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: 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: A method for delivering a biologically active substance including the steps of: (a) combining said biologically active substance with a macromer; (b) forming a mixture of the combination formed in step (a); (c) polymerizing said mixture to form articles; and (d) administering said articles, or a portion thereof, to a mammal, where step (c) takes place in the absence of a polymerizable monovinyl monomer, is disclosed.

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: Method for preparing an implantable device for a sustained delivery of a substance within a body of a human or an animal subject, the method including; dissolving a biocompatible polymer in a suitable solvent solution to produce a polymer-solvent solution; adding the substance to the polymer-solvent solution to produce a polymer-solvent solution-substance admixture; drying the polymer-solvent solution-substance admixture to form a substantially dry mass; and one or more of the following three steps: (1) adding a second polymer-solvent solution-substance admixture to the dry mass and this second polymer-solvent solution-substance admixture is then allowed to dry; and/or, (2) refrigerating the mass; and/or, (3) adding a liquid to the mass to cause the mass to soften and thereafter manipulating the softened mass to a desired shape.

Abstract: Block copolymers based on poly(ortho esters) containing amine groups. These block copolymers have both hydrophilic and hydrophobic blocks. They form micelles in aqueous solution, making them suitable for encapsulation or solubilization of hydrophobic or water-insoluble materials; and they also form bioerodible matrices for the sustained release of active agents.

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: This invention relates to the chemoprevention of prostate cancer and, more particularly, to a method of suppressing or inhibiting latent prostate cancer comprising administering to a mammalian subject a chemopreventive agent and analogs and metabolites thereof. The chemopreventive agent prevents, prevents recurrence of, suppresses or inhibit prostate carcinogenesis; and treats prostate cancer.

Abstract: The invention relates to a formulation comprising honey, at least one essential oil and/or at least on essential oil derivative. It also relates to the different uses of said formulation in the pharmaceutical, cosmetic and food industries.

Abstract: A biocompatible connective tissue repair composition which comprises a therapeutic material and a carrier comprising a means for achieving reverse phase characteristics, and methods for using said composition. The therapeutic material can be demineralized bone powder, and the carrier can be a poloxamer such as poloxamer 407.

Abstract: The present invention is directed to a method for the treatment of autism comprising administering to a person in need of such treatment a therapeutically effective amount of a lipid-soluble thiamine derivative. The lipid-soluble thiamine derivative is preferably tetrahydrofurfuryl disulfide (TTFD). TTFD administration methods may include suppository forms, transdermal carriers, such as gels, lotions, or creams; and oral carriers, such as tablets or capsules.

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 topical application of an azalide antibiotic such as azithromycin to the eye is useful in treating or preventing ocular infections. In one embodiment, the azalide antibiotic is supplied to the eye in a depot for sustained release. A more convenient dosing regimen can also be provided by the use of an appropriate depot. Furthermore, a composition containing a combination of medicaments is also provided.

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 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: A drug delivery device for delivering hormonal and other veterinary treatments intra&ndash, vaginally. A substance dispenser (21) is separate from the supporting device (20). The dispenser is in the form of drug impregnated gills or vanes (6, 7). In other aspects the drug may be dispensed by a micro&ndash, pump in the supporting device or the drug may be coated on the dispenser.

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 implanted 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.

Abstract: Bioerodible polyorthoesters useful as orthopedic implants or vehicles for the sustained delivery of pharmaceutical, cosmetic and agricultural agents contain amine functionalities and &agr;-hydroxy acid-containing groups.

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 implanted 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.

Abstract: Intra-vaginal delivery procedures including compositions and units therefor whereby an effective releasable amount of oestradiol 17&bgr; is released to achieve an efficacious effect insofar as oestrus expression is concerned. Preferably a cyclodextrin is utilized to enhance absorption.

Abstract: A highly storage-stable composition for vaginal administration of clindamycin is disclosed which is useful for the treatment of bacterial vaginosis. The composition is a vaginal suppository containing an antimicrobially effective amount of clindamycin dispersed in a Hard Fat NF suppository base. Hard Fat NF suppository bases provide a clindamycin product having long term storage stability while providing efficacy against bacterial vaginosis which is equivalent to clindamycin vaginal creams.

