Abstract: The invention relates to a pharmaceutical composition for the treatment of allergic and autoimmune diseases by in vivo generation of tolerogenic dendritic cells (DCs) and macrophages using tolerizing liposomes loaded with at least one maturation inhibitor of DCs and at least one antigen or allergen or peptide derived thereof, made of at least one preparation, and comprising a matrix suitable for locally restricted sustained release of therapeutically effective doses of therapeutics including tolerogenic liposomes tailored for effective phagocytosis, at least one immune modulator of phagocytosis, and optionally at least one immune modulator suitable for enhancing the suppressive function of regulatory T cells and/or inhibiting the production of pro-inflammatory cytokines, and/or inhibiting the biological activity of secreted pro-inflammatory cytokines at the site of antigen or allergen presentation.

Abstract: The present invention provides liposome compositions containing substituted ammonium and/or polyanion, and optionally with a desired therapeutic or imaging entity. The present invention also provide methods of making the liposome compositions provided by the present invention.

Abstract: The invention concerns lipid assemblies, liposomes having an outer surface comprising a mixture of anionic and cationic moieties; wherein at least a portion of the cationic moieties are imino moieties that are essentially charged under physiological conditions, and their use for serum resistant transfection of cells.

Abstract: The present invention provides methods for delivery of therapeutic agents to a subject using multi-component liposomal systems. The methods include administration of a therapeutic liposome containing an active agent, followed by a administration of an attacking liposome that induces release of the agents from the therapeutic liposome.

Abstract: The present disclosure generally relates to methods of making nanoparticles having about 0.2 to about 35 weight percent of a therapeutic agent; and about 10 to about 99 weight percent of biocompatible polymer such as a diblock poly(lactic) acid-poly(ethylene)glycol.

Abstract: This invention relates to devices, systems and methods for delivering preprogrammed quantities of an active ingredient to a biological system over time without the need for external power or electronics.

Abstract: Described herein are compositions of antibodies and carrier proteins and methods of making and using the same, in particular, as a cancer therapeutic. Also described are lyophilized compositions of antibodies and carrier proteins and methods of making and using the same, in particular, as a cancer therapeutic.

Abstract: The present invention comprises poly(vinyl benzoate) nanoparticle suspensions as molecular carriers. These nanoparticles can be formed by nanoprecipitation of poly(vinyl benzoate) in water using Pluronic F68 as surfactant, to create spherical nanostructures measuring about 200-250 nm in diameter which are stable in phosphate buffer and blood serum, and only slowly degrade in the presence of esterases. Kinetics experiments in phosphate buffer indicate that 78% of the coumarin-6 was encapsulated within the polymer matrix of the nanoparticle, and the residual 22% of coumarin-6 was surface-bound and quickly released. The nanoparticles are non-toxic in vitro towards human epithelial cells (IC50>1000 ?g/mL) and primary bovine primary aortic endothelial cells (IC50>500 ?g/mL), and exert non-observable bactericidal activity against a selection of representative test microbes (MIC>250 ?g/mL).

Abstract: The present disclosure generally relates to therapeutic nanoparticles. Exemplary nanoparticles disclosed herein may include about 1 to about 20 weight percent of a vinca alkaloid; and about 50 to about 99 weight percent biocompatible polymer.

Abstract: A process for producing a preparation in powder form containing at least one carotenoid. The process contains the following steps: i) suspending one or more carotenoids a) in an aqueous molecular dispersed or colloidal solution of at least one modified starch b) and sucrose c), ii) comminuting the suspended particles, and iii) subsequently converting the suspension optionally in the presence of a coating material into a dry powder; where the suspension contains in process step ii), based on the dry matter of the aqueous suspension, from 1 to 25% by weight of at least one carotenoid, and the ratio of carotenoid a) to sucrose c) is from 1:2 to 1:80 by weight.

Abstract: In one embodiment a layered pharmaceutical formulation includes two or more pharmaceutical layers and an intermediate layer disposed between at least two of the two or more pharmaceutical layers, the intermediate layer configured to dissolve in vivo to thereby leave the two or more pharmaceutical layers substantially intact. In one embodiment, an active pharmaceutical ingredient in at least one of the pharmaceutical layers is selected from bupropion, zonisamide, naltrexone, topiramate, phentermine, metformin, olanzapine and fluoxetine.

