Abstract: The present invention relates to topical compositions comprising 10-hydroxystearic acid or a salt thereof and at least one nonionic emulsifier. The present invention also relates to a method to retard or inhibit the re-crystallisation of 10-hydroxystearic acid or a salt thereof in a topical composition, said method comprising formulating 10-hydroxystearic acid or a salt thereof in the presence of at least one nonionic emulsifier.

Abstract: An aerosol liposome of a marine extract and a method of producing the same are introduced. The marine extract is extracted from cell membranes of marine processing streams, including phosphatidylserine (PS), phosphatidylcholine (PC), phosphatidylethanolamine (PE), phosphatidylinositol (PI), and lysophosphatidylcholine (LysoPC), further including at least phosphatidylserine (PS). The aerosol liposome is of a particle diameter of less than 2,000 nm. The surface of the aerosol liposome carries phosphatidylserine (PS) molecules. The aerosol liposome of a marine extract, thus provided, is simple and stable and can be absorbed through the mouth, nose, upper respiratory tract, and epidermis and engulfed by macrophages therein to quickly alleviate or regulate systematic inflammatory responses and prevent inflammation-related diseases.

Abstract: Disclosed herein are novel lipids and liposomal compositions prepared using such compounds and related methods of neutralizing or otherwise modifying such liposomal compositions. The lipids described herein are useful for example, as liposomal vehicles to facilitate the delivery of encapsulated polynucleotides to target cells and the subsequent transfection of such target cells. In certain embodiments, one or more of the compounds that comprise the liposomal delivery vehicle may be neutralized or further modified such that the properties of the liposomal delivery vehicle are modified.

Abstract: A stable dry powder composition for inhalation includes acetylsalicylic acid in particles having a mass median aerodynamic diameter (MMAD) in a range of about 1 ?m to about 5 ?m. The dry powder composition may contain a pharmaceutically acceptable excipient, such as a stearate, in an amount ranging from about 0.04% (w/w) to about 0.06% (w/w), or from about 0.4% (w/w) to about 0.6% (w/w), of the composition.

Abstract: Disclosed herein are pharmaceutical compositions comprising a plurality of first beads each comprising: a core; a first layer comprising pilocarpine or a pharmaceutically acceptable salt thereof; and a second layer comprising a first polymer. Also disclosed are pharmaceutical compositions comprising a plurality of second beads each comprising: a core; and a first layer comprising tolterodine or a pharmaceutically acceptable salt thereof. Further disclosed are pharmaceutical formulations comprising: a) a plurality of the first beads; b) a plurality of the second beads; or c) a plurality of the first beads and a plurality of the second beads.

Abstract: Procedure for preparing enteric-coated pellets containing a proton pump inhibitor with benzimidazole structure, useful for preparing multi-particle pharmaceutical compositions for oral use that comprises the following stages: I) coat pure cellulose cores with a hydroalcoholic suspension that contains the proton pump inhibitor, a dibasic amino acid and polyvinylpyrrolidone; II) isolate the coated pure cellulose cores obtained in Stage I; III) apply an enteric coating to the particles obtained in Stage II above; and IV) dry the particles obtained in Stage III above and separate by size.

Abstract: A dry granulation process using a twin-screw extruder for granulating a powder mixture which includes at least one active ingredient and at least one carrier. The process includes steps of kneading the powder mixture in the screw barrel of the twin-screw extruder at a barrel temperature below a melting point of the at least one active ingredient and a melting point or a glass transition temperature of the at least one carrier to provide a kneaded powder mixture, and extruding the kneaded powder mixture to form granules. Granules and tablets produced using the dry granulation process in the twin-screw extruder are also provided.

Abstract: The present invention relates to a self-assembly preparation method of a nanocomposite material, and more particularly, relates to a self-assembly preparation method of a nanocomposite material comprising steps of: spraying a drug-containing solution onto metal aerosol nanoparticles to form a drug layer on the metal aerosol nanoparticles; and spraying a polymer-containing solution onto the metal aerosol nanoparticles, on which the drug layer is formed, to form a polymer layer on the drug layer, whereby since the method involves no liquid chemical process upon producing the metal aerosol nanoparticles, the processes are simple and can be performed even at a low temperature to suppress deformation of an organic or a drug, and the release rate of the drug, or the like can be easily controlled through metal types of metal aerosol nanoparticles, modification, and the like.

