Abstract: The first aspect of the invention relates to a method of inducing changes in the cervical mucus of a person to achieve a contraceptive effect, and wherein the method involves administering to the person an effective amount of ebrotidine sufficient to achieve a contraceptive effect. The second aspect of the invention involves a method for treating atrophic vaginitis urinary incontinence and their associated signs and symptoms, in a person, the method involves administering to the person an effective mount of an agent sufficient to treatment of atrophic vaginitis, the agent being selected from a group consisting of stimulants or antagonists, purinergic receptors, a sodium ion update agents and an anion secretion inhibitors.

Abstract: A novel and useful apparatus for delivering an anesthetic locally to the cervical region of a female is provided, wherein the apparatus comprises a ring having a surface and at least one depression on the surface. An anesthetic composition comprising an anesthetic agent and an excipient are placed within the at least one depression. The ring is comprised of a pharmaceutically acceptable inert material that is biocompatible. Furthermore, the ring is of sufficient size such that it can be inserted into the vaginal canal of a female. In the vaginal canal, the anesthetic agent is immediately released from the anesthetic composition and directly anesthetizes the cervical region.

Abstract: Methods, devices, and compositions for treatment of dysmenorrhea comprise an intravaginal drug delivery system containing an appropriate pharmaceutical agent incorporated into a pharmaceutically acceptable carrier whereby the pharmaceutical agent is released into the vagina and absorbed through the vaginal mucosa to provide relief of dysmenorrhea. The drug delivery system can be a tampon device, vaginal ring, pessary, tablet, suppository, vaginal sponge, bioadhesive tablet, bioadhesive microparticle, cream, lotion, foam, ointment, paste, solution or gel. The system delivers a higher concentration to the muscle of the uterus, the primary site for the dyskinetic muscle contraction, which is the pathophysiologic cause of dysmenorrhea.

Abstract: A method for decreasing the frequency of transmission of human immunodeficiency virus or herpesviruses or for preventing the transmission of or treating a sexually transmitted bacterial infection by administering to a human an anti-human immunodeficiency virus amount or an anti-herpesvirus amount or an anti-bacterial amount of cellulose acetate phthalate (CAP) or hydroxypropyl methylcellulose phthalate (HPMCP), such as in micronized form, or a combination thereof, either alone or in combination with a pharmaceutically acceptable carrier or diluent. The CAP and/or HPMCP may be employed as a suspension of micronized particles and may further contain a water miscible, non-solvent for CAP or HPMCP, such as glycerol.

Abstract: Disclosed is a vaginal ring intended for the release of at least one drug over a prolonged time period. The vaginal ring contains a ring body made of a first polymeric material having at least one hollow internal channel defining an opening to the exterior of said body and which channel is adapted to receive a drug-containing core through said opening, and an intravaginally administerable drug-containing core disposed in the channel. The core is positioned in the vaginal ring body suitably prior to use in order to substantially avoid initial bursts of drug into the tissues of the subject and resultant side effects such as nausea and vomiting. The core contains a pharmaceutically effective amount of at least one intravaginally administerable drug dispersed in a second polymeric material. The first and second polymeric materials may be the same or different. Representative drugs include contraceptive agents and other steroidal substances for use in hormone replacement therapy.

Abstract: An intravaginal drug delivery device comprising at least one active agent dispersed in a polymer matrix, wherein the concentration of active agent at the outer surface of the device at the time of use is not substantially higher than the concentration of the active agent in the remainder of the device, a method of treatment therewith and a process for its preparation.

Abstract: Methods, devices, and compositions for treatment of dysmenorrhea comprise an intravaginal drug delivery system containing an appropriate pharmaceutical agent incorporated into a pharmaceutically acceptable carrier whereby the pharmaceutical agent is released into the vagina and absorbed through the vaginal mucosa to provide relief of dysmenorrhea. The drug delivery system can be a tampon device, vaginal ring, pessary, tablet, suppository, vaginal medicated tampon, vaginal sponge, bioadhesive tablet, bioadhesive microparticle, cream, lotion, foam, ointment, paste, solution or gel. The system delivers a higher concentration to the muscle of the uterus, the primary site for the dyskinetic muscle contraction, which is the pathophysiologic cause of dysmenorrhea.

