Abstract: A method for producing a composition comprising nanoparticles of a biologically active compound.

Abstract: The present invention relates to pharmaceutical compositions comprising safinamide and, more particularly, to taste-masked particles comprising said active ingredient or pharmaceutically acceptable salts thereof, oral dosage forms that include said particles and a process for preparing them.

Abstract: The present invention provides an abuse deterrent oral fixed-dose composition, comprising a stimulant or opioid and an abuse deterrent active, wherein the abuse deterrent active is configured to be bioavailable only when the composition is crushed, ground or dissolved.

Abstract: Methods are provided for promoting the adsorption of an active agent to microparticles by modifying the structural properties of the active agent in order to facilitate favorable association to the microparticle.

Abstract: Embodiments of the present disclosure include devices, and methods of making such devices, for delivery of one or more active agents with short or long zero-order release kinetics. Embodiments also include implantable or injectable drug delivery systems capable of controlled release over long periods of time for therapeutic agents.

Abstract: An “inverse” precipitation route to precipitate aqueous soluble species with copolymers as nanoparticles having a hydrophilic, polar core and a less polar shell is described. The aggregation of these nanoparticles to form larger microparticles and monoliths provides a highly loaded construct (e.g., a depot) for the sustained and controlled release of actives.

Abstract: The invention relates to protein nanocapsules that exhibit material properties that change in different in vivo environments. A zwitterion moiety on the surface of the nanocapsule can protect the protein from opsonization in a first environment, yet uncouples from the protein nanocapsule in a second environment (e.g. at a pH of less than 6.5). In embodiments of the invention, the uncoupled protein nanocarrier is then internalized by mammalian cells (e.g. tumor cells).

Abstract: A transdermal delivery system for systemic delivery of donepezil is described, where the system comprises an adhesive matrix drug reservoir layer comprised of a copolymer of acrylic acid/vinyl acetate, triethyl citrate, and donepezil base generated in situ by reaction of donepezil HCl and an alkaline salt. The system is provided for treatment of Alzheimer's disease, and achieves transdermal delivery of the therapeutic agent at steady state that is bioequivalent to administration of the therapeutic agent orally.

Abstract: The present invention relates to an aqueous composition for ophthalmological use or otolaryngological use, the aqueous composition containing: (A) a petrolatum; and two or more (B) nonionic surfactants.

Abstract: The invention provides a topical pain medication and a method of manufacturing and suing the same. In one embodiment, the medication includes: (1) enriched resveratrol having a concentration of trans-resveratrol therein that substantially exceeds the natural concentrations of trans-resveratrol in naturally occurring resveratrol, and (2) at least one inactive ingredient configured to mix with the resveratrol to form the topical medication. In one embodiment, the method includes: (1) processing resveratrol to increase the concentration of trans-resveratrol therein and (2) mixing at least one inactive ingredient with the resveratrol to form the topical medication.

Abstract: The present disclosure relates, in some embodiments, to an immunogenic compositions for the treatment of cancer, methods of preparing an immunogenic composition for the treatment of cancer, and methods of treating cancer subjects with an immunogenic composition. Some embodiments of the present disclosure relate to an immunogenic composition operable as a treatment of cancer in a subject having a subject weight, the immunogenic composition including; an immunoactive tissue extract comprising a protein composition, wherein the immunogenic composition has a final concentration of the protein composition of about 6 mg to about 10 mg of the protein composition per kg of the subject weight; an immune response activator comprising a BCG solution, wherein the immunogenic composition has a final concentration of the immune response activator of about 0.525 to about 0.

Abstract: A method for treating depression in patients with depression and bipolar disorder who have not responded to antidepressants and to avoid dose dumping upon ingestion of alcohol. The present invention also relates to an oral dosage form for administration of ketamine and a method of preparing an oral dosage form for administration of ketamine, preferably once or twice a day.

