Abstract: Provided herein are pharmaceutical compositions, intravitreal implants and particle suspensions comprising a polymer matrix and at lest one therapeutic agent that is released in a substantially linear manner for a particular duration.

Abstract: The present invention relates to a polymer composite for controlled release of an agent. In particular, the present invention relates to a stimuli-responsive polymer composite that can provide for controlled release of an agent in response to light. The polymer composite may be particularly suitable for the controlled delivery of a drug that is modulated by light.

Abstract: This invention relates to an oral immunotherapy (OIT) composition comprising granules that contain an allergenic protein, such as peanut protein, along with a humectant, such as trehalose, and a binder, such as hypromellose. The composition may further comprise a filler, such as mannitol and a lubricant, such as stearic acid. OIT compositions, methods of preparing OIT compositions and methods of treatment of food allergy using OIT compositions are provided.

Abstract: An antibacterial colloid, comprising: a plurality of metal nanoparticles. wherein the plurality of metal nanoparticles have an average particle diameter less than 10 nm; a plurality of metal ions, wherein the plurality of metal ions have a concentration greater than 20 ppm; and a medium, wherein the medium comprises a protein component containing at least a functional group for reduction, wherein the antibacterial colloid is free from nitrate ions.

Abstract: The invention relates to stable vancomycin hydrochloride powder for oral liquid formulations. Also provided herein are methods of using vancomycin oral liquid formulations for the treatment of certain diseases such as Clostridium difficile pseudomembranous colitis and Staphylococcal enterocolitis as well as kits and related products thereof.

Abstract: Disclosed is a performance-enhancing supplement for pulmonary administration wherein the supplement consists of a base e-liquid and a selected combination of supplement ingredients. The base liquid is selected from vegetable glycerin or propylene glycol, and the combination of ingredients is selected from at least three of pineapple lime extract, riboflavin, L-tyrosine, L-theanine, taurine, caffeine, agmatine sulfate, citrulline malate, and beetroot. The resulting performance-enhancing supplement is provided in a standard vape cartridge for use in an electronic cigarette device.

Abstract: A method for chemically induced homing of extracellular vesicles (EVs) to a specific tissue or organ in a subject for either treatment or diagnosis of a medical condition, the method comprising administering to the subject an amount of a homing agent. The homing agent is at least one of a derivative of poly(ethylene glycol), or a derivative of phenothiazine. The EVs are homed to the homing agent in the subject.

Abstract: The invention relates to nutritional compositions comprising specifically designed lipid globules that are especially suited for preterm infants, small for gestational age infants and infants with retarded growth due to physical or mental stress after birth, for promoting catch-up growth and/or for use in improving body composition, improving adipose tissue distribution, decreasing visceral adipose tissue based on body weight and/or on total adipose tissue, and/or decreasing the ratio visceral adipose tissue to subcutaneous adipose tissue, in such infants, and/or providing nutrition to such infants.

Abstract: Provided herein are compositions and methods for wound healing. In particular, provided herein are spray dried suramin for use in wound healing and other applications.

Abstract: The disclosure features novel methods of producing nucleic acid lipid nanoparticle (LNP) compositions employing a modifying agent after formation of a precursor nucleic acid lipid nanoparticle, the produced compositions thereof, and methods involving the nucleic acid lipid nanoparticles useful in the delivery of therapeutics and/or prophylactics, such as a nucleic acid, to mammalian cells or organs to, for example, to regulate polypeptide, protein, or gene expression.

Abstract: An improved immediate release solid dosage form of naproxen with a certain particle size distribution for the intragranular portion, and a certain particle size distribution for the carbonate portion that allows naproxen to remain in solution and achieves fast dissolution and fast absorption of naproxen. The invention provides a naproxen dosage form that when administered to a human in a fasted state provides an average blood plasma naproxen concentration of at least 15-20 ?g/ml in 10 minutes or less. The invention also provides a naproxen dosage form that when administered to a human in a fed state provides an average blood plasma naproxen concentration of at least 15-20 ?g/ml in 50 minutes or less.

