Abstract: Chronic wounds may be treated by debriding necrotic and other devitalized tissue from the wound, and applying to the wound an extracellular polymeric substance solvating system comprising a metal ion sequestering agent, surfactant and buffering agent. The solvating system disrupts biofilms which may be present in the wound and aids or enables the resumption of normal healing.

Abstract: A controlled releasing composition comprising a plurality of microparticles and a matrix as well as the preparation method thereof is disclosed. The plurality of microparticles comprise a first material and the matrix comprises a second material. The melting temperature of the first material is higher than the melting temperature of the second material.

Abstract: A biodegradable polyurethane scaffold, comprising at least one polyisocyante, polyisocyanate prepolymer, or both, at least one polyester polyol, at least one catalyst, wherein the density of said scaffold is from about 50 to about 250 kg m-3 and the porosity of the scaffold is greater than about 70 (vol %) and at least 50% of the pores are interconnected with another pore, and wherein the scaffold incorporates at least one biologically active component in powder form.

Abstract: A drug delivery device may include a base to be percutaneously affixable in an attachment zone of a synovial joint and a sustained-release drug carrier coupled to the base. The drug delivery device may also include an access device to provide access to the attachment zone. The attachment zone may comprise a non-articulating portion of a bone and/or cartilage with the synovial joint and the drug carrier may elute the drug into the synovial fluid sufficient to sustain a therapeutically effective concentration of the drug in the synovial fluid for at least 8 hours.

Abstract: Provided are topical fosfomycin-tobramycin compositions for the treatment and/or prevention of ophthalmic, otological, and dermatologic inflammation and/or bacterial infections and methods of treating ophthalmic, otological and dermatological inflammation and/or bacterial infections.

Abstract: A combination therapy for treating a bacterial biofilm comprises a therapeutically effective amount of an antibiotic comprising an aminoglyco side or tetracycline, or a combination of two or more thereof, and a cationic porphyrin in an amount effective for enhancing the effectiveness of the antibiotic in treating the bacterial biofilm. A method of treating a bacterial biofilm comprising Pseudomonas aeruginosa comprises contacting the bacterial biofilm with a combination therapy comprising a therapeutically effective amount of an antibiotic, and a cationic porphyrin in an amount effective for enhancing the effectiveness of the antibiotic in treating the bacterial biofilm.

Abstract: The invention provides a tobramycin formulation for delivery by aerosolization in the form of additive-free, isotonic solution whose pH has been optimised to ensure adequate shelf-life at room temperature. Said formulation can be advantageously used for the treatment and prophylaxis of acute and chronic endobronchial infections, in particular those caused by the bacterium Pseudomonas aeruginosa associated to lung diseases such as cystic fibrosis.

Abstract: This invention relates to a fulvic acid and antibiotic combination for use in the treatment of various diseases and conditions. The invention further relates to the use of the combination for the treatment of various diseases and conditions, including bacterial infection. In particular, the bacteria are antibiotic resistant bacteria.

Abstract: The present invention relates to mechanically hemostatic body-absorbable compositions having a putty-like consistency. The compositions preferably comprise a finely powdered, carboxylic acid salt and a liquid block copolymer of ethylene oxide and propylene oxide.

Abstract: A pharmaceutical low dose, antibiotic combination of two antibiotics selected from a carbapenem and an aminoglycoside, present as a single unit fixed low dose injection effective at very low concentrations. The antibiotic combination is suitable for the treatment of bacterial/multibacterial infections, and is particularly suitable for neonates, children, and other patients with low tolerance, and who are prone to serious fatal mixed multi-bacterial infectious diseases where potential toxicity due to higher doses is a cause for concern.

Abstract: A fosfomycin plus tobramycin combination formulation for delivery by aerosolization is described. The concentrated fosfomycin tobramycin combination formulation containing an efficacious amount of fosfomycin plus tobramycin is able to inhibit susceptible bacteria. Fosfomycin and tobramycin are formulated separately in a dual ampoule such that when reconstituted, the pH is between 4.5 and 8.0 or as a dry powder. The method for treatment of respiratory tract infections by a formulation delivered as an aerosol having mass medium average diameter predominantly between 1 to 5?, produced by a jet or ultrasonic nebulizer (or equivalent) or dry powder inhaler.

