Abstract: The present invention provides a method of treating lysosomal storage diseases such as Hurler syndrome and Batten disease in individuals in need of such treatment, comprising the step of administering to said individuals a therapeutically effective dose of an aminoglycoside. In addition, this method may further comprise treating the individual with enzyme replacement therapy. Furthermore, the present invention provides method of pharmacologically suppressing premature stop mutations in an individual with these lysosomal storage diseases, comprising the step of administering to said individual a pharmacologically effective dose of an aminoglycoside.

Abstract: The present invention is directed to a process for preparing a 2,26,6-d4-morpholine derivative represented by Structural Formula (I): or a salt thereof.

Abstract: The present invention relates to the use of a Compound of formula I preferably 4-[3,5-bis(2-hydroxyphenyl)-[1,2,4]triazol-1-yl]benzoic acid or a pharmaceutically acceptable salt thereof for the preparation of a medicament for use in the treatment of biofilm formation, e.g. of P. aeruginosa, e.g. in cystic fibrosis patients.

Abstract: The subject matter of the invention is a material depot which dispenses an antibacterial active ingredient material into a human or animal body via the surface of the depot. The surface of the material depot is larger than the envelope of the material depot. The increased surface of the material depot effects a higher level of the antibacterial active ingredient material at the location of the implant and permits effective destruction in situ of both sensitive pathological germs and partially resistant germs.

Abstract: Compounds able to affect production and/or activity of a redox active compound, which include candidate therapeutic compounds and candidate compounds for enhancing power output of a microbial fuel cell, and related compositions, methods and systems.

Abstract: The present invention relates to therapeutic nanoemulsion compositions and to methods of utilizing the same. In particular, nanoemulsion compositions are described herein that find use in the treatment and/or prevention of infection (e.g., respiratory infection (e.g., associated with cystic fibrosis)), in burn wound management, and in immunogenic compositions (e.g., comprising a Burkholderia antigen) that generate an effective immune response (e.g., against a bacterial species of the genus Burkholderia) in a subject administered the immunogenic composition. Compositions and methods of the present invention find use in, among other things, clinical (e.g. therapeutic and preventative medicine), industrial, and research applications.

Abstract: A composition for inhalation, comprising at least: a) an effective amount of an antimicrobial aminoglycoside derivative or a salt thereof, and b) an effective amount of a biofilm modifier which is a macrolide derivative or a salt thereof.

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 present invention relates to methods and compositions for the treatment of pulmonary inflammation. In particular, methods and compositions using aerosol levofloxacin or ofloxacin to reduce pulmonary inflammation are provided.

Abstract: A composition for inhalation which contains at least an effective amount of an antimicrobial aminoglycoside compound or a salt thereof, and an effective amount of a biofilm modifier which is a macrolide compound or a salt thereof.

Abstract: A device for administering two or more therapeutic agents simultaneously, comprising two or more nebulizers and a single connector linking the nebulizers to a nebulizer mouthpiece. Also provided is a method of administering two or more therapeutic agents simultaneously, comprising administering the therapeutic agents simultaneously with the device of the present invention to a subject in need thereof.

Abstract: The present invention is directed to linear, biodegradable polyesteramide (PEA) polymers synthesized with repeating units derived from aminophenol esters and diacids. These PEAs have a monomer repeat represented by as well as a variety of uses to coat, form or comprise medical devices, combination medical devices and pharmaceutical compositions, including sustained release formulations.

Abstract: The invention features a method for treating a subject diagnosed with, or at risk of developing, a bacterial infection by administering to the subject a combination of biologically active agents.

Abstract: Disclosed herein are a collagen-based matrix for use as a restorative material and a method for the preparation thereof. An atelocollagen dispersion is spread at a predetermined thickness over a plate and freeze-dried to form a porous collagen membrane. An atelocollagen dispersion is separately spread over a plate and pressurized to form a dense collagen membrane. This is overlaid with the porous collagen membrane and immersed in an EDS solution in ethanol to crosslink the two membranes with each other. From the bilayer structure thus constructed, EDS is removed, followed by lyophilization and cutting into an appropriate size.

