Abstract: This invention provides: 1) a method of treating androgen-deprivation induced osteoporosis and/or bone fractures and/or loss of Bone Mineral Density (BMD) in a male subject suffering from prostate cancer; 2) a method of preventing androgen-deprivation induced osteoporosis and/or bone fractures and/or loss of Bone Mineral Density (BMD) in a male subject suffering from prostate cancer; 3) a method of suppressing or inhibiting androgen-deprivation induced osteoporosis and/or bone fractures and/or loss of BMD in a male subject suffering from prostate cancer; and 4) a method of reducing the risk of developing androgen-deprivation induced osteoporosis and/or bone fractures and/or loss of BMD in a male subject suffering from prostate cancer, by administering to the subject a pharmaceutical composition comprising an anti-estrogen agent and/or its analog, derivative, isomer, metabolite, pharmaceutically acceptable salt, pharmaceutical product, hydrate, N-oxide, or any combination thereof as described herein.

Abstract: A composition for treatment of bacterial infections of the eye is disclosed which comprises a lytic enzyme composition specific for the infecting bacteria, and a carrier for delivering said lytic enzyme. The carrier for delivering at least one lytic enzyme to the eye may be but is not limited to the use of an isotonic solution.

Abstract: A medical device comprising a supporting structure having a coating on the surface thereof, the coating containing a therapeutic substance, such as, for example, a drug. Supporting structures for the medical devices that are suitable for use in this invention include, but are not limited to, coronary stents, peripheral stents, catheters, arterio-venous grafts, by-pass grafts, and drug delivery balloons used in the vasculature.

Abstract: By blending glycyrrhizin with an ester mixture comprising a C6-18 fatty acid glycerol ester with a C6-18 fatty acid macrogol ester, glycyrrhizin can be efficiently absorbed via mucosae, in particular, digestive mucosae to achieve a therapeutically effective plasma glycyrrhizin concentration.

Abstract: Products comprising an oxygen-generating additive for reducing the amount of skin irritation and inflamation and odor are disclosed. Specifically, products such as training pants and diapers are disclosed which contain a carbohydrate-hydrogen peroxide crystalline powder which, when wetted, produces a stream of oxygen which can be used by various bacteria on and near the wearer's skin during metabolism resulting in a significant decrease in the amount of volatile organic compounds produced by the bacteria during metabolism.

Abstract: A tampon for treatment of Streptococcus Group B infections of the vagina is disclosed which comprises a lytic enzyme composition specific for the infecting bacteria, and a carrier for delivering the lytic enzyme.

Abstract: Disclosed are methods for treating urinary incontinence in a mammal wherein a composition comprising a biocompatible polymer, a biocompatible solvent, and a contrast agent is delivered to the periurethral tissue of the mammal.

Abstract: Personal care and hygiene formulations for topical application to mucosal surfaces. These formulations include an amphiphilic lipid carrier in the form of a colloidal composition which can include a micellar aggregate or mixed micelles dispersed in a continuous aqueous phase, or an emulsion of lipid droplets suspended in a continuous aqueous phase, and an active agent which is an anti-microbial agent. The lipid carrier has high adhesiveness to mucous membranes such as the soft tissues of the oral cavity. The lipid carrier also has a high load capacity for the active agent to be carried to these tissues. These formulations have the desirable properties of carrying a large amount of active agent for controlled and prolonged release thereof at the desired site, such as mucous membrane surfaces and surrounding tissue. Accordingly, the present invention provides a formulation for oral or topical application including an anti-microbial agent and a lipid.

Abstract: Disclosed are compositions suitable for use in embolizing blood vessels which compositions comprise a polymer, a biocompatible solvent and a contrast agent. The polymer is selected from the group consisting of polyacrylonitrile, polyurethane, polyvinylacetate, cellulose acetate butyrate, nitrocellulose and copolymers of urethane/carbonate and copolymers of styrene/maleic acid.

