Abstract: A process for preparing a formulation comprising a complex comprising an effective amount of ferrous iron bound to a pharmaceutically acceptable cationic resin and at least one pharmaceutically acceptable carrier is described. Such a formulation may optionally include other desirable dietary supplements including, e.g., vitamins, omega fatty acids, and/or fluoride. The formulation is particularly well adapted for pediatric use, but is also useful for use in adult populations.

Abstract: The present invention is directed to compositions of a linear polyol and a salt of a crosslinked cation exchange polymer comprising a fluoro group and an acid group. These compositions are useful to bind potassium in the gastrointestinal tract.

Abstract: The present invention relates to taste masked dosage forms of bitter tasting anti-retroviral drugs comprising a complex of the said anti-retroviral drug and an ion-exchange resin and one or more of other pharmaceutically acceptable excipients. It further relates to the processes for the preparation thereof.

Abstract: The present invention relates to a delivery system for pharmaceutical compositions relying in part on an ionic interaction to control and facilitate release of the treating agent. More specifically, the invention relates to an extended controlled-release system having an ionic treating agent and an ionic polymer, wherein the polymer is sufficiently ionized to release the treating agent in a controlled manner over an extended period of time and the composition does not require an emulsion system for administering the treating agent.

Abstract: Disclosed are compounds of formula (I): or a pharmaceutically acceptable N-oxide, salt, hydrate, solvate, complex, bioisostere, metabolite or prodrug thereof, which are of use in the treatment of infection with, and diseases caused by, Clostridium difficile.

Abstract: The present invention provides methods and compositions for the treatment of ion imbalances. In particular, the invention provides compositions comprising sodium-binding polymers and pharmaceutical compositions thereof. Methods of use of the polymeric and pharmaceutical compositions for therapeutic and/or prophylactic benefits are disclosed herein. Examples of these methods include the treatment of hypertension, chronic heart failure, end stage renal disease, liver cirrhosis, chronic renal insufficiency, fluid overload, or sodium overload.

Abstract: A novel process of manufacturing sevelamer carbonate from a polyallylamine carbonate or bicarbonate chloride salt. Process for manufacture of carbonate and/or bicarbonate salts of water insoluble polymers containing amino groups that are useful as anion binders in the gastrointestinal (GI) system. The process arranges the polyallylamine chain in a solution in such a way that the cross-linking reaction with epichlorohydrin can be controlled at a desired reaction rate.

Abstract: Compositions which deliver adsorbents, alone or in combination with active drug “degrading molecules,” in a site-specific manner to the intestine, and which eliminate or at least lower the concentration of residual unwanted material within the intestine, and methods of treatment using the compositions, are disclosed. The compositions are ideally designed to specifically release the adsorbents in a programmed manner at a specific site of the intestinal tract. Programmed delivery prevents adsorbents from interfering with the normal absorption process of a given molecule after oral absorption, until it reaches the lower part of the small intestine. The compositions can be used to adsorb, and therefore remove, any residual drug, metabolite thereof, or bacterial toxin after oral or parenteral administration which would otherwise cause adverse effects in the lower intestine and/or colon.

Abstract: Methods for making comb-type antithrombotic conjugate wherein substantially all side chains of water soluble poly(vinyl alcohol) (PVA) are extended by ring-opening polymerization to form a copolymer wherein substantially all terminals are conjugated to an antithrombotic molecule. In addition, a method is provided for applying a coating comprising a comb-type anti-thrombotic conjugate to at least a portion of an implantable device to prevent or reduce the formation of thrombosis on the surface of the device. A first or sub-layer of the coating is prepared by mixing a polymeric material and a biologically active agent with a solvent, thereby forming a homogeneous solution. A second or outer layer comprising a comb-type anti-thrombotic conjugate may be applied over the inner drug-containing layers using, for example, a dip coating or spray coating process.

Abstract: Disclosed is a pharmaceutical composition comprising a stable polyallylamine hydrochloride polymer in which between about 4% to about 12% by weight of the polymer is a chloride anion and a pharmaceutically acceptable carrier or diluent.