Abstract: A drug for preventing vascular restenosis comprises a compound that inactivates ?1-protease inhibitor and ?2-macroglobulin as active constituents, which are associated with occurrence of vascular restenosis after coronary artery intervention. Preferably, the drug is coated on a surface of an implantable intravascular device and locally administered to the affected area by application of the implantable intravascular device to a narrowed area.

Abstract: Provided are electrokinetically-altered fluids (gas-enriched (e.g., oxygen-enriched) electrokinetic fluids) comprising an ionic aqueous solution of charge-stabilized oxygen-containing nanostructures in an amount sufficient to provide, upon contact with a cell, modulation of at least one of cellular membrane potential and cellular membrane conductivity, and therapeutic compositions and methods for using same in treating cystic fibrosis or a symptom thereof. The electrokinetically-altered fluid compositions and methods include electrokinetically-altered fluids optionally in combination with other therapeutic agents (e.g., antibiotics, albuterol, budesonide, etc.). Particular embodiments comprise use and/or synergy with tobramycin for treating bacterial infection, and use and/or synergy with a bronchiodilator.

Abstract: The invention relates to a new pharmaceutical composition, a method of treatment of infection and also a process to prepare the composition. The infectious complications are important causes of morbidity and mortality. Hospital acquired pneumonia (HAP) remains the most severe nosocomial infection in intensive care units. Beta-lactams alone are always considered inadequate when P. aeruginosa and/or methicillin-resistant S. aureus are implicated as pathogens or copathognes. The present invention provides the desired empirical therapy for control of all bacterial infections. The invention provides antibiotic combination products for delivering at least two different antibiotics, through parenteral dosage form comprising protein-synthesis-inhibiting antibiotic which is amikacin or its sulphate salt and non-protein-synthesis-inhibiting antibiotic which is cefepime or its hydrochloride salt. The invention provides a total solution, against multiresistant P. aeruginosa, or Acinetobacter spp.

Abstract: An antimicrobial composition, including a synergistic combination of three or more agents as an active ingredient. Each of the three or more potentiating agents can be selected from the following types of compounds: sequestering agents, carbohydrates and carbohydrate derivatives, terpenes/terpenoids, amines and amine derivatives, plant-derived oils, sulfonates, phenols, fatty acids, dibenzofuran derivatives, organo isothiocyanates, quaternary ammonium compounds, peroxides and peroxide donors, and macrolide polyenes. At least two of the three or more potentiating agents are not of the same type of compound. The antimicrobial composition can have strong antimicrobial efficacy in control of microorganisms having resistance to currently used antimicrobials.

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: A local system for the liberation of an active principle is described which consists of spherical bodies which are composed of polymethyl methacrylate or polymethyl methacrylate co-methyl acrylate and, if necessary, zirconium dioxide and/or barium sulphate and a pharmaceutical active principle, which contains at least one hemostyptically effective compound stable at least up to 120° C., preferably a calcium salt. The local system for the liberation of an active principle is provided as medical product or drug.

Abstract: The invention is directed toward an osteoimplant for application to a bone defect site to promote new bone growth at the site which comprises a new bone growth inducing composition of demineralized allograft bone material mixed with an aqueous phosphate buffered gelatin which when lyophilized to remove water from the composition crosslinks the gelatin to form a solid structure and when rehydrated is flexible

Abstract: The invention relates to porous drug delivery devices and related methods. In an embodiment, the invention includes an active agent delivery system including a reservoir body defining a plurality of interconnected pores, an active agent disposed within the interconnected pores, and a first polymeric layer disposed over the reservoir body. In an embodiment, the invention includes an implantable medical device including a porous substrate defining a plurality of interconnected pores, an active agent disposed within the interconnected pores, and a first polymeric layer disposed over the reservoir body. In an embodiment, the invention includes a method of making an active agent delivery system including forming a porous reservoir body, inserting an active agent within the porous reservoir body, and applying a polymeric layer over the porous reservoir body. Other embodiments are also included herein.