Abstract: This invention provides a method of treating a disease state in mammals that is alleviated by treatment with a protein kinase inhibitor, especially an ERK inhibitor, which method comprises administering a compound having the pharmacophoric features Grp1, Grp2 and Grp3: Grp 1 is an optionally substituted aryl or aliphatic group; Grp 2 is a heteroaromatic ring having one to three nitrogens, said ring comprising a hydrogen bond acceptor HBA2 optionally bonded to a hydrogen bond donor HBD2, and Grp3 is a heteroaromatic ring comprising a hydrogen bond donor HBD1, with distances between the pharmacophoric features defined in the specification. The method is useful for treating cancer, stroke, diabetes, hepatomegaly, cardiovascular disease, Alzheimer's disease, cystic fibrosis, viral disease, autoimmune diseases, atherosclerosis, restenosis, psoriasis, allergic reactions, inflammation, neurological disorders or a hormone-related disease.

Abstract: A local anesthetic is used for the manufacture of a medicament for use against dysmenorrhoea and premenstrual syndrome and for increasing fertility. A pharmaceutical composition may also be used that comprises a pharmaceutically effective dose of a local anesthetic together with a pharmaceutically acceptable excipient. The invention also relates to a process for using a catheter to pertubate the fallopian tubes to reduce dysmenorrhoea and premenstrual syndrome symptoms in a woman with the pharmaceutical composition that is intended to reach and exert an effect in the peritoneal cavity.

Abstract: The present invention concerns compositions and methods for using a &bgr;-adrenergic agonist for treating endometriosis, for treating infertility, and for improving fertility. The present invention further concerns formulating such a composition or method in such a way as to provide therapeutically sufficient levels of the &bgr;-adrenergic agonist locally while avoiding adverse systematic concentrations in the host, thereby minimizing or avoiding adverse side effects.

Abstract: Embodiments of the present invention generally relate to devices and processes related to estrus synchronization. Particular embodiments of devices and processes of the present invention slowly release progesterone over a period of time for estrus synchronization.

Abstract: A treatment procedure is disclosed which involves the short term, non-permanent occlusion of the patient's blood vessels by depositing a bioabsorbable embolic mass within the patient's blood vessel. The procedure is particularly suitable for treating uterine disorders by occluding a patient's uterine arteries. A therapeutically effective time period for occlusion of a uterine artery is from about 0.5 to about 48 hours, preferably about 1 to about 24 hours, with occlusion times of about 1 to about 8 hours being suitable in many instances. The embolic mass may bioabsorbable particulate with minimum transverse dimensions of about 100 to about 2000 micrometers, preferably about 300 to about 1000 micrometers. The particulate may be a polymeric material formed of polylactic acid, polyglycolic acid or copolymers thereof, or a swellable copolymer of lactic acid and polyethylene glycol.

Abstract: By providing a therapeutic agent in a mixture of surfactants and water, a unique, improved, liquid based foam producing formulation is realized which is useable for a wide variety of applications. In the preferred embodiment, the improved liquid based foaming producing formulations incorporate one or more therapeutic agents which comprise a silver-based composition. As a result, the formulation is useable for a wide variety of medical applications for preventing, treating, or reducing the spread or transmission of bacteria, virus, infections, and the like.

Abstract: A novel strain of Lactobacillus plantarum, referred to as LB931, has now been isolated. The strain has been deposited at Deutsche Sammlung von Mikroorganismen, Braunschweig, DE. It has been assigned accession number DSM11918. Accordingly LB931 can be used for treating and/or preventing urogenital infections. LB931 can advantageously be included in pharmaceutical compositions and in products for personal care, such as feminine hygiene products, diapers and sanitary napkins.

Abstract: Bioadhesive, closed-cell foam film, sustained release, delivery devices for administering an active agent or combination of active agents to a subject are provided. Methods for making such delivery devices and to methods for using such delivery devices offering the controlled and sustained release of an active agent or combination of active agents to a subject, preferably a near zero-order release, are also provided.

Abstract: The present invention relates to a liquid formulation for a feminine wipe. The preferred formulation has an anti-irritant agent, a pH adjuster namely citric acid, and at least one preservative.

