Abstract: The invention disclosed herein is a process for increasing the desired concentration of a pharmaceutically active ingredient relative to fill composition viscosity for dosage units. The process is particularly useful in the preparation of soft gelatin capsules containing pharmaceutically active ingredient. As a result of the process, lesser quantities of inactive ingredients are needed to accomplish the same therapeutically effective dosage, thereby significantly increasing the concentration of the pharmaceutically active ingredient resulting in either a reduction in overall fill volume and dosage unit size or an increase in concentration of pharmaceutically active ingredient per unit dosage form.

Abstract: An implantable device for delivery of a macromolecular drug compound is provided. The device comprises a core having an outer surface and a membrane layer positioned adjacent to the outer surface of the core. The core comprises a core polymer matrix within which is dispersed a drug compound having a molecular weight of about 0.5 kDa or more, the polymer matrix containing a hydrophobic polymer. Further, the membrane layer comprises a membrane polymer matrix within which the macromolecular drug compound is optionally dispersed. The membrane polymer matrix contains a hydrophobic polymer in combination with a hydrophilic compound, and the weight ratio of the hydrophobic polymer to the hydrophilic compound within the membrane polymer matrix ranges from about 0.25 to about 200.

Abstract: An implantable device for delivery of a macromolecular drug compound is provided. The device comprises a core having an outer surface and a membrane layer positioned adjacent to the outer surface of the core. The core comprises a core polymer matrix within which is dispersed a drug compound having a molecular weight of about 0.5 kDa or more, the polymer matrix containing a hydrophobic polymer. Further, the membrane layer comprises a membrane polymer matrix within which the macromolecular drug compound is optionally dispersed. The concentration of the macromolecular drug compound in the core is greater than the concentration of the macromolecular drug compound in the membrane layer.

Abstract: A composition includes sintered ferrous amino acid particles prepared by sintering a ferrous amino acid chelate which includes ferrous ions and an amino acid. The sintered ferrous amino acid particles have an average particle size ranging from 500 to 2600 nm and a weight average molecular weight ranging from 1,500 Dalton to 600,000 Dalton. Also disclosed herein are a method for inhibiting and/or killing a virus in a subject and applications of such method. The method includes administering to the subject the composition.

Abstract: The disclosure provides nanometer sized water clusters comprising or consisting essentially of ultrapure water that encapsulate a solute, wherein the water clusters have a median diameter of between about 2 to about 400 nanometers and uses thereof. Also provided by the disclosure are processes and methods for making nanosized water clusters, including processes and methods for encapsulating hydrated solutes in nanosized water clusters.

Abstract: This invention provides for a compound of formula (I): or a pharmaceutically acceptable salt thereof, wherein R1-R3, n, p, L1 and L2 are defined herein. The compounds of formula (I) and pharmaceutically acceptable salts thereof are cationic lipids useful in the delivery of biologically active agents to cells and tissues.

Abstract: Nanoparticles are provided comprising an inner core comprising a non-cellular material, and an outer surface comprising a bacterial membrane, e.g., a bacterial membrane derived from a bacteria outer membrane vesicle. Also provided are compositions, e.g., medicament delivery systems and pharmaceutical compositions, comprising the present nanoparticles. Also provided are uses of the present nanoparticles, pharmaceutical compositions and medicament delivery systems for treating and/or preventing a disease or condition, e.g., bacterial infection, in a subject.

Abstract: Provided herein is a water- and sweat-resistant transdermal drug delivery system for application to the skin of a mammal that comprises a patch having a diameter between 1 and 8 cm in length and a surface area between 4 and 8 cm2. Also provided are methods of producing the transdermal drug delivery system and methods of treatment comprising the use of the transdermal drug delivery system.

Abstract: The present invention provides methods for reducing pain in a subject in need of such pain reduction by delivering, e.g., intrathecally or epidurally, a volatile anesthetic such as a halogenated ether compound in an amount effective to reduce pain. Chronic or acute pain may be treated, or the anesthetic may be delivered to the subject to anesthetize the subject prior to a surgery. In certain embodiments, isoflurane, halothane, enflurane, sevoflurane, desflurane, methoxyflurane, xenon, and mixtures thereof may be used. Dosing regimens including a one-time administration, continuous and/or periodic administration are contemplated.

Abstract: The invention relates to compounds, which are directed against protozoa, for use in the treatment of protozoal infections. The compounds are characterized in that they inhibit the formate-nitrite transporter of protozoa.

Abstract: Compositions and methods for managing or treating chronic pain are provided. More particularly, methods are provided for managing or treating chronic pain by administering to a patient in need thereof an effective amount of propofol or a propofol derivative having limited anesthetic properties. Methods of modulating HCN channel gating are also provided. Pharmaceutically acceptable compositions for, e.g., modulating HCN channel gating are further provided.

