Abstract: Methods and compositions for treating 25-hydroxyvitamin D insufficiency and deficiency in a patient are described herein. The method includes orally administering to the patient a delayed, sustained release formulation including a first ingredient selected from the group consisting of 25-hydroxyvitamin D2, 25-hydroxyvitamin D3, or a combination of 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3, or it includes gradually administering to the patient a sterile intravenous formulation including a first ingredient selected from the group consisting of 25-hydroxyvitamin D2, 25-hydroxyvitamin D3, or a combination of 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3.

Abstract: The invention relates to a multiparticulate modified release composition that, upon administration to a patient, delivers ticlopidine in a bimodal, multimodal or continuous manner. The multiparticulate modified release composition comprises a first component and at least one subsequent component, the first component comprising a first population of active ingredient containing particles and the at least one subsequent component comprising a second population of active ingredient containing particles. The invention also relates to a solid oral dosage form containing such multiparticulate modified release composition, and to methods for inhibiting platelet aggregation, inhibiting blood clotting, and reducing risk of stroke in a patient.

Abstract: The present invention provides a composition comprising a platelet aggregation inhibitor, for example, cilostazol, or a salt or derivative thereof, useful in the treatment and prevention of ischemic symptoms. The invention provides a composition which comprises nanoparticulate particles comprising the platelet aggregation inhibitor and at least one surface stabilizer. The nanoparticulate particles have an effective average particle size of less than about 2000 nm. The invention provides also a composition that delivers a platelet aggregation inhibitor, or nanoparticles comprising the same, in a pulsatile or continuous manner.

Abstract: The present invention is directed to compositions comprising a nanoparticulate antibiotic having improved bioavailability. Preferably, the antibiotic comprises nanoparticulate cephalosporin particles with an effective average particle size of less than about 2000 nm and are useful in the treatment of bacterial infection. The invention also relates to a controlled release composition comprising a cephalosporin or a nanoparticulate cephalosporin that in operation delivers the drug in a pulsed or bimodal manner for the treatment of bacterial infection. The nanoparticulate cephalosporin particles may be formulated as a controlled release drug delivery system whereby the particles are coated one or more times with one or more natural or synthetic hydrophilic or hydrophobic polymer coating materials or dispersed throughout a natural or synthetic hydrophilic and/or hydrophobic polymer matrix.

Abstract: A pharmaceutical or medicinal herbal composition and method of making the composition comprised of a mixture of the following herbal ingredients: Glycine max, Plumbago zeylanica, Terminalia arjuna, Trigonella-foenum-graceum, Coleus forskohlii, Commiphora mukul, Camellia sinensis, and Azadirachta indica.

Abstract: Pharmaceutical fixed dose combination products are formed by merging a fixed dose of a first pharmaceutical formulation from primary module, with a fixed dose of a second pharmaceutical formulation from a secondary module In a preferred embodiment the first and second pharmaceutical formulations are separated from one another in a three piece capsule, a capsule-in-a-capsule or a tablet-in-a-capsule, and the primary and secondary modules are interchangeable.

Abstract: This process relates to a pharmaceutical composition of an Na-K-ATPase ligand which will stimulate Na/K-ATPase signaling in a pharmaceutically acceptable vehicle. In one embodiment, the composition may be used to treat a skin disorder. In another embodiment, the composition may be used to inhibit cardiac fibrosis.

Abstract: Disclosed are oral dosage forms containing a Ras antagonist including FTS and structural analogs thereof, and at least one pharmaceutically acceptable excipient other than a cyclodextrin, and methods of orally administering same to treat diseases and disorders responsive to the Ras antagonists.

Abstract: The present invention relates to pharmaceutical compositions in the form of fixed combination comprising non-steroidal anti-inflammatory drug or its single enantiomers or salts thereof, antipyretic-analgesic drug and proton pump inhibitor or its single enantiomers or salts thereof. The invention also relates to processes for the preparation of such compositions.

Abstract: The invention relates to the use of blueberry extract for the preparation of a therapeutic composition for oral administration for the treatment and prevention of tinnitus.

Abstract: In an aspect of the present invention, a sweetened gelatin capsule comprises a dose and a gelatin capsule encapsulating the dose. The gelatin capsule comprises a gelatin substance, a gelatin softener, water, and a sweetener. The concentration by weight of the water in the gelatin capsule is from about 6% to about 10%. The concentration by weight of the sweetener in the gelatin capsule is from about 0.002% to about 0.003%.