Abstract: Onapristone extended-release formulations and methods of administering onapristone extended-release formulations are provided. Onapristone extended-release formulations provide sufficient therapeutic activity as compared to immediate-release formulations with reduced potential for adverse side effects.

Abstract: Drug delivery using bio-affecting drugs, particularly with shape changing drug delivery devices. Embodiments are included for depots for delivery of a therapeutic agent that change from an elongated state ex vivo to a coil in vivo where the agent is released.

Abstract: Polymeric nanoparticles, microparticles, and gels for delivering cargo, e.g., a therapeutic agent, such as a peptide, to a target, e.g., a cell, and their use for treating diseases, including angiogenesis-dependent diseases, such as age-related macular degeneration and cancer, are disclosed. Methods for formulating, stabilizing, and administering single peptides or combinations of peptides via polymeric particle and gel delivery systems also are disclosed.

Abstract: The present invention provides a modified release formulation of lacosamide. The modified release formulation of the present invention comprising lacosamide and modified release polymer provides modified release of lacosamide with minimal Cmax to Cmin peak to trough variation over a period of at least 12 hrs.

Abstract: A composition comprising a nanoparticle, wherein the nanoparticle comprises a polymer/copolymer conjugated to a moiety is disclosed. A method of forming a nanostructure includes stirring poly(lactide-co-glycolide (PLGA) and 11-Ethyl-3-(dimethylaminopropyl) carbodiimide (EDC) in CH2Cl2 to create a PLGA mixture, n-boc-ethyelenediamine and N,N-Diisopropylethylamine (DIEA) are added to the PLGA mixture to create a reaction mixture. The reaction mixture is then precipitated in cold diethyl ether to form a purified polymer, which is then dried. The dried and purified polymer is then reconstituted in CH2Cl2:TFA solution and stirred under inert conditions. The product of the reconstituting step is evaporated to form a clear viscous residue that is dissolved in CH2Cl2 and then precipitated in cold ether to form a polymer. These functional polymers can encapsulate a variety of bioactives forming nanosystems improving the performance of bioactives.

Abstract: The present invention includes a low dose and sustained release formulation of 2,4-dinitrophenol (DNP). The compositions of the invention are useful for preventing or treating a disease or disorder, such as non-alcoholic fatty liver disease, non-alcoholic steatohepatitis, insulin resistance and/or diabetes, in a subject in need thereof.

Abstract: The present invention is a method of preparing a buccal delivery system for treating digestive distress comprising heating a sugar base to lower the water content to about less than or equal to 5 wt. %, removing the sugar base from the heat source, adding the non-volatile ginger extract having at least 10% gingerol by weight, adding the gingerol active to the hot sugar matrix and converting it into a ratio of gingerol and shogaol, ambient cooling the base to a malleable form in which individual dosages are shaped, wherein the gingerol and shogoals are present in an amount and ratio of from 2:1 to 10:1 gingerol to shogoals; where the gingerol and newly formed shogaols are immediately released; and where the typical dosage of the combination is in the range of about 1.0 to 5.4 g.

Abstract: A deacetylnemorone abietane diterpenoid is utilized in the prevention of growth and development of pathogenic cells, e.g., cancer cells. The deacetylnemorone can have the following structure: or a tautomer there of in which R1, R2, and R3 are independently selected from —H, C1-10 alkyl, C1-10 alkoxy, C1-10 alkenyl, C1-10 alkenoxy, —OH, —OAc, —CHO, -Ph, —OC6H5, —OC6H4OH, —COC6H5, —OCONH2, —OCONHCH3, —OCOC6H4NH2, —NH2, or ?O. The deacetylnemorone shows efficacy in treatment and prevention of a wide range of cancer types as well as other neoplastic diseases as a chemo-preventative, a primary or secondary cytotoxic agent, a sensitizer for other therapies, or one component of a combinatorial treatment.

Abstract: Dosage forms, drug delivery systems, and methods related to sustained release of dextromethorphan or improved therapeutic effects are disclosed. Typically, bupropion or a related compound is orally administered to a human being to be treated with, or being treated with, dextromethorphan.