Abstract: The object of the present invention is to minimize the risks of dose dumping associated with the concomitant consumption of alcohol and certain modified-release pharmaceutical or dietetic forms. The invention relates to an oral form comprising microparticles of the reservoir type for the modified release of at least one active principle (AP), characterized in that it is resistant to immediate dumping of the dose of AP in the presence of alcohol. In particular, the oral form according to the invention is characterized in that the time taken to release 50% of the AP in an alcoholic solution is not reduced more than 3-fold relative to the time taken to release 50% of the AP in an alcohol-free aqueous medium. The form comprises an agent D, which is a pharmaceutically acceptable compound whose hydration or solvation rate or capacity is greater in an alcohol-free aqueous medium than in alcoholic solution.

Abstract: Depot formulations including therapeutic proteins are provided. The therapeutic proteins can be toxin-based therapeutic proteins. The depot formulations release the therapeutic protein within sustained effective levels for at least one month following a single administration. The toxin-based therapeutic proteins can include ShK-based proteins.

Abstract: Provided herein is a method of treating a condition in a host that is responsive to an agonist, the method comprising administering to the host a multi-layer pharmaceutical composition comprising the agonist and an antagonist thereof, wherein the agonist and antagonist are not in direct contact with one another in the intact form of the composition.

Abstract: A biocompatible polymer material is described that exhibits mechanical and physical properties that are fundamental to many medical devices and treatment of many medical diseases and disorders. The material is composed of a combination of acrylate monomers polymerized via a microemulsion polymerization. Multiple applications of the polymer material are presented.

Abstract: Cationic polymers are provided for delivering anionic active agents, preferably in the form or nanoparticles and other nanostructures. The polymer can be a polycation homopolymer or a copolymer containing a polycation block. The polycations and polycation containing polymers can contain dicarboxylic acid ester units and units of (a-amino acid)-?, ?-alkylene diester units. The nanoparticles can contain high loadings of anionic active agents, with sustained release of the active agents. Methods of making the polycations and polycation containing polymers are provided. Methods of making the nanoparticles and formulating them for administration to an individual in need thereof are also provided.

Abstract: A nano-composition that includes nanoparticles, a method of forming the nano-composition, and a method of using the composition. The nanoparticles include a nano-shell and one or more compounds co-encapsulated within the nano-shell. The nano-shell of each nanoparticle includes one or more chitosan polymers and one or more polymers subject to each chitosan polymer being covalently bonded to the one or more polymer. Each chitosan polymer in the nano-shell of each nanoparticle includes chitosan, tri-methylated chitosan, or a combination thereof. The one or more polymers in the nano-shell of each nanoparticle include poly (lactide-co-glycolide) (PLGA), one or more fatty acids, or combinations thereof subject to each fatty acid including oligomer epigallocatechin-3-gallate (OEGCG), hyaluronic acid, oleic acids, myristic acid, caprylic acid, or combinations thereof.

Abstract: The invention features sublingual film formulations of dopamine agonists and methods of treating Parkinson's disease, tremors, restless leg syndrome, sexual dysfunction, and depressive disorders therewith.

Abstract: The present invention relates to topical pharmaceutical emulsion compositions comprising a therapeutically effective amount of 3,5-Dihydroxy-4-isopropyl-trans-stilbene or a pharmaceutically acceptable salt thereof, an oil phase, a water phase, a surfactant, and an antioxidant, and wherein the emulsion composition is homogeneous and/or the active is solubilized in the oil phase. The invention also relates to methods of treating a dermatological condition or disorder in a patient by administering the present compositions to the skin of the patient.

Abstract: A method of treating a disease state or condition in humans via topical brainstem afferent stimulation therapy via the administration of a cannabinoid drug(s) and a second therapeutically active agent(s) to the back of the neck of a human patient to provide regional neuro-affective therapy is disclosed. In certain preferred embodiments, the cannabinoid drug(s) are not psychoactive or substantially not psychoactive. In certain embodiments, the drugs are incorporated into a pharmaceutically acceptable topical carrier, e.g., a cream. In certain preferred embodiments, the cannabinoid drug(s) comprises cannabidiol.

