Abstract: The present disclosure provides compounds that modulate protein function, to restore protein homeostasis, and cell-cell adhesion. The disclosure provides methods of modulating protein-mediated diseases, such as cytokine-mediated diseases, disorders, conditions, or responses. Compositions, including in combination with other cytokine and inflammatory mediators, are provided. Methods of treatment, amelioration, or prevention of diseases, disorders, or conditions associated with a protein, are provided.

Abstract: The present disclosure is directed to a pharmaceutical formulation intended for oral delivery of synthetic or natural poorly permeable molecules or salts/solvates thereof having a therapeutic activity. The pharmaceutical formulation can include a synthetic or natural poorly permeable molecule or salt or solvate thereof in an amount 0.01-10 wt. % of the total weight of the formulation; a lipophilic phase comprising triglycerides of fatty acids in an amount of 50-80 wt. % of the total weight of the formulation; and at least one lipophilic surfactant comprising partial esters of polyol and fatty acids in an amount of about 10-50 wt. % of the total weight of the formulation.

Abstract: The present disclosure relates to metformin glycinate and methods of using metformin glycinate for the treatment of diseases including diabetes mellitus, obesity, dyslipidemia, diseases associated with IL-10 up-regulation, and diseases or disorders associated with elevated or increased ceramide levels. Pharmaceutical formulations comprising metformin glycinate are also disclosed.

Abstract: Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.

Abstract: Disclosed herein are compositions and methods for treating lung disorders including lung tumors by pulmonary administration of compositions comprising taxane particles such as docetaxel or paclitaxel particles.

Abstract: The present invention relates to gastroretentive formulations and to processes for preparation of the same. Particularly, the invention relates to gastroretentive dosage forms comprising at least one swelling agent and at least one swelling retardant.

Abstract: A composition for an enteric hard capsule by taking advantage of conventionally unknown thermal gelation characteristics of a neutralized aqueous solution of an enteric polymer, so as to obtain an enteric capsule having sufficient water and acid resistances. More specifically, the composition has hypromellose acetate succinate having a molar substitution with an acetyl group per anhydroglucose unit of 0.6 to 0.8 and a ratio of the molar substitution with an acetyl group to a molar substitution with a succinyl group per anhydroglucose unit of 2.0 to 4.0, a neutralizer, and water method produces an enteric hard capsule having the steps of: immersing a core pin heated at 50 to 80° C. in the composition, taking the immersed core pin out of the composition, and drying a gel layer of the hypromellose acetate succinate formed on the taken-out core pin.

Abstract: A capsule for detection of gastrointestinal motility and a method for preparing such a capsule is provided. The capsule comprises a capsule enclosure and a preset quantity of radiopaque markers filled in the capsule. The radiopaque markers further comprise a solid X-ray contrast agent, a medical plastic with a density of at most at 1.4 g/cm3 and an auxiliary agent.

Abstract: In various embodiments, the present disclosure provides compositions and methods for treating and/or preventing cardiovascular-related diseases in subject in need thereof having triglyceride levels of about 200 mg/dL to about 499 mg/dL, and hsCRP levels ?2.0 mg/L.

Abstract: A novel method for the preparation of biodegradable polymers is disclosed. The method produces polymers of high molecular weight and particularly allows for stirring throughout the polymerization reaction.

Abstract: A composition comprising probiotic bacteria, the composition comprising: (a) a core composition containing the probiotic bacteria and a stabilizer, wherein the total amount of probiotics in the mixture is from about 10% to about 90% by weight of the core composition; (b) an innermost coating layer, layered on said core composition, comprising at least one hydrophobic solid fat or fatty acid having a melting point lower than 60° C.; (c) an intermediate coating layer layered on said innermost coating layer, which when present in an aqueous solution in the amount of 0.1% weight/weight over the weight of the solution, has a surface tension lower than 60 mN/m, when measured at 25° C.; and (d) an outer coating layer, layered on said intermediate coating layer; wherein the composition is in the form of particles; food products containing the composition and methods of preparation thereof.

Abstract: The invention relates to a film-forming composition comprising a fluidised hydroxypropyl starch and sorbitol, and to a film-coating method using said composition. The invention further relates to film-coated solid forms comprising a fluidised hydroxypropyl starch and sorbitol in the coating.

Abstract: The present invention provides novel pharmaceutical compositions of dimethyl fumarate. The pharmaceutical compositions of the present invention comprises a first pharmaceutical bead composition and a second pharmaceutical bead composition, wherein the first pharmaceutical bead composition is an enterically coated immediate-release composition and the second pharmaceutical bead composition is an enterically coated controlled-release composition, wherein the first pharmaceutical bead composition and the second pharmaceutical bead composition both comprise dimethyl fumarate Methods of using the pharmaceutical compositions of the present invention for treating multiple sclerosis are also included.

