Abstract: Provided herein are topical formulations. The topical formulation may comprise: (i) pregabalin, (ii) water, (iii) DMSO, (iv) a keto acid, and (v) and/or a fatty alcohol. The topical formulation may also comprise (i) pregabalin, (ii) DMSO, (iii) a keto acid and (iv) a fatty acid ester. It has been discovered that the combinations of DMSO with a keto acid such as levulinic acid and/or and a fatty acid ester such as lauryl lactate, or combinations of DMSO with a keto acid such as levulinic acid and/or with a fatty alcohol such as oleyl alcohol are excellent penetration enhancers and, as such, can be incorporated in a skin-applied formulation to facilitate administration of pregabalin.

Abstract: Provided herein is an oral liquid suspension that includes topiramate, as well as methods of medical treatment that include orally administering the oral liquid suspension.

Abstract: The present invention pertains to a pharmaceutical, or nutraceutical, “self-emulsifying solid dispersion” composition for oral administration which contains (a) a drug or a nutraceutical that is water-insoluble or poorly water-soluble; (b) at least one surfactant; (c) one carrier selected from the group consisting of silicic acid, a silicate, or any combination thereof; and (d) at least one carbohydrate filler.

Abstract: Disclosed herein are lipid emulsified systems containing antihistamines. Also disclosed herein are pharmaceutical compositions containing the lipid emulsified systems and other chemotherapeutic agents, and methods of chemoprevention and cancer treatment with compositions containing the lipid emulsified systems.

Abstract: Disclosed herein are novel pharmaceutical formulations of a neurokinin-1 (NK-1) receptor antagonist suitable for parenteral administration including intravenous administration. Also included are formulations including both the NK-1 receptor antagonist and dexamethasone sodium phosphate. The pharmaceutical formulations are stable oil-in-water emulsions for non-oral treatment of emesis and are particularly useful for treatment of subjects undergoing highly emetogenic cancer chemotherapy.

Abstract: Microemulsions are disclosed herein that include a discontinuous internal phase comprising an aqueous solution encompassed within an internal emulsifier; a continuous oil phase encompassing the internal phase; and an external emulsifier encompassing the oil phase. Also disclosed are methods for the use of such microemulsions as drug delivery devices, and methods for treating glaucoma and reducing intraocular pressure.

Abstract: The present invention provides a liposomal topical formulation or a liposomal topical formulation base having barrier-forming siliconic components, methods for making the same, and methods for using the same in the treatment of dermatological diseases and conditions, including male pattern baldness.

Abstract: Provided herein are nanocarriers for delivery of immunosuppressive agents. In some embodiments, provided herein are nanocarriers comprising a core comprising a poly(ethylene glycol)-block-poly(propylene sulfide) copolymer and least one therapeutic agent. In some embodiments, the nanocarriers may further comprise a targeting ligand displayed on a surface of the nanocarrier. The at least one therapeutic agent may be an anti-inflammatory agent. The disclosed nanocarriers may be incorporated into pharmaceutical compositions for use in methods of treating an inflammatory condition or preventing transplantation rejection in a subject.

Abstract: The disclosure generally relates to lipid nanodiscs, in particular to lipid nanodiscs formed from polymers. A lipid nanodisc according to the disclosure includes a lipid bilayer having a first hydrophilic face and a second hydrophilic face opposing the first hydrophilic face, and a hydrophobic edge between the opposing hydrophilic faces, and a polymer encircling the hydrophobic edge of the lipid bilayer. The polymer includes a first monomeric unit having a pendant hydrophobic group and a second monomeric unit having a backbone hydrophilic group. Methods of making and characterizing the lipid nanodiscs are also disclosed.

Abstract: The present invention is directed to a storage-stable formulation of long-chain RNA. In particular, the invention concerns a dry powder composition comprising a long-chain RNA molecule. The present invention is furthermore directed to methods for preparing a dry powder composition comprising a long-chain RNA molecule by spray-drying. The invention further concerns the use of such a dry powder composition comprising a long-chain RNA molecule in the preparation of pharmaceutical compositions and vaccines, to a method of treating or preventing a disorder or a disease, to first and second medical uses of such a dry powder composition comprising a long-chain RNA molecule and to kits, particularly to kits of parts, comprising such a dry powder composition comprising a long-chain RNA molecule.

Abstract: Provided herein are compositions with enhanced sweetness or reduced caloric content per weight when compared to the sweetener carbohydrate or sweetener polyol component thereof, and methods for the preparation thereof.