Abstract: The present invention relates to a pharmaceutical composition comprising a therapeutically effective amount of a calcium receptor-active compound and at least one pharmaceutically acceptable excipient, wherein the composition has a controlled dissolution profile. The present invention further relates to a method of manufacturing the pharmaceutical composition, as well as a method of treating a disease using the pharmaceutical composition.

Abstract: Summary: The invention relates to a monolithic pharmaceutical dosage form comprising a hot melt-extruded first segment (S1) and a second segment (S2); wherein the first segment (S1) contains at least a first pharmacologically active ingredient (A1) and/or the second segment (S2) contains at least a second pharmacologically active ingredient (A2); and the segment (S1) and/or the segment (S2) is tamper-resistant and/or exhibits a breaking strength of at least 300 N.

Abstract: The present invention is directed to, inter alia, methods and kits for the treatment of depression (preferably, treatment resistant depression), or for the treatment of depression in a suicidal patient, and/or for the treatment and/or prevention of suicidality (e.g. suicidal ideations) comprising administering esketamine according to certain dosing regimens.

Abstract: The present invention provides various pharmaceutical compositions comprising an S1P receptor modulator, e.g. an S1P receptor agonist. In one aspect, there is provided a pharmaceutical composition having a coating. In other aspects, rapid disintegrating compositions are provided. In a further aspect, a pharmaceutical composition which is free of sugar alcohols is provided. In another aspect, the invention provides a pharmaceutical composition comprising a coating comprising an S1 Preceptor modulator.

Abstract: The disclosure provides skin probiotics, fermented media extract and fermentation byproducts thereof for the treatment of skin disease and disorders as well as for the prevention/treatment of acne and MRSA.

Abstract: Neonatal seizure is different from adult seizure, and many antiepileptic drugs that are effective in adults often fail to treat neonatal seizure. Gluconic acid, a natural organic acid enriched in fruits and honey, is shown herein to potently inhibit neonatal epilepsy both in vitro and in vivo. Sodium gluconate is shown to inhibit epileptiform burst activity in cell cultures and protect neurons from kainic acid-induced cell death. Sodium gluconate also inhibited epileptiform burst activity in brain slices in a manner that was much more potent in neonatal animals than in older animals. Consistently, in vivo EEG recordings also revealed that sodium gluconate inhibited the epileptic seizure activity in a manner that was much more potent in neonates than in adult animals. Mechanistically, sodium gluconate inhibits voltage-dependent CLC-3 Cl? channels both in neuronal cultures and in hippocampal slices.

Abstract: The invention provides a method for a disease or condition associated with dopamine deficiency (e.g. depression, schizophrenia, or Parkinson's disease) in a mammal in need of such treatment comprising administering a compound that binds to RXR to the mammal.

Abstract: Some embodiments of the present application are directed to oral formulations of L-ornithine phenylacetate and methods of preparing the same. These oral formulations offer alternative administration route than the standard intravenous administration of L-ornithine phenylacetate for treating hyperammonemia in patients having various acute and chronic liver diseases and disorders, for example, acute liver failure, liver cirrhosis, liver decompensation, portal hypertension, hepatic encephalopathy, or patients with urea cycle disorders.

Abstract: Compositions and methods useful for inducing an increase in fatty acid oxidation or mitochondrial biogenesis, reducing weight gain, inducing weight loss, or increasing Sirt1, Sirt3, or AMPK activity are provided herein. Such compositions can contain synergizing amounts of a sirtuin-pathway activators, including but not limited to resveratrol, in combination with beta-hydroxymethylbutyrate (HMB), keto isocaproic acid (KIC), leucine, or combinations of HMB, KIC and leucine.

Abstract: Particle formulations are disclosed that include polymeric particles containing a small molecule drug and a high molecular weight therapeutic protein. Methods of making and using the particle formulations also are disclosed. These particle formulations are of use to treat an autoimmune disease, such as diabetes, or an inflammatory disease.

Abstract: The present invention relates to a topical solution comprising a retinoid or its pharmaceutically acceptable salts thereof and process of preparing it.