Abstract: A lipid or other hydrophobic or amphiphilic compound (collectively referred to herein as “hydrophobic compounds”) is integrated into a polymeric matrix for drug delivery to alter drug release kinetics. In embodiments where the drug is water soluble, the drug is released over longer periods of time as compared to release from the polymeric matrix not incorporating the hydrophobic compound into the polymeric material. In contrast to methods in which a surfactant or lipid is added as an excipient, the hydrophobic compound is actually integrated into the polymeric matrix, thereby modifying the diffusion of water into the microparticle and diffusion of solubilized drug out of the matrix. The integrated hydrophobic compound also prolongs degradation of hydrolytically unstable polymers forming the matrix, further delaying release of encapsulated drug.

Abstract: The present invention relates to the treatment of gastrointestinal disease and/or cancer, and a method of weight gain, via the ingestion of polymeric compositions in humans, animals or birds in need of said treatment. The invention provides methods for the treatment of cancer, the treatment and/or prevention of gastrointestinal disease and/or infection and/or diarrhea and a method for increasing weight gain in humans, animals or birds comprising administering to said humans, animals or birds an effective amount of a pharmaceutical or veterinary composition or feed additive, comprising an effective amount of a polymer and/or copolymer, having the repeating polymeric unit (I) wherein R is H or alkyl, usually C1 to C4, or this unit in hydrated, hemiacetal or acetal form, together with a pharmaceutically or veterinarally acceptable carrier, diluent, adjuvant, excipient and/or controlled release system.

Abstract: A local anesthetic is used for the manufacture of a medicament for use against dysmenorrhoea and premenstrual syndrome and for increasing fertility. A pharmaceutical composition may also be used that comprises a pharmaceutically effective dose of a local anesthetic together with a pharmaceutically acceptable excipient. The invention also relates to a process for using a catheter to pertubate the fallopian tubes to reduce dysmenorrhoea and premenstrual syndrome symptoms in a woman with the pharmaceutical composition that is intended to reach and exert an effect in the peritoneal cavity.

Abstract: Antimicrobial and contraceptive compositions and methods which prevent and/or reduce the risk of transmission of sexually transmitted diseases through sexual activity as well as prevent and/or reduce the risk of pregnancy are provided.

Abstract: The present invention teaches a composition comprising a &bgr;-adrenergic agonist in a bioadhesive carrier. Preferably, the composition comprises terbutaline in polycarbophil. The present invention additionally teaches the local administration of a &bgr;-adrenergic agonist for the purpose of treating or preventing dysmenorrhea or premature labor. Using this composition and the method of treatment provides sufficient local levels of the drug to provide therapeutic efficacy, but avoids many untoward adverse events.

Abstract: An aqueous douche or enema is disclosed, containing a water-soluble zinc salt at an anti-viral concentration, designed for use shortly before and/or shortly after intercourse. Unlike a lubricant for use during intercourse, this type of rinsing liquid will not contain glycerine or similar lubricating components, and will be designed to not leave behind a film-type residue. However, this type of “pericoital” rinse (i.e., intended for pre-coital or post-coital use) will leave behind positively-charged zinc ions. Due to electrostatic attraction, these Zn++ ions will cling to negatively-charged canyons and other “binding sites” in proteins that are exposed and accessible on the surfaces of cells and virus particles. The binding of Zn++ ions to negatively-charged sites in these surface proteins will alter and disrupt the ability of viruses (including herpes and HIV) to bind to and infect human cells.

Abstract: New compositions are disclosed that comprise the phytochemical Diindolylmethane (DIM), as well as its precursor, Indole-3-carbinol (I3C), and cogener, 2-(Indol-3-ylmethyl)-3,3′diindolylmethane (LTR-1), acceptable carriers and/or excipients. These compositions are administered to prevent or reduce symptoms associated with mastalgia and endometriosis.

Abstract: Non-absorbent substrates for use in inhibiting the production of exoproteins from Gram positive bacteria, such as harmful proteins produced by Staphylococcus species, are provided. The substrates are particularly useful for inhibiting the production of TSST-1, alpha-toxin and/or enterotoxins A, B and C from S. aureus bacteria. The substrates include an alkyl polyglycoside incorporated in or on at least a portion of the substrate. The alkyl polyglycoside typically has an HLB of about 10 to 15 and/or an average number of carbon atoms in the alkyl chain of about 8 to about 12.

