Abstract: The present invention relates to solid dispersions of amorphous 1,1,1,3,3,3-hexafluoro-2-(((5-fluoro-2-(1-(2-fluorobenzyl)-5-(isoxazol-3-yl)-1H-pyrazol-3-yl)pyrimidin-4-yl)amino)methyl)propan-2-ol (Compound I) or a pharmaceutically acceptable salt thereof. It also relates to pharmaceutical compositions and pharmaceutical oral dosage unit forms comprising them, and their uses thereof.

Abstract: Disclosed herein is a tablet for oral suspension comprising carglumic acid and its use.

Abstract: The present disclosure relates to a controlled release complex of a carboxylated polymer having carboxyl groups having a degree of substitution of about 0.1 to about 1.0, forming a complex through ionic interaction with an antimalarial alkaloid extract; a solid oral dosage form comprising the same, and a solid oral dosage form comprising an antimalarial drug combination which comprises the controlled release complex of the present invention and an antimalarial drug.

Abstract: The present document describes a dosage form for delivery of an active ingredient comprising: a first carboxylated polymer having carboxyl groups, having a degree of substitution of at least 0.2, a molecular weight of at least 200 kDa, and at least 30% of said carboxyl groups being complexed with a divalent cation; alone or in a co-complex with at least one of a) a control release polymer chosen from an insoluble polymer or a polymer having a reduced water solubility at 30° C., and a soluble polymer; and b) a second carboxylated polymer having carboxyl groups complexed with a divalent cation. The document also describes processes of making a carboxylated polymer having carboxyl groups, having a degree of substitution of at least 0.2, a molecular weight of at least 200 kDa, and at least 30% of said carboxyl groups being complexed with a divalent cation, and an inclusion complex, a co-complex, or both comprising the same.

Abstract: The present invention relates to solid dosage forms comprising coatings based on natural ingredients, such as naturally-occuring esterified and non-esterified polyuronic acids, optionally in combination with stabilising lipophilic component(s) (e.g. surfactant(s)) and/or other stabilising components. The inventors have made the surprising discovery that polysaccharide-based coatings can be stabilised, and often imparted with gastric resistant properties, through the inclusion of particular additives and/or additional layers. In particular, polyuronic acid-containing coatings may be stabilised and rendered more robust through the inclusion of a lipophilic component (e.g. surfactant), an esterified polyuronic acid, and/or the deployment of an additional coating layer containing stabilising agents that affect the disintegration and/or dissolution of the polyuronic acid.

Abstract: The present disclosure relates to a pharmaceutically stable soft capsule formulation containing two or more different compositions, wherein each single ingredient can be formulated as a composite formulation, and a formulation with improved stability can be provided by minimizing a reaction between two or more different compositions.

Abstract: The present invention relates to a soft capsule shell and a soft capsule. The present invention provides a soft capsule shell prepared from a film-forming composition including 1.5 to 5 wt % of a first gelling agent, 30 to 40 wt % of a starch, 10 to 25 wt % of a plasticizer and 35 to 55 wt % of water, wherein the first gelling agent is a gellan gum with the following properties: the gellan gum solution obtained by dissolving 1.5 wt % of the gellan gum in water at 90° C. for 30 minutes has a viscosity ranging from 10 to 60 mPa·s as measured by a rotational viscometer, wherein the soft capsule shell includes 0 to 3 wt % of starch granules, and the starch granules are those with an average particle size of 10 microns to 50 microns. The invention provides the soft capsule shell with the enteric effect.

Abstract: The present invention relates to a composite formulation for oral dosage that comprises an API selected from 1-(3-cyano-1-isopropyl-indol-5-yl)pyrazol-4-carboxylic acid or a pharmaceutically acceptable salt thereof and does not comprise a pH modifier as an excipient. Since the composite formulation for oral dosage according to the present invention does not comprise a pH modifier, it has the advantage of having a high level of dissolution rate as well as enhanced dosing convenience and productivity, in spite of comprising a high content of API.

Abstract: The present disclosure relates to compositions and methods that enable the formation of pharmaceutically relevant particles that can be used for therapy. In particular, the methods disclosed herein allow the controlled formation of circular particles having low internal void spaces comprising bioactive therapeutic agents.

Abstract: Disclosed herein are compositions comprising synthetic nanoparticles and methods of use thereof for reducing inflammation of the eye and/or skin.

Abstract: The presently disclosed subject matter provides compositions and methods for administering a nanoparticle or microparticle and a therapeutic agent to the suprachoroidal space in the eye.