Abstract: A skin-care pouch includes a sealed enclosure storing therein a number of carbide aggregations including carbides in the form of small pieces, granules or particles, water-absorbent shape-keeping agent which is gelled by absorbing water upon contact therewith and so on. The sealed enclosure in the form of a bag is formed of a fabric capable of permeating water and the carbides therethrough to be placed into contact with a desired portion of skin where care or treatment thereof is desired.

Abstract: The invention involves methods and compositions useful in delivering micronutrients to cells. By formulating the micronutrient in the form of an ester that is convertible to the active form of the micronutrient, one can combine it with a co-ester that inhibits esterases, so that the micronutrient can reach the targeted cells prior to degradation. Both methods and compositions are described.

Abstract: A urethral suppository having a shaft shaped for cooperating with the action of the periurethral musculature to retain the suppository within the urethra, and having a knob extending from an end of the shaft sized to prevent over insertion of the suppository. A method of delivering one or more therapeutic agents to the urethra and associated structures, the method involving insertion of the urethral suppository into the urethra.

Abstract: Particles of a substantially water insoluble biologically active substance, such as Cyclosporin, are loaded with a charged glyceryl ester as an electrostatic stabilizer which imparts to the particles a zeta potential and having an active substance:stabilizer weight ratio of 1:1 to 400:1 and an average particle diameter of 1 nanometer to 10 micrometers. Compositions having such particles are found to be useful delivery systems.

Abstract: A composition for treatment of bacterial infections of the vagina is disclosed which comprises a lytic enzyme composition specific for the infecting bacteria, and a carrier for delivering said lytic enzyme. The lytic enzyme is which is specific for the group B Streptococcus, is genectically coded for by a specific bacteriophage.

Abstract: The present invention provides antiviral proteins, peptides and conjugates, as well as methods of obtaining these agents. The antiviral proteins, peptides and conjugates of the present invention can be used alone or in combination with other antiviral agents in compositions, such as pharmaceutical compositions, to inhibit the infectivity, replication and cytopathic effects of a virus, such as a retrovirus, in particular a human immunodeficiency virus, specifically HIV-1 or HIV-2, in the treatment or prevention of viral infection.

Abstract: Devices, methods, and compositions for treating vaginal fungal, bacterial, viral and parasitic infections by intravaginal or transvaginal administration of therapeutic and/or palliative antifungal, antibacterial, antiviral or parasiticidal drugs to the vagina or to the uterus.

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: This invention provides the chemoprevention of prostate cancer and, more particularly, to a method of preventing prostate carcinogenesis comprising the steps of administering to a human subject having a precancerous precursor of prostate adenocarcinoma, a pharmaceutical preparation comprising a chemopreventive agent to prevent, prevent recurrence of, suppress or inhibit prostate carcinogenesis. The present invention provides a safe and effective method for suppressing or inhibiting latent prostate cancer and is particularly useful for treating subjects having elevated risk of developing prostate cancer, for example, those having benign prostatic hyperplasia, prostate intraepithelial neoplasia (PIN), or an abnormally high level of circulating prostate specific antibody (PSA), or who have a family history of prostate cancer.

Abstract: This invention provides the chemoprevention of prostate cancer and, more particularly, to a method of preventing prostate carcinogenesis comprising the steps of administering to a human subject having a precancerous precursor of prostate adenocarcinoma, a pharmaceutical preparation comprising a chemopreventive agent to prevent, prevent recurrence of, suppress or inhibit prostate carcinogenesis. The present invention provides a safe and effective method for suppressing or inhibiting latent prostate cancer and is particularly useful for treating subjects having elevated risk of developing prostate cancer, for example, those having benign prostatic hyperplasia, prostate intraepithelial neoplasia (PIN), or an abnormally high level of circulating prostate specific antibody (PSA), or who have a family history of prostate cancer.