Abstract: The present invention relates to extended-release pharmaceutical compositions comprising pregabalin or a salt thereof, which are adapted to release the pregabalin active ingredient according to a dual release profile. The formulations comprise two components, the first (fast ER) providing extended-release of the active ingredient in a short controlled manner lasting from about 4 to about 6 hours, and the second (slow ER or maintenance) providing extended release of the active ingredient over a period of 24 hours. The proportion of each component in the formulation may be adjusted to achieve the desired AUC and therapeutic effect following oral administration to a subject. The invention further relates to methods of using the pharmaceutical compositions for treating conditions and disorders which are responsive to pregabalin treatment, such as neuropathic pain associated with diabetic peripheral neuropathy (DPN), post herpetic neuralgia (PHN), epilepsy, seizures and fibromyalgia.

Abstract: Embodiments of the invention relate generally to increasing adult height in individuals with no light perception (NLP).

Abstract: The invention relates to self-assembling microparticles comprising a solid matrix and probiotic bacteria, wherein the solid matrix comprises soybean protein and a divalent or trivalent metal, and wherein the probiotic bacteria are distributed throughout the solid matrix; said matrix protects said probiotic bacteria during processing, storage, as well as during transit through the gastrointestinal tract, thus prolonging their lifetime and facilitating release into the intestine and improving their probiotic effect. The present invention also relates to the method for obtaining the self-assembling microparticles and to the products and compositions incorporating them.

Abstract: Shown herein is a nutritional supplement containing apple cider vinegar (ACV), including compositions, formulations, and combinations of ingredients in the ACV nutritional supplement, as well as processes for manufacturing these supplements. The nutritional supplement can include ACV, a gelling agent such as pectin or gelatin, an oligosaccharide, a disaccharide, and water.

Abstract: Described are methods for using cyclodextrin to treat, inhibit, prevent, ameliorate, or cure diabetes or conditions relating to diabetes.

Abstract: Shown herein is a nutritional supplement containing apple cider vinegar (ACV), including compositions, formulations, and combinations of ingredients in the ACV nutritional supplement, as well as processes for manufacturing these supplements. The nutritional supplement can include ACV, a gelling agent such as pectin or gelatin, an oligosaccharide, a disaccharide, and water.

Abstract: Provided is a die roll for manufacturing softgels, a softgel, and methods for producing a softgel. The die roll includes a die roll surface and a pocket defined therein. The pocket includes a floor, an interior sidewall surface, a chamfer, and an exterior sidewall surface. The floor is recessed relative to the die roll surface and the interior sidewall surface is connected to the floor and extends above the die roll surface to the chamfer. The pocket also includes a landing surface that is elevated from the die role surface and connects the chamfer to the exterior sidewall surface of the pocket. The landing surface includes a taper (such that the landing surface tapers inwardly towards the pocket floor) and a radius (such that the landing surface is not flat). Also provided is a softgel having a trailing edge thickness that is at least about 40% the thickness of the softgel wall thickness.

Abstract: The present invention provides a new use or method of use of a thylakoid extract, for oral route of administration, and a composition comprising the thylakoid extract in adjunction with an acceptable carrier for oral administration. Besides the pharmaceutical use, the thylakoid extract enters the composition of food or food supplements, or medication for its innocuity and its capacity to provide a diet enriched in anti-oxidants and anti-inflammatory compounds. Therefore, in accordance with the present invention is provided the use of athylakoid extract in the making of an oral composition for treating preventing a disease or disorder involving the formation of reactive oxygen species or inflammation. Also is provided a method for treating or preventing a disease or disorder involving the formation of reactive oxygen species inflammation in an individual, which comprises the step of orality administering an effective dose of a thylakoid extact.

Abstract: The disclosed are shelf-stable beta-hydroxyisovaleric acid containing soft gel compositions and methods for making such compositions. In certain aspects, disclosed compositions comprise a plant-based capsule shell and a liquid formulation comprising beta-hydroxyisovaleric acid and at least one excipient, wherein the soft gel capsule is shelf-stable. In certain aspects, the excipient is selected from selected from choline salt, betaine, phosphatidylcholine, alpha-glycerophosphocholine, carnitine, adenosine 5?-triphosphate, or a combination thereof.

Abstract: The present disclosure provides methods and compositions related to nanoparticles comprising an encapsulated hydrophobic drug. The methods described herein provide nanoparticles having a small size and a narrow size distribution.

Abstract: A process for the preparation of an oral disintegrating tablet comprising the antihypertensive telmisartan and the tablet obtained by the process.