Abstract: The present invention describes a polyoxaester copolymers containing amines and/or amido groups and blends thereof with other polymers that may be used to produce surgical devices such as sutures, sutures with attached needles, molded devices, and the like. The polyoxaesters copolymer of the present invention is formed from a first divalent repeating unit of formula IA:[--C(O)--R.sub.30 --C(O)--] IAa second divalent repeating unit of the formula IB:[O--C(O)--C(R.sub.1)(R.sub.2)--O--(R.sub.3)--O--C(R.sub.1)(R.sub.2)--C(O)-- ]Iand a third repeating unit of the formula:[--O--R.sub.12 --].sub.U, XVIand optionally a fourth repeating unit with a formula selected from the group consisting of:[--O--R.sub.4 --].sub.A, II[--O--R.sub.5 --C(O)--].sub.B, III([--O--R.sub.5 --C(O)].sub.P --O--).sub.L G XIand combinations thereof wherein R.sub.12 contains an internal amine or internal amide group.

Abstract: This invention relates to formulations comprising film-forming components capable of forming per se a physical barrier to pathogens. Thermoreversible gels such as poloxamers are particularly preferred for that use. The film-forming formulations may further comprise microbicides, spermicides or any other drug, which choice is guided by the pathogen, organism or the disease to be inactivated or treated. The formulations are therefore efficient as a physical, and optionally, as a chemical or pharmacological barrier as well as usable as a sustained drug-release system at the locus of administration. A part of the drug may also be entrapped in liposomes or other drug carriers. These formulations are intended for use in the prevention of sexually transmitted diseases, as well as in the treatment of infections, cancer, inflammation or any disease or state which requires a pharmacological treatment. Formulations are applicable to mucosae, skin and eye, for example.

Abstract: The invention provides a method for making a selenium-carrier conjugate by covalently attaching (i) an organic selenium compound selected from the group consisting of RSeH, RSeR, RSeR', RSeSeR and RSeSeR', wherein R and R' are each an aliphatic residue containing at least one reactive group selected from the group consisting of aldehyde, amino, alcoholic, carboxylic, phosphate, sulfate, halogen or phenolic reactive groups and combinations thereof, to (ii) a carrier having a constituent capable of forming a covalent bond with said reactive groups of said selenium compound to produce a selenium-carrier conjugate which is capable of specific attachment to a target site. The carrier may be a protein, such as an antibody specific to a bacteria, virus, protozoa, or cell antigen, including without limitation, cell surface antigens, a peptide, carbohydrate, lipid, vitamin, drug, lectin, plasmid, liposome, nucleic acid or a non-metallic implantable device, such as an intraocular implant or a vascular shunt.

Abstract: The present invention is dealing with a drug delivery system, preferably in a ring-shaped form suitable for vaginal administration, for the simultaneous release of a progestogenic steroid compound and an estrogenic steroid compound in a fixed physiological ratio over a prolonged period of time. The drug delivery system comprises at least one compartment comprising a thermoplastic polymer core containing the mixture of the progestogenic and estrogenic compounds and a thermoplastic polymer skin, the progestogenic compound being initially dissolved in the polymer core material in a relatively low degree of supersaturation.

Abstract: A method for decreasing the frequency of transmission of human immunodeficiency virus or herpesviruses by administering to a human an anti-human immunodeficiency virus amount or an anti-herpesvirus amount of cellulose acetate phthalate (CAP) or hydroxypropyl methylcellulose phthalate (HPMCP), such as in micronized form, or a combination thereof, either alone or in combination with a pharmaceutically acceptable carrier or diluent. The CAP and/or HPMCP may be employed as a suspension of micronized particles and may further contain a water miscible, non-solvent for CAP or HPMCP, such as glycerol.