Abstract: A patient-friendly drug delivery system and method for targeted populations, such as pediatric and geriatric patients is provided, which system and method include a pharmaceutical composition in the form of mini-tablets. A method of inducing and maintaining sleep in a human in need thereof with the mini-tablets is provided. A method of manufacturing mini-tablets is provided.

Abstract: The invention provides an oral extended release formulation for the treatment of treatment-resistant depression, treatment-resistant anxiety, and phobia.

Abstract: The invention relates to a process for preparing a time controlled, immediate release drug delivery system for oral administration of a first active ingredient to a subject in need thereof. The invention additionally relates to a dual drug delivery device, comprising the time controlled, immediate release drug delivery system according to the invention, further comprising a spray coating comprising a testosterone.

Abstract: Exemplary embodiments of the disclosure may be drawn to ingestible delivery devices. An ingestible delivery device may include a first compartment and a second compartment. A lipase may be contained within the first compartment, and a fat may be contained within the second compartment. The first compartment may be sealed from the second compartment prior to exposure to a trigger, preventing the lipase and the fat from contacting each other, and at least one of the first compartment or the second compartment may at least partially rupture upon exposure to the trigger, allowing the lipase and the fat to contact each other.

Abstract: Disclosed is a microcapsule containing: (i) a microcapsule core having an active material, and (ii) a microcapsule wall formed of a first polymer and second polymer. The first polymer is a sol-gel polymer. The second polymer is gum arabic, purity gum ultra, gelatin, chitosan, xanthan gum, plant gum, carboxymethyl cellulose, sodium carboxymethyl guar gum, or a combination thereof. The weight ratio between the first and second polymer is 1:10 to 10:1. Also disclosed are processes for preparing the microcapsule and uses of the microcapsules in consumer products.

Abstract: A formulation for injection molding of a pharmaceutical carrier comprises 43.5-97% (w/w) of one or more polyethylene oxide polymer having a weight average molecular weight of MW 94,000-188,000; and optionally one or more excipients.

Abstract: This disclosure relates to microcapsule particles for targeted delivery of drugs. In certain embodiments, the particles comprise polyelectrolyte polymers, e.g., layers of anionic polymers and cationic polymers. In certain embodiments, the particles have a fibrinogen coating. In certain embodiments, the particles contain a polysaccharide core and/or a polysaccharide coating encapsulating drugs, proteins, clotting agents, coagulation factors, or anticoagulants. In certain embodiments, this disclosure contemplates methods of using particles disclosed herein to prevent or reduce onset of or duration of bleeding. In certain embodiments, this disclosure contemplates methods of using particles disclosed herein to prevent or reduce onset of blood clotting.

Abstract: There is described, inter alia, a coated bead comprising: (a) a granule; (b) a first layer coated over the granule, the first layer comprising a first amount of an active pharmaceutical ingredient comprising a central nervous system stimulant; and (c) a second layer coated over the first layer, the second layer being present in an amount sufficient to substantially delay release of the active pharmaceutical ingredient in the first layer until after the coated bead reaches a distal intestine portion of a subject to whom the coated bead is administered; and (d) the third layer coated over the second layer, the third layer comprising a second amount of the active pharmaceutical ingredient, the third layer being configured to permit substantially immediate release of the active pharmaceutical ingredient comprised therein. Embodiments related to a solid oral pharmaceutical composition are also described.

Abstract: Described herein are polymeric nanoparticles that include a therapeutic agent, and methods of making and using such therapeutic nanoparticles. In some embodiments, the contemplated nanoparticles may include an excipient.

Abstract: Inflammatory bowel disease (IBD) is a chronic inflammatory gastrointestinal disorder that affects more than 1 million individuals in the USA. Described herein are nanoparticle mucus penetrating formulations for administration of drugs for improved mucosal distribution and tissue penetration such as in the treatment of IBD.

