Abstract: This invention relates to a naproxen formulation suitable for encapsulation into a soft gel dosage unit by increasing the stability, concentration, and bioavailability of naproxen. Fill formulations of the invention may include other active pharmaceutical ingredients and combinations of two or more active pharmaceutical ingredients. This invention also provides for adjusting pH values of fill formulations without additional process steps. A process for increasing the achievable concentration of an active NSAID pharmaceutical ingredient, such as naproxen, relative to fill composition for dosage units is also provided. The highly concentrated formulation of this invention permits a reduction in the fill volume or dosage unit size, or an increase in concentration of the active pharmaceutical ingredient per dosage form. The invention also relates to a formulation of optimal stability suitable for supporting a fill composition compatible with the soft gel dosage unit.

Abstract: The present invention relates to a method of reducing or preventing the symptoms associated with the common cold. The method comprises administering to a subject an effective amount of a pharmaceutical composition before presenting with at least one symptom of the common cold. The pharmaceutical composition comprises a non-steroidal anti-inflammatory drug and a co-agent selected from the group consisting of: fexofenadine, ketotifen, desloratadine, salts thereof, and combinations thereof.

Abstract: A fuel additive composition comprising an anthocyanidin; an amino acid; and a catalyst. The anthocyanidin may comprise delphinidin chloride. The amino acid may comprise aspartic acid, leucine acid, glutamic acid, a non-natural amino acid, or a combination thereof. Embodiments of the present invention also relate to a method for making of fuel additive, the method comprising: providing an anthocyanidin; contacting the anthocyanidin with an amino acid to form an anthocyanidin-amino acid mixture; contacting the anthocyanidin-amino acid mixture with a catalyst. The method may further comprise contacting the anthocyanidin-amino acid mixture with ethanol and/or an acid. The method may further comprise adjusting the pH of the anthocyanidin-amino acid mixture to less than 7.

Abstract: A tumescent composition comprising a drug or a therapeutic agent in a tumescent solution, wherein a tumescent concentration of the drug or therapeutic agent is simultaneously below a threshold for local, subcutaneous tissue toxicity, above a threshold for positive local therapeutic effect, and above a concentration safely achievable by intravenous (IV), intramuscular (IM) or oral (PO) delivery; and the tumescent solution comprises a vasoconstrictor; a pharmaceutically acceptable carrier; and optionally a local anesthetic, wherein the tumescent solution does not comprise an antibiotic.

Abstract: Methods and compositions containing a phorbol ester or a derivative of a phorbol ester are provided for the treatment of chronic and acute conditions. Such conditions may be caused by disease, be symptoms or sequelae of disease. Chronic and acute conditions may be due to viral infections such as HIV and AIDS, neoplastic diseases stroke, kidney disease, urinary incontinence, autoimmune disorders, Parkinson's disease, prostate hypertrophy, aging, or the treatment of such diseases. Additional compositions and methods are provided which employ a phorbol ester or derivative compound in combination with at least one additional agent to yield more effective treatment tools against acute and chronic conditions in mammalian subjects.

Abstract: A method of increasing the solubility of a water-insoluble or slightly water-soluble hydrophobic organic compound in an aqueous solvent includes adding a saponin component selected from escin, glycyrrhizin, and Quillaya saponaria extract to the aqueous solvent in an amount sufficient to trigger the formation of micelles, wherein in a first step the hydrophobic organic compound is pre-dissolved in an organic solvent, and in a second step the organic solvent comprising the pre-dissolved compound is admixed to the aqueous solvent, whereby at least a part of the insoluble or slightly soluble hydrophobic organic compound gets solubilized and dissolved in the aqueous solvent, yielding an aqueous composition having an increased concentration of said organic compound dissolved therein. Also indicated are pharmaceutical or cosmetic compositions including a water-insoluble or slightly water-soluble organic compound dissolved in an aqueous solvent at substantially increased concentrations.

Abstract: The invention relates to a composition and use of the composition in the treatment of a disorder, for example, a neurological disease associated with retinoid signaling. The invention also includes the use of a retinoid encapsulated in nanoparticles. The retinoid encapsulated nanoparticles are adapted to increasing lifespan and conferring neuroprotective effects such as preserving motor units, reducing motor impairment, or reducing neuroinflammation in a subject.

Abstract: A new class of synthetic cyclodextrin dimers is described. Exemplary cyclodextrin dimers can treat atherosclerotic plaques by targeting various forms cholesterol both intracellularly and extracellularly. Also provided are methods of depleting atherosclerotic plaques of cholesterol, cholesterol esters, 7-ketocholesterol and 7-ketocholesterol esters by treatment with such cyclodextrins. Further described are subclasses of dimers that have high specificity for 7-ketocholesterol.