Abstract: The present invention relates to a technology for constructing and producing, in the form of virus-like particles (VLPs), alfalfa mosaic virus (AMV) isolated from a plant transformed using a recombinant vector for plant expression that is targeted to the chloroplast, and provides a recombinant vector comprising a polynucleotide encoding a recombinant protein in which a chloroplast-targeting protein and an AMV capsid protein are fused. The present invention also provides a transgenic plant transformed by the recombinant vector, a method for isolating and purifying a target protein from the transgenic plant, a method for producing virus-like particles using same, and the like.

Abstract: Disclosed is a percutaneous absorption formulation containing melatonin which is a pharmacologically active substance useful for treating insomniac patients and sleep disorder patients.

Abstract: In aspects, the present disclosure provides a method of treating or preventing uterine fibroids (UF) or polycystic ovary syndrome (PCOS) in a female mammal, the method comprising, consisting essentially of, or consisting of administering to the female mammal an effective amount of doxercalciferol. In aspects, the present disclosure provides a method of treating insulin resistance, infertility, obesity, and/or hyperandrogenism related to PCOS in a female mammal.

Abstract: The present invention provides a high-dose oral pharmaceutical composition and high drug loading of isotretinoin with low fill-weight, and smaller size capsules, and methods of preparation and use thereof.

Abstract: The disclosure provides various new and existing compounds for use alone or as formulated in a composition (e.g., medicaments) and related methods and uses for treating, preventing, inhibiting, ameliorating or delaying the onset of a disease, disorder or condition associated with ferroptosis in a mammalian subject. Such ferroptosis related diseases, disorders or conditions can include: Friedreich's ataxia, Leigh syndrome, Leber's Hereditary Optic Neuropathy (LHON), (proliferative, non-proliferative, diabetic or hypertensive) retinopathy, refractory epilepsy, Parkinson's disease (PD), Alzheimer's disease (AD), Huntington's disease (HD), Amyotrophic Lateral Sclerosis (ALS), ischemic stroke, a cardiomyopathy (e.g. cardiac ischemia-reperfusion injury, myocardial infarction, Barth cardiomyopathy, hypertrophic cardiomyopathy or heart failure), renal injury, renal ischemia reperfusion injury or acute renal failure.

Abstract: The present invention describes stable topical barrier compositions comprising primary polyamines and uses thereof for protecting the skin from external stressors, for improving skin's moisture and fort stimulating healing of the skin. These compositions may be used in a variety of cosmetic and therapeutic applications including for promoting wound healing, for reducing or preventing the formation of hypertrophic scar tissue, for reducing or preventing skin irritation and inflammation, for increasing skin's moisture and/or for reducing or preventing skin's signs of aging.

Abstract: The present invention relates to a topical pharmaceutical composition in the form of an aqueous gel comprising at least amitriptyline and/or a pharmaceutically acceptable salt thereof with a content between 10 and 30% by weight relative to the total weight of the composition, and water.

Abstract: This disclosure relates to dosage forms containing an enantiomerically enriched or pure bupropion such as an enantiomeric excess of (S)-bupropion, enantiomerically enriched (S)-bupropion, or enantiomerically pure (S)-bupropion and methods of using these dosage forms. These dosage forms may be administered to human beings in a reduced amount as compared to the amount of racemic bupropion that would be administered in the same situation.

Abstract: The present invention relates benzylidene aminoguanidine derivatives as NR2B-selective NMDA receptor antagonists and their therapeutic applications.

Abstract: The present disclosure provides an enteral or urinary pharmaceutical formulation comprising (A) a compound of formula I, (I), wherein R1 is a C1-C3 alkyl; X is —C(R2)(R3)—C(R4)(R5)— or —C?C—, wherein R2, R3, R4, and R5 are each independently H or In methyl; Y is —CH?CH—CH2—, —CH2—CH?CH—; —C?C—CH2; —CH2—C?C—; or —C(R7)(R8)—C(R9)(R10)—C(R11)(R12)—, wherein R7, R8, R9, R10, R11 and R12, are each independently H or methyl; provided that (1) when X is —C?C—, Y is —C(R7)(R8)—C(R9)(R10)—C(R11)(R12)— and that (2) when Y is not —C(R7)(R8)—C(R9)(R10)—C(R11)(R12)—, X is —C(R2)(R3)—C(R4)(R5)—; and R6 is H or CH3, or a stereoisomer or a mixture thereof, or a pharmaceutically acceptable salt, ester or solvate thereof; and (B) (a) at least one pharmaceutically acceptable excipient; or (b) at least one other therapeutic agent; or (c) a combination of (a) and (b); and a use thereof for the treatment or prevention of an ammonia-associated disease or disorder, or a symptom thereof.

