount of silver nitrate to the tissue sufficient to induce blockage of the Fallopian tube. At least one silver nitrate bearing bead is introduced through the uterine opening of the Fallopian tube by use of a catheter or other device suitable for manipulating the bead. Alternatively, a plurality of beads can be introduced into the Fallopian tube. In a preferred embodiment, one or more silver nitrate bearing beads are arranged on a string to facilitate later removal of the beads. The method of the present invention delivers an amount of silver nitrate to the tissue sufficient to cause tissue necrosis and blockage of the Fallopian tube.

Abstract: Described herein is an intravaginal drug delivery system. In an embodiment the intravaginal drug delivery system includes a progestin and estrogen compound, and releases the active ingredients in a fixed physiological ratio over a prolonged period of time to produce a contraceptive state in a female.

Abstract: Disclosed is a method and apparatus of contraception. The apparatus can include an implant sized for insertion into a fallopian tube. The implant can comprise a plurality of loose, bulked fibers. The fibers can be formed from one or more bioabsorbable materials, for example, the method can include inserting the implant into a fallopian tube and occluding the fallopian tube with the implant.

Abstract: A method is provided for manufacturing a medicated tampon assembly having a tampon body, the method including applying a formulation including a therapeutic agent to a substrate to produce a plurality of dosage forms; separating one of the dosage forms from the substrate; and coupling one of the dosage forms to the tampon body. A medicated tampon assembly is provided including a dosage form including a formulation including a therapeutic agent; a substrate portion separated from a substrate, wherein the substrate portion is coupled to the dosage form; and a tampon body having a distal end, wherein the substrate portion is coupled to the distal end of the tampon body.

Abstract: There are provided compositions and methods to aggregate mucus using a plurality of positively charged nanoparticles. There are also provided compositions and methods for inducing contraception in the subject.

Abstract: Compositions and methods for vaginal, buccal or nasal transmucosal delivery of drugs and for cryoprotecting of cells and embryos. For cryoprotection, the composition consisting essentially consist of a non-ionizable glycol derivative. For transmucosal delivery, the compositions essentially consist of a non-ionizable glycol derivative in a combination with a pharmaceutically active agent. For transmucosal delivery, the non-ionizable glycol derivative may be further combined with a mucoadhesive agent and/or a penetration enhancer and/or lipophilic or hydrophilic carrier for adhesion to and transport through a mucosa. The compositions are particularly suitable for administration of drugs through a nasal, buccal and vaginal mucosa or for long-term preservation of cell or embryos.

Abstract: The present invention relates to implantable or insertable medical devices that treat uterine and urological conditions that cause chronic pelvic pain and other symptoms. In another aspect, the present invention relates to methods of manufacturing such implantable or insertable medical devices.

Abstract: The present invention is directed to flexible, compressed intravaginal rings comprising a substantially homogeneous compressed mixture comprising a polymethacrylate, a plasticizer, and an active agent, and methods of making and using the same, and apparatus for making the same.

Abstract: Topical cream, ointment, lotion, gel, foam formulations and slow release formulations or devices are provided including certain CCR5 antagonists as prophylactics for the prevention, retardation or inhibition of transmission of Human Immunodeficiency Virus (HIV) infection from one human to another.

Abstract: This invention is directed to ?-1-6-glucans, compositions and devices comprising the same, and methods of use thereof in modulating immune responses. The ?-1-6-glucans of certain embodiments of the invention are enriched for O-acetylated groups and/or conjugated to a solid support or linked to a targeting moiety.

Abstract: The present invention relates to a drug delivery device that is useful for topical treatment of various infections such as skin and nail, or vaginal infections.

Abstract: The pharmaceutical preparation for treating endometriosis contains at least 28, preferably 30, daily dose units, each of which contain dienogest, cyproterone acetate, or chlormadinone acetate at a daily dose that is at most twice that required to inhibit ovulation together with one or more pharmaceutical aids and/or carriers. The daily dose units are administered in a method of prophylaxis and/or therapy of endometriosis continuously during a time interval of at least 169 days or 25 weeks, preferably more than two years. The method effectively reduces endometriosis and associated pain, while undesirable side effects including bone density decrease are reduced or eliminated.

Abstract: Methods for treating or reducing the risk of transmission of chlamydia to a recipient by topically applying a metalloprotease inhibitor to a site on the recipient which is likely to be exposed to Chlamydia. Topical compositions containing metalloprotease inhibitors are also disclosed for treating or reducing the risk of transmission of Chlamydia, as well as barrier contraceptive devices coated therewith.