Abstract: Provided is a composition for reducing hair loss and thickening hair and a preparation method thereof, and more particularly to a composition for preventing hair loss and thickening hair that includes beads composed of carrageenan, cellulose, agar, charcoal powder, acrylate copolymer, caffeine, amino acid, keratin, gellan gum, Ulva lactuca powder, menthol, salicylic acid, dexpanthenol, niacinamide, zinc pyrithione, biotin, etc.

Abstract: The present invention is directed to the field of RNA formulation, in particular to lyophilization of RNA. The invention provides a method for lyophilization of RNA. The present invention further concerns a lyophilized composition obtainable by the inventive method, a pharmaceutical composition, a vaccine and a kit or kit of parts. Moreover, the present invention provides a novel use of a lyoprotectant for lyophilizing RNA, the use of the inventive method in the manufacture of a medicament as well as the first and second medical use of the composition obtainable by the inventive method, the pharmaceutical composition, the vaccine or the kit or kit of parts according to the invention.

Abstract: Extended release pyridostigmine dosage forms, suitable for maintaining stable plasma concentrations with reduced or minimized initial burst release/dose dumping of pyridostigmine, are provided. The dosage forms include matrix tablets, gastroretentive tablets, and pellets, the latter being suitable for dosing in capsules, tablets, and sachets, as well as for sprinkling on foodstuffs. The disclosure also provides methods for improving patient compliance by administering once-a-day extended release pyridostigmine bromide dosage forms that provide a superior controlled drug release.

Abstract: Provided are modified release compositions in a solid oral dosage form comprising amisulpride in the form of an unequal mixture of (R)-amisulpride and (S)-amisulpride, or pharmaceutically acceptable salts thereof, where the amount of (R)-amisulpride is greater than the amount of (S)-amisulpride, and medicaments comprising the same used for the treatment of various diseases and disorders, and methods of using same for the treatment of various diseases and disorders, including, but not limited to, dosage regimens. In addition, provided are formulations employing polymorphs of enantiomeric amisulpride.

Abstract: An aqueous enteric coating composition including hydroxypropylmethylcellulose, acetate succinate, and a basic amino acid.

Abstract: Provided are an enteric coated pharmaceutical composition and use thereof. The enteric coated pharmaceutical composition comprises chitosan citrate, a pharmaceutically acceptable carrier, and an enteric coating, wherein chitosan citrate is coated by the enteric coating and comprises a chitosan moiety of 50 to 75% deacetylation.

Abstract: The invention relates to a process for coating a solid, water-insoluble particulate matter, with a metal oxide comprising: (a) contacting the solid, water-insoluble particulate matter with an ionic additive and an aqueous medium to obtain a dispersion of said particulate matter having positive charges on its surface; (b) subjecting the particulate matter to a coating procedure comprising precipitating a metal oxide salt onto the surface of the particulate matter to form a metal oxide layer thereon to thereby obtain particulate matter coated by a metal oxide coating layer; (c) repeating step (b) at least 4 more times; and (d) aging said coating layer. The invention further relates to particles comprising a particulate matter coated by a metal oxide layer, to a use of the particles for topical administration, and to a method for preventing, reducing, or eliminating pests at a locus, using the particles.

Abstract: A hydrogel delivery composition and method, including degradable microcapsules suspended in a degradable thermo-responsive hydrogel. The hydrogel is thermo-responsive at a physiological temperature and changes after application to a more solid state due to body temperatures. The composition includes one or more treatment agents to be released over time as the composition degrades. The composition can be varied to modify the structure and/or release of the treatment agent. The degradable microcapsules include one or more of magnesium hydroxide (Mg(OH)2), bovine serum albumin (BSA), polyethylene glycol (PEG), and sucrose to improve release duration.

Abstract: A nanocarrier including a silica body having a surface and defining a plurality of pores that are suitable to receive molecules therein is described. The nanocarrier also includes a lipid bilayer coating the surface, and a cargo-trapping agent within the phospholipid bilayer. The phospholipid bilayer stably seals the plurality of pores. The cargo-trapping reagent can be selected to interact with a desired cargo, such as a drug.

Abstract: The present disclosure relates to benzene-1,3,5-tricarboxamide derived ester lipid compounds, compositions, lipid-like nanoparticles, and methods for delivery of therapeutic, diagnostic, or prophylactic agents.

Abstract: The invention described herein provides various indirubin compositions for treating diseases.

Abstract: A method of treatment for HIV or other viral infection involves the administration of a biopolymer based hydrogel nanoparticles and/or microparticles that are comprised of chitosan, hydroxyethyl cellulose (HEC), and linseed oil polyol. These biopolymer based hydrogel nanoparticles and/or microparticles are the antiviral agent that can be employed alone or in combination with other drugs for treatment of the viral infection. Evidence demonstrates the pre-treatment with nanogels is highly effective at lowering HIV growth. Therefore, this antiviral biopolymer based hydrogel nanoparticles and/or microparticles may also be employed as a prophylactic.