Abstract: The invention provides methods for treating auditory impairments in a subject in need of treatment comprising administering to said subject an effective amount of a composition comprising, as an active agent, one or more of a carboxy alkyl ester, a quinic acid derivative, a caffeic acid derivative, a ferulic acid derivative, or a quinic acid lactone or derivative thereof or pharmaceutically acceptable salt thereof and an acceptable carrier or excipient, so as to treat auditory impairments in the subject.

Abstract: Described herein are compositions that include an aqueous phase and 5 to 30%, by weight, of an oil phase, based on the total weight of the composition. The oil phase comprises the omega-3 fatty acid triglyceride eicosapentaenoic acid triglyceride, docosahexaenoic acid triglyceride, or mixtures thereof. The composition further comprises at least one amphoteric surfactant, at least one co-surfactant, and at least one co-solvent. The compositions comprise less than 0.03% by weight of sodium oleate, based on the total weight of the composition. Also described are methods for preparing such compositions as well as such compositions for use as a medicament, in particular for use in treating stroke, sepsis, Alzheimer's disease or cancer. Also featured are methods of treating these conditions by parenterally administering a composition to a patient in need and methods of providing parenteral nutrition to such patients by administering to them a composition as described herein.

Abstract: This invention is directed to analogs of 5-(tetradecyloxy)-2-furancarboxylic acid (TOFA) and their use in the treatment of dermatological disorders or conditions characterized by sebaceous gland hyperactivity, such as acne and oily skin, and other dermatological disorders and conditions. This invention is also directed to pharmaceutical compositions comprising analogs of TOFA and a pharmaceutically acceptable excipient for dermatological or oral administration.

Abstract: The present invention relates to a solid pharmaceutical composition for oral administration characterized in that it comprises a benzofuran derivative with antiarrhythmic activity, or one of the pharmaceutically acceptable salts thereof, as an active principle, and a pharmaceutically acceptable nonionic hydrophilic surfactant optionally in combination with one or more pharmaceutical excipients.

Abstract: The invention relates to the combined use of at least one monoterpene which can be applied systemically, in particular perorally, and at least one respiratory tract therapeutic agent which can be applied topically, in particular through inhalation, for the prophylactic and/or therapeutic treatment, in particular combination therapy and/or co-medication, of respiratory tract diseases, in particular bronchopulmonary diseases. Through the combined use of the systemic monoterpene with the topical, in particular inhaled respiratory tract therapeutic agent, the effect or efficiency of the topical or inhaled respiratory disease therapeutic agent can be increased significantly, in particular in a synergistic manner, on the one hand, and the required dosage thereof can be reduced significantly on the other hand, combined with the resulting advantages (e.g., avoidance or reduction of side effects).

Abstract: Disclosed herein are seventeen new compounds obtained from an acetone-extracted product of gamboge resin. The seventeen new compounds have activities in inhibiting the growth of tumor/cancer cells.

Abstract: A composite comprising 3?-hydroxygenistein and a use for inhibition of melanogenesis are revealed herein. An effective dose of 3?-hydroxygenistein is applied to skin for inhibition of tyrosinase activity and further inhibition of melanogensis, so that 3?-hydroxygenistein can be used in cosmetic composition.

Abstract: A method of treating a chronic wound in a subject in need of such treatment is provided. The method includes administering to the subject at least one antioxidant agent in an amount effective to treat the wound. In some versions, the antioxidant agent is ?-tocopherol or N-acetyl cysteine, or a combination of these compounds.

Abstract: The present invention discloses a method for producing trans-2-nonadecyl-4-hydroxymethyl-1,3-dioxolane comprising mixing alkanes and pyridinium chlorochromat for an oxidation reaction; obtaining a product by the oxidation reaction for processing an aldolization reaction and then purifying for obtaining a trans-2-nonadecyl-4-hydroxymethyl-1,3-dioxolane compound. According to the method of the present invention, it is able to promote the productivity and reduce the cost.