Abstract: A formulation comprising at least one ketogenic agent, at least one cannabinoid, at least one polyphenol, at least one phytonutrient, at least one dietary nutrient, at least one antioxidant, and at least one mineral, and mixtures and combinations thereof utilized for performance, cardiometabolic, cognitive, and women's health and wellness.

Abstract: Compositions and methods for the solubilization of steroid hormones are disclosed.

Abstract: The present disclosure relates to aqueous composition comprising hydroxypropyl methyl cellulose acetate succinate (HPMCAS) polymer dispersed in water, wherein the dispersed polymer is partially neutralized with at least one alkaline material. The instant disclosure also relates to compositions for use in methods of making capsule shells endowed with bulk enteric properties. The present disclosure also relates to capsules made according with the compositions and methods of the present disclosure.

Abstract: A new route is shown for at delivery in fighting drug resistant infections. Nanotubes and antibiotics and complexed non-covalently, with no chemical bonding, but through adsorption of antibiotics onto the nanotube surface governed by sufficiently strong molecular attraction between hydrophobic systems of the two. This allows the antibiotics to be freed from the nanotubes more easily as they reach the cell membrane. When antibiotics are introduced with nanotubes in this manner, bacterial resistance is mitigated by nanotube transport potentially into the membrane of the bacteria. Nanotubes used in this way help to overcome antibiotic resistance.

Abstract: A mixing device and methods of utilizing the same. More specifically, embodiments of the present disclosure relate to a mixing device that may be used to make medications and specialized pharmaceuticals for administration via intrathecal infusion therapy, or the like. A mixing device may comprise an upper chamber, a lower chamber having four compartments for accepting an amount of medication, wherein the upper chamber and the lower chamber may be coupled and may be used to mix and make medication accessible via a Luer Lock adapter, termination, or the like, wherein the device is in compliance with USP 797 standards.

Abstract: The present invention relates to a controlled release formulation comprising the active compounds tesofensine and a beta blocker, such as metoprolol or carvedilol, or a pharmaceutically acceptable salt thereof. The invention further relates to use of the controlled release formulation in a method of treatment of diabetes, obesity, or an obesity associated disorder.

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

Abstract: Biomedical devices for implantation with decreased pericapsular fibrotic overgrowth are disclosed. The device includes biocompatible materials and has specific characteristics that allow the device to elicit less of a fibrotic reaction after implantation than the same device lacking one or more of these characteristic that are present on the device. Biocompatible hydrogel capsules encapsulating mammalian cells having a diameter of greater than 1 mm, and optionally a cell free core, are disclosed which have reduced fibrotic overgrowth after implantation in a subject. Methods of treating a disease in a subject are also disclosed that involve administering a therapeutically effective amount of the disclosed encapsulated cells to the subject.

Abstract: The invention is directed to pharmaceutical compositions such as tablets that exhibit delayed release properties when administered as either whole or half tablets. The invention is also directed to delayed release tablets comprising deferiprone for oral administration, for which twice daily administration is bioequivalent to the same daily dose of an immediate release tablet administered thrice daily. The invention is also directed to methods of making and using the same.

Abstract: Disclosed in certain embodiments is a solid oral dosage form comprising a plurality of particles, each particle comprising (i) a core comprising an active agent susceptible to abuse and an internal adhesion promoter, wherein the cores are (i) dispersed in a matrix comprising a controlled release material or (ii) coated with a controlled release material. The dosage form can also include an alcohol resistant material.

Abstract: A liquisolid tablet formulation, comprising a microcrystalline cellulose carrier; a silica coating; a crosslinked polyvinylpyrrolidone (PVP) superdisintegrant; a solvent comprising polyethylene glycol (PEG) 200 and caprylocaproyl macrogol-8 glycerides; tadalafil; and dapoxetine, wherein the liquid load factor of the formulation is 0.2-0.4 is provided. Methods of making the liquisolid tablet and methods of using the formulation for the treatment of male sexual dysfunction are also provided.

Abstract: A pharmaceutical soft gelatin capsule dosage form that includes (a) a shell that includes gelatin; and (b) a fill that includes at least one active ingredient, one or more polyethylene glycol, and a modified guar gum. The pharmaceutical soft gelatin capsule dosage form maintains its shell integrity (hardness) and fill viscosity after storage.

Abstract: A method for improving athletic or physical performance in a human includes administering to the human a composition or supplement formulation including a single administration of inorganic nitrate (NO3?), a single administration of inorganic nitrite (NO2?), or a combination thereof; and an additive. A method for increasing endurance in a human includes administering to the human a composition or supplement formulation including a single administration of inorganic nitrate (NO3?), a single administration of inorganic nitrite (NO2?), or a combination thereof; and an additive.

