Abstract: The invention relates to a preparation for restenosis prevention. The preparations for restenosis prevention known as yet do not reach sufficient active agent concentrations in the affected sections of the vascular walls as higher doses cause undesirable side effects. The present invention is a preparation to which at least one antihyperplastic agent is added that has a distribution ratio between butanol and water .gtoreq.0.5. The lipophilic active agent is absorbed by the vascular wall fast and in sufficient quantity. The preparation may be a liquid that can pass through capillaries and may contain a contrast agent so that the active agent is transferred into the vascular wall without any additional effort while the usually required contrast radiograms are taken. The preparation may also be applied to a catheter.

Abstract: The invention relates to a preparation for restenosis prevention. The preparations for restenosis prevention known as yet do not reach sufficient active agent concentrations in the affected sections of the vascular walls as higher doses cause undesirable side effects. The present invention is a preparation to which at least one antihyperplastic agent is added that has a distribution ratio between butanol and water .gtoreq.0.5. The lipophilic active agent is absorbed by the vascular wall fast and in sufficient quantity. The preparation may be a liquid that can pass through capillaries and may contain a contrast agent so that the active agent is transferred into the vascular wall without any additional effort while the usually required contrast radiograms are taken. The preparation may also be applied to a catheter.

Abstract: The invention relates to a preparation for restenosis prevention. The preparations for restenosis prevention known as yet do not reach sufficient active agent concentrations in the affected sections of the vascular walls as higher doses cause undesirable side effects. The present invention is a preparation to which at least one antihyperplastic agent is added that has a distribution ratio between butanol and water .gtoreq.0.5. The lipophilic active agent is absorbed by the vascular wall fast and in sufficient quantity. The preparation may be a liquid that can pass through capillaries and may contain a contrast agent so that the active agent is transferred into the vascular wall without any additional effort while the usually required contrast radiograms are taken. The preparation may also be applied to a catheter.

Abstract: A biodegradable biodelivery device is disclosed. The biodelivery device is formed from a polymer comprising the reaction product of a polyol and a polyacid. When exposed to water, the polymer degrades through hydrolysis. Of particular advantage, the polymer can be formed so as to be elastic and flexible. In one embodiment, the polymer is formed into a vaginal insert. As the polymer degrades, the polymer releases acid to a vaginal environment for decreasing the pH of the environment.

Abstract: Condoms having an elastomeric layer and coating containing an anhydrous warming lubricant and at least one or more ingredients dispersed therein, the coating being disposed on one or both surfaces are provided. The ingredients disposed on the elastomeric layer can be solid particles or encapsulated ingredients that are insoluble in the anhydrous warming lubricant and soluble in water. Methods of producing and using these condoms are also provided.

Abstract: Test methods for assessing irritation of portions of skin are provided. The method may include irritating a portion of skin by contacting the portion of skin with a chemical irritant; irritating the portion of skin by physical irritation; and assessing erythema or dryness of the portion of skin after irritating the steps. Alternatively, the method may include irritating a portion of skin with a chemical irritant; irritating the portion of skin by physical irritation; treating the irritated portion of skin by wiping the irritated portion of skin with a test sample; and assessing erythema or dryness of the portion of skin after the wiping step. A method of irritating a portion of skin to assess one of erythema and dryness may include irritating a portion of skin with a chemical irritant and irritating the portion of skin by physical irritation.

Abstract: Multi-layered vaginal rings 2 comprising silicone elastomers and pharmaceutically active ingredients are disclosed. The rings comprise a number of layers, at least one of which contains a pharmaceutically active ingredient, and each of which is a silicone elastomer. The multiple layers preferably are produced from these layers of different compositions, including an inner layer 4, a middle layer 5, and an outer layer 6. After extrusion and simultaneous curing, however, the ring 2 includes a contiguous body which comprises a continuous silicone body providing unimpeded diffusion of the pharmaceutically active ingredient from the inner layer (s) 4 to the outer layer (s) 6. Methods of producing these vaginal rings and of using them are also disclosed.

Abstract: The subject invention provides a drug delivery system comprising at least one compartment comprising (i) a drug-loaded thermoplastic polymer core layer, (ii) a drug-loaded thermoplastic polymer intermediate layer and (iii) a non-medicated thermoplastic polymer skin covering the intermediate layer, wherein said core layer is loaded with crystals of a first (pharmaceutically) active compound and said intermediate layer is loaded with, crystals of the second (pharmaceutically) active compound.