Abstract: Crosslinked compositions formed from water-insoluble copolymers are disclosed. These compositions are copolymers having a bioresorbable region, a hydrophilic region and at least two cross-linkable functional groups per polymer chain. Crosslinking of these polymers can be effected in solution in organic solvents or in solvent-free systems. If crosslinking occurs in a humid environment, a hydrogel will form. If crosslinking occurs in a non-humid environment, a xerogel will form which will form a hydrogel when exposed to a humid environment and the resulting crosslinked materials form hydrogels when exposed to humid environments. These hydrogels are useful as components in medical devices such as implantable prostheses. In addition, such hydrogels are useful as delivery vehicles for therapeutic agents and as scaffolding for tissue engineering applications.

Abstract: A method of inhibiting the production of exoproteins from Gram positive bacteria, such as harmful proteins produced by Staphylococcus species, is described. The method is particularly useful for inhibiting the production of TSST-1, alpha-toxin and/or enterotoxins A, B and C from S. aureus bacteria. The method may be based on exposing Gram positive bacteria to alkyl polyglycoside incorporated into an absorbent product. Alternatively, the methods can include causing Gram positive bacteria to come into contact with the alkyl polyglycoside in other forms, e.g., when formulated with a pharmaceutically acceptable carrier or incorporated in or on a non-absorbent substrate. Typically, the alkyl polyglycoside has an HLB of at least about 10 and an alkyl group with an average of 8 to 14 carbon atoms.

Abstract: Formulations have been developed for regional delivery of drugs, for example, into a cavity such as the pelvic region, peritoneal region, or directly on organs of interest. Regional delivery increases comfort and bioavailability of the drug, resulting in rapid and relatively high blood levels in the regions to be treated in the substantial absence of side effects due to the high levels required for efficacy following systemic delivery. In the preferred embodiment, these formulations consist of drug micro or nanoparticles, which may be formed of drug alone or in combination with an excipient or polymeric carrier. The excipient or polymer may be used to manipulate release rates and to increase adhesion to the affected region. The drug formulation can be applied as a dried powder, a liquid suspension or dispersion, or as a topical ointment, creme, lotion, foam or suppository.

Abstract: Microbicidal and spermicidal devices, methods, and compositions containing sodium dodecyl sulfate or related anionic surfactants as active ingredients for the prevention and control of pregnancy and sexually transmitted disease, including conditions caused by non-enveloped viruses such as human papilloma virus.

Abstract: An absorbent article for inhibiting the production of exoproteins from Gram positive bacteria, such as potentially harmful proteins produced by Staphylococcus species, is described. The absorbent article is particularly useful for inhibiting the production of TSST-1, alpha-toxin and/or enterotoxins A, B and C from S. aureus bacterium. An alkyl polyglycoside is incorporated into the absorbent article. For example, alkyl polyglycoside may be coated on the fibers of a liquid-permeable cover of a catamenial tampon.

Abstract: An intravaginal bio-erodible microbicidal barrier device. The device comprises (a) at least one micronized compound selected from the group consisting of cellulose acetate phthalate and hydroxypropylmethylcellulose phthalate, and (b) at least one pectin, such as an apple pectin, and optionally at least one water soluble or water dispersible cellulose compound selected from the group consisting of hydroxypropylmethylcellulose, methylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, hydroxyethylmethylcellulose, hydroxyethylethylcellulose and hydroxypropylethylcellulose. The device is prepared by a combination of foaming, freezing and freeze-drying processes.

Abstract: Polymeric compositions having improved capability of solubilizing a drug in a hydrophilic environment to form a solution, comprising: a biodegradable polyester oligomer; and biodegradable AB-type, ABA-type, or BAB-type block copolymers are disclosed. The copolymers are comprised of about 50.1 to 65% by weight of a biodegradable, hydrophobic A polymer block comprising a biodegradable polyester, and about 35 to 49.9% by weight of a hydrophilic B polymer block comprising a polyethylene glycol (PEG), and wherein the block copolymer has a weight averaged molecular weight of between 2400 to 4999. The biodegradable polyester oligomer of said composition is within a range of 0.01% to 30% by weight of the total polymer mixture, and the content of the biodegradable AB-type, ABA-type, or BAB-type block copolymer is within a range of 70% to 99.99% by weight of the total polymer mixture.