Abstract: Disclosed is a vaginal ring intended for the release of at least one drug over a prolonged time period. The vaginal ring contains a ring body made of a first polymeric material having at least one hollow internal channel defining an opening to the exterior of the ring body and which channel is adapted to receive a, drug-containing core through the opening, and an intravaginally administerable drug-containing core disposed in the channel. The core is positioned in the vaginal ring body suitably prior to use in order to substantially avoid initial bursts of drug into the tissues of the subject and resultant side effects such as nausea and vomiting. The core contains a pharmaceutically effective amount of at least one intravaginally administerable drug dispersed in a second polymeric material. The first and second polymeric materials may be the same or different. Representative drugs include contraceptive agents and other steroidal substances for use in hormone replacement therapy.

Abstract: Single and multiple layer membranes such as gloves and condoms include one or more deactivating barrier layers and/or indicating layers to indicate to a user membrane breach or the presence of a harmful substance in blood or body fluids. A membrane may include one or more permeable or semipermeable layers to disperse contained substances such as lubricants, biocides, spermicides, or indicators outwardly, and may also include permeable or semipermeable layers to allow transmission of body fluids or other environmental fluids inwardly into contact with an indicating or treating substance. An intermediate layer of a multi-layer membrane may include a substance to wipe, cleanse, sterilize, or otherwise treat a piercing needle. A membrane may include a sealing or coating to entrap indicators or other agents such as biocides therein. A method of making membranes such as gloves results in a double glove having discrete inner or outer layers joined only in a cuff region.

Abstract: There is disclosed a composition and method for reducing or alleviating the discomforting symptoms associate with menstruation, particularly menstrual pain. The composition is administered by topical or local administration to the uterus or vaginal tissues of a women in need thereof, and contains an omega fatty acid in combination with a cyclo-oxygenase inhibitor. Preferred omega fatty acids include docosahexaenoic acid and eicosapentaenoic acid, and preferred cyclo-oxygenase inhibitors include, ibuprophen, acetylsalicylic acid and salicylic acid. The composition may further include pharmaceutically acceptable carriers or diluents, and may be locally applied via intracervical or intrauterine application, or may be topically applied to the skin of the lower abdomen.

Abstract: The present invention relates to a method of administering progesterone to a normogonadal or a functionally agonadal human female undergoing an assisted reproduction technique. The invention further provides a method of hormone replacement for a human female. In a preferred embodiment of the present invention, progesterone is provided by intravaginal administration of a progesterone-containing polysiloxane ring.

Abstract: The present invention describes a prepolymer of aliphatic polyoxaesters containing amines and/or amido groups having polymerizable end groups that may be used to produce surgical devices such as sutures, sutures with attached needles, molded devices, and the like.

Abstract: A process is disclosed for making devices which release active material, e.g. a drug, at a controlled rate, which device comprises a closed container and the active material. The device is made by first making a hollow envelope, e.g. by extrusion or moulding, followed by introducing the active material into the void of the envelope. The device may have a ring or cylindrical form.

Abstract: An intravaginal drug delivery device for prolonged release of an active ingredient comprising a biocompatible polymer matrix containing an active ingredient to be released and an effective amount of at least one fatty acid ester and a method of inducing contraception in female warm-blooded animals, including humans.

Abstract: The present invention describes a crosslinked aliphatic polyoxaesters containing amines and/or amido groups and blends thereof with other polymers that may be used to produce surgical devices such as sutures, sutures with attached needles, molded devices, and the like. The crosslinked aliphatic polyoxaesters of the present invention is formed from an aliphatic polyoxaester having a first divalent repeating unit of formula I:?O--C(O)--C(R.sub.1)(R.sub.2)--O--(R.sub.3)--O--C(R.sub.1)(R.sub.2)--C(O)-- !Iand a second repeating unit of the formula:?--O--R.sub.12 --!.sub.U, XVIand optionally a third repeating unit with a formula selected from the group consisting of:?--O--R.sub.4 --!.sub.A, II?--O--R.sub.5 --C(O)--!.sub.B, III(?--O--R.sub.5 --C(O)!.sub.P --O--).sub.L G XIand combinations thereof wherein R.sub.12 contains an internal amine or internal amide group wherein the aliphatic polyoxaester has been crosslinked.