Abstract: Transluminal drug delivery method and device embodiments can include a urethral suppository formulated to prevent or treat diseases of the urethra and surrounding organs, such as interstitial cystitis or urethritis, by enhancing the absorption of a therapeutic agent of the suppository into body tissues without adversely affecting the natural defense mechanisms of these tissues. Adverse effects on the glycosaminoglycan (GAG) barrier can be mitigated or eliminated by the presence of a suitable polysaccharide in the suppository.

Abstract: A rectally insertable device for localized drug delivery to the anal sphincter of a subject, a method of using the device and the use of the device is disclosed. The device comprises a shell for containing an active pharmaceutical ingredient, the shell being substantially impermeable to the active pharmaceutical ingredient wherein a lower portion of the shell is configured to release the active pharmaceutical ingredient from the shell and wherein when the device is inserted into the rectum of the subject, the lower portion of the shell is proximal to the anal sphincter, such that the active pharmaceutical ingredient is released proximal to the anal sphincter.

Abstract: A device for drug delivery to an orifice of a subject, comprising a shell which is elastically stressed by an active pharmaceutical ingredient, said shell containing and being substantially impermeable to said active pharmaceutical ingredient, wherein said shell has at least one hole sized for in-vivo release of said active pharmaceutical ingredient as a result of elastic stressing.

Abstract: A medicament delivery device and method of delivering a medicament is provided wherein the device is insertable into the uterine myometrium for the delivery of medicaments to the pelvic area and organs thereof, for example, the bladder, peritoneum, the vulva, vagina, fallopian tubes, ovaries, and uterus, and then to the bloodstream.

Abstract: The present invention relates to a method of easing childbirth using a composition having a lubricant effect for use in particular during human vaginal delivery. The methods comprise applying a bioadhesive composition comprising (a) a polyacrylic acid, (b) a water-soluble thickener and (c) a humectant and (d) optionally water.

Abstract: The present invention relates to monolithic intravaginal rings comprising progesterone, methods of making, and uses thereof. The intravaginal rings comprise progesterone, a polysiloxane elastomer, and a pharmaceutically acceptable hydrocarbon or glycerol esters of a fatty acid.

Abstract: The invention relates to the use of an antimycotic agent and an epithelial cell or endothelial cell adhesion inhibitor for producing a combination drug for the topical treatment of Candida mycoses selected from vulvovaginal candidiasis, oropharyngeal candidiasis (oral thrush), diaper dermatitis (diaper thrush) and intertriginous (Candida) eczema.

Abstract: A method, medicated feminine sanitary products and compositions for reducing menstrual blood loss in a female are provided. The method comprises delivering an active agent to the uterine cavity by administering intravaginally to the female a therapeutically effective amount of the active agent on a medicated feminine sanitary product during menstrual bleeding, wherein the medicated feminine sanitary product is routinely utilized to absorb the menstrual flow, wherein the active agent is incorporated in the medicated feminine sanitary product as a pharmaceutically acceptable composition, the active agent is any of an antifibrinolytic and a hemostatic agent.

Abstract: A microbicidal delivery system including: a microbicidal composition including a microbicidal compound including a dendrimer including one or more surface groups of formula (IV); a microbicidally active derivative thereof, or pharmaceutically acceptable salt or solvate thereof; and a carrier, excipient or diluent therefor; and a prophylactic device; the microbicidal composition being carried on a surface of the prophylactic device and being compatible therewith.

Abstract: A method of capturing bodily fluid intravaginally providing an intravaginal device that has a fluid storage element having a longitudinal axis and is in fluid communication with at least one fluid transport element. The method involves providing at least one fluid transport element that is bendable about an axis substantially parallel to the longitudinal axis of the fluid storage element and positioned within a human vagina.