Abstract: The present invention relates to combinations of local anesthetics for improved pain relief in patients.

Abstract: An energy-promoting composition includes an exogenous ketone body component that provides a source of caloric energy, a vasodilator component, a stimulant component, such as caffeine, and optionally a nootropic component. In most if not all cases, the vasodilator, stimulant, and nootropic components do not themselves provide a source of caloric energy but may increase metabolism of available caloric energy. The separate components beneficially and synergistically interact with one another to enhance the overall energy-promoting effect of the composition more rapidly and to a greater degree than if one or more of the components are omitted. The energy-promoting composition is also formulated to minimize the crash effect common to stimulants such as energy drinks.

Abstract: A composition of an aqueous gel made up of therapeutically effective amounts of a hormone supplement, cannabidiol (CBD), eucalyptol, menthol, one or more salicylic glycosides, and 2,5-Dimethoxy-p-cymene. The hormone supplement is made up of either homeopathic somatropin or L-DOPA, or both.

Abstract: Compositions and methods are presented that, upon administration prior to trauma, are effective to prevent and/or reduce severity of sequelae of TBI upon trauma. Advantageously, the compositions presented herein can be orally administered, have an excellent safety profile, and will not require a prescription by physician or hospital admission.

Abstract: The present specification provides combinations of active agents for the improved treatment of Her2+ cancers and associated methods of treatments. The combinations comprise an RXR agonist and a Her2-targeted therapeutic agent and may optionally further comprise thyroid hormone.

Abstract: The development of innovative inhalation formulations and preparation methods are provided to be used in the prophylaxis of COVID-19-related mortality from a broad-spectrum serine protease inhibitor NM, which has a potent anti-viral and anti-inflammatory potential. A drug for the infection treatment of SARS-COV-2, Influenza A, Influenza B and NL63 viruses includes the drug substance Nafamostat mesylate, which is a serine protease inhibitor in its inhalation form.

Abstract: Provided are methods of administering synthetic tri terpenoids, such as bardoxolone methyl or omaveloxolone, to a patient in need thereof while avoiding adverse drug interactions with cytochrome P450 3A4 (CYP3A4) modulators. Such treatment methods comprise avoiding, contraindicating, or discontinuing concomitant use or co-administration of a cytochrome P450 3A4 modulator.

Abstract: The present application relates to vanadium compounds. More specifically, the present application relates to pharmaceutical compositions comprising vanadium salts, use thereof and methods using the same. The present application also includes compositions comprising vanadium compounds and a therapeutic or prophylactic virus providing for increased virus infection, spread, titer, activity, cytotoxicity and/or immunotherapeutic activity.

Abstract: Provided in some embodiments are titration packages, kits, and methods of treating pulmonary arterial hypertension comprising prescribing and/or administering to a patient in need thereof 2-(((1r,4r)-4-(((4-chlorophenyl)(phenyl)carbamoyloxy)methyl)cyclohexyl)methoxy)acetic acid (Compound 1), or a pharmaceutically acceptable salt, hydrate, or solvate thereof, via a titration scheme that comprises the up-titration of Compound 1, or a pharmaceutically acceptable salt, hydrate, or solvate thereof, over a period of no more than about nine weeks until an optimized dose is administered.

Abstract: The invention relates to a method and a composition for treating or preventing an inflammatory, autoimmune and/or Coronavirus disease and/or symptom. In some embodiments, the-invention relates to a method or a composition for treating or preventing a Coronavirus disease-19 (COVID-19) as well as preventing and curing long term COVID-19 side effects. The composition is a herbal mineral composition or includes the active ingredients that may be found in herbs together with a mineral.

Abstract: Embodiments of the invention relate to the treatment of sleep disturbances in individuals with Smith-Magenis Syndrome (SMS).

Abstract: The disclosure is directed to formulations comprising cannabinoids. More particularly, the cannabinoid formulations can be designed to align with an individual's genotype based on a defined list of polymorphisms.

Abstract: The invention relates to psychoactive medicines including 2C-B, methylone, MBDB, their respective metabolites, isomers, enantiomers, polymorphs, and analogues (2C-series and cathinones); their preparation, formulations, intermediates, routes of administration, dosing and schedule for medical uses for psychiatric and neurological conditions and disorders.

Abstract: The present invention belongs to the field of medicine, and more precisely to the field of medicine useful in the treatment of cardiac diseases with contributing mitochondrial dysfunction. The present invention relates to a composition a pharmaceutical composition comprising a PPAR-modulator and an urolithin derivative of formula I: wherein R1, R2 and R3 independently represents H or OH and its use thereof in the treatment of various cardiac diseases linked to cardiac diseases with contributing mitochondrial dysfunction.