Abstract: A controlled release composition comprising an extruded core of active material and excipients, said core being coated in a water insoluble coating. Preferably the core comprises a pharmaceutically acceptable active ingredient together with microcrystalline cellulose, a clay such as kaolin and a binder such as poly(vinyl-pyrrolidine).

Abstract: Antimicrobial metal-based compositions, which are photostable, non-staining, and which are easily absorbed into lipophilic matrices, contain silver cations, complexed by acyclic polyether polymers through the formation of a "host-guest relationship" where the acyclic polyether is the "host" and the silver cation is the "guest," wherein stabilization of this "host-guest relationship" is accomplished through the use of excess anions. The compositions are useful for topical treatment of infections caused by bacteria, fungus and viruses in humans and animals and for treating medical devices, foams and adhesives to impart infection-resistance.

Abstract: The present invention describes a new aliphatic polyoxaesters that is bioabsorbable and may be used to produce surgical devices such as sutures, sutures with attached needles, molded devices, and the like. The invention also contemplates a process for producing these polyesters. The aliphatic polyoxaesters of the present invention have a first divalent repeating unit of formula I:[O--C(O)--C(R.sub.1) (R.sub.2)--O--(R.sub.3)--O--C(R.sub.1)(R.sub.2)--C(O)--] Iand a second repeating unit of the formula:[--O--R.sub.12 --].sub.U, XVIand optionally a third repeating unit with a formula selected from the group consisting of:[--O--R.sub.4 --].sub.A, II[--O--R.sub.5 --C(O)--].sub.B, III([--O--R.sub.5 --C(O)].sub.P,--O--).sub.L G XIand combinations thereof wherein R.sub.12 contains an internal amine or internal amide group.

Abstract: A medical device for insertion into a vaginal cavity comprising an elastomeric ring containing a compound selected from the group consisting of a compound of the formula ##STR1## wherein R.sub.1 is hydrogen or alkyl of 1 to 6 carbon atoms, R.sub.2 and R.sub.5 are individually alkyl of 1 to 6 carbon atoms, n is an integer from 2 to 6, R.sub.3 and R.sub.4 are individually aryl of 6 to 12 carbon atoms optionally substituted with 1 or 2 members of the group consisting of halogen and alkyl and alkoxy of 1 to 6 carbon atoms and their non-toxic, pharmaceutically acceptable acid addition salts for the treatment and prevention of cancer.

Abstract: A virucidal, spermicidal vaginal gel consisting essentially of povidone iodine having a povidone to iodine ratio of about 15:1 or higher containing from about one percent to about twenty percent low molecular weight povidone having a molecular weight of about 20 kd or lower, the gel having a viscosity such that a conical body drawn from a body of the same does not visibly slump at 37C. for a period of at least one minute and a method of preventing sexual transmission of disease and preventing pregnancy using the same are disclosed.

Abstract: The present invention teaches that relatively low levels of serum progesterone, 1 to 6 ng/ml, may be used to prevent endometrial cancer. The vaginal delivery of progesterone using a cross-linked polycarboxylic polymer produces this low serum progesterone level while also providing the full secretory transformation of the endometrium, indicating the efficacy of the progesterone. Such low levels of serum progesterone will decrease the risk of breast cancer experienced by women undergoing hormone replacement therapy ("HRT") and minimize the potential of other undesirable progesterone associated side effects.

Abstract: A dissolvable element containing an agent material is used for local administration of the agent material in an internal body area. The dissolvable element is made of dissolvable polymer material and/or complex carbohydrate material which are food grade materials and have selected dissolving properties, such that it remains in substantially solid form before use, and dissolves due to human body temperatures and moisture during use to release the agent material in a desired timed release and dosage. As a contraceptive, the dissolvable element is preferably a film made of polyvinyl alcohol, polyethylene oxide, hydroxypropyl methyl cellulose and/or carboxymethyl cellulose. The dissolvable element may be formed as a laminate of different film layers for compound release properties, or it may be ground into particles and incorporated in a tampon or suppository. The dissolvable element may be foamed as a means for increasing its dissolution rate.