Abstract: A paste is provided from which bone cement can be formed, which is to the largest extent possible bubble-free and has a high impact strength. The paste includes (i) 15-50 weight percent of at least one mono-functional, hydrophobic methacrylic acid ester, (ii) 40-85 weight percent of at least one filler, (iii) 0.01-4 weight percent of at least one radical initiator soluble in the methacrylic acid ester (i) and having at least one peroxide group, (iv) 0.01-4 weight percent of at least one radical initiator soluble in the methacrylic acid ester (i) and having no peroxide groups, (v) 0.000001-3 weight percent of at least one accelerator soluble in the methacrylic acid ester (i) and capable of forming radicals from the radical initiators according to (iii) and (iv), (vi) 0.001-5 weight percent of at least one halide salt, and (vii) 0.2-3 weight percent of at least one cross-linking agent.

Abstract: The present application describes organic compounds that are useful for the treatment, prevention and/or amelioration of human diseases.

Abstract: The invention is directed to a method of stimulating PRF in a viral cell by administering an aminoglycoside antibiotic to said cell. In another embodiment, the invention is directed to a method of inhibiting viral replication by administering an aminoglycoside antibiotic to a viral cell. The invention is also directed to method of treating a viral infection in a patient suffering therefrom comprising administering to said patient an aminoglycoside antibiotic.

Abstract: A gastroretentive drug delivery system is provided. Said system comprises a hollow vesicle and a drug-containing layer which surrounds the hollow vesicle. Said hollow vesicle preferably has a single chamber structure. The size in maximal diameter direction of said hollow vesicle is preferably 0.5-3.5 cm. The gastroretentive drug delivery system preferably contains an isolating layer and/or waterproofing layer between the hollow vesicle and the layer containing drug.

Abstract: An aminocarboxylic acid chelating agent, preferably EDTA, or a salt thereof has been found to be useful for inhibiting particulate formation in piperacillin/tazobactam parenteral combinations. The composition may also contain a buffer, preferably citrate, and optionally an aminoglycoside. The product may be in the form of a frozen composition that can be thawed for use. The product may also be in the form of a cryodesiccated powder that can be reconstituted by addition of an aqueous vehicle to reform a solution.

Abstract: Use of cilastatin to reduce the nephrotoxicity of different compounds. The invention refers to use of cilastatin to prepare a medicinal product to reduce the nephrotoxicity of a nephrotoxic compound that enters the cells of the proximal tubule through cholesterol rafts. The invention is based on the discovery that a great number of nephrotoxic compounds, including drugs, enter the cells of the proximal tubule through the cholesterol rafts, and that cilastatin is able to interfere with this transport mechanism, decreasing the nephrotoxicity of such compounds to a variable extent. The nephroprotective effect is common to compounds of different chemical nature and solubility and is specific for the kidney, causing no interference with the effects of nephrotoxic drugs having their targets in other organs. Therefore, administration of cilastatin allows for decreasing the nephrotoxic effects of different drugs without reducing their therapeutic effects.

Abstract: Powder formulations for inhalation which comprise microparticles containing an antibiotic and magnesium stearate are useful for the treatment of bacterial infections associated with certain pulmonary diseases.

Abstract: This invention pertains to the formulation of nanoparticles that have intrinsic antimicrobial and anti-inflammatory activity. The nanoparticles can be impregnated with one or more therapeutic agents and thereby enhance the antimicrobial and/or anti-inflammatory activity of such agents, and also other properties that the therapeutic agents provide.