Abstract: The presently disclosed subject matter is directed to dual specificity mitogen-activated protein kinase phosphatase (DUSP-MKP) inhibitors that sensitize cancer cells immune cell killing and methods of using the disclosed DUSP-MKP inhibitors for the treatment of cancer.

Abstract: The present invention relates to methods for the treatment or prevention of fatigue associated with disordered sleep, for example, in multiple sclerosis, fibromyalgia, Fabry's disease, Parkinson's disease, or traumatic brain injury, using cyclobenzaprine. The present invention further relates to a biomarker for the therapeutic effects of a cyclobenzaprine treatment.

Abstract: The present invention relates to pharmaceutical compositions comprising a 2-amino-2-[2-(4-C2-20-alkyl-phenyl)ethyl]propane-1,3-diol compound or a pharmaceutically acceptable salt thereof, and to the use thereof for treating, preventing or delaying the progression of multiple sclerosis in a paediatric patient or a patient suffering from a specific condition.

Abstract: Methods of storing and methods of stabilizing pharmaceutical compositions comprising cysteamine, or a pharmaceutically acceptable salt thereof, are provided. Methods of distributing pharmaceutical compositions comprising cysteamine, or a pharmaceutically acceptable salt thereof, and methods of treating cystinosis also are provided.

Abstract: Compositions for treatment of cystinosis, products for administering eye drops, and products for storing contact lenses are provided. Compositions include solutions that can contain an effective amount of cysteamine to treat cystinosis, and an oil with a lower density than the solution. Also provided is a product including a bottle for containing a solution, the bottle being substantially free of O2. Also provided is a contact lens holder for storing one or more contact lenses in a solution, the holder including barrier layers reducing the amount of O2 entering the contact lens holder.

Abstract: Disclosed herein are compositions of antipurinergic agents and methods of use thereof for treating cognitive developmental disorders and autism spectrum disorders (ASD) in patients in need thereof.

Abstract: The present disclosure provides compositions and methods for treating patients suffering from opioid dependency and/or addiction wherein the patient is administered a pharmaceutical composition that disrupts the protein-protein interface between nNOS and PSD95.

Abstract: Compositions including an odd chain fatty acid, and salts and derivatives thereof, and methods for metabolic syndrome treatment and prophylaxis are provided, including compositions and methods for treating diabetes, obesity, hyperferritinemia, elevated insulin, glucose intolerance, dyslipidemia and related conditions. Methods for the diagnosis and monitoring of metabolic syndrome are also provided.

Abstract: The present invention is directed to a method of treating an amyloid-3 peptide disease in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of a compound that enhances mitochondrial proteostasis.

Abstract: In various embodiments, the present invention provides methods of treating and/or preventing cardiovascular-related disease and, in particular, a method of reducing or preventing sdLDL oxidation in a subject, the method comprising administering to the subject a pharmaceutical composition comprising eicosapentaenoic acid or a derivative thereof.

Abstract: A medical composition for reducing the rate of new-onset diabetes caused by administration of a statin or for inhibiting an increase in blood glucose level by administration of a statin, the composition containing at least one ingredient selected from the group consisting of icosapentaenoic acid and pharmaceutically acceptable salts or esters thereof as an inactive ingredient.

Abstract: The invention provides unit dosage forms, kits, and methods useful for treating viral infections.

Abstract: Provided herein are methods for treatment of a neurodegenerative disease, such as Late Infantile Neuronal Ceroid Lipofuscinosis, including administering to a subject in need of such treatment a composition comprising a therapeutically effective amount of an agent comprising a fibrate.

Abstract: A method of stimulating ventilatory and/or respiratory drive in a subject in need thereof includes administering to the subject a therapeutically effective amount of a composition comprising a D-cysteine alkyl ester, adduct thereof, or pharmaceutically acceptable salt, tautomer, or solvate thereof.

Abstract: Provided herein are compositions containing compounds, or pharmaceutically acceptable salts, that metabolize to monomethyl fumarate with certain pharmacokinetic parameters and methods for treating, prophylaxis, or amelioration of neurodegenerative diseases including multiple sclerosis using such compositions in a subject, wherein if the compositions contain dimethyl fumarate, the total amount of dimethyl fumarate in the compositions ranges from about 43% w/w to about 95% w/w.

Abstract: The invention provides pharmaceutical compositions containing omega-3 oil and a non-hydrophilic co-solvent that have an increased absorption rate. The pharmaceutical compositions may further contain one or more pharmaceutical organic molecules. The invention further provides kits containing these pharmaceutical compositions, methods for formulating pharmaceutical compositions containing omega-3 oil, and methods for decreasing the likelihood of developing cardiovascular disease, decreasing triglyceride or LDL cholesterol levels, decreasing pain or inflammation, treating diabetes, chronic pulmonary diseases, or irritable bowel syndrome, decreasing symptoms of an autoimmune disease or allergic conditions.