Abstract: Biostable, multipurpose, microbicidal intravaginal devices in the form of rings, ringed-meshes, sponges, or diaphragms for use by women and condoms for use by male partners are provided, wherein each of the devices contains a drug effective in treating a particular vaginal infection, while further exhibiting at least one additional function selected from the group dealing with non-hormonal contraception, management of sexually transmitted diseases, viral infections, and retroviral infections as well as the treatment of cervical cancer.

Abstract: A drug dosage form is provided in the form of a solid tablet which is greater than 50% by weight the local anesthetic agent. The local anesthetic agent may be selected from the group consisting of an aminoamide, an aminoester, and a combination thereof. The drug tablet may be in the form of a mini-tablet which is greater than 70 wt % drug, with the balance being excipient. For example, the anesethetic agent may include lidocaine, in a salt or base form, combined with binder and lubricant excipients. Implantable drug delivery devices including the tablets are also provided, e.g., one or more of the drug tablets may be contained in a biocompatible housing. The drug tablets may be substantially cylindrical with flat end faces, and the device may have from 10 to 100 drug tablets aligned in the housing with the flat end faces of adjacent tablets abutting one another.

Abstract: The present invention relates to a delivery system comprising a core and a membrane encasing said core, wherein said core and membrane consist essentially of an elastomer composition and said core comprises at least one therapeutically active agent. The delivery system is characterized in that the membrane comprises at least one regulating agent. The invention also relates to a method for controlling the release of at least one therapeutically active agent from a delivery system.

Abstract: The invention relates to the use of octenidine dihydrochloride for manufacturing a semisolid pharmaceutical composition for the treatment of wounds, atopic dermatitides, infected eczemas, dermatomycoses, vaginal infections, acne, herpes and/or for controlling multidrug-resistant pathogens, where the composition comprises from 0.005 to 5% by weight octenidine dihydrochloride, and a corresponding composition.

Abstract: Described herein are polymeric compositions that comprise at least one polymer residue and at least one crosslinking moiety, wherein the polymer residue is crosslinked by the crosslinking moiety and wherein the crosslinking moiety is formed from a reaction between a boronic acid moiety and a hydroxamic acid moiety. Also, described are methods of making and using such polymeric compositions.

Abstract: The present invention provides methods and compositions for administration of Lactobacillus iners alone or together with at least one other probiotic organism such as Bifordobacterium, or another Lactobacillus for reduction of the risk of urogenital infection and concomitant restoration and/or maintenance of a healthy urogenital flora. A method of treatment of vaginal infections is also contemplated.

Abstract: The present composition combines an RNAIII-inhibiting peptide (RIP) with an antimicrobial peptide, such as a cathelicidin, that is capable of binding and neutralizing lipidic and polyanionic components of bacterial cell envelope. In another embodiment, the RIP is combined with an antibiotic, with or without an antimicrobial peptide. The present composition is advantageously used in a method of treatment of bacterial sepsis.

Abstract: A vaginal drug delivery system includes a device formed of porous material that holds a flowable therapeutic formulation. The device, preferably in a soft, prewetted state, is inserted into the vagina to reside typically at or near the cervix where it continuously releases the flowable therapeutic formulation through its outer surface which is in contact with the vaginal surfaces. In operation, the flowable therapeutic formulation migrates via capillary forces from a reservoir that is centrally located in the device and through a covering that envelopes the reservoir.

Abstract: The invention provides an immunostimulatory nucleic acid comprising CpG motifs, and methods of use thereof in stimulating immunity.

Abstract: A vaginal treatment composition that rapidly forms a gel when placed into contact with monovalent or polyvalent cations, such as sodium (Na+) and calcium (Ca2+) cations naturally found in vaginal mucosa, is provided. The gel may form in less than about 1 hour, in some embodiments less than about 1 minute, and in some embodiments, less than about 30 seconds. Among other things, such rapid gelation reduces the likelihood of leakage during use. In addition, because the gel may form intravaginally, it is more likely to retain its structure and shape over an extended period of time. In this manner, the gel may provide the prolonged release of a therapeutic agent that inhibits and/or treats vaginal infection. For instance, the gel may remain within the vagina for about 2 to about 48 hours to provide the desired effect.