Abstract: A method of forming an ocular delivery device includes exposing a solid, shaped cellulose polymer to a solution including an active pharmaceutical ingredient (API) and a solvent capable of solubilizing the API, wherein the polymer absorbs at least a portion of the solution, including the API and solvent. The method may further include removing at least a portion of the absorbed solvent from the polymer by allowing the absorbed solvent to evaporate from the polymer or by drying the polymer. A variety of cellulose polymers may be used, including hydroxypropyl cellulose. A variety of APIs may be used, including Cyclosporine, Tobramycin and Vancomycin. Ocular delivery devices prepared by the methods may be used to treat a variety of eye disorders.

Abstract: The invention relates to a dermatological pharmaceutical composition for the treatment of skin inflammation diseases, such as dermatitis, atopic dermatitis, vitiligo, alopecia areata, acne, psoriasis and pruritus. The invention comprises a base anti-inflammatory agent, such as indometacin; one or more optional active ingredients selected alternatively from among at least a corticoid and an antibiotic; and a combination of topical antioxidants used to potentiate the anti-inflammatory effect, selected from among green tea, lipoic acid, curcumin, ascorbyl palmitate, Coenzyme Q10, resveratrol, Pycnogenol™, L-camosine, taurine, vitamin E, vitamin C, papaya extract, isoflavones, manganese, lycopene and quercetin. At least one of the topical antioxidants is a peroxisome proliferator-activated receptor-gamma (PPAR-?) activator. The invention also includes at least one antioxidant substance with an antiproliferative effect on keratonocytes, e.g.

Abstract: A fosfomycin plus tobramycin combination formulation for delivery by aerosolization is described. The concentrated fosfomycin tobramycin combination formulation containing an efficacious amount of fosfomycin plus tobramycin is able to inhibit susceptible bacteria. Fosfomycin and tobramycin are formulated separately in a dual ampoule such that when reconstituted, the pH is between 4.5 and 8.0 or as a dry powder. The method for treatment of respiratory tract infections by a formulation delivered as an aerosol having a mass median aerodynamic diameter predominantly between 1 to 5?, produced by a jet or ultrasonic nebulizer (or equivalent) or dry powder inhaler.

Abstract: The invention provides a tobramycin formulation for delivery by aerosolization in the form of additive-free, isotonic solution whose pH has been optimised to ensure adequate shelf-life at room temperature. Said formulation can be advantageously used for the treatment and prophylaxis of acute and chronic endobronchial infections, in particular those caused by the bacterium Pseudomonas aeruginosa associated to lung diseases such as cystic fibrosis.

Abstract: The invention provides implantable drug releasing materials comprising a calcium phosphate composition, a biodegradable polymer adsorbed onto the calcium phosphate composition, wherein the polymer comprises acidic amino acid residues, and a drug adsorbed onto or reacted with the polymer. The invention is further directed to dental and bone implants and implantable medical devices comprising the implantable drug releasing material, methods for preparing the implantable drug releasing material, and methods for delivering the implantable drug releasing material to bone or teeth.

Abstract: Composite structures composed of a device as a core structure, being a medical device or article, and a porous polymeric coat and designed capable of encapsulating bioactive agents while retaining the activity of these agents are disclosed. Further disclosed are processes of preparing such composite structures.

Abstract: The present invention relates to methods and compositions to treat subjects having cystic fibrosis. These compositions comprise the class of isothiocyanates. Isothiocyanates, absorbed by a cell are conjugated with glutathione GSH by glutathione-s-tranferase (GST). The conjugates are substrates of the multi-drug resistance associated (MRP)/multi-drug resistance (MDR) proteins. These proteins are functionally redundant to the cystic fibrosis transmembrane conductance regulator (CFTR), allowing for the substrate conjugates to be exported from the cell. The export of GSH conjugates restores intracellular and extracellular levels of GSH to normal levels. Normalizing both extracellular and intracellular GSH via the increased conjugation of isothiocyanates with GSH, and subsequent export, can significantly rectify numerous enzymatic processes and correct the pathologies that are typical of patients suffering from cystic fibrosis.