Abstract: This invention provides compounds of Formulae (IA), (IB), (IC), (ID), (IE), (IF), (IG), (IH), (IJ), (IK), (IL), (II), (III), (IIIA), and (IIIB); pharmaceutically acceptable salts and solvates thereof; and compositions thereof.

Abstract: There is provided a neurostimulator and method for delivering to a subject a stimulation in response to a predicted or detected condition. The neurostimulator including: a power circuit for providing electrical power to the neurostimulator; a recording array having a plurality of electrodes for recording a plurality of neurophysiological signals corresponding to a plurality of sites of the subject; a signal processor configured to: determine a phase synchrony among the neurophysiological signals; and associate selected phase synchrony calculations with the prediction or detection of a neurological or neurophysiological condition; and one or more stimulators for delivering to the subject a stimulation in response to the predicted or detected condition.

Abstract: A transdermal composition comprising ibuprofen or salts thereof and a gelling agent which can be used for the treatment of such disorders as pain, inflammation, arthritis, muscle spasm and associated symptoms in humans and animals.

Abstract: Improved formulations for topical treatment that ensure at least localized transdermal or systemic delivery of an active agent through skin, nails or hair follicles are disclosed.

Abstract: The present invention provides a method of inhibiting dependence to an opioid by a human subject in need thereof. The method comprises administering an effective amount of a pharmaceutical composition to the subject during opioid therapy. The pharmaceutical composition comprises a) a non-steroidal anti-inflammatory drug (NSAID); and b) a co-agent selected from the group consisting of: fexofenadine, ketotifen, desloratadine, cetirizine, salts thereof and combinations thereof.

Abstract: The invention describes a long-acting veterinary composition comprising at least one ketoprofen ester prodrug. The composition also comprises at least one veterinary acceptable triglyceride, and optionally, at least one preservative, and optionally, at least one additional veterinary acceptable excipient. The invention also describes a method of treating an animal for fever, pain, and/or inflammation by administering the long-acting composition comprising at least one ketoprofen ester prodrug to the animal in need thereof.

Abstract: Described herein are oral pharmaceutical compositions suitable for chewing, sucking, or buccal dissolution comprising soft gel capsules and liquid fills, methods for making the same, and methods for treating subjects in need thereof with such capsules. In particular, oral pharmaceutical compositions comprising chewable, suckable, or dissolvable soft gel capsules with various flowable fill compositions are described.

Abstract: Compositions for topical administration of a hedgehog inhibitor compound are described. In one embodiment, the hedgehog inhibitor compound is patidegib and the topical composition comprises the compound in a solvent system of a monohydric primary alcohol and a polyol in a w/w ratio of between about 0.9-1.8. In another embodiment, the hedgehog inhibitor is itraconazole and the topical composition comprises the compound in a solvent system comprising a monohydric primary alcohol and an optionally lower alkyl end-capped oligomeric alkylene glycol in a w/w ratio of between about 0.8 and 2.6 and a fused bicyclic ether. Method of using the compositions are also described, where in one embodiment, the compositions are topically applied for treating or preventing basal cell carcinoma.

Abstract: A liquid throat spray composition for topical application to a sore throat including an aqueous solution of an NSAID and cyclodextrin.

Abstract: A thermally conductive silicone composition is shown and described herein. The thermally conductive silicone composition comprises (A) an ionically modified siloxane, and (B) a thermally conductive filler comprising a first filler and a second filler, where the first filler and/or the second filler comprises a plurality of filler types, the plurality of filler types differing from one another in terms of particle size and/or morphology. The ionically modified siloxane may function as a dispersing aid or wetter for efficient dispersion of thermal conducting organic and inorganic fillers to achieve high thermal conductivity.

Abstract: An aqueous oral liquid pharmaceutical composition system with reduced propensity for agglomeration and phase separation which is particularly amendable to the suspension of one or more pharmaceutical actives that are substantially insoluble in water. The oral liquid pharmaceutical composition may further comprise pharmaceutical actives that are soluble in water and dissolve in the aqueous medium. In the composition of the invention both suspended and any dissolved active agents are distributed homogeneously.

Abstract: An ophthalmic lens or an intraocular lens releasing anthocyanin for the benefit of a user's eyes includes a matrix and anthocyanin dispersed in the matrix. An ophthalmic lens package includes a lens protection solution and the ophthalmic lens, the ophthalmic lens is immersed in the lens protection solution.