Abstract: A process for producing a small-sized, lipid-based cochleate. Cochleates are derived from liposomes which are suspended in an aqueous two-phase polymer solution, enabling the differential partitioning of polar molecule based-structures by phase separation. The liposome-containing two-phase polymer solution, treated with positively charged molecules such as Ca2+ or Zn2+, forms a cochleate precipitate of a particle size less than one micron. The process may be used to produce cochleates containing biologically relevant molecules.

Abstract: The present invention relates to compositions comprising a combination of one or more antiseptic and an antibiotic. It is based, at least in part, on the discovery that such combinations tend to deter the formation of antibiotic-resistant organisms. In preferred, nonlimiting embodiments of the invention, the antibiotic is minocycline and the antiseptic is a chlorhexidine compound, triclosan, or benzalkonium chloride, and in particular embodiments, a silver salt or a bismuth salt is added. Examples of specific, nonlimiting embodiments of the invention include combinations of (i) minocycline, triclosan, and a bismuth salt; (ii) minocycline, a chlorhexidine compound, and a bismuth salt; and (iii) minocycline, benzalkonium chloride, and a bismuth salt. The present invention further provides for articles, such as, but not limited to, medical articles, which have been treated with or which otherwise comprise a combination of antiseptic and antibiotic.

Abstract: An intravaginal bio-erodible microbicidal barrier device. The device comprises (a) at least one micronized compound selected from the group consisting of cellulose acetate phthalate and hydroxypropylmethylcellulose phthalate, and (b) at least one water soluble or water dispersible cellulose compound selected from the group consisting of hydroxypropylmethylcellulose, methylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, hydroxyethylmethylcellulose, hydroxyethylethylcellulose and hydroxypropylethylcellulose. The device is prepared by a combination of foaming, freezing and freeze-drying processes.

Abstract: Devices, methods, and compositions for vaginal delivery of bisphosphonates. A targeted site delivery of bisphosphonates to the vagina using a medicated intravaginal device comprising a bisphosphonate composition formulated for transvaginal delivery. A method for treatment of osteoporosis and related bone and skeleton diseases, for prevention of bone breakdown and loss of bone mass and strength by intravaginal administration of bisphosphonates to the vagina and transvaginal delivery of bisphosphonates to the general circulation.

Abstract: The present invention provides solid pharmaceutical compositions for improved delivery of a wide variety of pharmaceutical active ingredients contained therein or separately administered. In one embodiment, the solid pharmaceutical composition includes a solid carrier, the solid carrier including a substrate and an encapsulation coat on the substrate. The encapsulation coat can include different combinations of pharmaceutical active ingredients, hydrophilic surfactant, lipophilic surfactants and triglycerides. In another embodiment, the solid pharmaceutical composition includes a solid carrier, the solid carrier being formed of different combinations of pharmaceutical active ingredients, hydrophilic surfactants, lipophilic surfactants and triglycerides. The compositions of the present invention can be used for improved delivery of hydrophilic or hydrophobic pharmaceutical active ingredients, such as drugs, nutrionals, cosmeceuticals and diagnostic agents.

Abstract: The present invention provides compositions and methods of preparing a bilayer structure for encapsulating multiple containment units. These containment units can contain therapeutic, diagnostic agents or imaging agents that can be released through the bilayer structure. A suitable example of such a containment unit is a unilamellar or multilamellar vesicle.

Abstract: The present invention encompasses a solid dose delivery vehicle for ballistic administration of a bioactive material to subcutaneous and intradermal tissue, the delivery vehicle being sized and shaped for penetrating the epidermis. The delivery vehicle further comprises a stabilizing polyol glass loaded with the bioactive material and capable of releasing the bioactive material in situ. The present invention further includes methods of making and using the solid dose of the invention.

Abstract: Disclosed are methods for treating incontinence in a mammal wherein a composition comprising a biocompatible polymer, a biocompatible solvent, and a contrast agent is delivered to the periurethral tissue of a mammal.