Abstract: Microparticle compositions comprising metal ion-lipid complexes for drug delivery are described including methods of making the microparticle compositions and methods of treating certain conditions and disease states by administering the microparticle compositions. The metal ion-lipid complexes can be combined with various drugs or active agents for therapeutic administration. The microparticle compositions of the present invention have superior stability to other microparticle compositions resulting in a microparticle composition with longer shelf life and improved dispersability. The microparticle compositions of the present invention have a transition temperature (Tg) of at least 20° C. above the recommended storage temperature (Tst) for drug delivery.

Abstract: A composition for oral delivery of a poorly absorbed drug is disclosed. The composition includes the drug, an enhancer for increasing absorption of the drug through the intestinal mucosa, a promoter, which further increases the absorption of the drug in the presence of the enhancer, and optionally a protector for protecting the drug from physical or chemical decomposition or inactivation in the gastrointestinal tract. Illustrative enhancers include sucrose fatty acid esters, and illustrative promoters include aminosugars and amino acid derivatives, such as poly(amino acids). Illustrative protectors include methylcellulose, poly(vinyl alcohol), and poly(vinyl pyrrolidone).

Abstract: A biodegradable composition containing an antibiotic or a physiologically active substance for use in surgical treatment of infection. A highly safe and biocompatible composition showing appropriately sustained release of an antibiotic or physiologically active substance which produces excellent antibiotic and bone regenerating effects. A composition having excellent effects in treatment of bone infection occurring after operations for total arthroplasty and/or bone fracture. (1) A medical composition for treatment of bone infection comprising an antibiotic and a polysaccharide.

Abstract: A biodegradable polyurethane scaffold, comprising at least one polyisocyante, polyisocyanate prepolymer, or both, at least one polyester polyol, at least one catalyst, wherein the density of said scaffold is from about 50 to about 250 kg m-3 and the porosity of the scaffold is greater than about 70 (vol %) and at least 50% of the pores are interconnected with another pore, and wherein the scaffold incorporates at least one biologically active component in powder form.

Abstract: The invention relates to a novel solubilized small molecule topical formulation for the transdermal delivery of small molecule agents comprising: a small molecule agent, one or more micelle forming compounds, one or more skin penetration enhancers, a surfactant, and one or more solvents, wherein the small molecule agent is solubilized in the solvent. The invention further relates to the use of the topical formulation as well as the process for making the topical formulation.

Abstract: The present invention relates to novel aminoglycoside antibiotics, a process for producing the same, and pharmaceutical use thereof. More specifically, the present invention relates to compounds represented by formula (I), a process for producing the same, and use of the same as antimicrobial agents. wherein R represents amino or hydroxyl.

Abstract: A method of treating chronic infection with B. cepacia complex (BCC) in a patient suffering from cystic fibrosis (CF) comprising administering a fluidosomal formulation of tobramycin to the patient.

Abstract: The invention provides a method for preparing microparticles comprising mixing a first cross-linkable reagent in aerosol form with a second cross-linking reagent in aerosol form to thereby to form microparticles.

Abstract: Compositions and methods, including novel homogeneous microparticulate suspensions, are described for treating acute wounds, chronic wounds and/or a wound or epithelial tissue surface that contains bacterial biofilm, including unexpected synergy between bismuth-thiol (BT) compounds and certain antibiotics, to provide topical formulations including antiseptic formulations, for management and promotion of wound healing and in particular infected wounds. Previously unpredicted antibacterial properties and anti-biofilm properties of disclosed BT compounds and BT compound-plus-antibiotic combinations are also described, including preferential efficacies of certain such compositions for treating gram-positive bacterial infections, and distinct preferential efficacies of certain such compositions for treating gram-negative bacterial infections.

Abstract: A method is provided for treatment of a condition including at least one weakened vertebra or one compression fracture of a vertebra, wherein in at least one embodiment, the vertebra is injected by vertebroplasty or kyphoplasty with particles, grains or granules or a mixture thereof, or an implant suspension including at least one resorbable fluid vehicle and particles, grains or granules or a mixture thereof, wherein the particles, grains or granules individually have a mean length from one side to the opposite side, through a geometrical centre, of up to 5 mm. Moreover, at least one embodiment of the present invention also provides use of the particular or granular material disclosed above, for the manufacture of a medicament for the vertebroplastic treatment or kyphoplastic treatment of a condition including at least one weakened vertebra or one compression fracture of a vertebra.