Abstract: Orally administrable pharmaceutical compositions and methods of administration are provided. The pharmaceutical compositions provide abuse deterrent properties.

Abstract: The present invention relates to a transmucosal administration system to administer quinones, benzoquinones, and especially 1,4-benzoquinones, via the oromucosal route.

Abstract: The present invention relates to a pharmaceutical formulation which provides for extended release of an active pharmaceutical ingredient selected from N-[2-hydroxy-3-(1-piperidinyl)-propoxy]-pyridine-1-oxide-3-carboximidoyl chloride, its stereoisomers and the acid addition salts thereof.

Abstract: The present specification discloses pharmaceutical compositions, methods of preparing such pharmaceutical compositions, and methods and uses of treating a severe pain in an individual using such pharmaceutical compositions.

Abstract: The present specification discloses pharmaceutical compositions, 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: An oral controlled-release multiparticulate dosage form comprises a plurality of individually enteric coated particulates containing an L-carnitine that independently disperse in a patient's stomach after oral ingestion and travel through the stomach and past the pyloric sphincter without substantially releasing the L-carnitine in the stomach. The individual particulates contain (a) a solid core containing the L-carnitine, (b) a subcoating containing a cellulosic water soluble polymer over the core, and (c) an enteric coating over the subcoating. The dosage form may be used to treat conditions associated with a reduction of the amount of L-carnitine in the body.

Abstract: Disclosed herein are pharmaceutically acceptable complex formulations comprising complexes of Ivacaftor, or a salt or derivative thereof, together with complexation agents and pharmaceutically acceptable excipients; processes for the preparation thereof; and pharmaceutical compositions containing them. The complexes possess instantaneous redispersibility, increased apparent solubility and permeability compared to KALYDECO, no observable food effect which deliver the opportunity of precise dosing and ease of administration of the reconstituted complex Ivacaftor in solution form.

Abstract: A free standing liquid membrane is disclosed that can selectively separate objects based on the kinetic energy value of the objects such that either an object having a first kinetic energy value can pass through the free standing liquid membrane while retaining the membrane and/or an object having a second kinetic energy value is prevented from passing through the membrane while retaining the membrane. Advantageously, the free standing liquid membrane can remain intact for seconds to hours with multiple objects passing through the membrane.

Abstract: In various embodiments, the present invention provides methods of treating and/or preventing cardiovascular-related disease and, in particular, a method of blood lipid therapy comprising administering to a subject in need thereof a pharmaceutical composition comprising eicosapentaenoic acid or a derivative thereof.

Abstract: The present invention relates to a composition for a hydrogel sheet including a cellulose ether, a gelling agent, and a gelling promoter, a hydrogel sheet prepared therefrom, and a method of preparing the hydrogel sheet. According to the present invention, the composition for a hydrogel sheet can be used to prepare a hydrogel sheet capable of maintaining the shape thereof without a support by limiting a type of the gelling agent and/or a viscosity of the cellulose ether included in the composition.

Abstract: The present invention relates to one or more SGLT2 inhibitors or pharmaceutically acceptable forms thereof for use in the treatment and/or prevention of a metabolic disorder in a feline animal, preferably wherein the metabolic disorder is one or more selected from the group consisting of: ketoacidosis, pre-diabetes, diabetes mellitus type 1 or type 2, insulin resistance, obesity, hyperglycemia, impaired glucose tolerance, hyperinsulinemia, dyslipidemia, dysadipokinemia, subclinical inflammation, systemic inflammation, low grade systemic inflammation, hepatic lipidosis, atherosclerosis, inflammation of the pancreas, neuropathy and/or Syndrome X (metabolic syndrome) and/or loss of pancreatic beta cell function and/or wherein the remission of the metabolic disorder, preferably diabetic remission, is achieved and/or maintained.

Abstract: A composition which comprises a prebiotic or a mixture thereof that, upon application to an individual's skin, has a beneficial effect on the skin and that is incorporated in the composition in the form of a multiplicity of tiny beads which comprise, in addition to the prebiotic, a matrix-forming agent, for example, mannitol and hydroxypropyl methylcellulose, and a filler, for example, microcrystalline cellulose, and a personal care composition which includes the beads.

Abstract: Oral film dosage forms that provide improved solubilization and stabilization of an active ingredient in particle form include at least one primary crystallization inhibitor in an amount that inhibits growth and/or agglomeration of the active ingredient, a polyoxyethylated fatty acid glycerides in an amount that further enhances inhibition of crystallization, growth and agglomeration of the particles of the pharmaceutically active ingredient; and at least one plasticizer present in an amount that is effective to increase flexibility and elasticity of the film dosage form.