Abstract: Methods of using the formulations disclosed herein to treat or prevent a broad spectrum of enveloped viruses are provided. In particular, a method of treating or preventing a disease state caused by an enveloped type virus can include agents of a formula wherein R1, is selected from the group consisting of OH, OR6, NHR6, and NR6R7 where R6 and R7 are selected from the group consisting of alkyl, aryl, methyl and heteroaryl; R2 is selected from the groups consisting of OR6, acyl, alky, aryl, and sulfonyl; R3 is selected from the group consisting of OR6 alkyl, aryl, substituted aryl, and heteroaryl; R4 and R5 are independently selected from the groups consisting of hydrogen, methyl or alkyl, substituted alkyl, aryl, and substituted aryl; and whereby, administration of the compound allows for the treatment of enveloped viruses.

Abstract: A combination of three well-known and FDA approved compounds has been discovered to significantly suppress the proliferation of pancreatic cancer cells in clinically relevant models of pancreatic cancer. Embodiments of the invention include compositions of matter comprising a combination of agents such as metformin, simvastatin, and digoxin as well as methods of treating cancers using such agents. Illustrative methods include combining a population of pancreatic cancer cells with amounts of metformin, simvastatin, and digoxin sufficient to inhibit expression of BIRC5 protein in the population of pancreatic cancer cells, thereby inhibiting the growth of the population of pancreatic cancer cells.

Abstract: Pharmaceutical composition comprising an aqueous solution of a taxane and an aqueous solution of a hydrophobic statin intended for use in treatment or prevention of human melanoma.

Abstract: An inhalable composition for use as a medicament in the treatment of a subject wherein said composition comprises: one or more cannabinoids or a pharmaceutically acceptable derivative or salt thereof; a propellant; a monohydric or polyhydric alcohol; and a glycol and/or glycol ether, characterised in that the ratio of monohydric or polyhydric alcohol to glycol or glycol ether by weight is from 6:1 to 1:1, wherein the composition is administered in the form of an aerosol having a fine particle fraction of 60% or more.

Abstract: The present invention provides a plant-based flavonoid pharmaceutical composition and its synthetic for inhibition of phosphau'dylinositol-4-kinases and consequent prevention and treatment of RNA viruses including but not limited to viral hepatitis, as well as activity against cancer, malaria, autoimmune disorders and inflammation, prevent organ transplant rejection and as a radiation sensitizer. A method for isolating specific plant-based flavonoid pharmaceutical compositions from raw plant material as well as a method for synthesizing the compositions are also disclosed.

Abstract: Methods and compositions for treating myotonia and dystrophies.

Abstract: A use of ovatodiolide for preparing a composition used for inhibiting protein synthesis of gastric Helicobacter pylori, wherein the ovatodiolide achieves an effect of inhibiting gastric Helicobacter pylori by inhibiting the expression of 30S ribosomes RpsB of gastric Helicobacter pylori and further inhibiting its protein synthesis.

Abstract: The present invention relates to (+)-1-(3,4-dichlorophenyl)-3-azabicyclo[3.1.0]hexane and pharmaceutically acceptable active salts, polymorphs, glycosylated derivatives, metabolites, solvates, hydrates, and/or prodrugs of (+)-1-(3,4-dichlorophenyl)-3-azabicyclo[3.1.0]hexane and their use alone or in combination with additional psychotherapeutic compositions in the treatment of conditions affected by monoamine neurotransmitters, including treatment of refractory individuals.

Abstract: This document provides materials and methods related to bacterial compositions containing at least one bacterial organism having tryptophan decarboxylase activity. For example, bacterial compositions containing at least one bacterial organism having tryptophan decarboxylase activity and methods for using such bacterial compositions to improve gastrointestinal epithelial function and/or to treat gastrointestinal disorders are provided.

Abstract: The inventors unexpectedly discovered that aldoxorubicin lacks cardiotoxicity in patients treated with aldoxorubicin alone or in combination with ifosfamide/mesna. Notably, no evidence of cardiac toxicity of aldoxorubicin was found, even at doxorubicin equivalent cumulative doses of up to 10,000 mg/m2.

Abstract: A cancer targeted therapeutic agent includes a drug-linker-AS1411 structure. The drug may be selected from monomethyl auristatin E (MMAE), monomethyl auristatin F (MMAF), cytarabine, gemcitabine, maytansine, DM1, DM4, calicheamicin and a derivative thereof, doxorubicin, duocarmycin and a derivative thereof, pyrrolobenzodiazepine (PBD), SN-38, a-amanitin, or a tubulysin analog.

Abstract: The present invention relates to a pharmaceutical composition, comprising Tecovirimat, cyclodextrin and an additive, and optionally a pharmaceutically acceptable excipient. The present invention also relates to a method for preparing the pharmaceutical composition. The composition improves the solubility of Tecovirimat in water by using cyclodextrin and meglumine in combination, as compared with the solubility of Tecovirimat in water by using cyclodextrin or meglumine alone.