Abstract: The present invention provides a novel tablet with improved tablet appearance and improved swallowability. The tablet contains a pharmaceutically acceptable anion exchange resin represented by colestimide as an active ingredient, and has a visibility-resolved tablet edge.

Abstract: The present invention provides methods and compositions for the treatment of ion imbalances. In particular, the invention provides polymeric and pharmaceutical compositions comprising crosslinked amine polymers. Methods of use of the polymeric and pharmaceutical compositions for therapeutic and/or prophylactic benefits are disclosed herein. Examples of these methods include the treatment of renal diseases and hyperphosphatemia.

Abstract: A process for preparing a formulation comprising a complex comprising an effective amount of ferrous iron bound to a pharmaceutically acceptable cationic resin and at least one pharmaceutically acceptable carrier is described. Such a formulation may optionally include other desirable dietary supplements including, e.g., vitamins, omega fatty acids, and/or fluoride. The formulation is particularly well adapted for pediatric use, but is also useful for use in adult populations.

Abstract: A wound closure apparatus and associated methods are provided which utilize blood fluid by activating the clotting cascade of blood fluid within a substantially enclosed sterile container then introducing the blood fluid to the wound site to complete clotting. An apparatus for providing ways of inhibiting anticoagulating agents and slowing fibrin clot degradation are also disclosed. Kits are also disclosed. The invention provides a clotting cascade initiation apparatus including a substantially enclosed sterile containment chamber within which an aliquot of blood fluid, either autologous or from donor sources, can be received and retained. In preferred embodiments, the sterile containment chamber further includes a heparin binding agent which will bind heparin and remove it from the blood fluid. In further embodiments, the containment chamber will also include a procoagulating agent, wherein a clotting cascade can be initiated when the blood fluid is accepted into the sterile containment chamber.

Abstract: A coated drug-ion exchange resin complex comprising a core composed of a drug complexed with a pharmaceutically acceptable ion-exchange resin is provided. The drug-ion exchange resin complex is in admixture with a release retardant. The coating is a polyvinyl acetate polymer and a plasticizer. Methods of making and products containing this coated complex are described.

Abstract: The present invention is directed to compositions of a linear polyol and a salt of a crosslinked cation exchange polymer comprising a fluoro group and an acid group. These compositions are useful to bind potassium in the gastrointestinal tract.

Abstract: The present invention relates to a macromolecule having a controlled terminal group stoichiometry, the macromolecule including a surface layer, at least one subsurface layer and at least two terminal groups including: a first terminal group which is a residue of a pharmaceutically active agent, a derivative thereof or precursor therefor; and a second terminal group selected to modify the pharmacokinetics of the pharmaceutically active agent and/or macromolecule, wherein terminal group stoichiometry refers to the number and type of terminal groups.

Abstract: The present invention includes compositions and methods for delivering one or more unit dosage units by modifying the release profile of an optionally coated drug-resin complex suspended in an ionic salt solution, wherein the optionally coated drug-resin complex includes one or more active agents loaded on to one or more ion-exchange resin particles, and wherein the release of the one or more active agents is modulated by the one or more ionic salts in solution.

Abstract: The present invention provides methods and compositions for the treatment of ion imbalances. In particular, the invention provides compositions comprising potassium binding polymers and pharmaceutical compositions thereof. Methods of use of the polymeric and pharmaceutical compositions for therapeutic and/or prophylactic benefits are disclosed herein. Examples of these methods include the treatment of hyperkalemia, such as hyperkalemia caused by renal failure and/or the use of hyperkalemia causing drugs.