Abstract: This invention provides the chemoprevention of prostate cancer and, more particularly, to a method of preventing prostate carcinogenesis comprising the steps of administering to a human subject having a precancerous precursor of prostate adenocarcinoma, a pharmaceutical preparation comprising a chemopreventive agent to prevent, prevent recurrence of, suppress or inhibit prostate carcinogenesis. The present invention provides a safe and effective method for suppressing or inhibiting latent prostate cancer and is particularly useful for treating subjects having elevated risk of developing prostate cancer, for example, those having benign prostatic hyperplasia, prostate intraepithelial neoplasia (PIN), or an abnormally high level of circulating prostate specific antibody (PSA), or who have a family history of prostate cancer.

Abstract: This invention provides the chemoprevention of prostate cancer and, more particularly, to a method of preventing prostate carcinogenesis comprising the steps of administering to a human subject having a precancerous precursor of prostate adenocarcinoma, a pharmaceutical preparation comprising a chemopreventive agent to prevent, prevent recurrence of, suppress or inhibit prostate carcinogenesis. The present invention provides a safe and effective method for suppressing or inhibiting latent prostate cancer and is particularly useful for treating subjects having elevated risk of developing prostate cancer, for example, those having benign prostatic hyperplasia, prostate intraepithelial neoplasia (PIN), or an abnormally high level of circulating prostate specific antibody (PSA), or who have a family history of prostate cancer.

Abstract: The present invention relates to complexes between (1) a target-binding moiety; (2) a cavity-forming moiety; and (3) a pharmacological compound to be delivered to a target, wherein the pharmacological compound is buried inside of the cavity-forming moiety, but not covalently bound to either the target-binding moiety or the cavity-forming moiety. The complexes of thus invention may be used as to deliver a pharmacological compound to cells, tissues, organs, viruses, microorganisms or other surfaces that are characterized by an entity that binds the target-binding moiety portion of the complex. The present invention also relates to pharmaceutical compositions comprising the non-covalent complexes of this invention. The invention also relates to methods of delivering a pharmacological compound to a target in a patient. The present invention also relates to the use of the complexes of this invention for the separation of chemical entities from their chiral forms or contaminants.

Abstract: Crosslinked compositions formed from a water-insoluble copolymer are disclosed. These compositions are copolymers having a bioresorbable region, a hydrophilic region and at least two crosslinkable functional groups per polymer chain. These compositions are able to form hydrogels in aqueous environments when crosslinked. These hydrogels are good sealants for implantable prostheses when in contact with an aqueous environment. In addition, such hydrogels can be used as delivery vehicles for therapeutic agents.

Abstract: A method is provided for producing elastin or elastin-based materials or tropoelastin materials which have a substantially reduced level of calcification. These materials are typically capable of being formed into a fused layer. The subject method comprises providing unreacted elastin or elastin-based biomaterials or tropoelastin materials, and pretreating the unreacted elastin or elastin-based biomaterials or tropoelastin materials with an aliphatic alcohol prior to reaction thereof. In this way, when the pretreated unreacted elastin or elastin-based biomaterials or tropoelastin materials is reacted subsequently, elastin or elastin-based materials or tropoelastin materials are produced which have a substantially reduced level of calcification as compared with elastin or elastin-based materials or tropoelastin materials produced from non-pretreated counterpart unreacted elastin or elastin-based biomaterials or tropoelastin materials.

Abstract: The present invention is directed to multibinding compounds which are &bgr;2 adrenergic receptor agonists and are therefore useful in the treatment and prevention of respiratory diseases such asthma, bronchitis, and the like. They are also useful in the treatment of nervous system injury and premature labor.

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 biocompatible connective tissue repair composition which comprises a therapeutic material and a carrier comprising a means for achieving reverse phase characteristics, and methods for using said composition. The therapeutic material can be demineralized bone powder, and the carrier can be a poloxamer such as poloxamer 407.

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 solution or gel composition containing activated chlorine dioxide and phosphates, such as disodium hydrogen phosphate, sodium dihydrogen phosphate, trisodium phosphate, and sodium monofluorophosphate, is disclosed for treating herpes virus. The preferred concentration ranges are between about 0.005% to about 2.0% chlorine dioxide, and between about 0.02% to about 3.0% of a phosphate compound. The phosphate compound retards escape of chlorine dioxide in the pH range of 6.0 to 7.4, at which pH chlorine dioxide becomes activated and releases sufficient chlorine dioxide to reduce motility and become lethal to the involved micro-organisms.

