Abstract: The present disclosure relates to pharmaceutical capsules comprising lumateperone, in free, or pharmaceutically acceptable salt form, optionally in combination with one or more additional therapeutic agents, processes for manufacture thereof and methods of use in the treatment or prophylaxis of disease.

Abstract: Provided herein are compositions and methods for treating respiratory and pulmonary vascular disease. In particular, provided herein are spray dried simvastatin for delivery to the lung.

Abstract: Described herein are oral pharmaceutical compositions suitable for chewing, sucking, or buccal dissolution comprising soft gel capsules and liquid fills, methods for making the same, and methods for treating subjects in need thereof with such capsules. In particular, oral pharmaceutical compositions comprising chewable, suckable, or dissolvable soft gel capsules with various flowable fill compositions are described.

Abstract: A composition comprising a cannabinoid, in particular a phytocannabinoid or a synthetic cannabinoid, where the cannabinoid is stabilised against oxidation and/or photochemical degradation, characterized in that the composition comprises a micellar solution of composite micelles in an aqueous solution and where the composite micelles encapsulate the cannabinoid.

Abstract: A nanoparticle for treatment of cancer is provided comprising a poloxamer surfactant, a Vitamin E TPGS and an anticancer compound.

Abstract: An insulin composition comprises an insulin analogue and polymer blend. The insulin analogue contains cysteine substitutions at positions B4 and A10 (to form cystine B4-A10), and one or more additional substitutions selected from the group consisting of: a connecting domain of 5-11 amino acids between insulin A- and B domains; a non-beta-branched amino-acid substitution at position A8; a non-beta-branched acidic or polar side chain at position A14; a halogenic modification of PheB24 at the ortho position; and substitution of lysine at position B29 by Glu, Ala, Val, Ile, Leu, amino-propionic acid, amino-butryic acid, or Norleucine. The insulin analogue is compatible with a process of manufacture that includes one or more steps within the temperature range 90-120° C. The encapsulated insulin analogue may optionally contain free PEG or be PEGylated. The insulin analogue-encapsulated polymer blend may be cast as a microneedle patch for topical administration or as micropellets for subcutaneous injection.

Abstract: The present invention relates to: human-derived Lactobacillus fermentum MG4231 or Lactobacillus fermentum MG4244; and a pharmaceutical composition, a food composition, a quasi-drug composition and a health functional food for preventing or treating obesity-related diseases, all of which include the same as an active ingredient. A Lactobacillus fermentum MG4231 strain or MG4244 strain of the present invention exhibits an anti-obesity activity for inhibiting a lipase enzyme activity, inhibiting preadipocyte differentiation and inhibiting triglyceride accumulation, has an excellent ability to form colonies on the epithelial cells of a digestive tract by means of an excellent auto-aggregation ability, and has resistance to acid and bile, thereby being variously usable as a pharmaceutical composition, a food composition, a quasi-drug composition and a health functional food for the purpose of treating and preventing obesity-related diseases.

Abstract: Methods for preparing isotopically modified 1,4-diene systems from non-isotopically modified 1,4-dienes involve selective oxidation of one or more bis-allylic position(s), or the preparation of isotopically modified 1,4-diene systems via trapping pi-allylic complexes with a source of deuterium or tritium. Such methods are useful for preparing isotopically modified polyunsaturated lipid including polyunsaturated fatty acids and polyunsaturated fatty acid derivatives.

Abstract: Preconcentrates comprising a fatty acid oil mixture and at least one surfactant, and methods and uses thereof are disclosed. The preconcentrates are capable of forming a self-nanoemulsifying drug delivery system (SNEDDS), a self-microemulsifying drug delivery system (SMEDDS), or self-emulsifying drug delivery systems (SEDDS) in an aqueous solution.

Abstract: The invention relates to stable preparations of thymoquinone and methods of making and administering stable preparations of thymoquinone. Embodiments of the methods provide compositions comprising thymoquinone with phosphatidylcholine and/or guggulsterol and/or guggulsterol derivatives and/or sodium cholesteryl sulfate, in tablet, capsule, gel, or ointment forms, and method of administering the preparations.

Abstract: Sweetener and flavor compositions with improved taste profiles are disclosed. Also disclosed are methods of making and methods of using such sweetener and flavor compositions.

Abstract: The present invention discloses a bexarotene softgel capsule and a preparation method thereof. The bexarotene softgel capsule including: a softgel capsule shell and contents, in which the contents include bexarotene, low molecular weight polyethylene glycol, high molecular weight polyethylene glycol, and polysorbate. The bexarotene softgel capsule of the formula can avoid a problem of drug degradation caused by high temperature heat release and degassing difficulty in a process of preparing the bexarotene softgel capsule in the prior art while maintaining the drug release characteristics, and the preparation method has a simple production process and can significantly improve a problem of poor dosage uniformity while filling a capsule in the prior art.