Abstract: An oral methylphenidate powder which is reconstitutable into a final oral aqueous sustained release formulation containing at least about 50%, or at least about 80% by weight water based on the total weight of the suspension, is provided. The powder is a blend containing a combination of an uncoated methylphenidate-ion exchange resin complex, a barrier coated methylphenidate-ion exchange resin complex-matrix, and a water soluble buffering agent such that upon formed into an aqueous liquid formulation, the formulation has a pH in the range of about 3.5 to about 5, or about 4 to about 4.5. Following administration of a single dose of the oral aqueous methylphenidate suspension, a therapeutically effective amount of methylphenidate is reached in less than one hour and the composition provides a twelve-hour extended release profile.

Abstract: A process for preparing a formulation comprising a complex comprising an effective amount of ferrous iron bound to a pharmaceutically acceptable cationic resin and at least one pharmaceutically acceptable carrier is described. Such a formulation may optionally include other desirable dietary supplements including, e.g., vitamins, omega fatty acids, and/or fluoride. The formulation is particularly well adapted for pediatric use, but is also useful for use in adult populations.

Abstract: The present invention provides methods and compositions for the treatment of ion imbalances. In particular, the invention provides compositions comprising potassium binding polymers and pharmaceutical compositions thereof. Methods of use of the polymeric and pharmaceutical compositions for therapeutic and/or prophylactic benefits are disclosed herein. Examples of these methods include the treatment of hyperkalemia, such as hyperkalemia caused by renal failure and/or the use of hyperkalemia causing drugs.

Abstract: Provided is a novel prophylactic and/or therapeutic agent for glomerular disease wherein a pharmaceutically acceptable anion exchange resin, typified by colestimide, is an active ingredient thereof.

Abstract: A pharmaceutical composition in the form of a tablet including a first portion and a second portion, wherein said first portion includes guaifenesin having an immediate release profile and a second drug having a sustained release profile, and wherein the second portion includes guaifenesin having a sustained release profile. The second drug can be in the form of a drug-resin complex. The second drug can be either an anti-tussive or a decongestant. The drug-resin complex includes a drug complexed to an ion exchange resin. The ion exchange resin can be a polystyrene sulfonate resin, polacrilex resin, polacrilin potassium, cholestyramine resin, or a colestyramine resin. The drug-resin complex can be provided with a coating, the coating thickness being selected to obtain the desired release profile. The drug-resin complex can be provided with a coating level of from 5% to 50%. The coating level can be from 10% to 35%.

Abstract: The present invention discloses an improved copper-based fungicide/bactericide composition. The improved composition offers higher biological activity over typical copper-based products, while requiring significantly less copper in the composition. The present invention also discloses methods of making the improved copper-based fungicide/bactericide composition. The present invention further discloses methods of using the improved copper-based fungicide/bactericide composition.

Abstract: Methods are described for determining the amount of metabolites of leflunomide in a sample. More specifically, mass spectrometric methods are described for detecting and quantifying teriflunomide in a sample.

Abstract: The present invention relates to solid pharmaceutical combinations for oral administration comprising nicotinic acid or a nicotinic acid compound or mixtures thereof in an extended release form and an HMG-CoA reductase inhibitor, which are useful for altering lipid levels in subjects suffering from, for example, hyperlipidemia and atherosclerosis, without causing drug-induced hepatotoxicity, myopathy, or rhabdomyolysis.

Abstract: A sustained release formulation for opioid drugs is described. The formulation contains an opioid-ion exchange resin complex having a hybrid coating. The hybrid coating contains a cured polyvinylacetate polymer and a pH-dependent enteric coating layer mixed therein. Also provided are methods of making and using same.

Abstract: The present invention discloses an improved copper-based fungicide/bactericide composition. The improved composition offers higher biological activity over typical copper-based products, while requiring significantly less copper in the composition. The present invention also discloses methods of making the improved copper-based fungicide/bactericide composition. The present invention further discloses methods of using the improved copper-based fungicide/bactericide composition.

Abstract: Provided herein are biocidic compositions including an ion exchange material, wherein when said material is in an environment capable of transporting H+, said ion exchange material is adapted to cause the death of at least one cell within or in contact with said environment. A selectively permeable barrier layer may be provided covering the ion exchange material. Also provided herein are methods of making the foregoing biocidic compositions. In addition, provided herein are methods of using the foregoing biocidic compositions to cause the death of at least one cell.