Abstract: This invention provides a spermicidally and virucidally effective, vaginally applicable formulation, having the following approximate composition of essential ingredients: at least one benzalkonium chloride, in an amount from 0.05 to 0-0.2%; at least one spermicide selected from the group consisting of nonoxynols in an amount of from 0.05-12%, octoxynol-9 in an amount of from 0.05-4%, and triclosan in an amount from 0.05-2%; a biologically acceptable emollient, in an amount from 1-5%; hydroxypropyimethyl cellulose, in an amount from 0.1-3%; sodium carbomer, in an amount from 0.1-1%; de-ionized water, making up the balance. The composition has the attributes of (a) a semi-solid, essentially clear gel consistency and appearance, and (b) the ability to maintain a presence in the human vagina in the presence of mucous secretions therein, in virucidally effective amounts, for at least 24 hours after application thereto.

Abstract: A process for the preparation of a bioadhesive laminate comprising a hot-melt extruded reservoir layer and a hot-melt extruded backing layer is provided. The reservoir layer comprises a thermoplastic bioadhesive composition containing an active agent. An active agent-containing thermoplastic bioadhesive hydrophilic composition is hot-melt coextruded with a hydrophobic composition to form at least a bi-layered laminate. The hydrophilic composition and the hydrophobic composition have at least one polymer in common. In addition, the melt flow index of the hydrophobic composition is within 50% of the melt flow index of the hydrophilic composition. As a result, the laminate has a uniform transverse cross-section and/or a uniform longitudinal cross-section throughout a major of the length of the laminate. Moreover, when the laminate is divided into unit doses of approximately the same size, they have a high degree of content uniformity with respect to the active agent(s) present therein.

Abstract: The subject invention provides a drug delivery system comprising at least one compartment consisting of (i) a drug-loaded thermoplastic polymer core, (ii) a drug-loaded thermoplastic polymer intermediate layer and (iii) a non-medicated thermoplastic polymer skin covering the intermediate layer, wherein said intermediate layer is loaded with (a) crystals of a first pharmaceutically active compound and with (b) a second pharmaceutically active compound in dissolved form and wherein said core is loaded with said second compound in dissolved form.

Abstract: Biodegradable cross-linked particles, as well as related compositions and methods, are disclosed.

Abstract: A fiber-reinforced composite ring for the controlled release of at least one bioactive agent includes a biocompatible matrix reinforced with absorbable/biodegradable fibers capable of providing the mechanical properties needed for inserting and maintaining the ring in a body cavity for a desired period of time. Such ring system as can be used for the intravaginal, intraperitoneal, and subcutaneous delivery of at least one bioactive agent, including those used as contraceptives, antimicrobial agents, and/or antiviral agents, as well as those for the treatment of cancer.

Abstract: This invention describes a partially absorbable, fiber-reinforced composite in the form of a ring, or a suture-like thread, with modified terminals for use as a controlled delivery system of at least one bioactive agent, wherein said composite comprising an absorbable fiber construct capable of providing time-dependent mechanical properties of a biostable elastomeric matrix containing an absorbable microparticulate ion-exchanger to modulate the release of the bioactive agent(s) for a desired period(s) of time at a specific biological site; this can be a vaginal canal, peritoneal cavity, scrotum, prostate gland, an ear loop or subcutaneous tissue. Such drug delivery systems can be used for the local administration of at least one bioactive agent, including those used as contraceptive, antimicrobial, anti-inflammatory and/or antiviral agents as well as for cancer treatment.

Abstract: A biodegradable biodelivery device is disclosed. The biodelivery device is formed from a polymer comprising the reaction product of a polyol and a polyacid. When exposed to water, the polymer degrades through hydrolysis. Of particular advantage, the polymer can be formed so as to be elastic and flexible. In one embodiment, the polymer is formed into a vaginal insert. As the polymer degrades, the polymer releases acid to a vaginal environment for decreasing the pH of the environment.

Abstract: The present invention is directed to compositions comprising at least one nitric oxide donor and at least one second therapeutically active agent with antimicrobial or wound healing capability. In one embodiment, the nitric oxide donor is a nanoparticle which is designed to control for the amount and duration of release of nitric oxide. The nanoparticle may further comprise the additional therapeutically active agent. The composition is useful for enhancing wound healing and for treating and preventing microbial infection. In one embodiment, the composition is directed toward reducing oral bacteria or dental plaque. The combination of one or more nitric oxide donors and one or more additional therapeutically active agent results in unexpected synergistic effects, wherein both the antimicrobial efficacy of the nitric oxide and the antimicrobial or wound healing efficacy of the second therapeutically active agent are enhanced.