Abstract: Compounds useful in inhibiting endo-exonuclease activity and treating cancer have the formula (I) wherein R3 is selected from the group consisting of loweralkyl, oxyalkyl, cycloalkyl, aryl, heteroaryl, heterocycloalkyl, aminoalkyl or a halogen; R4 is selected from the group consisting of H, loweralkyl, oxyalkyl, cycloalkyl, aryl, heteroaryl, heterocycloalkyl, aminoalkyl or a halogen; and wherein R5 is a loweralkyl; or formula (II) wherein R1 is selected from the group consisting of loweralkyl, oxyalkyl, cycloalkyl, aryl, heteroaryl, heterocycloalkyl, aminoalkyl or halogen; R2 is selected from the group consisting of H, loweralkyl, oxyalkyl, cycloalkyl, aryl, heteroaryl, heterocycloalkyl, aminoalkyl or halogen; and wherein R5 is a loweralkyl comprising a linear carbon chain of at least two carbons connecting the first “O” to the second “O”.

Abstract: The invention relates to a DPP-IV inhibitor (preferably vildagliptin or a pharmaceutically acceptable salt thereof), and metformin or a pharmaceutically acceptable salt thereof, for use in treating type 2 diabetes. The invention also relates to the use of a DPP-IV inhibitor (preferably vildagliptin or a pharmaceutically acceptable salt thereof), and metformin or a pharmaceutically acceptable salt thereof, in the manufacture of a medicament for treating type 2 diabetes. The invention also relates to a method of treating type 2 diabetes using a DPP-IV inhibitor (preferably vildagliptin or a pharmaceutically acceptable salt thereof), and metformin or a pharmaceutically acceptable salt thereof.

Abstract: Ketogenic compositions include a non-racemic mixture of beta-hydroxybutyrate salts and acid(s) enriched with the R-enantiomer. The compositions are enriched with the R-enantiomer to elevate ketone bodies and increase the rate at which ketosis is achieved yet contains an amount of the S-enantiomer to provide alternative benefits. Beta-hydroxybutyric acid is more rapidly absorbed and utilized by the body than salts or esters, enhances taste, and reduces the need to include citric acid or other edible acids. Beta-hydroxybutyrate salts are more slowly absorbed and utilized by the body and can provide one or more electrolytes. Compositions for increasing ketone body level in a subject may contain a dietetically or pharmaceutically acceptable carrier and a non-racemic mixture of R-beta-hydroxybutyrate and S-beta-hydroxybutyrate, wherein the non-racemic mixture of R-beta-hydroxybutyrate and S-beta-hydroxybutyrate contains from about 50.5% to 99.

Abstract: This disclosure provides generally for antimicrobial compositions and methods of use comprising an anthocyanin, an anthocyanidin or metabolites thereof. Methods for promoting healing of a wound using these compositions are also disclosed. These compositions have broad spectrum antimicrobial activity and are safe for human and animal uses. Further, these compositions are safe for medical uses and industrial uses as antiseptic preparations to reduce or prevent microbial growth, including killing bacterial biofilms.

Abstract: The present specification discloses pharmaceutical compositions formulated as a suspension for oral administration, the suspension comprising solid particles of a non-steroidal anti-inflammatory drug (NSAID) in an oil carrier comprising one or more free fatty acids, a glycerolipid, and a phospholipid as well as 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: In some embodiments, the present invention provides certain compositions and methods that may be useful in the treatment and/or prevention of a neurodevelopmental disorder, such as autism or an autism spectrum disorder (ASD). In some such embodiments, compositions are provided that contain at least one fenamate active agent, such as mefenamic acid, or an analogue or derivative thereof. In some embodiments, such compositions may also comprise an additional active agent, such as gabapentin, or an analogue or derivative thereof.

Abstract: The present invention relates to a pharmaceutical formulation suitable for parenteral administration containing carglumic acid and a buffering agent having a pKa from 5.5 to 9.0 at 25° C.; according to an embodiment, the buffering agent may have a pKa from 7.5 to 8.5, preferably a pKa of about 8.07, such as trometamol. The formulation may also contain at least one bulking agent, such as mannitol. The invention also includes a method for manufacturing a lyophilised sterile formulation by freeze-drying a water solution containing carglumic acid, a buffering agent having a pKa from 5.5 to 9.0 at 25° C., preferably from 7.5 to 8.5, and optionally a bulking agent to obtain a freeze-dried powder.

Abstract: Compositions including a complex of fatty acids (e.g., including one or more C4 to C40 fatty acids, such as a C4 to C20 fatty acid) and one or more amino acids (and particularly one or more amino acids having electrically charged basic side chains, e.g., Arginine, Lysine, etc.) for use as an anti-pathogenic composition. These compositions may include the complex of fatty acid:amino acid having a lamellar supramolecular structure. In particular, described herein are therapeutic compositions of undecylenic acid:Arginine forming a complex of undecylenic acid and Arginine.

