Abstract: A tampon adapted to deliver a therapeutic agent, the tampon including a tampon body that is manufactured at a first manufacturing facility; and a dosage form coupled to the body, wherein the dosage form includes a formulation including a therapeutic agent, and wherein the dosage form is manufactured at a second manufacturing facility. Also, a method for producing a medicated tampon including manufacturing a tampon body at a first manufacturing facility; manufacturing a dosage form at a second manufacturing facility, wherein the dosage form includes a formulation including a therapeutic agent; and coupling the dosage form to the tampon body.

Abstract: A tampon adapted to deliver a therapeutic agent, the tampon including a tampon body having a distal end; and a dosage form affixed to the distal end of the tampon body, wherein the dosage form includes a formulation including a therapeutic agent, and wherein the dosage form comprises a plurality of layers. Also, a method for manufacturing a medicated tampon adapted to deliver a therapeutic agent, the method including manufacturing a tampon body having a distal end; producing a dosage form having a plurality of layers, wherein the dosage form includes a formulation including a therapeutic agent; and affixing the dosage form to the distal end of the tampon body.

Abstract: A polysaccharide selected from xanthan gum and HPMC is used for the treatment or prophylaxis of IBD, especially Crohn's Disease, left-sided ulcerative colitis or pouchitis.

Abstract: A method for the prevention or treatment of symptoms of hypertension in a patient who is resistant to antihypertensive effects of an antihypertensive compound administered in the absence of melatonin comprises administering to said patient melatonin in an amount effective to ameliorate or prevent symptoms of hypertension in said patient.

Abstract: The present invention provides a method for preparing a tablet for the vaginal administration of progesterone for systemic use. The method comprises first mixing water with micronized progesterone, the total amount of water mixed with said micronized progesterone not exceeding the maximum wetting capacity of the micronized progesterone, drying the wetted, micronized progesterone; mixing the dry micronized progesterone with other pharmaceutically acceptable excipients or diluents; and; forming a tablet by direct compaction of the dry micronized progesterone. Tablets prepared by this method are also provided.

Abstract: Metal-containing materials, as well as their preparation and use are disclosed. The metal-containing material can be, for example, an antimicrobial material, an anti-biofilm material, an antibacterial material, an anti-inflammatory material, an anti-fungal material, an anti-viral material, an anti-cancer material, a pro-apoptosis material, anti-proliferative, MMP modulating material, an atomically disordered, crystalline material, and/or a nanocrystalline material. In certain embodiments, the metal-containing material is an atomically disordered, nanocrystalline silver-containing material.

Abstract: Novel methods for the chemical ablation of tissue (e.g. prostatic tissue) are described. These methods include the steps of: (a) providing one or more solid salt dosage form comprising 50-100% w/w salt; and (b) inserting one or more of such solid salt dosage forms into the tissue. The solid salt dosage form is optionally inserted into the tissue under real-time ultrasonic observation. An advantage of the present invention is its ability to eliminate toxic byproducts. For example, where NaCl-based solid salt dosage forms are used to effect localized chemical ablation, the concentration is ultimately reduced to the level of normal saline (i.e., about 0.9%) upon absorption by the body of the subject being treated.

Abstract: The present invention refers to a pharmaceutical composition suitable for the transdermal or transmucosal administration of one or more active agents, in form of a gel or a solution, comprising as a permeation enhancers a combination of: a) saturated fatty alcohol of formula CH3—(CH2)n—CH2OH or saturated fatty acid CH3—(CH2)n—CH2COOH wherein n is an integer number 8÷22, preferably 8÷12, most preferably 10, or unsaturated fatty alcohol or fatty acid of formula: CH3(CnH2(n-1))—OH or CH3(CnH2(n-1))—COOH wherein n is an integer number 8÷22, b) a ternary vehicle or carrier consisting of a C1÷C4 alkanol, a polyalcohol in particular propylenglycol and water, c) optionally also a monoalkylether of diethylenglycol.

Abstract: Probucol derivatives and pharmaceutical compositions containing the same to be employed in treatment or prophylaxis of diseases.

Abstract: The invention is directed to a suppository based vaccine delivery system for immunizing against urogenital and anorectally transmitted infectious disease in humans and animals and a method for treating the same. More particularly, this invention is directed to a suppository based vaccine delivery system for the prophylaxis against or treatment of urogenital or anorectal transmitted infectious diseases, such as from viral or microbial pathogens.

Abstract: A water soluble, biodegradable reverse thermal gelation system comprising a mixture of at least two types of tri-block copolymer components is disclosed. The tri-block copolymer components are made of a hydrophobic biodegradable polyester A-polymer block and a hydrophilic polyethylene glycol B-polymer block. The drug release and gel matrix erosion rates of the biodegradable reverse thermal gelation system may be modulated by various parameters such as the hydrophobic/hydrophilic component contents, polymer block concentrations, molecular weights and gelation temperatures, and weight ratios of the tri-block copolymer components in the mixture.