Abstract: The present invention relates to a method for obtaining nanostructures, specifically nanoemulsions and nanocapsules of carotenoids such as curcumin and astaxanthin. This method—using particular concentrations of the ingredients forming the nanostructures—allows high association efficiencies of the active ingredient in the nanostructures containing these ingredients and protection of these nanostructures from environmental factors such as oxidation and light. The invention also relates to the nanoemulsions and nanocapsules of curcumin and astaxanthin for use in the food, pharmaceutical and cosmetics industries, among others.

Abstract: Described herein are compositions and methods that, in some embodiments, are specifically configured to treat different types of constipation. In particular, described herein are compositions and methods for treating IBS-C, opioid induced constipation, and chronic idiopathic constipation. In addition to treating the symptom of constipation, these embodiments of the compositions and methods described herein are configured to address specific etiologies and/or pathophysiologies associated with the constipation types of IBS-C, opioid induced constipation, and chronic idiopathic constipation.

Abstract: The invention provides compositions and methods for treating seizure disorders such as epilepsy in humans and animals using, in a first embodiment, the combination of (i) an effective amount of a barbiturate drug, such as phenobarbital or primidone, which solely enhances GABAergic inhibition in a patient suffering a seizure disorder; and (ii) phytocannabinoid cannabidiol (CBD) in a dosage amount sufficient to overcome the hepatic metabolic effect stimulated by the barbiturate drug and provide bioavailable CBD to the patient in clinically efficacious amounts.

Abstract: The present invention relates to an oral thin film comprising at least one cellulose derivative and at least one pharmaceutically active agent, the at least one pharmaceutically active agent having a water solubility of at most 50 g/L at 20° C. and a pH of 6 to 7 and being contained in the oral thin film in an amount of at least 20 wt. % in relation to the total weight of the oral thin film, and to a method for production of said oral thin film, and use thereof as a medicament.

Abstract: The present disclosure relates to methods, compositions and products for treating pain, and/or pain related symptoms, associated with dysmenorrhea in a subject. In certain embodiments, the present disclosure provides a method of treating pain, and/or pain related symptoms, associated with dysmenorrhea in a subject, the method comprising intrauterine and/or vaginal administration to the subject of an effective amount of an agent that reduces activation of the innate immune system and thereby treating the pain and/or the pain related symptoms in the subject. Other embodiments are also disclosed.

Abstract: Compounds and methods of scavenging bifunctional electrophiles and reducing the occurrence of lysyl-levuglandin adducts in a subject in need thereof by administering a levuglandin adduct formation inhibiting amount of a compound of the following formula: wherein the variables are defined herein.

Abstract: The present invention relates to fluoroethylnormemantine or one of the salts thereof for the treatment of anxiety and, more particularly, post-traumatic stress conditions, either alone or in combination with chemical antidepressant treatments or cognitive and behavioral techniques.

Abstract: In certain embodiments, this disclosure relates to methods of treating or preventing nephrogenic diabetes insipidus comprising administering an effective amount of a compound of Formula (I) or derivatives thereof, as described herein, to a subject in need thereof. In certain embodiments, the subject has been diagnosed with nephrogenic diabetes insipidus.

Abstract: Provided are methods of treating pulmonary artery hypertension with a Kv11.1 (ERG or hERG1) channel inhibitor. In certain embodiments, the Kv11.1 channel inhibitor is dofetilide. In certain embodiments, a subject to be treated using a method of the disclosure is not in need of treatment for an irregular heart rhythm, e.g., atrial fibrillation.

Abstract: Disclosed herein are compounds that may be specific to PPAR and/or EGF receptors, and methods of making and using same.

Abstract: The present disclosure describes methods of treatment (e.g., combination treatment) by ferroptotic induction, as well as compositions and dosing regimens that are part of such methods. Surprisingly, it is presently found that delaying administration of a ferroptosis-inducing agent until after starting hormone therapy results in enhanced ferroptotic induction in a subject. Thus, in certain embodiments, combination therapies are presented herein that include multiple administration steps whereby a ferroptosis-inducing agent is administered some time after hormone therapy has begun.