Abstract: The present invention is directed to a homogeneous, thermoreversible gel film comprising a film forming amount of a water soluble, thermoreversible alginate, and optionally at least one of a plasticizer, a second film former, a bulking agent, and a pH controlling agent; and processes for the preparation thereof. The present invention is also directed to soft capsules and solid forms containing the gel film, as well as processes for the preparation thereof.

Abstract: The invention relates to a pharmaceutical composition comprising a suspension consisting of an oil with a high concentration of alkyl esters of polyunsaturated fatty acids (PUFA) and to microcapsules comprising at least one polymer and a statin.

Abstract: A room temperature stable aqueous cannabinoid formulation is disclosed. In preferred embodiments, the cannabinoid formulation comprises dronabinol in a mixture of buffer solution, and organic cosolvents such as ethanol, propylene glycol and polyethylene glycol.

Abstract: The present invention discloses methods of making a mixture of theaflavin, theaflavin-3-gallate, theaflavin-3?-gallate and theaflavin 3,3?-digallate, pharmaceutical compositions of the above mixture of theaflavins, diet supplement compositions of the above mixture of theaflavins and methods for using the above mixtures of theaflavin and pharmaceutical compositions thereof to treat or prevent various diseases. The present invention also discloses methods of making theaflavin, theaflavin-3-gallate, theaflavin-3?-gallate and theaflavin 3,3?-digallate, each as a separate compound, pharmaceutical compositions of the above compounds, diet supplement compositions of the above compounds and methods for using the above compounds to treat or prevent various diseases.

Abstract: A preparation for the treatment of diarrhoea comprising a bulking agent and an anti-diarrhoeal agent wherein the anti-diarrhoeal agent is provided in the form of an anti-motility agent.

Abstract: Disclosed herein is an extended release pharmaceutical formulation suitable for once daily administration, comprising a highly water soluble core consisting essentially of about 30 to about 40% by weight of venlafaxine hydrochloride, about 50 to about 80% by weight of water soluble diluent and about 2 to about 10% of water soluble binder and a coating layer having an effective combination of rate controlling polymers comprising water-soluble polymer and water insoluble, water permeable polymer.

Abstract: The invention discloses a chewable composition for oral delivery of bioactive agents having nanoparticles that are composed of chitosan, poly-glutamic acid, and at least one protein drug or bioactive agent characterized with a positive surface charge and their enhanced permeability for paracellular protein drug and bioactive agent delivery.

Abstract: A method of treating gastroesophageal reflux disease (GERD), ulcers of the stomach or duodenum, or Zollinger-Ellison Syndrome in a human, by administering pantoprazole sodium multiparticulates is described. The pantoprazole multiparticulates have a spheroid core of pantoprazole or an enantiomer thereof, or a salt thereof, a surfactant, and a disintegrant; a sub coat which is comprised of hydroxypropyl methylcellulose (hypromellose) and water, an enteric coat on the subcoat, and a final seal coat over the enteric coat, which is composed of hydroxypropyl methylcellulose (hypromellose) and water.

Abstract: A process for preparing gelatin hard capsule having enhanced film strength by the steps including i) adding 1˜10 wt part of PEG mixture of PEG 600 and PEG 1500 in weight ratio 40˜60:60˜40 to the solution having 100 wt part of gelatin; ii) adding 0.1˜1.2 wt part of emulsifier mixture containing acetyl glycerine fatty acid ester and sodium lauryl sulfate to the resulting mixture; and iii) allowing the obtained mixture to stand, adjusting its viscosity and forming a hard capsule therefrom. Further, this gelatin hard capsule has equal film distribution with minimum cracking or chipping when hygroscopic material is inserted.

Abstract: Pantoprazole sodium multiparticulates are described which avoid sticking to nasogastric and gastronomy tubes. The pantoprazole multiparticulates have a spheroid core of pantoprazole or an enantiomer thereof, or a salt thereof, a surfactant, and a disintegrant; a sub coat which is comprised of hydroxypropyl methylcellulose(hypromellose) and water, an enteric coat on the sub-coat, and a final seal coat over the enteric coat, which is composed of hydroxypropyl methylcellulose(hypromellose) and water.

Abstract: The present invention relates to a novel thixotropic oily vehicle comprising between about 0.2% to about 5% (w/w) of a colloidal silica and between about 0.2% to about 5% (w/w) of a hydrophilic polymer in an edible oil. The interaction between the hydrophylic polymer and the colloidal silica in the above concentration ranges confers thixotropy and a low viscosity under shear on the solution. The invention also relates to capsules filled with the above thixotropic solution used as a fill mass.