Abstract: The present invention relates to the supply of coenzyme Q which is highly useful in maintaining human health, and provides a method and preparations whereby coenzyme Q can be efficiently supplied to patients having difficulties in oral administration, aged having swallowing difficulties and patients with diseases caused by topical disorders. It is found that the coenzyme Q concentration in the blood or topical mucosae can be elevated by using a composition for transmucosal administration containing oxidized coenzyme Q and/or reduced coenzyme Q as the active ingredient, wherein the total content of the oxidized coenzyme Q and the reduced coenzyme Q amounts to 0.0001 to 99% by weight of the whole composition.

Abstract: The present disclosure relates to biodegradable intravaginal rings for the delivery of therapeutic or prophylactic agent, inter alia, antiviral agents. The present disclosure further relates to biodegradable polyurethanes which will allow therapeutic/prophylactic agents to be released in a controlled manner that will not degrade when in use, but will degrade upon disposal.

Abstract: A vaginal device for delivery of an anti-migraine or anti-nausea drug to the uterus and/or to the general circulation through vaginal mucosa. The device is at least partially coated with one or several layers of fluid impermeable material forming a cap, film, foam, foil or strip incorporated with mucoadhesive composition comprising the anti-migraine or anti-nausea drug.

Abstract: This invention relates to an extended release formulation comprising a solid non-steroidal non-ionized hydrophilic drug, having a molecular weight below 500 Dalton and having a solubility of at least 0.1 wt % in ethylene vinyl acetate copolymer having a vinyl acetate content of 28%, which formulation is a vaginal device having a skin and which device comprises an inner compartment made of a thermoplastic polymer, which polymer is containing the drug. The polymer is preferably made of ethylene-vinyl acetate copolymer.

Abstract: A method utilizing a dissolvable device for the internal delivery of medication and more particularly to the use of films, fibers or non-woven fabrics made of a safe polymer material incorporating a medication that is released by dissolution of the films, fibers or non-woven fabrics over time, and more particularly a treatment method for controlling or regulating the pH in the vagina by stabilizing and adjusting the pH in the vagina by minimizing the impact of the vaginal flora.

Abstract: Devices, such as medical devices for inhibiting conception, and methods of using and/or making these devices. In one aspect of the disclosure, a medical device has a delivery system and a first insert, which is removably coupled to the delivery system and which is designed to be deployed within a portion of a first fallopian tube, and a second insert, which is removably coupled to the delivery system and which is designed to be deployed within a portion of a second fallopian tube. Other aspects of the disclosure include, among other things, inserts made from one or more polymers; inserts which are designed to pierce and remain in place; and inserts which are implanted through a fluid delivery system.

Abstract: Non-absorbent articles containing an additive are disclosed. The non-absorbent articles include an effective amount of an inhibitory compound such as cerulenin, triclosan, or hexachloroprene, for example, to substantially inhibit the production of TSST-1 by Gram positive bacteria.

Abstract: An applicator for introducing a therapeutic substance into a body cavity of a subject in need of the therapeutic substance is provided. The applicator has the look and feel of a conventional tampon applicator but delivers a therapeutic substance. Generally, the applicator has a first outer member having a shape suitable for insertion into a body cavity of a mammal and has a dispensing end and a second end distal to the dispensing end. A second inner member is coaxially and slidably housed within the first member such that one end of the second inner member is within the first member. The applicator of the present invention also has at least one aperture located in a side wall of the outer member. The aperture is located on the side wall of the outer member between the dispensing end and the second end of the outer member.

Abstract: Uterine cervical cancer Computer-Aided-Diagnosis (CAD) according to this invention consists of a core processing system that automatically analyses data acquired from the uterine cervix and provides tissue and patient diagnosis, as well as adequacy of the examination. The data can include, but is not limited to, color still images or video, reflectance and fluorescence multi-spectral or hyper-spectral imagery, coherent optical tomography imagery, and impedance measurements, taken with and without the use of contrast agents like 3-5% acetic acid, Lugol's iodine, or 5-aminolevulinic acid. The core processing system is based on an open, modular, and feature-based architecture, designed for multi-data, multi-sensor, and multi-feature fusion. The core processing system can be embedded in different CAD system realizations.