Abstract: The invention relates to nanoscale particles suited especially for use in tumor therapy by hyperthermia. Said particles comprise a (preferably superparamagnetic) iron oxide-containing core and at least two shells surrounding said core. The (innermost) shell adjoining the core is an envelope which comprises groups capable of forming cationic groups and is broken down by human or animal tissue at such a slow rate as to allow for association of the core surrounded by said envelope with the surface of cells and/or for absorption of said core into the inside of cells.

Abstract: An intravaginal antimicrobial drug delivery device is disclosed having an antimicrobial agent dispersed throughout a biocompatible elastomeric system. Also disclosed is a method of making the antimicrobial drug delivery device.

Abstract: A method for preventing, inhibiting, or treating vaginitis or bacterial vaginosis using polystyrene sulfonate is provided. The polystyrene sulfonate used in the present invention inhibits Trichomonas (a flagellate protozoon), Gardnerella, and other vaginitis/vaginosis-causing bacteria. The method of this invention generally comprises the application of an effective amount of an inhibitory agent into the vagina of a female in need of prevention, inhibition, and/or treatment of vaginitis and/or bacterial vaginosis. Preferably the polystyrene sulfonate in contained in an aqueous based composition, more preferably in an aqueous based composition buffered to a pH of about 3.5 to about 7.5, and even more preferably in an aqueous based composition buffered to a pH of about 3.5 to about 5.

Abstract: The proliferation of uterine fibroid leiomyoma cells is inhibited by certain Fibroid Cell Growth Inhibitor (FGI) agents. The pharmacological doses of these FGI agents in the milieu of uterine fibroid cells can be made high enough to not only inhibit proliferation, but to also causes cell death. Non-invasive or minimally invasive, non-systemic delivery methods are used to deliver the FGI agent to the milieu of the target fibroid leiomyoma cell population, thereby avoiding the disadvantages and side effects of surgical and systemic hormonal therapy interventions in the treatment of uterine fibroids. The FGI agents are substrates that are normally present or are well tolerated in the human body. The efficacy of the FGI agents appears to be related to their ability to moderate the Protein Kinase C and Mitogen Activated Protein Kinase pathways. Specific FGI agents shown to be useful to inhibit growth or proliferation of uterine fibroid cells include: &agr;-tocopherol, &agr;-tocopherol succinate, and troglitazone.

Abstract: Crosslinked compositions formed from water-insoluble copolymers are disclosed. These compositions are copolymers having a bioresorbable region, a hydrophilic region and at least two cross-linkable functional groups per polymer chain. Crosslinking of these polymers can be effected in solution in organic solvents or in solvent-free systems. If crosslinking occurs in a humid environment, a hydrogel will form. If crosslinking occurs in a non-humid environment, a xerogel will form which will form a hydrogel when exposed to a humid environment and the resulting crosslinked materials form hydrogels when exposed to humid environments. These hydrogels are useful as components in medical devices such as implantable prostheses. In addition, such hydrogels are useful as delivery vehicles for therapeutic agents and as scaffolding for tissue engineering applications.

Abstract: Devices, methods, and compositions for cancer therapy by administration of chemotherapeutic agents and/or inhibitors of membrane efflux systems to the vagina for topical and systemic tumor targets.

Abstract: The invention is of a topical medicament and associated methodology for use thereof, through the use of which Peyronie's disease may be effectively, cost effectively, and painlessly treated. The primary active ingredient is a calmodulin blocker, the preferred such ingredient being trifluroperizine.

Abstract: Bioerodible, sustained release preparations are provided for placement into the bladder through the urethra which provided sustained release of drugs. Configurations are provided which are insertable through a catheter, such as a coiled filament, patch or a flowable gel. The device is bioeroded during or after the sustained release of the drug such that there is no blockage of the urinary tract while the device is in place within the bladder.

Abstract: A formulation and methods for inducing sustained regional local anesthesia in a patient comprising a substrate comprising a local anesthetic and an effective amount of a biocompatible, biodegradable, controlled release material prolonging the release of the local anesthetic from the substrate to obtain a reversible local anesthesia when inplanted or injected in a patient, and a pharmaceutically acceptable, i.e., non-toxic, non-glucocorticoid augmenting agent effective to prolong the duration of the local anesthesia for a time period longer than that obtainable from the substrate without the augmenting agent.