Abstract: The present invention is directed to a composition of Lactobacillus fermentum for use in the treatment of a fructose-related disease and a related method of treatment.

Abstract: Disclosed are an aqueous composition for preparing a hard capsule, a preparation method therefor, a hard capsule, and a method for recycling hard capsule scraps. The disclosed aqueous composition for preparing a hard capsule comprises a water-soluble cellulose ether, an alcohol, and water. In addition, the method for recycling hard capsule scraps comprises the step of dissolving hard capsule scraps comprising a water-soluble cellulose ether into a mixture solution comprising water and an alcohol so as to prepare an aqueous composition for preparing a recycled hard capsule.

Abstract: The present invention is generally directed to substantially pure cannabidiol, stable cannabinoid pharmaceutical formulations, and methods of their use.

Abstract: The present invention discloses a composition and method of use for the general improvement of hypertension, high cholesterol, and cardiovascular health. The novel composition is comprised of thiamin (vitamin B1), vitamin B2 (as riboflavin-5?-phosphate), niacin (vitamin B3, as niacinamide), vitamin B6 (as pyridoxine hydrochloride), folic acid, vitamin C, vitamin D, calcium (as calcium carbonate), magnesium (as magnesium taurate), aged garlic extract, olive leaf extract (as 20% oleuropein), coenzyme Q10 (as ubiquinol), L-Arginine (as hydrochloride), L-Citrulline (as malate), and lycopene.

Abstract: Disclosed in certain embodiments is an immediate release solid oral dosage form comprising a plurality of particles, each particle comprising: (i) a core comprising a first active agent; (ii) a coating comprising a second active agent layered over the core; and (iii) a material that is sensitive to acidic pH layered over the coated core; wherein the dosage form releases at least about 70% of the second active agent within 45 minutes as measured by in-vitro dissolution in a USP Apparatus 2 (paddle) at 50 rpm in 500 ml 0.1 N HCl at 37° C.

Abstract: Apparatuses, methods, and systems for extraction, isolation, purification, and conversion of various cannabinoids, and modifications of whole-plant hemp extracts therewith are presented. A method for preparing a whole-plant hemp extract based product includes extracting cannabinoids from plant materials, such as one or more hemp varieties of Cannabis sativa. The method also includes separating and purifying CBD from the extracted cannabinoids, converting purified CBD to ?9-THC and ?8-THC and concurrently converting ?9-THC to CBN, purifying and separating the CBN, and combining the purified CBN with a whole-plan hemp extract. Products and supplements related to the method are also described.

Abstract: In various embodiments, the present invention provides methods of treating and/or preventing NASH and/or PBC comprising administering to a subject in need thereof a pharmaceutical composition comprising eicosapentaenoic acid or a derivative thereof.

Abstract: The invention relates to granules and pharmaceutical compositions comprising a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid and a lubricant obtained by mixing hereof for more than 5 minutes prior to granulation as well as processes for their preparation and use thereof in medicine.

Abstract: Sweetener and flavor compositions with improved taste profiles are disclosed. Also disclosed are methods of making and methods of using such sweetener and flavor compositions.

Abstract: Pharmaceutical compositions comprising at least one active pharmaceutical ingredient or a pharmaceutically acceptable salt thereof, at least one hydrophilic plastomer, at least one hydrophilic elastomer, and at least one deliquescent plasticizer, wherein the pharmaceutical compositions provide extended release of the API and have abuse deterrent properties. Methods for preparing the pharmaceutical compositions in which the components of the composition are humidified such that the deliquescent plasticizer deliquesces, thereby plasticizing the hydrophilic polymers.

Abstract: This invention relates to cocrystals of naloxone and of naltrexone and their use as opioid antagonists. The cocrystals of the invention include naloxone isonicotinamide cocrystal, naloxone hydrochloride piperazine cocrystal, naltrexone menthol cocrystal, naltrexone thymine cocrystal, naltrexone 2,5-dihydroxybenzoic acid cocrystal, naltrexone salicylic acid cocrystal, naltrexone hydrochloride piperazine cocrystal and naltrexone hydrochloride sulfathiazole cocrystal. A drug-in¬ adhesive transdermal patch containing the opioid analgesic fentanyl or an analog thereof and a cocrystal of naloxone or naltrexone is disclosed. Also disclosed is a method of treating pain, such as acute, chronic or intermittent pain, by applying a drug-in-adhesive transdermal patch of the invention to the skin of a patient in need thereof.

Abstract: The present invention relates to, inter alia, pharmaceutical compositions comprising EPA and one or more cardiovascular agents, and to therapeutic methods for treating various diseases and disorders using the same.

Abstract: The present invention relates to a method of administering an effective dose of highly purified eicosapentaenoic acid as free-fatty acid (EPA-FFA) to reduce fecal calprotectin levels and reduce the risk of clinical relapse in UC patients. The eicosapentaenoic acid, in the free fatty acid (EPA-FFA) form, has a purity of at least 95%, and more preferably at least 99%.