Abstract: Treatment and diagnostic methods are provided for pulmonary disease, including chronic obstructive pulmonary disease. Various pro-inflammatory mediators are elevated in a model of COPD that can be used predict the presence of COPD and/or subtypes of COPD in human patients. Profiles of these mediators can also predict the responsiveness of some patients to certain therapies, including thromboxane receptor antagonist treatment. Methods are provided for diagnosing a subject as a pulmonary disease candidate that include determining leukocyte expression in the subject of at least one pro-inflammatory mediator and identifying the subject as a pulmonary disease candidate when leukocyte expression in the subject of the pro-inflammatory mediator is increased compared to leukocyte expression of the pro-inflammatory mediator in a healthy individual. The pulmonary disease candidate can also be treated by administering a therapeutically effective amount of a thromboxane receptor antagonist.

Abstract: A pharmaceutical composition as a solid oral dosage form is described, comprising: i) a combination of two pharmacological active principles, dexketoprofen salt with an organic or inorganic base and tramadol salt with an organic or inorganic acid, wherein: the organic or inorganic base is selected in the group: trometamol, trimethylamine, dimethylamine, ethylamine, triethylamine, diethylamine, L-lysine, L-arginine, diethanolamine, sodium hydroxide, calcium hydroxide the organic or inorganic acid is selected in the group: hydrochloric, hydrobromic, phosphoric, sulfuric, methanesulfonic, benzenesulfonic, toluenesulfonic, acetic, propionic, malic, maleic, succinic, citric, L-tartaric, lactic, malonic, aspartic, glutamic; ii) microcrystalline cellulose as a filler; iii) a binder selected in the group: maize starch, pre-gelatinized maize starch, hypromellose or their mixtures; iv) pharmaceutically acceptable excipients.

Abstract: A pull-out wand is disclosed for use with a water delivery device. The pull-out wand may include one or more sensors, such as a touch sensor and/or a proximity sensor.

Abstract: A transdermal composition comprising ibuprofen or salts thereof and a gelling agent which can be used for the treatment of such disorders as pain, inflammation, arthritis, muscle spasm and associated symptoms in humans and animals.

Abstract: The present specification discloses pharmaceutical compositions, methods of preparing such pharmaceutical compositions, and methods and uses of treating a chronic inflammation and/or an inflammatory disease in an individual using such pharmaceutical compositions.

Abstract: The present invention relates to the use of 4-phenylbutyric acid, or one of the salts thereof, for improving the resistance of plants to harmful biological organisms, in particular to bacteria, viruses and nematodes, and for inhibiting hypersensitive cell death induced by such harmful biological organisms. The present invention also relates to the use of 4-phenylbutyric acid, or one of the salts thereof, as an antimicrobial agent for preventing or treating plant diseases caused by phytopathogens.

Abstract: The invention features 4-((phenoxyalkyl)thio)-phenoxyacetic acids and analogs, compositions containing them, and methods of using them as PPAR delta modulators to treat or inhibit the progression of, for example, dyslipidemia.

Abstract: It is the object of the present invention a composition containing an N-acyl-ethanolamine in a solubilized form, particularly a solution for ophthalmic, intra-articular or intravesical use. Particularly, the present invention relates to a water-soluble composition comprising one or more N-acylethanolamines (NAE) in the form of an inclusion complex in methyl-beta-cyclodextrin (M?CD).

Abstract: An injection-molded shell of a dosage form of good quality is producible by a) providing a composition comprising i) from 25 to 90 weight percent of ethylcellulose, ii) from 7.5 to 60 weight percent of a polysaccharide or polysaccharide derivative being different from ethylcellulose, and iii) from 2.5 to 50 weight percent of at least one component being different from polysaccharides and polysaccharide derivatives, based on the total weight of the composition, with the proviso that the composition comprises zero or not more than 10 weight percent of gelatin and zero or not more than 10 weight percent of a polymer comprising homo- or copolymerized acrylic acid, homo- or copolymerized methacrylic acid, a homo- or copolymerized acrylate or a homo- or copolymerized methacrylate, and b) subjecting the composition to shearing and heat to plasticize the composition and injection-molding the plasticized composition into a three-dimensional shell of a dosage form.

Abstract: The present invention relates to carriers for the controlled release of active agents, comprising a core, comprising surface reacted natural or synthetic calcium carbonate, and at least one active agent, wherein said at least one active agent is associated with said natural or synthetic surface-reacted calcium carbonate, and wherein said surface-reacted natural or synthetic calcium carbonate is a reaction product of natural or synthetic calcium carbonate with carbon dioxide and one or more acids, wherein the carbon dioxide is formed in situ by the acid treatment and/or is supplied from an external source, and a coating encapsulating the core. It furthermore relates to the preparation of loaded carriers, as well as their use in different applications.