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: Disclosed are compositions for inhibiting transmission of a sexually transmitted infection that contain one or more polyanionic microbicides, such as carrageenans, including lambda carrageenan, as well as water-soluble metal salts and specified antiretroviral agents comprising NNRTIs and NRTIs. Also disclosed are methods for making and using the compositions.

Abstract: According to one claim of the invention, a method for occluding a fallopian tube in a vertebrate subject is described, which comprises comprising transcervically delivering a solid blocking material into the fallopian tube. In various embodiments, a fluid sealing material is delivered along with the solid blocking material. Other claims of the invention pertain to articles of manufacture, delivery devices and kits for use in occluding the fallopian tubes of a vertebrate subject.

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: The subject invention provides a drug delivery system comprising at least one compartment consisting of (i) a drug-loaded thermoplastic polymer core, (ii) a drug-loaded thermoplastic polymer intermediate layer and (iii) a non-medicated thermoplastic polymer skin covering the intermediate layer, wherein said intermediate layer is loaded with (a) crystals of a first pharmaceutically active compound and with (b) a second pharmaceutically active compound in dissolved form and wherein said core is loaded with said second compound in dissolved form.

Abstract: An intrauterine system (1) for the retention of a biologically active compound within the uterus of a female mammal is formed by a frame (16) defining an interior space (20) for receipt of a deposit of the compound (22). The frame has an open structure (18) allowing access to a substantial part of an outer surface of the deposit and the deposit has a rate controlling structure that controls a rate of release of the compound within the Uterus. Retention elements (6) are provided on the frame for retaining the frame within the uterus.

Abstract: The present invention relates to a non-hormonal, biocompatible, and biodegradable intravaginal device for the delivery of spermiostatic, spermicidal and anti-infectious agents. The present invention also relates to methods of contraception using such a device, as well as the prevention and treatment of sexually transmitted diseases and vaginal infections through the application of the device.

Abstract: The present invention relates to a non-hormonal, biocompatible, and biodegradable intravaginal device for the delivery of spermiostatic, spermicidal and anti-infectious agents. The present invention also relates to methods of contraception using such a device, as well as the prevention and treatment of sexually transmitted diseases and vaginal infections through the application of the device.

Abstract: According to an aspect of the invention, injectable bulking compositions are provided which contain the following: (a) fibers that are configured to prevent migration to locations in the body remote from the injection site, for example, because they have a minimum length that is sufficiently large to prevent migration of the fibers and/or because they have surface features that stimulate host tissue response to lock the fibers in position and (b) a carrier in an amount effective to render the composition injectable.

Abstract: The present invention provides a substantially clear gel designed to reduce itching discomfort when applied to the vulvar tissue. The gel includes at least one anesthetic, protectant, emulsifier, and pH modifier, such as a base. The gel has a pH adapted to vulvar use and may be applied to the vulvar tissues.

Abstract: Drug delivery compositions which are suitable for vaginal administration for the treatment of diseases and disorders in the urogenital tract are described. The compositions may be in the form of a tablet, liquid suspension or dispersion, dried powder, topical ointment, cream, foam, suppository, or aerosol. The drug delivery compositions are administered directly to the vagina and do not require the use of a solid device. This method of administration reduces the systematic levels of the drugs.

Abstract: Therapeutic device intended for the selective cytoreductive treatment of an obstruction in a natural lumen or passage of the human or animal body, said lumen being obstructed by the effect of a local cell proliferation, said device comprising a tubular element, in particular of cylindrical shape, intended to be placed in said natural lumen and sufficiently flexible to conform to said natural lumen, but sufficiently rigid to maintain an artificial channel in said lumen. The tubular element supports lengthwise a medicinal sleeve which is intended to come into line with, and into contact with, the obstruction once the natural lumen has been intubated, and is designed to deliver locally, at least in its outer surface portion, at least one therapeutic agent which is cytoreductive, in particular cytotoxic, through contact with the cells under whose effect said lumen is obstructed.

Abstract: According to an aspect of the present invention, urological medical devices are provided which comprise a substrate and hyaluronic acid, which is releasably disposed on or in the substrate.