Abstract: A dissolvable element containing an agent material is used for local administration of the agent material in an internal body area. The dissolvable element is made of dissolvable polymer material and/or complex carbohydrate material which are food grade materials and have selected dissolving properties, such that it remains in substantially solid form before use, and dissolves due to human body temperatures and moisture during use to release the agent material in a desired timed release and dosage. As a contraceptive, the dissolvable element is preferably a film made of polyvinyl alcohol, polyethylene oxide, hydroxypropyl methyl cellulose and/or carboxymethyl cellulose. The dissolvable element may be formed as a laminate of different film layers for compound release properties, or it may be ground into particles and incorporated in a tampon or suppository. The dissolvable element may be foamed as a means for increasing its dissolution rate.

Abstract: Compositions and methods which are effective to inhibit conception and to treat benign gynecological disorders for extended periods of time are described, wherein an effective amount of a gonadotropin hormone releasing hormone composition and an effective amount of an estrogenic composition are provided over a first period of time, in addition to a progestogen and optionally an androgenic composition. According to one protocol, the progestogen is provided for a second, shorter period of time; the progestogen is provided at a higher level for at least 5 to about 20 days, and then at a lower level for the remainder, if any, of the second period of time. In an alternative protocol, the progestogen is provided at a lower level substantially throughout the period of administration of gonadotropin hormone releasing hormone composition and estrogenic composition. An effective amount of the androgenic hormone is optionally provided over the first period of time.

Abstract: Contraceptive devices which are effective for extended periods of time are described, in the form of means for releasing an effective amount of a gonadotropin hormone releasing hormone composition and means for releasing an effective amount of an estrogenic hormone over a first period of time, and means for releasing an effective amount of a progestogen for a second period of time, the second period of time being substantially shorter than and running simultaneously with a portion of the first period of time. The gonadotropin hormone releasing hormone composition is selected from gonadotropin hormone releasing hormone, gonadotropin hormone releasing hormone analogues, gonadotropin hormone releasing hormone agonists, gonadotropin hormone releasing hormone antagonists and mixtures thereof. Contraceptive methods employing the devices are also described.

Abstract: The invention concerns an intravaginal device comprising a combination of 17.beta.-estradiol and a supporting matrix for treating hypoestrogenic women. The device releases continously 17.beta.-estradiol at a rate of about 0.5 to about 25 .mu.g/24 h. The invention also comprises a method of preparing the device and a method of treating hypoestrogenic women by using the device.

Abstract: Biocompatible and biodegradable poly(phosphoester-urethanes), compositions comprising the poly(phosphoester-urethanes), and methods of use as a drug delivery device and an implant.

Abstract: A vaginal progesterone suppository is provided in the form of a tablet which delivers biologically effective amounts of progesterone for at least about 48 hours, and blood amounts above basal levels for 72 hours. The tablet is formulated to preferably have a hardness on its edge of 8-13 kg, and disintegrates from its surface to form a milky suspension in 6-8 hours after it is inserted in the vaginal vault. The tablet contains, by weight, about 13-20% progesterone, 65-85% lactose, 2-10% corn starch paste binder, 3-10% corn starch disintegrant, and 0.1-0.9% magnesium stearate as a lubricant. The ratio by weight of progesterone to lactose is preferably 1:6, and the ratio of starch paste binder to starch disintegrant is preferably 1:1. This dosage form is an effective treatment for many progesterone deficiency conditions, and provides enhanced bioavailability.

Abstract: A prophylactic agent for controlling venereal diseases. As an active microbicidal component, the agent has an ammonium compound having hydrolyzable ester group.

Abstract: The invention disclosed provides an intra-vaginal device prepared using ingredients which slowly release in the vagina over a significant period of time. The present intra-vaginal device also usefully serves as a drug release means for controllably releasing a drug in the vagina. A method for controlled drug release in the vagina is also disclosed.

Abstract: The present invention pertains to biodegradable sustained-release composins capable of achieving the sustained release of a pharmaceutical or other agent. The compositions can be formed into implant devices which may be used to treat a wide variety of diseases and conditions. The implants are especially useful in treating diseases such as periodontal disease which require prolonged drug release.