Abstract: The present invention provides a rotigotine-containing patch comprising: a backing layer; and an adhesive agent layer, wherein the adhesive agent layer contains rotigotine and/or a pharmaceutically acceptable salt thereof, the adhesive agent layer further contains a styrene-based thermoplastic elastomer, a petroleum-based resin and/or a terpene-based resin, an aliphatic alcohol, and a cross-linked polyvinylpyrrolidone, and in the adhesive agent layer, a mass ratio of a content of the rotigotine and/or the pharmaceutically acceptable salt thereof in terms of rotigotine free form and a content of the cross-linked polyvinylpyrrolidone (content of the rotigotine and/or the pharmaceutically acceptable salt thereof in terms of rotigotine free form:content of the cross-linked polyvinylpyrrolidone) is 10:3 to 1:3.

Abstract: The invention relates to transdermal therapeutic system for the transdermal administration of buprenorphine, comprising a buprenorphine-containing self-adhesive layer structure comprising A) a buprenorphine-impermeable backing layer, and B) e a buprenorphine-containing pressure-sensitive adhesive layer on said buprenorphine-impermeable backing layer, the adhesive layer comprising a) at least one polymer-based pressure-sensitive adhesive, b) an analgesically effective amount of buprenorphine base or a pharmaceutically acceptable salt thereof and c) a carboxylic acid selected from the group consisting of oleic acid, linoleic acid and linolenic acid, levulinic acid and mixtures thereof, in an amount sufficient so that said analgesically effective amount of buprenorphine is solubilized therein to form a mixture, and the carboxylic acid buprenorphine mixture forms dispersed deposits in the said pressure-sensitive adhesive, wherein said buprenorphine-containing pressure-sensitive adhesive layer is the skin contact

Abstract: The invention relates to methods for preparing dispersible curcuminoid compositions.

Abstract: The invention provides methods and compositions for preventing or treating (e.g., slowing the progression of, arresting, and/or reversing) calciphylaxis in a subject in need thereof and, more particularly, the invention relates to methods of using menaquinone-7 (MK-7) and/or menaquinol-7 (MKH2-7) for preventing or treating calciphylaxis in a subject with one or more of the following: diabetes, chronic kidney disease, end stage renal failure, and COPD or a subject undergoing hemodialysis and/or receiving anticoagulant therapy and/or statin therapy.

Abstract: The invention provides methods and compositions for preventing or treating (e.g., slowing the progression of, arresting, and/or reversing) calciphylaxis in a subject in need thereof and, more particularly, the invention relates to methods of using menaquinone-7 (MK-7) and/or menaquinol-7 (MKH2-7) for preventing or treating calciphylaxis in a subject with one or more of the following: diabetes, chronic kidney disease, end stage renal failure, and COPD or a subject undergoing hemodialysis and/or receiving anticoagulant therapy and/or statin therapy.

Abstract: The invention provides methods and compositions for preventing or treating (e.g., slowing the progression of, arresting, and/or reversing) calciphylaxis in a subject in need thereof and, more particularly, the invention relates to methods of using menaquinone-7 (MK-7) and/or menaquinol-7 (MKH2-7) for preventing or treating calciphylaxis in a subject with one or more of the following: diabetes, chronic kidney disease, end stage renal failure, and COPD or a subject undergoing hemodialysis and/or receiving anticoagulant therapy and/or statin therapy.

Abstract: The present disclosure provides, inter alia, pharmaceutical compositions for and methods of treating an animal, including a human, and methods of preparing such compositions. In certain embodiments, the pharmaceutical compositions contain nonabsorbable compositions and may be used, for example, to treat diseases or other metabolic conditions in which removal of protons, the conjugate base of a strong acid and/or a strong acid from the gastrointestinal tract would provide physiological benefits such as normalizing serum bicarbonate concentrations and the blood pH in an animal, including a human. In certain embodiments, compositions for and methods of improving the quality of life and/or physical function score of such patients are also provided. In certain embodiments, compositions for and methods of slowing the progression of kidney disease in such patients are also provided.

Abstract: Disclosed herein are methods of improving cognitive function in a patient as measured by, for example, improvement in score on a validated scale that measures cognitive function, such as the Behavior Rating Inventory of Executive Function (BRIEF), by administering the test to a patient and obtaining a pre-treatment test score, treating the patient with fenfluramine or its pharmaceutically acceptable salt, and after treatment, re-administering the test of cognitive function to the patient and obtaining a post-treatment score, to allow observation of an improvement in the test score. In some embodiments, the patient is also being treated for the symptoms of epilepsy.