Abstract: Provided herein are compositions and methods for the treatment of androgen and estrogen receptors mediated conditions. Specifically, a composition that includes an effective amount of a selective estrogen receptor modulator (SERM) and an effective amount of a 5a-reductase inhibitor, or a pharmaceutically acceptable salt, ester or prodrug of the foregoing is provided. Also provided are methods for the treatment of aging related conditions and diseases.

Abstract: A compound for use in treating polycystic kidney disease is represented by Structural Formula (I): or a pharmaceutically acceptable salt thereof. A pharmaceutical composition comprises a compound represented by Structural Formula (I) or a pharmaceutically acceptable salt thereof. A method of treating polycystic kidney disease in a subject in need thereof comprises administering to the subject a therapeutically effective amount of a compound represented by Structural Formula (I) or a pharmaceutically acceptable salt thereof. Methods of treating in polycystic kidney disease in a subject in need thereof respectively comprise administering to the subject a therapeutically effective amount of a compound represented by Structural Formula (I) or a pharmaceutically acceptable salt thereof.

Abstract: This invention is directed to a topical cream containing allantoin in an oil-in-water emulsion formulation. A method is provided for treating or reducing keloid formation in a patient in need thereof comprising contacting the patient's skin with an effective amount of a composition comprising allantoin in an amount from about 3.0% to about 15% by weight and a pharmaceutically acceptable excipient. In contrast to other efforts to reduce keloid formation, the present invention uses topical compositions comprising allantoin as an active pharmaceutical ingredient at higher concentrations and reduces or eliminates the occurrence of keloid formation in a shorter period of time after using the topical composition comprising allantoin.

Abstract: Heterocyclic modulators of lipid synthesis are provided as well as pharmaceutically acceptable salts thereof; pharmaceutical compositions comprising such compounds; and methods of treating conditions characterized by dysregulation of a fatty acid synthase pathway by the administration of such compounds and combinations of such compounds and other therapeutic agents.

Abstract: The present disclosure relates to compounds, compositions and methods for the treatment of Hepatitis C virus (HCV) infection. Also disclosed are pharmaceutical compositions containing such compounds and methods for using these compounds in the treatment of HCV infection.

Abstract: The present disclosure is directed to compounds of formula (I), and pharmaceutically acceptable salts thereof, as mPGES-1 inhibitors. These compounds are inhibitors of the microsomal prostaglandin E synthase-1 (mPGES-1) enzyme and are therefore useful in the treatment of pain and/or inflammation from a variety of diseases or conditions, such as asthma, osteoarthritis, rheumatoid arthritis, acute or chronic pain and neurodegenerative diseases.

Abstract: The invention provides thiazole-substituted indolin-2-ones as inhibitors of cancer stem cell pathway kinases (CSCPK) and related kinases, and methods of using these compounds, to treat subjects in need thereof.

Abstract: The invention is directed to a pediatric oral suspension composition containing amoxicillin and clavulanate potassium where the clavulanate potassium is present in an amount equal to or less than about 21.5 mg/5 mL, and a method of treating bacterial infections by providing between about one to about fourteen dosage days of the composition.

Abstract: The present invention relates to a sterile pharmaceutical composition comprising tiotropium or a pharmaceutically acceptable salt thereof, for inhalation via nebulization to a subject (e.g. a human). The invention also relates to a process for preparing the pharmaceutical composition and its use in the treatment of respiratory diseases such as chronic obstructive pulmonary disease (COPD) in a subject.

Abstract: A pharmaceutical composition comprising sorafenib and GW5074. Said combination therapy inhibits cancer cell growth via c-Raf-PP2A-DAPK signaling transduction pathway in either in vitro or in preclinical animal model for orthotopic spontaneous kidney cancer which simulates clinical symptoms. Formation of the bond between c-Raf and GW5074 leads to conformational change which consequently increases the affinity between sorafenib and c-Raf. Binding with the specific drug target facilitates serine 308 dephosphorylation of DAPK by PP2A and induces necrosis in cancer cells. Serine 308 of DAPK protein may also be used as a biomarker for drug screening. This study provides a novel pharmaceutical composition comprising sorafenib and GW5074, a protein complex target consisting of c-Raf and DAPK for drug designing, as well as biomarkers including c-Raf protein, DAPK protein and phosphorylation status of DAPK for drug screening.