Abstract: A method and solution or gel topical preparation containing chlorine dioxide and a phosphate compound, such as disodium hydrogen phosphate, sodium dihydrogen phosphate, trisodium phosphate, and sodium monofluorophosphate, is disclosed for treating itching of the vagina. The preferred concentration ranges are between about 0.005% to about 2.0% chlorine dioxide, and between about 0.02% to about 3.0% phosphate compound. The phosphate compound retards escape of chlorine dioxide in the pH range of about 6.0 to 7.4, at which pH chlorine dioxide becomes activated and releases sufficient chlorine dioxide to reduce motility and become lethal to the involved micro-organisms.

Abstract: A method of delivering one or more therapeutic agents comprising providing a suppository comprising one or more therapeutic agents and a biocompatible carrier medium and shaped to be capable of cooperating with the periurethral musculature to retain the suppository in place in the urethra, inserting the suppository into the urethra, and retaining the suppository within the urethra by the action of the periurethral musculature for a period of time sufficient to permit the therapeutic agent to diffuse substantially into the urethra, the referred suppository comprising a shaft having a first end and a second end and shaped to be capable of cooperating with the action of the periurethral musculature to retain the suppository within the urethra and a substantially ellipsoidal knob extending from the second end of the shaft and sized to prevent insertion into the urethra.

Abstract: A solution or gel composition containing activated chlorine dioxide and a phosphate compound, such as disodium hydrogen phosphate, sodium dihydrogen phosphate, trisodium phosphate, and sodium monofluorophosphate, is disclosed for treating a Chlamydia infection. The preferred concentration ranges are between about 0.005% to about 2.0% chlorine dioxide, and between about 0.02% to about 3.0% phosphate compound. The phosphate compound retards escape of chlorine dioxide in the pH range of 6.0 to 7.4, at which pH the chlorine dioxide becomes activated and releases sufficient chlorine dioxide to reduce motility and become lethal to the involved micro-organisms.

Abstract: A method and solution or gel composition containing activated chlorine dioxide and phosphates, such as disodium hydrogen phosphate, sodium dihydrogen phosphate, trisodium phosphate, and sodium monofluorophosphate, is disclosed for lubricating the vagina and for treating HIV. The preferred concentration ranges are between about 0.005% to about 2.0% chlorine dioxide, and between about 0.02% to about 3.0% phosphate. The phosphate compound retards escape of chlorine dioxide in the pH range of about 6.0 to 7.4, at which pH the chlorine dioxide becomes activated and releases sufficient chlorine dioxide to reduce motility and become lethal to the involved micro-organisms.

Abstract: The present invention provides a base for suppository comprising oily or fatty base and polyethlene. The suppository prepared by the use of the base of the present invention has superior heat resistance which should not cause quality deterioration such as deformation and cracks, and shows good release, internal absorbability, safety and like compared to those of the suppositories used thus so far in the applied region.

Abstract: The present invention relates to pharmaceutical compositions and methods for improved solubilization of triglycerides and improved delivery of therapeutic agents. Compositions of the present invention include a triglyceride and a carrier, where the carrier is formed from a combination of at least two surfactants, at least one of which is hydrophilic. Upon dilution with an aqueous solvent, the composition forms a clear, aqueous dispersion of the triglyceride and surfactants. An optional therapeutic agent can be incorporated into the composition, or can be co-administered with the composition. The invention also provides methods of enhancing triglyceride solubility and methods of treatment with therapeutic agents using these compositions.

Abstract: A method for treatment of bacterial infections of the digestive tract is disclosed which comprises administering a lytic enzyme specific for the infecting bacteria. The lytic enzyme is preferably in a carrier for delivering said lytic enzyme. The bacteria to be treated is selected from the group consisting of Listeria, Salmonella, E. coli, Campylobacter, and combinations thereof. The carrier for delivering at least one lytic enzyme to the digestive tract is selected from the group consisting of suppository enemas, syrups, or enteric coated pills.

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.