Abstract: Eflornithine is an agent that can be used to treat glioma, especially glioma of WHO Grade II or Grade III such as anaplastic glioma. Eflornithine can suppress or prevent mutations in glioma which can cause the glioma to progress to a higher grade. The present invention describes pharmaceutical compositions that contain eflornithine or a derivative, analog, or prodrug thereof. The pharmaceutical compositions can be prepared in a number of dosage forms and may contain another therapeutically active agent or an agent that enhances the therapeutic activity of the eflornithine or the derivative, analog, or prodrug thereof. The present invention also describes a kit that includes dosage forms of pharmaceutical compositions according to the present invention.

Abstract: The invention relates to methods and related compositions for enhancing cancer therapy and in particular glutaminase inhibitor therapy. The methods involve methods for identifying patients susceptible to glutaminase inhibitor therapy as well as sensitizing patients to glutaminase inhibitor therapy.

Abstract: A pharmaceutical gel composition for intra-intestinal administration comprises (i) a dopamine replacement agent, (ii) a dopamine decarboxylase inhibitor (DDI), and (iii) a COMT inhibitor.

Abstract: It is provided a catechol-O-methyltransferase (COMT) inhibitor for use in the prevention and/or treatment of trans-thyretin-associated amyloidosis. It is also provided a catechol-O-methyltransferase (COMT) inhibitor for use in the prevention and/or treatment of transthyretin-associated amyloidosis in combination therapy with another COMT inhibitor, a benzoxazole derivative, iododiflunisal, diflunisal, resveratrol, tauroursodeoxycholic acid, doxocycline, or epigallocatechin-3-gallate.

Abstract: The invention features a pharmaceutical suspension containing drug particles, a drug delivery device anchored in the mouth for continuously administering the pharmaceutical suspension, and methods of their use.

Abstract: A method for preventing, improving, or treating fatty liver includes administering an effective amount of an azelaic acid or a pharmaceutically acceptable salt thereof to a subject. Azelaic acid which is a compound primarily contained in a natural product, has no or fewer side effects and reduces accumulation of triglycerides in liver tissue, and thus may prevent, improve, or treat a non-alcoholic fatty liver. In addition, due to an anti-inflammatory effect, azelaic acid may be used in the treatment of steatohepatitis. Therefore, the azelaic acid according to the present disclosure is expected to be effectively used in a food composition, a pharmaceutical composition and a health functional food composition to treat fatty liver or steatohepatitis.

Abstract: The present disclosure provides certain combination therapy technologies that are particularly useful for treating one or more diseases, disorders, or conditions that may be related to abnormal metabolism. In some embodiments, provided technologies provides combinations of TCA cycle acids and ketone bodies. In some embodiments, provided technologies provides combinations of TCA cycle acids and other carboxylic acids.

Abstract: Novel active compositions having antimicrobial and anti-inflammatory activity are described, the activity provided by an active component prepared in a suspension, the active component being at least a single chain fatty acid having a carbon length of 12, or between 12 and no more than 18. The fatty acid may be esterified and/or ethylated or methylated. As an antimicrobial the active component has activity against one or more microorganisms including Staphylococcus spp., Streptococcus spp., Mycobacterium spp., Clostridium spp., and Candida spp., with an MIC as low as 0.0018 ?g/ml. As an anti-inflammatory, it is at least as or is more effective than cyclosporine in preventing T-cell proliferation in response to a trigger, such as stimulation by the one or more microorganisms. The active component is more active when combined with a phospholipid (e.g., lecithin, phosphatidylcholine) and caused to form liposomal nanoparticles. It is also more active when caused to form coated liposomal nanoparticles.

Abstract: In various embodiments, the present disclosure provides methods reducing the risk of cardiovascular events in a subject on statin therapy by administering to the subject a pharmaceutical composition comprising about 1 g to about 4 g of eicosapentaenoic acid ethyl ester or a derivative thereof.

Abstract: The invention provides a method of inhibiting the conversion of carnitine to trimethylamine (TMA) and lowering TMAO in an individual comprising administering to the individual one or more compositions comprising a compound set forth in Formula (I): Wherein the compound is administered in an amount effective to inhibit conversion of carnitine to TMA in the individual.

Abstract: The present invention provides methods and pharmaceutical compositions for treating proliferative disorders.