Abstract: The present invention relates to methods for improving dose finding process for combinations of several drugs and/or adapting the dosage of combinatorial treatment. More particularly the invention relates to methods for identifying more efficient dose of active pharmaceutical ingredients (APIs) within combination therapies. This invention also relates to methods for optimizing a therapeutic efficiency of combined therapies.

Abstract: Provided is a method of activating immune cells and/or an immune system response in a subject. The method may comprise administering to a subject an effective amount of a compound of Formula (I): or a prodrug, derivative, and/or salt thereof. In some embodiments, the method comprises contacting an immune cell with a compound of Formula (I) or a prodrug, derivative, and/or salt thereof. Also provided are compounds, compositions, and kits for activating immune cells and/or an immune system response in a subject.

Abstract: Compounds, compositions and their use in the treatment or prevention of symptoms of Lowe Syndrome and Dent disease 2 are described, for instance, the use of such compounds in the treatment of Lowe Syndrome and Dent disease 2, or in the treatment or prevention of at least one symptom associated therewith.

Abstract: This disclosure provides compositions and methods for treating or preventing liver diseases and disorders with hyperammonemia or muscle wasting in a subject.

Abstract: The present invention relates to the enhancement of the efficacy of anticancer agents by a composition comprising an aqueous phase, an oil phase, EPA and DHA for use in the treatment of solid tumors, wherein EPA and DHA are present in an amount of at least 65% based on the total weight of the oil phase wherein the composition comprises EPA and DHA in a weight ratio between 1:2 and 1:4, or wherein the composition comprises EPA and DHA in a weight ratio between 6:1 and 4:1 and wherein the treatment comprises administering the composition and administering at least one anticancer agent.

Abstract: The use of a combination therapy to treat Alzheimer's disease is disclosed herein. The disclosed combination therapy comprises administration of a therapeutically effective amount of a combination of one or more agents used for treatment of the herpes simplex virus, one or more agents used for reducing insulin resistance, one or more anti-inflammatory agents, one or more agents for treatment of atheromatous plaques, and one or more agents for treating impaired neurogenesis.

Abstract: Biologically active cannabidiol analogs comprising a compound of the formula wherein one of R1 or R2 or both is/are the residue of a moiety formed by the reaction of an amino group of the amino acid ester of R1 or R2 or both with a dicarboxylic acid or a dicarboxylic acid derivative and the other R1 or R2 (in the case of the mono) is the residue of a dicarboxylic acid or dicarboxylic acid derivative or Hydrogen (H), (i.e. underivatized), and salts thereof. These CBD analogs are be useful in pain management in oncology and other clinical settings in which neuropathy is presented. Furthermore, these CBD-analogs are useful in blocking the addictive properties of opiates.

Abstract: It is provided an ophthalmic composition, particularly formulated as eye drops, comprising a non-ionic surfactant as active ingredient, wherein the non-ionic surfactant is present in an effective amount from 0.01 to 8 weight/volume % based on the total composition, for use in treating or preventing dry eye and/or for relieving one or more symptoms and/or signs of dry eye. The ophthalmic composition exerts a rapid effect in treating dry eye symptoms and signs while having very low incidence of side effects.

Abstract: The present technology relates to a method for treating anxiety or an anxiety-related disorder in an animal subject, the method comprising administering an effective amount of cannabidiol (CBD) to the animal subject.

Abstract: The present invention relates to a veterinary or pharmaceutical composition comprising: (i) about 1-65% w/v of a pyrethroid, or a salt thereof, (ii) a macrocyclic lactone, or a salt thereof, (iii) at least one alkalizing agent, (iv) at least one non aqueous solvent, wherein the pH of the composition is comprised between about 6.5 and 8.5, when measured by adding 25% of water to an aliquot of said composition. The invention further relates to the use of such composition for preventing and/or treating parasites infestations.