Abstract: Disclosed herein are compounds and compositions useful for reducing the risk of infection. In particular, disclosed herein are mandelic acid condensation polymers, compositions comprising such compounds, processes for producing such compounds, and methods of using such compounds.

Abstract: The disclosures herein provide compounds of Formula I, Formula II, Formula III, Formula IV, Formula V, Formula VI and Formula VII or its pharmaceutical acceptable compositions and salts, as well as polymorphs, enantiomers, stereoisomers, solvates, and hydrates thereof. The pharmaceutical compositions may be formulated for oral administration, delayed release or sustained release, transmucosal, syrup, topical, parenteral administration, injection, subdermal, oral solution, rectal administration, nanoparticle, buccal administration or transdermal administration. Such compositions may be used to treatment of urea cycle disorders and gout or its associated complications.

Abstract: The invention relates to the compounds of formula I or its pharmaceutical acceptable salts, as well as polymorphs, solvates, enantiomers, stereoisomers and hydrates thereof. The pharmaceutical compositions comprising an effective amount of compounds of formula I, and methods for the treatment of fibromyalgia pain may be formulated for oral, buccal, rectal, topical, transdermal, transmucosal, intravenous, parenteral administration, syrup, or injection. Such compositions may be used to treatment of injury, post-operative pain, osteoarthritis, rheumatoid arthritis, multiple sclerosis, spinal cord injury, migraine, HIV related neuropathic pain, post herpetic neuralgia, diabetic neuropathy, bipolar depression, stress, cancer pain, and lower back pain.

Abstract: The present invention relates to a process for the preparation of a compound of formula (I) or a pharmaceutically acceptable salt thereof: wherein R represents one or more groups independently selected from fluorine, chlorine, bromine, and iodine, said process comprising the cyclopropanation of a compound of formula (II) with ethylene carbonate or ethylene sulfate: wherein X is chlorine, bromine, iodine or a triflate group (CF3SO3) or a group wherein R is as defined above and G is —CN or —COOR2 wherein R2 is a C1-C4 straight or branched alkyl chain.

Abstract: Injectable formulations of water-soluble salts of diclofenac, which cause significantly less pain at the site of injection and can be administered by intradeltoid route, in addition to intragluteal and slow intravenous route.

Abstract: A process for producing a solubilized ibuprofen, preferably in the form of a granulate, the process comprising the steps of: providing a mixture comprising solid ibuprofen and a first base selected from the group consisting of sodium hydroxide, potassium hydroxide, sodium carbonate, potassium carbonate, sodium glycinate, potassium glycinate and tribasic sodium and potassium phosphates and mixtures thereof, and reacting the ibuprofen and the first base in essentially dry state. The obtainable granulate and the pharmaceutical compositions and dosage forms that may be produced therefrom are distinguished by their high solubility and rapid disintegration and dissolution in aqueous media, by their good flow properties and compressibility, by rapidly achieving onset of analgesic effect.

Abstract: The present invention provides a process for preparing a pharmaceutical composition of fingolimod comprising: (i) obtaining a intimate admixture comprising fingolimod or a pharmaceutically acceptable salt thereof, and at least one surfactant (wetting agent), e.g., an intimate admixture of the fingolimod and the at least one surfactant, and (ii) optionally combining the intimate admixture from step (i) with one or more excipients. Also provided are pharmaceutical compositions and dosage forms obtainable by the process, uses of the pharmaceutical compositions and dosage forms, and methods of treating appropriate diseases with the pharmaceutical compositions or dosage forms.

Abstract: Provided herein are compositions and methods for treating cancer by increasing the inhibitory effect of cetuximab on HIF1? expression by administering cetuximab in combination with anti-angiogenic thyroid hormone analogs such as tetrac or triac.

Abstract: The present invention provides compounds, and compositions comprising these compounds, which have immunomodulatory activity and/or anti-inflammatory activity.

Abstract: Methods of treating at least one condition chosen from pain, inflammation, and fever in a critically ill patient in need thereof, comprising administering to the critically ill patient an intravenous pharmaceutical composition comprising ibuprofen using a first dosage regimen, wherein the first dosage regimen produces a first pharmacokinetic profile in critically ill patients that is about equivalent to a second pharmacokinetic profile produced by administration of the intravenous pharmaceutical composition using a second dosage regimen of ibuprofen to non-critically ill patients, wherein the at least one condition of the critically ill patient is thereby treated.