Abstract: Disclosed are hydroquinone compounds, preparation methods therefor, and uses thereof in anti-tumor or immunomodulation. The structural formula of the hydroquinone compounds are shown by formula I, wherein X is C?O or CH2; Y is NH, O or absent; R is a substituted or unsubstituted alkyl group having at least one carbon atom, a substituted or unsubstituted cycloalkyl group having at least three carbon atoms, a substituted or unsubstituted alkenyl group or alkynyl group having at least two carbon atoms; and a substituted or unsubstituted aryl group or heteroaryl group containing at least four carbon atoms. The compounds provided slowly release 2-tert-butyl-4-methoxyphenol in vivo and maintain stable plasma concentration of 2-tert-butyl-4-methoxyphenol (T½=12˜24 h). The compounds provided by the present invention protect the phenolic hydroxyl group of 2-tert-butyl-4-methoxyphenol, avoid environmental oxidation and increase the environmental stability of drugs containing the compounds.

Abstract: Provided herein are stable enalapril oral liquid formulations. Also provided herein are methods of using enalapril oral liquid formulations for the treatment of certain diseases including hypertension, heart failure and asymptomatic left ventricular dysfunction.

Abstract: A tumescent contravenom solution including: (a) a vasoconstrictor, (b) a physiological crystalloid solution, and (c) optionally a contravenom agent that neutralizes tissue toxic enzymes present in a venom and/or a drug that impairs or paralyzes lymphatic smooth muscle function and impairs lymphatic transport of venom. Also described are methods of treating an envenomation in a subject, and a kit for performing the method of treating an envenomation.

Abstract: The present invention concerns mono- or di-substituted indole compounds, methods to prevent or treat dengue viral infections by using said compounds and also relates to said compounds for use as a medicine, more preferably for use as a medicine to treat or prevent dengue viral infections. The present invention furthermore relates to pharmaceutical compositions or combination preparations of the compounds, to the compositions or preparations for use as a medicine, more preferably for the prevention or treatment of dengue viral infections. The invention also relates to processes for preparation of the compounds.

Abstract: The invention provides compounds of Formula (I), or pharmaceutically acceptable salts thereof. The compounds, compositions, methods and kits of the invention are useful for the treatment of pain, cough, itch, and neurogenic inflammation.

Abstract: Provided herein are pharmaceutical formulations of dry-powder bendamustine suitable for pharmaceutical use. Also provided are methods of producing dry-powder bendamustine. The pharmaceutical formulations can be used for any disease that is sensitive to treatment with bendamustine, such as neoplastic diseases.

Abstract: This invention relates to topical compositions for combating ectoparasites and endoparasites in animals, comprising at least one isoxazoline active agent and a pharmaceutically acceptable carrier, optionally in combination with one or more additional active agents. This invention also provides for an improved methods for eradicating, controlling, and preventing parasite infections and infestations in an animal comprising administering the compositions of the invention to the animal in need thereof.

Abstract: The present invention relates to Substituted Quinolizine Derivatives of Formula (I): and pharmaceutically acceptable salts thereof, wherein R1 is as defined herein. The present invention also relates to compositions comprising at least one Substituted Quinolizine Derivative, and methods of using the Substituted Quinolizine Derivatives for treating or preventing HIV infection in a subject.

Abstract: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile, or a pharmaceutically acceptable salt, amorphous form, polymorph form, or pharmaceutical composition (including solid formulations or liquid formulations) thereof and the use thereof for treating diseases and disorders which can be treated with a RET kinase inhibitor, such as RET-associated diseases and disorders, e.g., proliferative disorders such as cancers, including hematological cancers and solid tumors, and gastrointestinal disorders such as IBS are disclosed.

Abstract: This invention relates to a compound with EP4 antagonistic activity, or a pharmaceutically acceptable salt with EP4 receptor antagonistic activities, which is useful in the treatment of cartilage disease. This invention also relates to a compound of formula (I), (II), (III), (IV), (Va) or (Vb), or a pharmaceutically acceptable salt thereof with EP4 receptor antagonistic activities, which is useful in the treatment of cartilage disease. This invention also relates to a pharmaceutical composition for the treatment of cartilage disease which comprises a therapeutically effective amount of a compound of formula (I), (II), (III), (IV), (Va) or (Vb), or a pharmaceutically acceptable salt thereof.

Abstract: The present invention is directed to immune adjuvants containing IAP inhibitors, including Smac mimetics. The invention further provides pharmaceutical compositions and vaccines containing an IAP inhibitor and an antigen. Methods of enhancing an immune response by administration of an IAP inhibitor, methods of treating or preventing cancer, methods of treating or preventing infections, methods of treating autoimmune disorders, and methods of potentiating cytokine or antibody production are also provided.