Abstract: A unit dose sustained-release oral dosage form containing a plurality of melt-extruded particles, each consisting essentially of a therapeutically active agent, one or more retardants, and an optional water-insoluble binder is disclosed. The particles have a length of from about 0.1 to about 12 mm and can be of varying diameters and each unit dose provides a release of therapeutically active agents over at least about 8 hours. Methods of preparing the unit doses as well as extrusion processes and methods of treatment are also disclosed.

Abstract: A formaldehyde-treated protein capsule for protecting any encapsulated substance from chemical modification in the rumen is generally disclosed. Also, processes for making and using the formaldehyde treated protein capsule arc generally disclosed. The formaldehyde treated capsule can contain substantially no excess formaldehyde on or within the capsule. Also, the protein capsule can be generally treated with formaldehyde after the capsule is loaded with the substance to be protected. The substance to be protected is not limiting by the treatment process. In another embodiment, a method for decreasing the amount of milk fat found in milk provided by a ruminant, such as a dairy cow, is generally provided.

Abstract: Pantoprazole sodium multiparticulates are described which avoid sticking to nasogastric and gastronomy tubes. The pantoprazole multiparticulates have a spheroid core of pantoprazole or an enantiomer thereof, or a salt thereof, a surfactant, and a distintegrant; a sub coat which is comprised of hydroxypropyl methylcellulose (hypromellose) and water, an enteric coat on the sub-coat, and a final seal coat over the enteric coat, which is composed of hydroxypropyl methylcellulose (hypromellose) and water.

Abstract: A process for the enzyme-catalyzed preparation of cyclic ester oligomers from dicarboxylic acids and/or dicarboxylic acid derivatives and diols, hydroxycarboxylic acids and/or hydroxycarboxylic acid esters, and/or linear ester oligomers in the presence of a solvent comprising a tertiary alcohol and a non-alcoholic solvent.

Abstract: Crystalline polymorphous forms of the rifaximin (INN) antibiotic named rifaximin ? and rifaximin ? useful in the production of medicinal preparations containing rifaximin for oral and topical use and obtained by means of a crystallization process carried out by hot-dissolving the raw rifaximin in ethyl alcohol and by causing the crystallization of the product by addition of water at a determinate temperature and for a determinate period of time, followed by a drying carried out under controlled conditions until reaching a settled water content in the end product, are the object of the invention.

Abstract: Sustained release pharmaceutical compositions contain a drug; microcrystalline cellulose; a diluent (such as starch); a glidant (such as talc); and one or more of ethylcellulose, stearic acid and a salt of stearic acid. Preferred drugs include those that exhibit a low degree of solubility combined with a high potency, particularly thyroid hormones, such as liothyronine.

Abstract: Granules for controlled release of Tamsulosin, the granules including Tamsulosin and a carrier matrix. The carrier matrix includes a) 2 to 25% by weight of an alginate and b) 30 to 70% by weight of a macromolecular substance selected from the group consisting of: methacrylic acid/ethyl acrylate 1:1 copolymer, methacrylic acid/methyl methacrylate 1:1 or 1:2 copolymers, aminoalkyl methacrylate copolymer, vinyl acetate/crotonic acid copolymer, polyvinyl acetate phthalate, ethylene-vinyl acetate, cellulose acetate phthalate, hydroxypropylmethylcellulose, sodium carboxymethylcellulose, carrageenan, crosslinked chitosan, polyethylene-vinyl acetate, poly-L-lactic acid, xanthan gum, polyvinyl acetate and mixtures thereof. The carrier matrix further includes 10 to 50% by weight of a hydrophobic substance selected from the group consisting of: glycerol behenate, glyceryl monostearate, wax, mono-, di- and trisubstituted glycerides, calcium stearate and mixtures thereof.

Abstract: The present invention relates to plant extracts, specifically, the extracts of Chinese medicine Chenopodium ambrosioides L. and the composition comprising thereof. The extracts of Chinese medicine Chenopodium ambrosioides L. are prepared by conventional methods for the extraction of volatile oil, and can be used to treat Helicobacter Pylori-induced diseases of digestive system, such as gastritis, gastric ulcer, etc., with easy availability of raw materials, simple preparations, prominent effects, and less side-effect.