Abstract: Disclosed is bucindolol substantially free of its R-stereoisomer. Also disclosed are pharmaceutical compositions that include bucindolol substantially free of its R-stereoisomer or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier. Also disclosed are methods of treating a patient that involve administering to the patient a therapeutically effective amount of a composition of the present invention.

Abstract: The present inventors successfully identified novel gatekeeper mutations for FGFR. Further, they discovered that mutant FGFR having the mutations demonstrate resistance to known FGFR inhibitors such as AZD4547, and at the same time demonstrate sensitivity to specific compounds. Mutant polypeptides having the mutations may be used as biomarkers in cancer treatment by FGFR inhibitors to prevent the development of side effects in therapy by conventional FGFR inhibitors, and to control the therapeutic mode for receiving the best therapeutic effect, thus making individualized treatment possible.

Abstract: The present invention relates to topical formulations of biaryl heterocyclic compounds and methods of use thereof for treating acne and other skin infections caused or mediated by Streptococcus pyogenes, Streptococcus agalactiae, Haemophilus influenza, Trichomonas vaginalis, Klebsiella sp., Enterobacter sp., Proteus sp., Propionibacterium acnes, Gardnerella vaginalis, or Staphylococcus aureus (including Methicillin-resistant Staphylococcus aureus (MRSA)) in a patient in need thereof. In certain embodiments, the acne or other skin infection is caused or mediated by Propionibacterium acnes, Gardnerella vaginalis, or Staphylococcus aureus.

Abstract: Provided herein, inter alia, are methods of treating cancer in a subject, by administering COH29 ((N-(4-(3,4-dihydroxyphenyl)-5-phenylthia-zol-2-yl)-3,4-dihydroxybenzamide)).

Abstract: Embodiments disclosed herein describe, amongst other things, dosage forms, compounds, compositions, pharmaceutical compositions that can be used in the treatment of, for example, restless leg syndrome.

Abstract: Described herein are pharmaceutical compositions for treating pain.

Abstract: Method for treating a viral infection in a patient, comprising administering to the patient a therapeutically effective amount of a compound, or a pharmaceutically acceptable salt thereof, comprising a moiety represented by figure (I), wherein R1 is a saturated or unsaturated bivalent hydrocarbon group. Viruses subject to treatment can include HIV and flaviviruses such as west nile, dengue, or hepatitis C virus. Compositions and methods of isolation and purification are also described including from the Red Sea sponge.

Abstract: In some embodiments, the present disclosure pertains to a composition including niacin up to about 1000 mg and berberine up to about 800 mg. In some embodiments, the niacin is in an amount of about 500 mg and the berberine is in an amount of about 100 mg. In some embodiments, the present disclosure pertains to a method that includes administering a composition to a subject in need thereof, where the composition includes niacin up to about 1000 mg and berberine up to about 800 mg. In some embodiments, the niacin is in an amount of about 500 mg and the berberine is in an amount of about 100 mg.

Abstract: Uses of an EGFR/HER2 inhibitor combined with a pyrimidine-type anti-metabolic drug are provided. Specifically, uses of an EGFR/HER2 receptor tyrosine kinase inhibitor combined with pyrimidine-type anti-metabolic drug in the preparation of drugs for treating cancers are provided.

Abstract: The instant invention relates to a process for the preparation of a pharmaceutical composition in sustained-release tablet form comprising from 600 milligrams to 2400 milligrams of Pirfenidone (PFD), in such a way that the drug is bioavailable during an extended period of time of 12 hours from its administration. In this way, the anti-fibrotic and anti-inflammatory action of the drug Pirfenidone is optimized. Moreover, the instant invention offers advantages and a higher therapeutic efficacy compared to other pharmaceutical forms of Pirfenidone for oral administration and its therapeutic application in the regression of chronic renal failure secondary to primary glomerulosclerosis; it shows a better activity with regard to the reduction and/or regression of deleterious effects in breast capsular contracture observed after the surgical implantation of breast implants in humans and has an important anti-TNF-? and anti-TGF-?1 action for the treatment of hepatic fibrosis.

Abstract: The present invention features compositions and methods for the treatment of HCV infection. In one embodiment, the compositions of the invention comprise (1) Compound 1 or a pharmaceutically acceptable salt thereof, and (2) Compound 2a or a pharmaceutically acceptable salt thereof. In another embodiment, the compositions of the invention comprise (1) Compound 1 or a pharmaceutically acceptable salt thereof, and (2) a prodrug of Compound 2a (e.g., one of Compounds 2b-2k or Examples 3-1 to 3-10) or a pharmaceutically acceptable salt of said prodrug.