Abstract: An agent for promoting excretion of an accumulative chlorine compound comprising a pharmaceutically acceptable anion exchange resin, which is a novel agent that is for promoting the excretion of an accumulative chlorine compound and is capable of efficiently excreting residual chlorinated compounds including dioxins as typical examples.

Abstract: Medical devices, wound dressings, and methods of dressing wounds are described. Devices and methods using silicone and pharmaceutically active agents are described. Devices including covers and bases are described.

Abstract: A composition and method useful in promoting healing of a bleeding wound site. The composition preferably includes a substantially anhydrous acid form of a cation exchange resin, which when applied over blood, provides an antimicrobial against planktonic microorganisms and biofilms in the wound. The resin is also capable, when applied in sufficient quantities, of providing a continuing and persistent antimicrobial against planktonic microorganisms and biofilms through dehydration and ion exchange with cations present in the blood and other body fluids. When the resin has a concentration of at least 26 mg/ml, it provides a >3 log reduction in biological activity of MRSA, MRSE and Pseudomonas aeruginosa.

Abstract: Disclosed herein include embodiments related to compositions, devices, computer systems, computer-implemented methods, and computer program products associated with an ingestible salt grabber.

Abstract: Methods and compositions are provided for stabilizing polypeptides for oral administration, particularly where enteric delivery is desirable. By administering the polypeptides with a bile sequestering agent, the stability of the polypeptide can be increased. Pharmaceutical formulations for this purpose are provided.

Abstract: The invention relates to pharmaceutical compounds and compositions comprised of a chemical moiety attached to an opioid such as oxycodone in a manner that substantially decreases the potential of the opioid to cause overdose. When delivered at the proper dosage the pharmaceutical composition provides therapeutic activity similar to that of the parent active agent. Further the compounds and compositions of the invention are useful in preventing addiction and susceptibility to addiction.

Abstract: Hollow conjugated polyelectrolyte (HCPE) microcapsules contain at least one conjugated polyelectrolyte and at least one other polyelectrolyte of complementary charge and the microcapsule has a hollow core. The conjugated polyelectrolyte is a polymer with a multiplicity of charged repeating units where a portion of the charged repeating units form a pi-conjugated sequence. The complementary polyelectrolyte is a polymer with a complementary charged repeating unit to the charged repeating units of the conjugated polyelectrolyte. The HCPE microcapsules can be formed by successively coating a sacrificial core with alternating layers of complementary polyelectrolytes, at least one of which is a conjugated polyelectrolyte. The sacrificial core can be removed to form the hollow center of a HCPE microcapsule.

Abstract: The present invention is directed to crosslinked cation exchange polymers comprising a fluoro group and an acid group, pharmaceutical compositions of these polymers, compositions of a linear polyol and a salt of such polymer. Crosslinked cation exchange polymers having beneficial physical properties, including combinations of particle size, particle shape, particle size distribution, viscosity, yield stress, compressibility, surface morphology, and/or swelling ratio are also described. These polymers and compositions are useful to bind potassium in the gastrointestinal tract.

Abstract: The present invention provides methods and compositions for the treatment of ion imbalances. In particular, the invention provides compositions comprising potassium binding polymers and pharmaceutical compositions thereof. Methods of use of the polymeric and pharmaceutical compositions for therapeutic and/or prophylactic benefits are disclosed herein. Examples of these methods include the treatment of hyperkalemia, such as hyperkalemia caused by renal failure and/or the use of hyperkalemia causing drugs.

Abstract: There is provided a protective media and a method of manufacturing the same. In one aspect, the protective media includes a porous dielectric carrier, an active agent incorporated in the porous dielectric carrier, and an electrostatic charge across at least a portion of the porous dielectric carrier. This innovative media is capable of eradicating microorganisms and/or toxins more efficiently than prior art solutions and can also self sterilize.