Abstract: Multi-layered vaginal rings 2 comprising silicone elastomers and pharmaceutically active ingredients are disclosed. The rings comprise a number of layers, at least one of which contains a pharmaceutically active ingredient, and each of which is a silicone elastomer. The multiple layers preferably are produced from these layers of different compositions, including an inner layer 4, a middle layer 5, and an outer layer 6. After extrusion and simultaneous curing, however, the ring 2 includes a contiguous body which comprises a continuous silicone body providing unimpeded diffusion of the pharmaceutically active ingredient from the inner layer (s) 4 to the outer layer (s) 6. Methods of producing these vaginal rings and of using them are also disclosed.

Abstract: A method of capturing bodily fluid in a mammalian body includes inserting the fluid management device into the mammalian body and transporting bodily fluid. The bodily fluid is transferred via at least one fluid transport element that is capable of interfacing with a mammalian body element to provide a substantially uninterrupted fluid conduit. The fluid conduit provides a fluid path between at least one fluid transport element and the storage element. A distal portion of the at least one fluid transport element is capable of extending away from the fluid storage element.

Abstract: The present invention provides improved intravaginal drug delivery devices, i.e., intravaginal rings, useful for the prophylactic administration of an antimicrobial compound, e.g., Dapivirine, to a human. The intravaginal rings of the invention address previous stability issues by utilizing a platinum catalyst (e.g., in the form of a platinum-siloxane complex) for the cross-linking reaction. The vaginal rings surprisingly achieve relatively high and steady release rates in vivo with a matrix ring containing a relatively small loading dose. While the matrix rings of the present invention have in vivo the steady release rates associated with reservoir rings, they are easier and less expensive to manufacture. The present invention also provides methods of blocking DNA polymerization by an HIV reverse transcriptase enzyme, methods of preventing HIV infection in a female human, methods of treating HIV infection in a female human, and methods of preparing platinum-catalyzed intravaginal rings.

Abstract: The present invention relates to a non-hormonal, biocompatible, and biodegradable intravaginal device for the delivery of spermiostatic, spermicidal and anti-infectious agents. The present invention also relates to methods of contraception using such a device, as well as the prevention and treatment of sexually transmitted diseases and vaginal infections through the application of the device.

Abstract: The present invention is directed to vaginal tablets comprising misoprostol and a pharmaceutically acceptable pH insensitive, hydrophilic cellulose material, wherein the vaginal tablets do not contain a hydrophobic release controlling agent, and wherein the misoprostol and the pharmaceutically acceptable pH insensitive, hydrophilic cellulose material are in a ratio of about 1:50 to about 1:800, and wherein the vaginal tablets do not substantially change the pH of a vaginal tract.

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: This invention relates to a polymeric pharmaceutical dosage form for the delivery, in use, of at least one pharmaceutical composition in a rate-modulated and site-specific manner. The dosage form comprises a biodegradable, polymeric, scaffold incorporating loaded with at least one active pharmaceutical ingredient (API). The polymer or polymers making up the scaffold degrade in a human or animal body in response to or in the absence of specific biological stimuli and, on degradation, release the API or APIs in an area where said stimuli are encountered. Preferably the polymeric scaffold is formed from poly (D1L-lactide) (PLA) and polymethacrylate (Eudragit S100/ES100) polymers.

Abstract: The present invention relates to a veterinary zoo-technical drug delivery system (device) for the simultaneous release of two or more active substances, which system releases the active substances in a substantially constant ratio over a prolonged period of time. The drug delivery system can be in different forms, such as e.g. an implant, or a intravaginal device such as a helical coil, a spring or a ring.

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: An intrauterine device and more specifically an intracervical device (ICD) for the local release of drugs in the loco-regional treatment of tumours of the uterine cervix comprises an elongated stem (2) to be positioned in the cervical canal (15), this stem consisting of an inner hollow core (3) and a coating (4) containing a gradual-release drug, the stem being attached to: a first element (5) for blocking the stem (2) inside the uterine cavity (12), and located at the cranial or upper end; a second blocking element (7, 71) positioned inside the vagina (11), against the ectocervix (16), located at the caudal or lower end of the stem (2).

Abstract: Methods and devices of sterilization by which the ovarian pathway is occluded by a plug, wherein placement of the plug may be visually confirmed. Other methods and devices are also described.