Abstract: Hard shell capsules filled with a pharmaceutical medicament and at least one modifier, selected to prevent abuse of the medicament are described. The modifier may have a high melting point, and therefore melt at a temperature too high to inject or be insoluble in liquid, having a density less than 1, to prevent “spiking” of drinks. The modifier may also be a waxy substance which cannot be crushed, a viscosity modifier, a dye or a taste modifier.

Abstract: The invention is directed to oral modified/controlled release drug formulations which provide a rapid initial onset of effect and a prolonged duration of effect. Preferably, the peak concentration is lower than that provided by the reference standard for immediate release formulations of the drug, and the duration of effect falls rapidly at the end of the dosing interval.

Abstract: The present invention relates to compositions and methods for treatment of various forms of pain. Specifically, the method involves administering to a patient a composition comprising butalbital, acetaminophen and caffeine in the gelcap dosage form, to treat and/or alleviate the occurrence or negative effects of various forms of headaches.

Abstract: The present invention provides methods for reducing A? deposition, A? neurotoxicity and microgliosis in an animal or human afflicted with a cerebral amyloidogenic disease, such as Alzheimer's disease (AD), by administering therapeutically effective amounts of the (R)-enantiomer of the dihydropyridine compound nilvadipine, also known as (?)-nilvadipine, to the animal or human. Further provided are methods for reducing the risk of A? deposition, A? neurotoxicity and microgliosis in animals or humans suffering from traumatic brain injury by administering (?)-nilvadipine after the traumatic brain injury and continuing treatment for a prescribed period of time thereafter.

Abstract: The invention provides antibodies with superior therapeutic efficacy and related methods of engineering such antibodies to increase their stability and resistance to proteases, e.g., in the digestive tract. Protease cleavage motifs are identified and subsequently modified to reduce or eliminate cleavage at that site. Methods of employing these orally deliverable antibodies as therapeutic compositions, particularly against gastrointestinal pathogens are also provided herein. In one aspect, the invention provides combinations of monoclonal antibodies, e.g., “synthetic polyclonals,” that work synergistically to neutralize bacterial toxins, particularly enteric bacterial toxins such as Clostridium difficile toxin A.

Abstract: A unit dose sustained-release oral dosage form containing a plurality of melt-extruded particles, each consisting essentially of a therapeutically active agent, one or more retardants, and an optional water-insoluble binder is disclosed. The particles have a length of from about 0.1 to about 12 mm and can be of varying diameters and each unit dose provides a release of therapeutically active agents over at least about 8 hours. Methods of preparing the unit doses as well as extrusion processes and methods of treatment are also disclosed.

Abstract: Disclosed in certain embodiments is a controlled release oral dosage form comprising a therapeutically effective amount of a drug susceptible to abuse together with one or more pharmaceutically acceptable excipients; the dosage form further including a gelling agent in an effective amount to impart a viscosity unsuitable for administration selected from the group consisting of parenteral and nasal administration to a solubilized mixture formed when the dosage form is crushed and mixed with from about 0.5 to about 10 ml of an aqueous liquid; the dosage form providing a therapeutic effect for at least about 12 hours when orally administered to a human patient.

Abstract: A suspendible enteric coating composition for encasing orally ingestible articles wherein the enteric coating composition comprises a pH-dependent polymer selected from a group containing alginates and alginic acids, a pH-independent water insoluble polymer selected from the group comprising ethylcellulose and ethylcellulose-containing compositions, and a plasticizer selected from the group containing triethyl citrate, glycerin, propylene glycol, triacetin, acetylated monoglycerides, dibutyl sebacate, polyethylene glycols, sorbitals, middle chain triglycerides and combinations thereof.

Abstract: The present invention relates to a pharmaceutical formulation which comprises (i) a capsule, and (ii) a core comprising crystalline 2?-cyano-2?-deoxy-N4-palmitoyl-1-?-D-arabinofuranosylcytosine and a liquid carrier.

Abstract: Disclosed herein are alternative, enhanced, and cheaper methods of improving cognitive functions in a subject using a lipid composition conjugated with omega-3 and omega-6 fatty acids, with specific amounts and specific conjugation patterns of LA, linolenic acid (alpha-linolenic acid, gamma-linolenic acid) DHA and eicosapentaenoyl (EPA), e.g. utilizing different sources of lipids. Disclosed herein is a lipid preparation, said preparation comprising a phosphatidylserine moiety, and poly-unsaturated fatty acid (PUFA) acyl groups, particularly long-chain poly-unsaturated fatty acid (LC-PUFA) acyl groups such as omega-3 and/or omega-6 acyl groups, wherein said PUFA is covalently bound to said glycerophospholipid. Said lipid preparations are particularly useful in the treatment of mental and cognitive disorders, e.g. ADHD (attention deficit hyperactivity disorder) and Alzheimer's disease.