Abstract: [Problem] To provide a composition for external skin use that has anti-inflammatory and antiallergic activity, and is very safe. [Solution] A composition for external skin use for inflammatory diseases contains dihomo-gamma-linolenic acid (DGLA) as the active ingredient thereof. It is preferable for the DGLA to be present as a glyceride, a phospholipid, or an alkyl ester. The amount of DGLA contained in the composition for external use is 0.1-50 wt %.

Abstract: The present invention relates to, inter alia, pharmaceutical compositions comprising a polyunsaturated fatty acid and to methods of using the same to treat or prevent cardiovascular-related diseases.

Abstract: Composition and method for treatment of Alzheimer's disease that includes ANAVEX2-73. Method of treatment of Alzheimer's disease using pharmaceutical compositions comprising ANAVEX2-73 according to an intermittent dosage regimen.

Abstract: This invention provides small organic molecules useful as therapeutics of neurodegenerative diseases. Small organic molecules that act as inhibitors of bone morphogenetic proteins (BMPs) are useful in the treatment of neuroinflammatory disorders, in particular multiple sclerosis.

Abstract: A pharmaceutical composition is described. The composition may include: (i) a drug component including at least one pharmaceutically acceptable salt of glycopyrrolate; and (ii) a propellant component including 1,1-difluoroethane (HFA-152a).

Abstract: The present invention relates to treatment of cancer, in particular to methods of sensitising cancer cells to an anti-cancer therapy by administering an effective amount of a modulator of Volume Regulated Anion Channels, i.e. a VRAC modulator.

Abstract: The present disclosure is directed to compositions comprising oxymetazoline and methods of stabilizing oxymetazoline compositions for long term storage.

Abstract: Long term storage stable bendamustine-containing compositions are disclosed. The compositions can include bendamustine or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable fluid which can include in some embodiments PEG, PG or mixtures thereof and an antioxidant or chloride ion source. The bendamustine-containing compositions have less than about 5% total impurities, on a normalized peak area response (“PAR”) basis as determined by high performance liquid chromatography (“HPLC”) at a wavelength of 223 nm, after at least about 15 months of storage at a temperature of from about 5° C. to about 25° C.

Abstract: The present invention relates to the compound [2-[(5-nitro-1,3-thiazol-2-yl)carbamoyl]phenyl]ethanoate (Nitazoxanide) or 2-hydroxy-N-(5-nitro-2-thiazolyl)benzamide (Tizoxanide) for treating cholestatic and fibrotic diseases.

Abstract: A once-a-day controlled release oral dosage form of methazolamide is provided. The dosage form comprises a therapeutically effective amount of methazolamide and a high molecular weight binder. The dosage is configured for once-daily administration to a subject in need thereof, and releases methazolamide over a period of about twenty-four hours.

Abstract: The present invention provides novel methods for treating Th2-mediated immune disorders and enhancing Th1-mediated immune responses in a subject comprising administering to the subject, a pharmaceutical composition comprising a serum-glucocorticoid regulated kinase 1 (SGK1) inhibitor and a pharmaceutically acceptable carrier. Methods for treating a wide range of autoimmune diseases are also taught. The present invention also provides methods for augmenting the treatment of subjects having viral or parasitic infections, or which have cancerous tumors.

Abstract: The present disclosure relates to pharmaceutical compositions useful for (and to a method of) treating autoimmune, respiratory and/or inflammatory diseases and conditions. The method involves administering to a subject in need thereof roflumilast N-oxide by inhalation. The present disclosure particularly relates to the treatment of asthma and chronic obstructive pulmonary disease (COPD) by administering roflumilast N-oxide by inhalation.

Abstract: There is provided a drug for preventing or treating inflammatory bowel disease, comprising as an active ingredient an RXR agonist which is a compound represented by Formula (1). In Formula (1), it is preferred that: R1 is an alkyl group; R2 is an alkyl group; W is NR3, and R3 is an alkyl group; X1 is CH; Y1 is N; X2 and Y2 are CH; and Z is a carboxyl group. Thus, a drug capable of strongly preventing or treating inflammatory bowel disease while suppressing the onset of side effects is provided.