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: A pharmaceutical composition comprising: at least one aminoglycoside antibiotic and (a) at least one ion chelating agent used for inhibiting particulate formation, or (b) at least one buffer, or (c) at least one ion chelating agents and at least one buffer simultaneously. The composition for use in controlling microbial infection can be formulated into a solution, or combined with at least one beta-lactam antibiotic, or combined with at least one of beta-lactam antibiotic and at least one beta-lactamase inhibitor into a solution in a container.

Abstract: A pharmaceutical composition comprising: at least one ?-lactam antibiotic and at least one ion-chelating agent; wherein when said pharmaceutical composition is used as an anti-microbial drug, it optionally comprises further at least one aminoglycoside antibiotic.

Abstract: A pharmaceutical composition, comprising: at least one ?-lactam antibiotic and at least one buffer component; wherein when the pharmaceutical composition is used as an anti-microbial drug, it optionally comprises further at least one aminoglycoside antibiotic mixed with the ?-lactam antibiotic and the buffer component.

Abstract: A method of treating or preventing infection at a surgical site comprising a bony defect and an implanted metal device is disclosed. Biodegradable microspheres are placed at the site and are capable of near-linear controlled release of an antibiotic agent for a predetermined period of time. The microspheres are configured to be large enough to avoid being phagocytosed and removed from the body, and small enough in diameter to not physically inhibit bone growth at said bony defect site. The microspheres are formed of polylactic-co-glycolic acid (PLGA), with or without polyethylene glycol (PEG), and sufficient antibiotic agent to produce bactericidal levels in body tissues. The microspheres exhibit near-linear delivery of the antibiotic agent for at least 4 weeks at levels exceeding the minimum inhibitory concentration (MIC) for organisms commonly found to be the cause of infections, and facilitate bone ingrowth or regrowth at the site.

Abstract: The present invention provides a topical composition comprising (a) at least one delivery agent compound and (b) a acyclovir compound. Methods of treatment, and methods of preparing the topical composition are also provided.

Abstract: Disclosed herein are methods of treating pulmonary disorders comprising administering to the patient an effective dose of a nebulized liposomal amikacin formulation for at least one treatment cycle, wherein: the treatment cycle comprises an administration period of 15 to 75 days, followed by an off period of 15 to 75 days; and the effective dose comprises 100 to 2500 mg of amikacin daily during the administration period.

Abstract: The present invention relates to methods and compositions for treating diseases ameliorated by increased mucociliary clearance and mucosal hydration by administering an effective amount of a sodium channel blocker as defined herein and an osmolyte to a subject to a subject in need of increased mucociliary clearance and mucosal hydration.

Abstract: Water-dispersible or water-soluble polymers, particularly those of the family of compounds comprising the poloxamers or the polyesters or amphiphilic agents (emulsifiers), and also lipophilic materials are dispersed by melting the components at suitable temperatures with admixture of pharmaceutically active substances by mechanical procedures, i.e. a lipophilic dispers phase is distributed in a hydrophilic continuous polymer phase to form a stable dispersion. By controlled cooling, curing, and storage followed by high-pressure molding at defined temperatures and operating pressures there are produced, in addition to other types of shaped bodies, dispersed polymeric fatty sticks distinguished by particularly good fracture strength, flexibility, and variable time-specific dimensional stability.

Abstract: A surfactant can be added, safely and effectively, to a drug solution containing any antimicrobial agent, such as an antibiotic like tobramycin, that is suitable for administration to the lungs via inhalation. Thus, when an aerosolized drug solution includes surfactant, Marangoni flows cause the drug particles, once deposited in the lungs, to spread over a wider surface area, thereby ensuring greater antimicrobial efficacy. A solution that contains, for example, an antibiotic and tyloxapol or another surfactant providing a similar surface tension to the composition is optimally delivered by the functional combination of a breath-actuated nebulizer and a high-flow compressor.

Abstract: Phospholipid based powders for drug delivery applications are disclosed. The powders comprise a polyvalent cation in an amount effective to increase the gel-to-liquid crystal transition temperature of the particle compared to particles without the polyvalent cation. The powders are hollow and porous and are preferably administered via inhalation.