Abstract: Disclosed is a prophylactic or therapeutic drug for Parkinson's disease, which comprises a trisulfide compound and is characterized by being administered in combination with a drug that is used for a dopamine supplementation therapy.

Abstract: The present invention relates to a composition comprising solid crystalline, non-impact or non-detonation sensitive particles comprising 2-bromo-1-(3,3-dinitroazetidin-1-yl)ethanone (ABDNAZ), methods of preparing the crystalline form, and its use.

Abstract: The invention relates to methods and compositions for treating or preventing drug-induced hearing loss.

Abstract: Compounds and methods to treat or prevent CNS diseases, such as Alzheimer's disease and brain injury inflammation, are disclosed herein. The compounds are soluble epoxide hydrolase (sEH) inhibitors and have improved physical properties, blood-brain-barrier (BBB) penetration and long drug-target residence time. Pharmaceutical compositions and kits comprising the compounds are also disclosed herein.

Abstract: This invention relates to treating age-related cognitive impairment. This invention in particular relates to the use of inhibitors of synaptic vesicle protein 2A (SV2A), such as levetiracetam, seletracetam, and brivaracetam, in improving cognitive function in subjects that exhibit age-related cognitive impairment or are at risk thereof, including, without limitation, subjects having or at risk for Mild Cognitive Impairment (MCI), Age-related Cognitive Decline (ARCD) or Age-Associated Memory Impairment (AAMI).

Abstract: The invention provides DNA damage response (DDR) pathway genes and their gene products as biomarkers to predict effective treatment of cancer using an MDM2 antagonist. Identifying one or more DDR pathway biomarkers in a cancer patient allows a determination to be made whether the patient's cancer is likely to be successfully treated using an MDM2 antagonist. Accordingly, the invention relates generally to a companion diagnostic for MDM2 antagonist therapy.

Abstract: In alternative embodiments, provided are methods for treating or ameliorating hyperactive ZAP70 kinase-related diseases or conditions, including any disease or conditions mediated by hyperactive T cells or disease or condition whose pathology is initiated, aggravated or mediated by hyperactive T cells, such as autoimmune disease (including for example, an autoimmune disease requiring allogeneic hematopoietic cell transplantation (HCT) in patients, rheumatoid arthritis (RA), inflammatory bowel disease (IBD), Crohn's disease, type 1 diabetes, multiple sclerosis, uncontrollable bullous pemphigoid, colitis, celiac disease, dermatitis and proteinuria), organ transplant rejection, graft-versus-host disease (GVHD) and/or B cell chronic lymphocytic leukemia (CLL). In alternative embodiments, methods as provided herein comprise administering to an individual in need thereof the FDA-approved cancer drug sunitinib (or SUTENT™), or salts or formulations thereof, for example sunitinib malate.

Abstract: Compositions and methods for treating skin conditions, ailments or diseases, such as autoinflammatory skin diseases such as psoriasis, dermatitis, pyoderma gangrenosum, palmoplantar pustulosis, prurigo nodularis and/or hidradenitis suppurativa, are described. The compositions comprise an agent that modulates the aryl hydrocarbon receptor, in particular an agent that agonizes the receptor. In one embodiment, the agent is indigo or a derivative of indigo, such as indirubin.

Abstract: The present disclosure relates generally to methods of treating various diseases, disorders, and conditions, such as depressive disorders (e.g., Major Depressive Disorder (MDD)), substance use disorders, anxiety disorders, eating disorders, pain, and headache disorders via administration of deuterated psilocin and pharmaceutically acceptable salts, polymorphs, or solvates thereof.

Abstract: Provided herein are compositions comprising ruboxistaurin free base and its salts thereof and methods of use for treating conditions of the skin.

Abstract: The present invention relates to a pharmaceutical composition comprising 1-(3-cyano-1-isopropyl-indol-5-yl)pyrazol-4-carboxylic acid or a pharmaceutically acceptable salt thereof, and a method of treating or inhibiting a hyperuricemia-related disease using the same, and the pharmaceutical composition of the present invention may effectively reduce the blood uric acid concentration in a patient with a hyperuricemia-related disease.

Abstract: Provided is a method for killing mites and treating xerophthalmia by compounds and salts, stereoisomers and solvates thereof.

Abstract: The present disclosure relates to stable, liquid pharmaceutical compositions of losartan or pharmaceutically acceptable salts thereof for oral administration. The present disclosure further provides powder compositions for reconstitution to provide a liquid formulation. In further aspects, the present disclosure relates to processes for preparation of such pharmaceutical compositions, and methods of treating a subject in need of losartan by administration of a formulation described herein.

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: 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.