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: The present invention relates to methods for treating a disease associated with insulin resistance selected from a nonalcoholic fatty liver disease (NAFLD) and its sequelae, a lipodystrophic syndrome or a combination thereof with the selective PPAR? agonist, INT131 and optionally vitamin E or compositions thereof. NAFLDs that may be treated with methods and compositions of the present invention include, but are not limited to, simple nonalcoholic fatty liver and nonalcoholic steatohepatitis (NASH). Lipodystrophic syndromes that may be treated with the methods and compositions of the present invention include, but are not limited to, generalized lipodystrophy including congenital generalized lipodystrophy and acquired generalized lipodystrophy and/or partial lipodystrophy, including congenital partial lipodystrophy and acquired partial lipodystrophy, all of which may or may not include hyperlipidemia and/or hyperglycemia and may or may not include NAFLD.

Abstract: A lipoic acid formulation can include water and an amount of a lipoic acid agent dissolved in the water. In some examples, a buffering agent can also be included in the formulation in an amount sufficient to dissolve the lipoic acid agent in the water. The lipoic acid formulation can generally have a pH of from about 6 to about 8.

Abstract: The present invention relates to methods of treating autoimmune diseases with siponimod in patients receiving additionally a beta-blocker.

Abstract: The disclosure herein provides combination therapies for the treatment of cancers such as Leukemia, lymphoma and triple negative breast cancer. The disclosure provides combination therapies of CDK inhibitors, e.g., a CDK inhibitor represented by Formula (I): or a pharmaceutically acceptable salt thereof together with a BCL-2 inhibitor or proteasome inhibitor for the treatment of cancer.

Abstract: An oral melatonin pharmaceutical dosage form that contains a sustained release dose of melatonin includes melatonin and an acid dispersed in a hydrogel-forming polymer matrix that combine after ingestion to form an acidic hydrogel containing the melatonin.

Abstract: The invention relates to dosage regimens for administering pharmaceutical compositions comprising 3-[5-amino-4-(3-cyanobenzoyl)-pyrazol-1-yl]-N-cyclopropyl-4-methylbenzamide for the treatment of a human patient suffering from COPD, or suffering from an acute exacerbation of COPD, or at risk of developing an acute exacerbation of COPD, or to prevent a reoccurrence of an acute exacerbation of COPD, or to prevent a treatment failure of an acute exacerbation of COPD, and to methods of prevention or reduction in the rate of acute exacerbations of COPD in a human patient.

Abstract: Provided are methods of treating patients suffering from or susceptible to at least one symptom of abuse of, dependence on, or withdrawal from at least one substance with Compound A. Also provided are methods of treating at least one phase of substance dependence on at least one substance in patients and certain methods of treating at least one phase of cocaine dependence in patients.

Abstract: Compositions containing one or more amino acids selected from the group consisting of 25 mol % to 45 mol % of leucine, and 20 mol % to 40 mol % of phenylalanine relative to the total content of leucine, lysine, valine, isoleucine, phenylalanine, histidine, and tryptophan, are useful for improving cognitive function, for improving anxiety-like symptoms, and for suppressing cerebral atrophy and are highly safe and can be ingested or administered continuously.

Abstract: Methods and pharmaceutical compositions are provided, which make use of compounds disclosed herein, including (I). The methods and compositions are useful for producing local or regional anesthesia or analgesia in nerve tissue of a subject.

Abstract: The disclosure is directed to methods of treating subjects exposed to nerve agents with dantrolene, or a pharmaceutically acceptable salt thereof.

Abstract: A method for increasing the number of CD4+ T-lymphocytes in the serum of a subject in need of such treatment comprising administering to the subject a pharmaceutical composition comprising an amount of an L-isomer of ?-lactam effective to increase the number of CD4+ T-lymphocytes in said patient's serum.

Abstract: A method of treating or preventing keratin hyperproliferation skin disorders is set forth. The method includes the administration of an mTOR inhibitor to a subject afflicted with the hyperproliferation disorder. The mTOR inhibitor can be administered to the subject via any means known in the art including oral, topical, and transdermal administration.

Abstract: Pharmaceutical compositions comprising an active pharmaceutical ingredient, a high viscosity liquid carrier material, a hydrophobic solvent, and a hydrophilic solvent are disclosed. Also disclosed are methods of manufacturing and using the compositions. The compositions are suitable for use, e.g., as depot formulations.

Abstract: Human therapeutic treatment compositions comprise at least two of a curcumin component, a harmine component, and an isovanillin component, and preferably all three in combination. The agents are effective for the treatment of human conditions, especially human cancers.

Abstract: A compound represented by formula (I) or a pharmaceutically acceptable salt thereof has potential use as an agent for treating essential tremor, small fiber neuropathy, dystonia, epilepsy associated with Alzheimer's disease, epilepsy associated with brain tumor, or brain tumor.