Abstract: Pharmaceutically acceptable hydrogel polymers of natural, recombinant or synthetic origin, or hybrids thereof, are introduced in a dry, less hydrated, or substantially deswollen state and rehydrate in a physiological environment to undergo a volumetric expansion and to affect sealing, plugging, or augmentation of tissue, defects in tissue, or of organs. The hydrogel polymers may deliver therapeutic entities by controlled release at the site. Methods to form useful devices from such polymers, and to implant the devices are provided.

Abstract: A linear polymer is obtained by reacting together a polyethylene glycol or polypropylene glycol; a PEG-PPG-PEG or PPG-PEG-PPG block copolymer; a difunctional amine or diol; and a diisocyanate. A controlled release composition comprises the polymer together with an active agent. Active agents of molecular weight 200 to 20,000 may be used.

Abstract: A vaginal therapeutic device made of copper metal has a shape to fit in the vagina and utilizes the copper metal as an antimicrobial agent to therapeutically treat abnormal biological conditions in the vagina.

Abstract: Described herein is a transmucosal delivery device and their use for delivering bioactive agents across a mucosal membrane. The delivery devices contain a pharmaceutically acceptable oxidizing and agents that facilitates the delivery of the blood stream across the mucosal membrane.

Abstract: The Human Immunodeficiency Virus poses a significant threat to the world's population. Current strategies to treat infectious agents have not been adequate to eradicate such deadly viral infections. HIV seeks out its host, a T-Helper cell, by utilizing glycoprotein 120 probes to engage a CD4 cell-surface receptor located on the surface of a T-Helper cell. Developing devices to offer HIV virions' probes the opportunity to engage the cell-surface receptors they are seeking offers a means of neutralizing the infectious threat of HIV. A device in the form of a solution containing a filter medium comprised of sheets or strips or spheres of lipid bilayer or virus-like structures or hypoallergenic surfaces to carry cell-surface receptors, each type of medium having affixed to its surface cell-surface receptors intended to engage and neutralize the infectious nature of HIV virions provides an effective strategy to avert AIDS.

Abstract: The polymeric implant is obtained from a renewable source, comprising a body formed by at least one biodegradable polymer selected from the group consisting of polyhydroxyalcanoates (PHAs) and copolymers thereof, said body incorporating, in its micro-structure, an active ingredient in a sufficient quantity to control at least one oestrus cycle of mammal animals. The invention further refers to a process for obtaining a polymeric implant comprising the steps of: mixing progesterone or progestogen, at least one polymer of the group of PHAs, one polymeric additive defined by poly(?-caprolactone), and at least one dispersant additive and/or solvent, to obtain a colloidal solution; evaporating the solvent of the colloidal solution, and forming a paste with the components dispersed therein; drying the paste to remove the residual solvents and control the granulometry of the polymer composite; extruding the polymeric composite and moulding the latter in an implant body.

Abstract: The Human Immunodeficiency Virus posses a significant threat to the world's population. Current strategies utilized to treat infectious agents have not been adequate to eradicate such deadly viral infections. HIV seeks out its host, a T-Helper cell, by having utilizing glycoprotein 120 probes to engage CD4 cell-surface receptors located on the surface of a T-Helper cell. Development of protective barrier techniques for women to utilize during sex that incorporate filter mediums that offer HIV virions' probes the opportunity to engage the cell-surface receptors they are seeking offers a means of neutralizing the infectious threat of HIV. Providing barriers with filter mediums comprised of sheets, strips, or spheres of lipid bilayer or virus-like structures or hypoallergenic surfaces to carry cell-surface receptors, each type of medium having affixed cell-surface receptors intended to engage HIV virions provides an effective strategy to prevent AIDS in women.

Abstract: The presently-disclosed subject matter provides compositions and methods for treating a cancer by providing a composition comprising a biocompatible polymeric matrix incorporating an effective amount of a phytochemical agent, a combination of phytochemical agents, or a phytochemical agent and a chemotherapeutic agent. Further, provided is a device for uterine cervical insertion for local delivery.

Abstract: The invention provides an immunostimulatory nucleic acid comprising CpG motifs, and methods of use thereof in stimulating immunity.

Abstract: There is provided a personal care product having a body side liner, a baffle and an indicator strip with two ends. The indicator has an amine sensitive dye near at least one end. The indicator extends from the target area just below the liner to just above the baffle such that the dye deposit is visible to an unaided eye. The dye changes color in the presence of amines which are characteristic of infection, thus alerting the user to the possibility of infection. Such an indicator placed in a feminine hygiene pad, for example, may be useful in the diagnosis of vaginitis.