Abstract: Pharmaceutical formulations comprising clevidipine in an oil-in-water formulation that is resistant to microbial growth and stable against the formation of impurities.

Abstract: The present application provides novel heterocyclic compounds and pharmaceutically acceptable salts thereof. Also provided are methods for preparing these compounds. These compounds are useful for inhibiting ERK1/2. By administering to a patient in need a therapeutically effective amount of one or more of the compounds of formula (I), wherein X, Y, Z, J, M, and R1 to R8 are defined herein, these compounds are effective in treating conditions associated with dysregulation of the RAS/RAF/MEK/ERK pathway. A variety of conditions can be treated using these compounds and include diseases which are characterized by abnormal cellular proliferation. In one embodiment, the disease is cancer.

Abstract: Disclosed herein are liquid diluents, formulations, and kits for preparing reconstituted suspensions of a proton pump inhibitor (e.g., omeprazole). The present disclosure also provides formulations for liquid diluents that do not have a tendency for gel formation following exposure to freeze-thaw cycles.

Abstract: Disclosed herein is a compound of formula (I), or a pharmaceutically acceptable salt thereof: (I). Also disclosed herein are uses of the compounds disclosed herein in the potential treatment or prevention of an IDO-associated disease or disorder. Also disclosed herein are compositions comprising a compound disclosed herein. Further disclosed herein are uses of the compositions in the potential treatment or prevention of an IDO-associated disease or disorder.

Abstract: An oral methylphenidate extended release tablet is described, which can be scored and still retain its extended release profile. The tablet contains a combination of an uncoated methylphenidate-ion exchange resin complex, a barrier coated methylphenidate-ion exchange resin complex-matrix, and an uncomplexed methylphenidate active component. Following administration of a single dose of the extended release methylphenidate chewable tablet, a therapeutically effective amount of methylphenidate is reached in less than about 20 minutes and the composition provides a twelve-hour extended release profile.

Abstract: An oral methylphenidate extended release tablet is described, which can be scored and still retain its extended release profile. The tablet contains a combination of an uncoated methylphenidate—ion exchange resin complex, a barrier coated methylphenidate—ion exchange resin complex—matrix, and an uncomplexed methylphenidate active component. Following administration of a single dose of the extended release methylphenidate chewable tablet, a therapeutically effective amount of methylphenidate is reached in less than about 20 minutes and the composition provides a twelve-hour extended release profile.

Abstract: The invention includes methods, kits, and pharmaceutical compositions for enhancing liver regeneration in a mammal in need thereof, comprising administering a therapeutically effective amount of an agent that increases nicotinamide adenine dinucleotide (NAD) activity. The methods may include administering a therapeutically effective amount of an agent that increases nicotinamide adenine dinucleotide (NAD) activity and a sirtuin 1 (Sirt1) agonist. The agent that increases NAD activity may be a NAD precursor. The NAD precursor may include one or more of tryptophan, nicotinic acid, nicotinic acid riboside, nicotinamide riboside (NR), nicotinamide, NADP, and NAD itself and a pharmaceutically acceptable salt thereof.

Abstract: The present invention provides 4-anilino-3-quinolinecarbonitriles compounds useful for treating a subject having an BcrAbl positive leukemia that is resistant to imatinib.

Abstract: The invention provides (+)-?-dihydrotetrabenazine succinate salt. Also provided are (+)-?-dihydrotetrabenazine succinate salt for use in medicine, pharmaceutical compositions comprising (+)-?-dihydrotetrabenazine succinate salt and a pharmaceutically acceptable excipient and the uses of (+)-?-dihydrotetrabenazine succinate salt as a VMAT2 receptor antagonist and in the treatment of a movement disorder such as Tourette's syndrome. The invention further provides a method for preparing the (+)-?-dihydrotetrabenazine succinate salt.

Abstract: Compounds of Formula I: or enantiomers thereof, metabolites thereof, derivatives thereof, deuterated derivatives thereof, prodrugs thereof, pharmaceutically acceptable salts thereof, N-oxides thereof, or a combination thereof, processes and intermediates for preparation thereof, compositions thereof, and uses thereof, are provided. Pharmaceutical compositions comprising a compound of formula I and a compound of Formula II: or enantiomers thereof, metabolites thereof, derivatives thereof, deuterated derivatives thereof, prodrugs thereof, pharmaceutically acceptable salts thereof, N-oxides thereof, or a combination thereof. Compositions and methods for improving the efficacy of DEX, or providing beneficial pharmacokinetic effects to DEX, comprising co-administering a compound of formula I or SARPO, and a compound of Formula II or DEX to a subject in need thereof, and dosage forms, drug delivery systems, methods of treatment thereof.