Abstract: Methods and systems for delivering biological products such as bone marrow aspirate (BMA) to different surgical sites during surgery (for example, arthroscopic surgery). The biological product is encapsulated or contained within a containment system comprising a carrier such as collagen carrier. The containment system may be formed of water soluble polymers, either natural, synthetic or semisynthetic, provided into films that may be made or molded into various shapes and sizes, and that may be manipulated to confer specific properties (such as solubility or degradation rates according to a specific environment, for example) of such films. The water soluble films may be processed into capsules, packets or other containers.

Abstract: A pharmaceutical composition comprising a camptothecin as active ingredient is herein described. In particular immediate-release therapeutic systems are described for the improved oral absorption of 7-[(E)-t-butyloxyminomethyl] camptothecin, comprising a matrix consisting of liquid amphiphilic substances or having a melting point lower than 60° C., in which the active principle is at least partially dissolved and/or dispersed and/or inglobated.

Abstract: The present invention relates to certain pharmaceutical compositions of a 5-HT2A serotonin receptor modulator and methods for preparing pharmaceutical composition related thereto. The pharmaceutical compositions are useful in the treatment of platelet aggregation, coronary artery disease, myocardial infarction, transient ischemic attack, angina, stroke, atrial fibrillation, reducing the risk of blood clot formation, asthma or symptoms thereof, agitation or a symptom, behavioral disorders, drug induced psychosis, excitative psychosis, Gilles de la Tourette's syndrome, manic disorder, organic or NOS psychosis, psychotic disorder, psychosis, acute schizophrenia, chronic schizophrenia, NOS schizophrenia and related disorders, sleep disorders, diabetic-related disorders, progressive multifocal leukoencephalopathy and the like.

Abstract: The present invention provides methods of treating a human or other mammal infected with a parasitic microorganism by administering an effective amount in unit dosage form of a C8-C16-alpha, beta-unsaturated aliphatic aldehyde, such as trans-2-dodecenal, to the human or other mammal. The parasitic microorganisms may include trypanosomes, bacteria, fungi and nematodes.

Abstract: The present invention relates to methods and compositions effective in preventing, attenuating, inhibiting the progression of, and treating eye diseases, e.g., age-related macular degeneration (AMD). The compositions comprise, as an active ingredient, an effective amount of 3,3?-diindolylmethane (DIM) and/or its precursor indole-3-carbinol (I3C). The compositions can further comprise additional agents such as carotenoids and other phytochemicals, which produce a synergistic effect in preventing, attenuating, inhibiting the progression of, and treating AMD and other eye diseases such as glaucoma, cataracts and diabetic retinopathy (DR). The compositions are particularly effective in treating and preventing wet AMD, and in preventing or inhibiting the progression of dry AMD (non-neovascular) to wet AMD (neovascular).

Abstract: The present invention provides a process to make a gelatine hydrolysate, a gelatine hydrolysate and gelatine compositions comprising gelatine hydrolysates. More specifically, the invention provides gelatine compositions having improved cross-linking and dissolution properties.

Abstract: Provided is a pharmaceutical composition comprising a 11-deoxy-prostaglandin compound represented by formula (I): and a fatty acid ester. By mixing the compound of formula (I) and a fatty acid ester, the compound of formula (I) will be stabilized.

Abstract: The current invention presents a dietary supplement obtained from a mixture of melatonin, vitamins and aminoacids for healing or regressing symptoms of gastroesophageal reflux disease (such as heartburn, regurgitation, dysphagia, coughing, hoarseness, chest pain and odynophagia), gastritis and several types of ulcerations.

Abstract: Provided are compounds useful for treating diseases associated with a cerebral accumulation of Alzheimer's amyloid, such as Alzheimer's disease. Also provided are methods of treating or reducing the risk of developing ?-amyloid production, ?-amyloid deposition, ?-amyloid neurotoxicity (including abnormal hyperphosphorylation of tau) and microgliosis associated with cerebral accumulation of Alzheimer's amyloid by administering therapeutically effective amounts of the compounds. Further provided are methods for diagnosing diseases associated with cerebral accumulation of Alzheimer's amyloid in animals or humans by administering diagnostically effective amounts of the compounds.

Abstract: The present invention is directed to size-stabilized drug nanoparticulate compositions and methods of preparation thereof.