Abstract: The invention relates to the use of one or more antimicrobial metals preferably selected from silver, gold, platinum, and palladium but most preferably silver, formed with atomic disorder, and preferably in a nanocrystalline form, for reducing inflammation or infection of the mucosal membrane. The antimicrobial metal may be formulated as, or used in the form of, a nanocrystalline coating of one or more antimicrobial or noble metals, a nanocrystalline powder of one or more antimicrobial or noble metals, or a liquid or solution containing dissolved species from a nanocrystalline powder or coating of one or more antimicrobial or noble metals.

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 delivery vehicle of the invention.

Abstract: Metal carbonyls are used to deliver CO having biological activity, for example vasodilatation and inhibition of transplant rejection. The metal of the carbonyl is typically of groups 7 to 10, e.g. Fe and Ru. The carbonyl preferably has one or more ligands other than CO, such as amino acids, to modulate the CO release property and solubility.

Abstract: A suppository of retaining in a lower region of rectum, which contains a suppository base containing: (A) a fatty acid triglyceride, (B) one or more C14-18 fatty acid glycerides, and (C) a base ingredient for retaining the suppository in the lower region of rectum, has quite high safety, does not melt by the body temperature when it is held by the fingers before insertion into the rectum so that it is easy to handle, does not deform by elevation of temperature during storage, and prevents stimulation to the rectum mucosa such as congestive hemorrhage and expansion of the rectum mucosa after the insertion.

Abstract: The present invention is directed to mucosal originated drug delivery systems and methods for using the drug delivery system to treat conditions in animals. Conditions amenable to treatment according to the invention are also described. The described mucosal drug delivery systems provide for drug release across a mucosal membrane as well as release away from the mucosal membrane.

Abstract: The invention relates to compositions and methods for treating and/or preventing lower gastrointestinal (GI) disorders in mammalian patients, more particularly for alleviating and/or preventing the lower GI symptoms associated with such disorders.

Abstract: A pharmaceutical composition for slow release of active ingredient in the gastrointestinal tract, comprising a plurality of active ingredient-containing particles coated with a material insoluble in gastric and intestinal juices, where the particles have as core a homogeneous mixture comprising an active pharmaceutical ingredient and a polymer insoluble in gastric and intestinal juices, with an average internal pore diameter not exceeding 35 ?m, makes efficient and pH-independent delaying of release possible even with comparatively small amounts of polymer. It is additionally distinguished by a long shelf life and is particularly suitable also for nonspherical particles.

Abstract: The present invention provides methods for preventing the transmission of HIV, methods for prophylaxis of HIV transmission and methods for reducing the risk of HIV transmission vaginally or rectally using compositions having at least one of polyquaternium, glycerin, methylparaben or proplyparaben. The invention further provides methods for inhibiting the transmission of a sexually transmitted disease using the compositions. Additionally, the invention provides combinations of compositions and devices used with such methods.

Abstract: Use of a non-fermented osmotic laxative as an active agent for preparation of a medicinal product for treating and/or preventing colon and/or rectum cancers. A method of treating or preventing colon or rectum cancer comprising administering to a mammal a therapeutically effective amount of a non-fermented osmotic laxative.

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, nutritional agents, cosmeceuticals and diagnostic agents.

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: 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: 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: A method of manufacturing a stable nanosuspension for delivery of a biologically active agent into the bloodstream of a subject is disclosed. A microfluidizable mixture is initially formed and processed via a microfluidization process to form the stable nanosuspension, which may be administered via the buccal mucosa or other suitable routes of administration. This product demonstrates increased bioavailability, enhanced period of onset, and enhanced stability for a controlled-release product.

Abstract: The present invention relates to an auxiliary substance for an active substance, such as a pharmacon. The auxiliary substance has a stabilizing action. The auxiliary substance further has a positive influence on the bioavailability of the active substance with which the auxiliary substance can be incorporated into a pharmaceutical preparation. The auxiliary substance is based on a fructan having a number-average degree of polymerization of at least 6 and is used in the form of a sugar glass.

Abstract: An aqueous air foam comprising a non-crosslinked cellulose ether selected from C1-C3-alkyl celluloses, C1-C3-alkyl hydroxy-C1-3-alkyl celluloses, hydroxy-C1-3-alkyl celluloses, or mixed hydroxy-C1-C3-alkyl celluloses, the foam having a foam quality FQ of from 60 to 97 percent and the foam quality being defined as FQ(%)=[air volume/(air volume+fluid volume)×100].

Abstract: The present invention relates to crosslinked polymers, synthesized through ring-opening polymerization of ethylenically unsaturated epoxides, in combination with &agr;-hydroxy acids using a hydrophilic macroinitiator, such as poly(ethylene glycol), to form substituted copolymers having ethylenically unsaturated functionality randomly distributed along the polyester polymer backbone. That copolymer is subsequently crosslinked to form a hydrogel network. More particularly, the present invention relates to the synthesis of biodegradable poly(&agr;-hydroxy acid-co-glycidyl methacrylate)-block-poly(ethylene glycol)-block-poly(&agr;-hydroxy acid-co-glycidyl methacrylate) copolymers, which are subsequently crosslinked to form hydrogel networks. The invention also relates to the use of these hydrogel networks in various applications, in particular, for the controlled release of drugs and proteins.