Abstract: The embodiments described herein include methods and formulations for treating lung and brain injury. The methods and formulations include, but are not limited to, methods and formulations for delivering effective concentrations of levocetirizine and montelukast to a patient in need. The methods and formulations can comprise conventional and/or modified-release elements, providing for drug delivery to the patient.

Abstract: A spray dried-powder composition for inhalation comprising particles (X) containing (a) between 5 and 50% by weight of at least one azole derivative in amorphous state but not in crystalline structure and (b) at least one matricial agent to the composition selected from a group consisting of polyol such as sorbitol, mannitol and xylitol; a monosaccharides such as glucose and arabinose; disaccharide such as lactose, maltose, saccharose and dextrose; cholesterol, and any mixture thereof, wherein the composition provides a dissolution rate of said azole derivative of at least, 5% within 10 minutes, 10% within 20 minutes and 40% within 60 minutes when tested in the dissolution apparatus type 2 of the United States Pharmacopoeia at 50 rotation per minute, 37° C. in 900 milliliters of an aqueous dissolution medium adjusted at pH 1.2 and containing 0.3% of sodium laurylsulfate.

Abstract: Solid dispersions of lurasidone or a pharmaceutically acceptable salt thereof are described, as well as pharmaceutical formulations thereof, and methods for making such formulations. Preferably, the solid dispersions are prepared by hot-melt extrusion or spray-drying, and comprise lurasidone with a pharmaceutically acceptable carrier (e.g., hydroxypropyl methyl cellulose acetate succinate (HPMC-AS), polyvinyl pyrrolidine vinyl acetate (PVP/VA) copolymer, hydroxypropyl methylcellulose phthalate (HPMCP), or mixtures thereof). The pharmaceutical composition may be orally administered to a patient in either the fed or fasted state, with a decrease or elimination of the food effect. Preferably, following oral administration of the pharmaceutical compositions, there is no substantial difference in the pharmacokinetic parameters (e.g., Tmax, Cmax, AUC0-t and/or AUC0-infinity) of lurasidone, regardless of whether the pharmaceutical compositions are administered to a subject in the fed or fasted state.

Abstract: Solid dispersions of lurasidone or a pharmaceutically acceptable salt thereof are described, as well as pharmaceutical formulations thereof, and methods for making such formulations. Preferably, the solid dispersions are prepared by hot-melt extrusion or spray-drying, and comprise lurasidone with a pharmaceutically acceptable carrier (e.g., hydroxypropyl methyl cellulose acetate succinate (HPMC-AS), polyvinyl pyrrolidine vinyl acetate (PVP/VA) copolymer, hydroxypropyl methylcellulose phthalate (HPMCP), or mixtures thereof). The pharmaceutical composition may be orally administered to a patient in either the fed or fasted state, with a decrease or elimination of the food effect. Preferably, following oral administration of the pharmaceutical compositions, there is no substantial difference in the pharmacokinetic parameters (e.g., Tmax, Cmax, AUC0-t and/or AUC0-infinity) of lurasidone, regardless of whether the pharmaceutical compositions are administered to a subject in the fed or fasted state.

Abstract: A method of killing bacteria and an antibiotic kit are provided herein. The method includes treating the bacteria with a DNA condensation-inducing compound; and subsequently treating the bacteria with an Eis inhibitor. The kit includes a DNA condensation-inducing compound packaged together with an Eis inhibitor.

Abstract: Provided are solid dispersions of Compound I having the formula: wherein Compound I is substantially amorphous, methods of manufacturing said solid dispersions, and methods of using said solid dispersions.

Abstract: The present invention relates to combinations comprising a positive allosteric modulator (“PAM”) of metabotropic glutamatergic receptor subtype 2 (“mGluR2”) or a pharmaceutically acceptable salt or a solvate thereof, or an orthosteric agonist of metabotropic glutamatergic receptor subtype 2 compound or a pharmaceutically acceptable salt or a solvate thereof, and a synaptic vesicle protein 2A (“SV2A”) ligand.