Abstract: The invention describes novel organic nitric oxide donor salts of a antimicrobial compounds, and novel compositions and kits comprising at least one organic nitric oxide donor salt of an antimicrobial compound, and, optionally, at least one nitric oxide enhancing compound and/or at least one therapeutic agent. The invention also provides methods for (a) treating bacterial infections; (b) treating viral infections; (c) treating fungal infections; and (d) treating lesions. In one embodiment the antimicrobial compounds of the invention are aztreonam, ciprofloxacin, doripenam, duramycin and tobramycin. The organic nitric oxide donors that form salts are preferably organic nitrates, organic nitrites, nitrosothiols, thionitrites and heterocyclic nitric oxide donors. The heterocyclic nitric oxide donors are preferably furoxans, sydnonimines, oxatriazole-5-ones and/or oxatriazole-5-imines.

Abstract: The present invention is related to a method for treating blepharitis, the method comprising administering to an ocular area of a subject in need thereof a composition comprising about 0.001% to about 0.01% (w/v) dexamethasone and an antibiotic, wherein the composition is substantially free of lipids, and wherein the composition is ophthalmically acceptable.

Abstract: The invention describes compositions and kits comprising at least one nitric oxide enhancing group antimicrobial compound, or pharmaceutically acceptable salts thereof, and novel compositions comprising at least one nitric oxide enhancing antimicrobial compound, and, optionally, at least one nitric oxide enhancing compound and/or at least one therapeutic agent. The invention also provides methods for (a) treating bacterial infections; (b) treating viral infections; (c) treating fungal infections; and (d) treating lesions. The antimicrobial compounds of the invention are preferably tobramycin, aztreonam, ciprofloxacin and doripenam. The nitric oxide enhancing antimicrobial compounds are substituted with at least one heterocyclic nitric oxide donor group and/or at least one nitroxide group. The nitric oxide enhancing groups are nitroxides and/or heterocyclic nitric oxide donors. The heterocyclic nitric oxide donors are furoxans, sydnonimines, oxatriazole-5-ones and/or oxatriazole-5-imines.

Abstract: Agents and methods for enhancing recombinant virus transduction in the bladder epithelium are described. A first method involves contacting the luminal surface of the bladder with a composition comprising a transduction enhancing agent and an oncolytic virus. Alternatively, the luminal surface of the bladder can be contacted first with a pretreatment composition comprising a transduction enhancing agent and, subsequently, with a composition comprising an oncolytic virus. Bladder treatment compositions comprising a transduction enhancing agent and an oncolytic virus are also described.

Abstract: Nanoparticles of a biodegradable polymer containing a hydrophilic, cationic drug, like streptomycin, and preparations containing the same, are disclosed. Pharmaceutical preparations containing the nanoparticles are administered, preferably orally, to individuals suffering from a disease or condition, and the nanoparticles release the drug, in vivo, to treat the disease or condition.

Abstract: A biodegradable, flexible covering for a breast implant is provided which comprises one or more biodegradable polymer layers dimensioned and shaped to cover at least a portion of the breast implant. The implant can be inserted into an opening of the covering immediately prior to surgery, but alternate configurations and times of insertion are contemplated as well as open or sheet type devices. The coverings can optionally contain one or more drugs for delivery at the surgical site, particularly for treating or preventing infection, pain, inflammation, capsular contracture, scarring or other complications associated with breast augmentation or breast reconstruction.

Abstract: Stabilized dispersions are provided for the delivery of a bioactive agent. The dispersions preferably comprise a plurality of perforated microstructures dispersed in a suspension medium that typically comprises a liquid fluorochemical. As density variations between the suspended particles and suspension medium are minimized and attractive forces between microstructures are attenuated, the disclosed dispersions are particularly resistant to degradation, such as by settling or flocculation. In particularly preferred embodiments the stabilized dispersions may be directly administered to the lung of a patient using an endotracheal tube or bronchoscope.

Abstract: The present invention provides a pharmaceutical composition comprising antibiotic combination products for delivering two or more different antibiotics simultaneously, wherein the two different antibiotics comprise one which consisting of concentration dependent killing and the other concentration independent killing or time dependant killing activity. The invention has been worked out utilizing pharmacokinetic and pharmacodynamic principles to optimize antibiotic regimen, to improve clinical results and to potentially decrease the development of resistance. Combination of ceftazidime and tobramycin has been evolved to specifically illustrate the invention.