Abstract: Cross-linked polyelectrolyte polymers with bound counterions that absorb about 20-fold or more of their mass in saline such as physiological saline a with the proviso that sodium does not exceed 60% of total bound counterions when hydrogen is the sole other counterion, are disclosed. Methods of preparing the disclosed polymers and for treating subjects such as patients in need of fluid removal and/or modulation of ions (e.g., sodium and/or potassium) are provided.

Abstract: Cross-linked polyelectrolyte polymers that absorb 60-fold or more, including greater than 60-fold, greater than 70-fold, greater than 80-fold, greater than 90-fold, greater than 100-fold, or greater than 110-fold or more, of their mass in a saline solution are disclosed. Methods for preparing such polymers with enhanced saline holding capacity and methods for treating diseases, disorders or conditions involving fluid overload and/or ion imbalances by administering the polymers are disclosed.

Abstract: Oral dosage forms of benzonatate useful for anti-tussive and anti-tussive/combination applications.

Abstract: The present invention relates to the use of isosteviol, steviol, and related compounds for elevating the plasma HDL-cholesterol level. The invention furthermore relates to the use of these compounds for reducing the body weight of a subject and/or lowering the plasma triglyceride level of a subject, including a concomitant elevation of the plasma HDL-cholesterol level. Preferably the compounds used are isosteviol and/or steviol, or pharmaceutically acceptable salts, solvates or prodrugs thereof. The compounds may furthermore be administered in combination with one or more further active compounds, such as e.g. LDL-cholesterol lowering agents. The invention furthermore relates to a method for elevating the plasma HDL-cholesterol level in a subject by administering to a subject in need of such treatment a plasma HDL-cholesterol level elevating amount of the compounds, described herein.

Abstract: The present invention relates to elastic, hydrophilic and substantially spherical microspheres useful for dermal augmentation and tissue bulking. The invention provides injectable compositions comprising the microspheres and a biocompatible carrier for use in dermal augmentation. The present invention further provides methods of dermal augmentation and tissue bulking, particularly for the treatment of skin contour deficiencies, Gastro-esophageal reflux disease, urinary incontinence, and urinary reflux disease, using the injectable compositions.

Abstract: Compounds of the formula R—NH-Q??(I) provide pharmacological agents which are glucokinase activators and thus may be employed for the treatment of glucokinase mediated conditions. Accordingly, the compounds of formula (I) may be employed for prevention and treatment of impaired glucose tolerance, Type 2 diabetes and obesity.

Abstract: The present invention provides methods and compositions for the treatment of ion imbalances. In particular, the invention provides compositions comprising sodium-binding polymers and pharmaceutical compositions thereof. Methods of use of the polymeric and pharmaceutical compositions for therapeutic and/or prophylactic benefits are disclosed herein. Examples of these methods include the treatment of hypertension, chronic heart failure, end stage renal disease, liver cirrhosis, chronic renal insufficiency, fluid overload, or sodium overload.

Abstract: The present invention relates to substituted triazole compounds of the formula (I): and pharmaceutically acceptable salts thereof, to pharmaceutical compositions containing them and their use in medicine. In particular, the invention relates to compounds for modulating SCD activity.

Abstract: A solid buffer including one or more ion exchange materials, wherein said solid buffer has a volumetric buffering capacity greater than about 20 mM H+/(L.pH unit) and further wherein, when said material is in an environment capable of transporting H+ ions, said solid buffer is adapted to cause the death of at least one target cell within or in contact with said environment. A selectively permeable barrier layer may be provided covering the solid buffer.

Abstract: A method of producing bronchorelaxation in the lungs of a human or animal affected by airway obstruction comprises administration of a pharmacologically effective amount to the body or to the intestine of said human or animal of an agent capable of binding mercury in elemental, ionic and/or organic form present in the body or in the intestinal lumen to enhance its excretion via the feces and/or the urine. A corresponding use of the agent and its use for the manufacture of a medicament are also disclosed.