Abstract: A topical preparation of danazol comprising a matrix base, danazol retained therein, and optionally a release-promoting agent is provided.The topical preparation is more effective than oral administration of danazol in the shrinkage of endometriosis tissue, the induction of pregnancy, and the like. It does not show any side effects that have been encountered in the oral administration of danazol. Thus, the preparation is very useful remedy for endometriosis.

Abstract: The invention disclosed provides an intra-vaginal device prepared using ingredients which slowly release in the vagina over a significant period of time. The present intra-vaginal device also usefully serves as a drug release means for controllably releasing a drug in the vagina. A method for controlled drug release in the vagina is also disclosed.

Abstract: The invention is for a vaginal dispenser comprising a wall surrounding an internal lumen and having a pair of ends with one end placed inside the other end to form a closed dispenser. A vaginally administrable beneficial agent is housed in the lumen for release by the dispenser over time.

Abstract: A crosslinked polymer network comprising the reaction product of a polyethylene oxide and a polyglycidoxypropylsiloxane is described. These materials form hydrogel networks having very high partition coefficients for selected pharmaceuticals and are suitable for controlled drug release and water purification.

Abstract: The specification describes and claims a method of making therapeutic rings from a curable silicone rubber based composition. The rings are capable of controlled release of the therapeutic agent in the human or animal body. The method includes the steps of:(i) extruding a first composition comprising a therapeutic agent and a first elastomer-forming silicone composition to provide a core;(ii) extruding a second composition comprising a second elastomer-forming silicone composition to provide a sheath enclosing the core;(iii) bringing together end portions of a piece of extruded core and sheath to form a ring,(iv) effecting crosslinking of the extruded core, and(v) effecting crosslinking of the extruded sheath.

Abstract: The invention concerns an intravaginal device comprising a combination of 17 .beta.-estradiol and a supporting matrix for treating hypoestrogenic women. The device releases continuously 17 .beta.-estradiol at a rate of about 0.5 to about 25 .mu.g/24 h.The invention also comprises a method of preparing the device and a method of treating hypoestrogenic women by using the device.

Abstract: A vaginal ring comprises a supporting ring 1 free of active agent. A layer 2, which contains an active agent such as a steroid, is applied on its outer rim, optionally in a continuous groove provided in the supporting ring. This layer, in turn, is coated with a layer 3 devoid of active ingredient. All components preferably comprise an LTV silicone elastomer. The ratio of the thickness of the layer 2, containing an active agent, to the layer 3, free of active agent, is about 5-50:1. As a result, a long-term and uniform release rate is achieved for the active agent.

Abstract: A method for producing, in a functionally agonadal human female body, an environment suitable for the implantation, nutrition, and development of an embryo, comprising the placement of at least one carrier containing at least one releasable steroid hormone into the vagina of the human female.

Abstract: Water absorptive polyurethane composition, having high mechanical strength, is formed of A. about 25% to about 75% of a hydrophilic polyether polyurethane which is the reaction product of diethylene glycol and a polyoxyethylene glycol having a molecular weight of about 1000 to about 8000 with a polyisocyanate and B. about 75% to about 25% of a hydrophobic polyester polyurethane which is the reaction product of a polyfunctional polyester derived from the condensation of a polyol with a polybasic acid with a polyisocyanate.

Abstract: This invention is directed to a delivery system and a method useful for preventing pregnancy in female mammals by administering an LHRH composition. The method comprises administering during the entire follicular phase of the menstrual cycle, beginning at the time of menses, an LHRH composition and sufficient levels of an estrogenic steroid to counteract the possibility of side effects which may develop during prolonged therepy with LHRH. Following the follicular phase, at the beginning of the luteal phase, and for the entire course of the luteal phase, the LHRH/estrogenic steroid combination administered during the follicular phase, in combination with a physiological amount of progestational steroid, is administered.The delivery system comprises means for administering the LHRH composition, estrogenic steroid and progestational steroid.