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 carrier, where the carrier is formed from a combination of a triglyceride and at least two surfactants, at least one of which is hydrophilic. Upon dilution with an aqueous medium, the carrier forms a clear, aqueous dispersion of the triglyceride and surfactants.

Abstract: The invention provides methods for induction of an antigen-specific, mucosal cytotoxic T lymphocyte response useful in preventing and treating infections with pathogens that gain entry via a mucosal surface.

Abstract: There is provided a suppository comprising at least one biocompatible polymer, wherein the biocompatible polymer is essentially non-biodegradable, and wherein the suppository essentially does not swell when contacted with an aqueous fluid. The suppository may further comprise a plurality of open cells at least partly separated from one another by an interpenetrating matrix comprising at least one biocompatible polymer in branched or crosslinked form. The plurality of interlinked, open cells are capable of containing an aqueous fluid, and the permeability of the suppository ensures that entry of body fluids into the open cells under practical circumstances occurs essentially without dehydration of mucousal membrane tissue contacting the suppository. The suppository furthermore preferably comprises a controlled release formulation.

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: Methods and pharmaceutical compositions for using desmethylselegiline. In particular, the present invention provides novel compositions and methods for using desmethylselegiline for selegiline-responsive diseases and conditions. Diseases and conditions responsive to selegiline include those produced by neuronal degeneration or neuronal trauma and those due to immune system dysfunction. Desmethylselegiline is the R-(−) enantiomer of N-methyl-N-(prop-2-ynyl)-2-aminophenylpropane. Claimed compositions include both the R-(−) isomer and mixtures of the R-(−) and S(+) isomers. Pharmaceutically acceptable acid addition salts may also be used. Effective dosages are a daily dose of at least about 0.015 mg/kg of body weight.

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: This invention provides compositions and methods for enhancing delivery of drugs and other agents across epithelial tissues, including the skin, gastrointestinal tract, pulmonary epithelium, ocular tissues and the like. The compositions and methods are also useful for delivery across endothelial tissues, including the blood brain barrier. The compositions and methods employ a delivery enhancing transporter that has sufficient guanidino or amidino sidechain moieties to enhance delivery of a compound conjugated to the reagent across one or more layers of the tissue, compared to the non-conjugated compound. The delivery-enhancing polymers include, for example, poly-arginine molecules that are preferably between about 6 and 25 residues in length.

Abstract: Pharmaceutical dosage units containing flupirtine or a pharmaceutically acceptable salt of flupirtine with controlled release of active substance using a delayed-action or controlled-release component. There are 0.001 to 20 parts delayed-action component for each part by weight flupirtine (calculated as the base) and the release rate of flupirtine is between 5 and 300 mg per hour. In some cases, the dosage units may also contain a rapidly releasing component of flupirtine or of one of its salts. The dosage units reduce the sedative effect of flupirtine.

Abstract: The invention concerns a method for the treatment of tumors sensitive to Paclitaxel, by intra-arterial injections of dispersions of microparticles of albumin incorporating Paclitaxel in physiological solutions.

Abstract: Improved molecularly imprinted polymers (MIPs) with both higher and more specific binding capacity for particular bile acids and/or salts, including the synthesis of such MIPs, the compounds themselves, and specific applications thereof. As an example of a particularly preferred specific application of these compounds, the present invention encompasses the use of the MIPs as sequestrants in the gastrointestinal tract, particularly in order to bind and therefore remove toxins from the gastrointestinal tract. In addition, the present invention is also useful for treatment of various diseases which are related to, and/or characterized by, an effect of bile acids and salts, such as atherosclerosis, liver disease and various diseases of the gastrointestinal tract. The MIP compounds of the present invention are also useful for combination therapy with other medications and for diagnosis and monitoring of diseases.

Abstract: Acid-labile active compounds are prepared in suppository form, particularly for rectal administration.

Abstract: The present invention relates to the use of oxidized thymosin &bgr;4 in therapy, more particularly in the treatment of diseases or conditions associated with an inflammatory response of septic shock.

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: 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 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: The pharmaceutical compositions of the present invention comprise rectally and vaginally administerable dosage forms that contain effervescent agents as penetration enhancers for drugs. Effervescence occurs in the rectum or vagina, once the dosage form is administered or at a predetermined time following administration. The effervescent agents can be used alone or in combination with pH adjusting substance, which further promote dissolution and absorption of the active ingredient.

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: 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: This invention pertains to a method that can control, treat, and prevent Diabetes Mellitus. The method includes means of administering a potent product, including mainly the active ingredient Linalool, in any one of several forms, alone or with other additives and catalysts, such as vitamin E to enable the body to handle and control, then correct the complications of Diabetes Mellitus. A modest percentage of users suffering from this disease can be cured completely while the majority of others improve remarkably and experience lower blood glucose and reduce the glycated hemoglobin HbAlc readings to what are medically acceptable and healthy levels. Others, who are vulnerable to the disease due to hereditary factors, or other reasons, can help prevent it. The method works in several ways, including activation of the pancreas and re-establishing the ability of body cells to utilize and handle better and well, the glucose in the blood, and regulate the level of natural insulin in the body.