Abstract: Compounds of a compound of compound of general formula (I) wherein X1, X2, A, R1R2, R3 and R4 are as defined herein; are useful as anti-mycobacterial agents, especially agents for the treatment of tuberculosis.

Abstract: A formulation comprised of particles which may be in groups and are comprised of a biocompatible polymer and an antimicrobial drug for controlled release of the drug is disclosed. The particles may be in an aqueous solution comprising thrombin and be dispersed in a gel. The formulation is administered to an area such as an open wound having an orthopedic implant therein and provides a therapeutically effective level of drug to the patient over therapeutically effective period of time.

Abstract: An aqueous or powder composition includes anti-gram-negative antibiotic or salt thereof being present at an amount ranging from about 100 mg/ml to about 200 mg/ml. Another aqueous or powder composition includes anti-gram-positive antibiotic or salt thereof being present at a concentration ranging from about 0.6 to about 0.9 of the water solubility limit, at 25° C. and 1.0 atmosphere, of the anti-gram-positive antibiotic or salt thereof. Other embodiments include unit doses, kits, and methods.

Abstract: Ophthalmic pharmaceutical compositions containing tobramycin, dexamethasone and deacetylated xanthan gum are described. The compositions provide longer ocular retention for enhanced ocular bioavailability of tobramycin and dexamethasone. In a preferred embodiment, the compositions also provide for improved suspension of dexamethasone. The concentration of ionizable species in the compositions is controlled so as to prevent precipitation of the xanthan gum as a result of ionic interactions between tobramycin and xanthan gum, while allowing for a restoration of viscosity upon topical application of the compositions to the eye. The use of deacetylated xanthan gum is disclosed, so as to avoid formulation instability caused by pH drift during storage.

Abstract: Stable and clear aqueous solution preparations comprising an aminoglycoside antibiotic or a pharmacologically acceptable salt thereof and bromfenac being a nonsteroidal antiinflammatory agent or a pharmacologically acceptable salt thereof.

Abstract: An antimicrobial accessory may include a polymer an antimicrobial mixed in the polymer, and an antioxidant. The antioxidant may include, for example, at least one of citric acid, maltol, kojic acid, malic acid, or vitamin A. In some examples, the antioxidant may include an ascorbate peroxidase in combination with ascorbic acid, a glutathione peroxidase in combination with glutathione, or a superoxide dismutase in combination with a metal such as Ni, Cu, Mn, or Fe. In some examples, the antimicrobial accessory may include at least three polymer layers. For example, the antimicrobial accessory may include a first layer comprising a biodegradable polymer and an antimicrobial. The antimicrobial accessory may further include a sacrificial diffusion layer formed on a surface of the first layer. The sacrificial diffusion layer may include a biodegradable polymer, which may be the same biodegradable polymer as in the first layer or may be a different biodegradable polymer.

Abstract: An antimicrobial accessory may include a polymer an antimicrobial mixed in the polymer, and an antioxidant. The antioxidant may include, for example, at least one of citric acid, maltol, kojic acid, malic acid, or vitamin A. In some examples, the antioxidant may include an ascorbate peroxidase in combination with ascorbic acid, a glutathione peroxidase in combination with glutathione, or a superoxide dismutase in combination with a metal such as Ni, Cu, Mn, or Fe. In some examples, the antimicrobial accessory may include at least three polymer layers. For example, the antimicrobial accessory may include a first layer comprising a biodegradable polymer and an antimicrobial. The antimicrobial accessory may further include a sacrificial diffusion layer formed on a surface of the first layer. The sacrificial diffusion layer may include a biodegradable polymer, which may be the same biodegradable polymer as in the first layer or may be a different biodegradable polymer.