Abstract: A method of treating cancer is described. The method includes administering a therapeutically effective amount of a TET2 activating compound or pharmaceutically acceptable salt thereof to a subject in need of treatment. The TET2 activating compounds are a-ketoglutarate derivatives. A method of treating or preventing cancer in a subject that includes the step of analyzing a biological sample to determine if cells of the biological sample exhibit a TET2 mutation in addition to administering a TET2 activator is also described.

Abstract: The present disclosure relates to a novel dosing regimen for the administration of siponimod or pharmaceutically acceptable co-crystals or salts thereof, in the treatment of stroke, in particular intracerebral hemorrhage (ICH).

Abstract: Provided are novel compounds of Formula (I or Ia?): and pharmaceutically acceptable salts thereof, which are useful for treating a variety of diseases, disorders or conditions, associated with LSD1. Also provided are pharmaceutical compositions comprising the novel compounds of Formula (I or Ia?), pharmaceutically acceptable salts thereof, and methods for their use in treating one or more diseases, disorders or conditions, associated with LSD1.

Abstract: The invention relates to methods for treating pruritus with NK-1 receptor antagonists such as serlopitant. The invention further relates to pharmaceutical compositions comprising NK-1 receptor antagonists such as serlopitant. In addition, the invention encompasses treatment of a pruritus-associated condition with serlopitant and an additional antipruritic agent, and the use of serlopitant as a sleep aid, optionally in combination with an additional sleep-aiding agent.

Abstract: The present invention related to stable N-((1R,2R)-1-(2,3-dihydrobenzo[b][1,4] dioxin-6-yl) -1-hydroxy-3-(pyrrolidin-1-yl)propan-2-yl) octanamide (2R,3R)-2,3-dihydroxysuccinate premix of formula (Ia) and its process for preparation thereof.

Abstract: Stereomerically pure (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione, substantially free of its (?) isomer, and prodrugs, metabolites, polymorphs, salts, solvates, hydrates, and clathrates thereof are discussed. Also discussed are methods of using and pharmaceutical compositions comprising the (+) enantiomer of 2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione are disclosed. The methods include methods of treating and/or preventing disorders ameliorated by the reduction of levels of TNF-? or the inhibition of PDE4.

Abstract: The instant invention is generally directed to a patient-friendly drug delivery system for targeted populations, such as pediatric and geriatric patients. Specifically, the present invention relates to a pharmaceutical composition in the form of mini-tablets. Even more specifically, the present invention relates to a pharmaceutical composition comprising a therapeutically-effective amount of melatonin in the form of mini-tablets.

Abstract: Method of treating trichomoniasis in a subject in need thereof involving administering to the subject a therapeutically effective amount of secnidazole in a microgranule formulation, wherein the microgranule formulation comprises a plurality of microgranules having a volume-weighted particle size distribution within a microgranule population, wherein the volume-weighted particle size distribution as measured from a representative sample of the microgranule population comprises (a) 10% of the microgranule population having a volume-weighted particle size about no less than 470 micrometers; (b) 50% of the microgranule population having a volume-weighted particle size between about no less than 640 micrometers and about no more than 810 micrometers; (c) 90% of the microgranule population having a volume-weighted particle size about no more than 1170 micrometers; or (d) a combination thereof, which can include some or all of (a) through (c) above.

Abstract: This application is directed to inhibitors of RAD51 represented by the following structural formula: in combination with a PARP inhibitor, and methods for their use, such as to treat cancer, autoimmune diseases, immune deficiencies, or neurodegenerative diseases.

Abstract: The present invention relates to methods and compositions for the treatment and prophylaxis of pulmonary arterial hypertension (PAH) in a human subject in need of such treatment, the methods comprising the pulmonary administration to the subject, preferably via inhalation of a composition comprising rapamycin or a prodrug or derivative thereof.

Abstract: Food compositions or dietary supplements comprising an effective amount of an additive that comprises at least one oral hypoglycemic agent for the treatment, prevention, control and management of blood sugar and insulin spikes associated with ingestion of food comprising sugars and simple carbohydrates. Methods for the use of oral hypoglycemic agents as additives during manufacture or preparation of food to lower the glycemic index of the food or glycemic response thereto are also described.