Abstract: The invention provides among other things a stable, sterile pharmaceutical formulation comprising lyophilized tobramycin, wherein the lyophilized tobramycin is in the form of a free-flowing powder. The invention also provides a method of producing a stable, sterile pharmaceutical product comprising lyophilized tobramycin. The invention also provides a pharmaceutical dosage form comprising the pharmaceutical formulation, as well as a method of treating a disease in a patient comprising administering a solution of the pharmaceutical formulation to a patient.

Abstract: The present invention provides methods for the treatment of an endobronchial infection in a patient by administering to the endobronchial system of the patient a dry powder aerosol composition comprising from 90 to 130 mg of an aminoglycoside antibiotic one to three times a day for a first treatment period of 20 to 36 days.

Abstract: This invention provides methods for enhancing production in a subject of a functional protein from a gene disrupted by a mutation, for example by the presence of a premature stop codon or by an exon skipping mutation, comprising administering to the subject an amount of an agent effective to suppress the mutation and an amount of an agent effective to increase transcription of the gene.

Abstract: The present invention relates to a composition for use as an antimicrobial medicament comprising a biocidally active compound. The invention also relates to a medicament comprising at least one biocidally active compound and a fungal cell or fungal cell fragment wherein molecules of the at least one biocidally active compound are encapsulated or partially encapsulated by the fungal cell or fungal cell fragment.

Abstract: Efflux pump inhibitors are co-administered with antimicrobial agents for the treatment of ophthalmic or otic infections. The agents may be co-administered directly to the site of infection (e.g., the eye or ear).

Abstract: The invention relates to hardly soluble antiphlogistic salts and antiphlogistic-antibiotic pharmaceutical preparations and their use. The hardly water soluble antiphlogistic antibiotics salts have as their cationic component one of the antibiotics gentamicin, clindamycin, neomycin, streptomycin, tetracycline, doxicyline, oxytetracycline and rolitetracycline and as their anionic component one of the antiphlogistics ibuprofen, naproxen, indomethacin, dexamethasone-21-phosphate, dexamethasone-21-sulfate, triamcinolone-21-phosphate and triamcinolone-21-sulfate. The antiphlogistic antibiotics salts are used in pharmaceutical preparations as controlled-release antibiotic/antibiotics drugs.

Abstract: Agents and methods for enhancing recombinant virus transduction in the bladder epithelium are described. A first method involves contacting the luminal surface of the bladder with a composition comprising a transduction enhancing agent and an oncolytic virus. Alternatively, the luminal surface of the bladder can be contacted first with a pretreatment composition comprising a transduction enhancing agent and, subsequently, with a composition comprising an oncolytic virus. Bladder treatment compositions comprising a transduction enhancing agent and an oncolytic virus are also described.

Abstract: A water-like fluid containing safe water and a significant quantity of soluble dietary fiber. The resulting solution is generally optically clear and has physical properties similar to potable water. The fluid is intended as a replacement for bottled, or other water, as a means to ensure proper hydration. Depending on the soluble fiber used the fluid is either non-caloric or extremely low in calories. The amount of soluble fiber is adjusted to a specific amount of water so that consumption of an adequate amount of fluid ensures hydration (e.g., eight 8 oz. glasses per day) will also providing an optimal amount of dietary fiber. This is particularly valuable in stressed situations where the diet may not provide adequate fiber without supplementation. The constant metered supply of fiber provided throughout the day is preferable to, and more convenient than, “bolus” administration of fiber through laxatives, etc.

Abstract: This invention pertains to therapeutic antibacterial/antifungal-wound healing compositions comprising a therapeutically effective amount of antibacterial agents and/or antifungal agents and/or wound healing composition alone. In one embodiment, the wound healing composition comprises (a) zinc oxide; (b) calcium channel blocker, and (c) fat-soluble vitamins admixed with antibacterial and antifungal agents. The therapeutic antibacterial/antifungal-wound healing compositions may be utilized in a wide variety of pharmaceutical products and administered orally or topically.