Abstract: Provided are lipid antiinfective formulations substantially free of anionic lipids with a lipid to antiinfective ratio is about 1:1 to about 4:1, and a mean average diameter of less than about 1 ?m. Also provided is a method of preparing a lipid antiinfective formulation comprising an infusion process. Also provided are lipid antiinfective formulations wherein the lipid to drug ratio is about 1:1 or less, about 0.75:1 or less, or about 0.50:1 or less prepared by an in line fusion process. The present invention also relates to a method of treating a patient with a pulmonary infection comprising administering to the patient a therapeutically effective amount of a lipid antiinfective formulation of the present invention. The present invention also relates to a method of treating a patient for cystic fibrosis comprising administering to the patient a therapeutically effective amount of a lipid antiinfective formulation of the present invention.

Abstract: Biodegradable polymeric microparticle compositions containing one or more active agents, especially those useful for treating or preventing or one or more diseases or disorders of the eye, and methods of making and using thereof, are described. The microsphere compositions release an effective amount of the one or more active agents for a period greater than 14 days in vivo, preferably greater than 60 days in vivo, more preferably up to 73 days in vivo, more preferably greater than 90 days in vivo, even more preferably over 100 days in vivo, and most preferably greater than 107 days in vivo. In a preferred embodiment, the microparticle compositions contain one or more active agents useful for managing elevated intraocular pressure (TOP) in the eye. In one embodiment, the microspheres are formed from polylactide-co-glycolide (“PLGA”); in another embodiment, the microspheres are formed from a blend PLGA and poly lactic acid (“PLA”).

Abstract: The present application describes organic compounds that are useful for the treatment, prevention and/or amelioration of human diseases.

Abstract: Bioactive, hydroforming luminal liner compositions are formed of high molecular weight crystalline, absorbable copolyesters dissolved in a liquid derivative of a polyether glycol that undergoes transformation into a tissue-adhering, resilient interior cover or liner for the controlled release of its bioactive payload at clinically compromised conduits in humans as in the case of bacteria- and yeast-infected vaginal canals, esophagi, and arteries following angioplasty.

Abstract: A first embodiment is a coating for a surface comprising an electrostatic self-assembly creating one or more coating layer(s); (i) wherein one or more high molecular weight bioactive molecule(s) is bound to a protein carrier wherein said protein carrier or said bound bioactive molecule is further bound to one or more of said coating layer(s) and/or (ii) wherein one or more low molecular weight bioactive molecule(s) is/are incorporated within one or more of said layers or later introduced to said layer or layers by post-treatment. A second embodiment is a method of coating a surface comprising introducing said surface into a solution of one or more positively charged water-soluble polyelectrolytes at a pH ranging from about 2 to about 12 and at a temperature ranging from about 4° C. to about 80° C. and incubating said surface for about 0.

Abstract: Ophthalmic pharmaceutical compositions containing tobramycin, dexamethasone and deacetylated xanthan gum are described. The compositions provide longer ocular retention for enhanced ocular bioavailability of tobramycin and dexamethasone. In a preferred embodiment, the compositions also provide for improved suspension of dexamethasone. The concentration of ionizable species in the compositions is controlled so as to prevent precipitation of the xanthan gum as a result of ionic interactions between tobramycin and xanthan gum, while allowing for a restoration of viscosity upon topical application of the compositions to the eye. The use of deacetylated xanthan gum is disclosed, so as to avoid formulation instability caused by pH drift during storage.

Abstract: Various aspects related to the preparation of congeners of the aminoglycosides gentamicin such as the congener C2 and using this compound or derivatives thereof and pharmaceutically active salts to treat diseases that involve genetic mutations which introduce a missense or premature stop codon into a gene. Still other aspects include treating human or animal patients with the gentamicin congener C2 and derivatives and pharmaceutical salt thereof to overcome, or to at least mitigate, the symptoms of disease and disorders such as some forms of Becker's or Duchenne muscular dystrophy, Hurler's Syndrome and Cystic Fibrosis that have as their etiology the presence of a premature stop codon in a gene whose proper expression is necessary for good health.