Abstract: The present invention provides a compound of formula (I) or a pharmaceutically acceptable salt thereof; a method for manufacturing said compound, and its therapeutic uses. The present invention further provides a combination of pharmacologically active agents and a pharmaceutical composition comprising said compound.

Abstract: In one aspect, a method of treating a disorder associated with chronic inflammation includes administering to an individual in need thereof a therapeutically effective amount of isomyosmine or a pharmaceutically acceptable salt thereof. In some aspects, the disorder is a cancer, an autoimmune disorder, hypertension, or autism. In other aspects, isomyosmine is administered to treat viral infections or disorders associated with elevated levels of hydrogen peroxide and/or other Reactive Oxygen Species (ROS).

Abstract: Compounds of formula (I) are provided which are useful in the treatment of diseases or conditions modulated at least in part by CCR6:

Abstract: Provided herein are pharmaceutical compositions comprising a vesicular monoamine transporter 2 (VMAT2) inhibitor (e.g., deutetrabenazine) and an excipient useful for treating stuttering in a subject in need thereof. Further provided are methods of treating stuttering in a subject in need thereof comprising administering an effective amount of a pharmaceutical composition of the present disclosure. Also provided herein are kits comprising such pharmaceutical compositions.

Abstract: This disclosure relates to methods administering various compounds in conjunction with dextromethorphan to a human being. Dosage forms, drug delivery systems, and methods related to dextromethorphan or dextrorphan and bupropion, hydroxybupropion, erythrohydroxybupropion, threohydroxybupropion, or a metabolite or prodrug of any of these compounds are also disclosed.

Abstract: Disclosed are linear discrete PEG constructs, which can be created and produced in a precise and reproducible way. Key to being able to do these things, where x in the discrete PEGx can vary from about 2 to about 64, is that the processes used to make each linear portion is controlled to give essentially one oligomer/one compound. Having a variable length linear discrete PEG construct that is (a) primarily an linear discrete PEG construct with diagnostic or therapeutic groups attached along a chain of attachment cores, which is attached to a preferential locator; (b) is an m-discrete PEG as the terminal construct on the linear portion, and “hidden”; (c or linear discrete PEG with a terminus group that can be either negatively or positively charged, or neutral; and any of the discrete PEG portions can be designed to be cleaved after entering the cell.

Abstract: The present invention relates to a pharmaceutical composition comprising a combination of trazodone or a salt thereof, and gabapentin or a salt or prodrug thereof, said combination having a synergistic effect in the treatment of pain.

Abstract: Provided is a stable pharmaceutical composition for oral administration comprising 6-ethyl-3-({3-methoxy-4-[4-(4-methylpiperazin-1-yl)piperidin-1-yl]phenyl}amino)-5-(tetrahydro-2H-pyran-4-ylamino)pyrazine-2-carboxamide (hereinafter referred to as compound A) or a pharmaceutically acceptable salt thereof, wherein the generation of related substances during storage is inhibited. In the stable pharmaceutical composition for oral administration, the proportion of crystals of compound A or a pharmaceutically acceptable salt thereof is 60% or more with respect to the total amount of compound A or a pharmaceutically acceptable salt thereof.

Abstract: Methods for treating prostate cancer, including advanced prostate cancer, in a subject in need thereof, include administering once-daily to the subject, at least 80 mg of N-(4-(1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxy-3-pyridazinyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-N?-methoxyurea, or a corresponding amount of a pharmaceutically acceptable salt thereof.

Abstract: The present disclosure relates to a class of pyrimidine derivatives having immunomodulating properties that act via TLR7 which are useful in the treatment of viral infections and cancers.

Abstract: The present disclosure provides compositions comprising a lyn kinase activator and TRPM8 agonist, and to methods of: reducing blood glucose levels, weight gain, or fat depot levels; treating metabolic syndrome, Syndrome X, obesity, prediabetes, type II diabetes, type I diabetes; treating hypercholesterolemia, hypertension, coronary heart disease, diabetic neuropathy, lipodystrophy, diabetic retinopathy, erectile dysfunction, kidney disease, dyslipidemia, dyslipoproteinemia, a peroxisome proliferator activated receptor-associated disorder, septicemia, a thrombotic disorder, or pancreatitis; inducing the beiging of adipocytes; and preventing pancreatic beta cell degeneration.