Abstract: The present invention provides a pharmaceutical composition for ameliorating and/or preventing leptin resistance. The pharmaceutical composition of the present invention contains flurbiprofen.

Abstract: Methods of treating a patient in need thereof, comprising administering to the critically ill patient an intravenous pharmaceutical composition comprising ibuprofen in an amount effective to treat at least one condition in the patient chosen from pain, inflammation, and fever and to provide a clinically relevant effect on mean arterial pressure of the patients during the dosage interval comprising no increase or no statistically significant increase in mean arterial pressure.

Abstract: Provided are methods, test devices, and diagnostic kits for predicting, assessing, and diagnosing the risk of a disease using salivary analysis. The methods comprise providing a whole (unfractionated) saliva sample from a subject; contacting an aliquot of the saliva with two or more lectins under conditions that allow the two or more lectins to bind to a lectin-binding component of the saliva; detecting the amount of bound lectin; and comparing the amount of bound lectin to the amount known to bind a saliva sample from a control patient, to predict the risk of a disease in the subject. Also provided are methods for reducing the risk of a disease and a method for assessing the risk of the disease at a defined level.

Abstract: The invention provides extended release pro-liposomal, non-aqueous, pharmaceutical formulations of a hydrophobic active pharmaceutical ingredient (API) of low water solubility but readily dissolved in alcohols and methods for making same. The formulations can be administered by infiltration into an incision, or by injection.

Abstract: A silicone gel (“silogel”) composition used to deliver pharmaceutical products transdermally as well as a method for producing the silogel composition, which may contain up to 80% additive ingredients. Preferred embodiments of the invention may include silogel compositions which provide high viscosity/no separation due to API. They are not temperature-sensitive, have no shear stress from the ointment mill/EMP, have no gumming up/stickiness, and no hardening.

Abstract: A system is described for long-term controlled release delivery of a drug or a therapeutic agent. According to the invention, one or more drugs or therapeutic agents contained in microspheres are mixed with a temperature sensitive hydrogel which is then introduced directly to the desired situs of the drug or therapeutic agent. The temperature sensitive hydrogel may also contain a drug or a therapeutic agent, for example, a pain relieving drug, for a short-term controlled release. The temperature sensitive hydrogel is in liquid state at room temperature, but upon injection, shortly becomes gelatinous. This system is particularly suitable for treatment of diseases, disorders, or conditions, for example, tumors, discogenic back pain, or arthritis, warranting localized administration of a drug or a therapeutic agent. In addition, the specification provides a method for production of a drug- or therapeutic agent-containing microspheres.

Abstract: The present invention relates to the use of a 2,5-dihydroxybenzene derivative of formula (I) or a pharmaceutically acceptable salt, solvate, isomer, or prodrug thereof for the treatment and/or prophylaxis of, inter alia, rosacea.

Abstract: The present disclosure relates to a semi-solid topical drug delivery formulation including a silicone-based excipient, at least one volatile solvent, at least one active configured to be topically delivered through a patient's skin for an intended therapeutic application, and at least one enhancer. The formulation may additionally optionally include at least one agent that provides occlusivity when the formulation is applied onto a patient's skin. The at least one active may be a healthcare and/or pharmaceutical active.

Abstract: A method for screening a patient for angioinhibition resistance and treating said patient having a disease susceptible to treatment via an anti-angiogenic agent. The screening method includes an assay for identifying the presence of angioinhibition resistance in patients by collecting patient blood or serum and subjecting it to a Chick Chorioallantoic Membrane (CAM) angiogenesis assay configured for accepting a human tumor wherein the human tumor xenograft includes a vasculature system. The screening method and assay further includes steps that include using the CAM results for identifying the endogenous pro-angiogenic non-peptide hormone concentrations of the blood sample by calculating the vascular activity of the vasculature system of the human tumor xenograft in the presence of anti-angiogenic drugs and inducing in the patient, a state of subclinical hypothyroidism prior to commencing anti-angiogenic treatment.

Abstract: The present invention relates to nanocrystalline solid dispersion compositions having discrete particles, wherein each discrete particle comprises crystals of at least one pharmaceutical active; veterinary active; nutraceutical active dispersed in the matrix of at least one crystallization inducer and/or coexisting with crystals of crystallization inducer, optionally along with pharmaceutically acceptable excipients. The present invention also encompasses a novel one-step process for generation of nanocrystalline solid dispersions. The present invention is particularly of use for improving the dissolution of pharmaceutical actives, veterinary actives; nutraceutical actives exhibiting dissolution-limited bioavailability. Dissolution enhancement is because of the decreased crystallite size of the pharmaceutical active.