Abstract: The present invention relates to a formulation comprising a pharmaceutically active ingredient and a coating. The invention also relates to the use of the formulation in the treatment and prevention of disorders of the gastrointestinal tract. Also disclosed are methods for preparing the formulations.

Abstract: In alternative embodiments, the invention provides compositions, e.g., formulations, used for gastric, gastrointestinal and/or colonic treatments or lavage, e.g., orthostatic lavage, e.g., for inducing the purgation (e.g., cleansing) of a gastrointestinal (GI) tract, including a colon; and methods for making and using them. In alternative embodiments, compositions and methods of the invention are used for the stabilization, amelioration, treatment and/or prevention of constipation, for the treatment of abdominal pain, particularly non-specific abdominal pain, and diarrhea, including diarrhea caused by a drug side effect, a psychological condition, a disease or a condition such as Crohn's Disease, a poison, a toxin or an infection, e.g., a toxin-mediated travelers diarrhea, or C. difficile or the pseudo-membranous colitis associated with this infection.

Abstract: Apparatuses, methods, and systems for extraction, isolation, purification, and conversion of various cannabinoids, and modifications of whole-plant hemp extracts therewith are presented. A method for preparing a whole-plant hemp extract based product includes extracting cannabinoids from plant materials, such as one or more hemp varieties of Cannabis sativa. The method also includes separating and purifying CBD from the extracted cannabinoids, converting purified CBD to ?9-THC and ?8-THC and concurrently converting ?9-THC to CBN, purifying and separating the CBN, and combining the purified CBN with a whole-plan hemp extract. Products and supplements related to the method are also described.

Abstract: The present invention relates to an improved method for producing a colloidal nitrocellulose dispersion made compatible with a system of acrylic monomers polymerized with surfactants in a water-based system under pressure. The self-emulsifiable system of the present invention is characterized by the latex formed by the nitrocellulose suspension in an aqueous medium, with nanometric particles and homogeneity and, consequently, a greater covering and smoothing power, high adherence, high gloss, greater chemical and mechanical resistance, rapid drying, less water retention when used in paints, varnish and sealant compositions for coatings in the fields of graphic printing, such as flexography and rotogravure, lamination, nail polish, metal-mechanics, decoration, glass, leather, plastics, wood surfaces, compounds and mortars, decorative wall paints, textiles, paper coatings and car paint repairs, inter alia.

Abstract: The present invention relates to a solid pharmaceutical dosage forms and methods for preparing the solid pharmaceutical dosage form that contains fingolimod or its pharmaceutically acceptable salts, conjugates or complexes thereof. The solid pharmaceutical dosage forms may rapidly disintegrate in a patient's oral cavity.

Abstract: The present invention discloses stable delayed release multiparticulate powder for oral suspension of proton pump inhibitor compounds comprising: a) a core with an effective amount of proton pump inhibitor and at least one or more pharmaceutical excipients, b) at least one water-soluble seal coating over core c) at least one enteric coating layer over the seal coat wherein the core is free of a surfactant. The prior art discloses restrictive formulation techniques and suggests higher amounts of various excipients to achieve desired technical attributes. The prepared test formulations exhibited desired pharmaceutical technical attributes like drug release, assay, stability, no polymorphic change, reduced sticking to nasogastric and gastronomy tubes, and packaging material.

Abstract: According to embodiments, a dry powdered composition which may be reconstituted to provide a gelatin product includes powdered gelatin and a pelletized colorant. The pelletized colorant includes a pigment-protein complex and at least one encapsulating agent for encapsulating the pigment-protein complex. The pelletized colorant has a rate of dissolution a rate of dissolution of less than 2 grams/minute in water having an initial temperature of from about 95° C. to about 100° C. Methods of making food products with the pelletized colorant are also disclosed. In embodiments, when the food products are measured on the L*a*b* color space, the food products have an L* value of about 49 to about 57, an a* value of about ?10 to about ?16, and a b* value of from about ?11 to about ?20.5.

Abstract: The present invention is directed towards compositions comprising a lecithin; a sugar alcohol, a sugar, or combinations of any thereof; and an alcohol. Compositions comprising a water soluble surfactant are further disclosed. Methods of separating oil from a mixture are disclosed. Methods of dispersing an oil are further disclosed. Compositions comprising a water-dilutable microemulsion are disclosed. Methods of making chewing gum are disclosed. Methods of recovering oil from a mixture are further disclosed.

Abstract: The present invention belongs to the pharmaceutical field, and in particular, it relates to a pharmaceutical formulation of palbociclib and a preparation method thereof. The pharmaceutical formulation comprises palbociclib, an acidic auxiliary material, and optionally a hydrophilic high-molecular material, which has better solubility and in vitro dissolution property as compared with the conventional formulation and can be used for enhancing in vivo absorption and bioavailability of palbociclib.

Abstract: The present invention provides improved processes for extracting and preparing lipids from biological sources for use in pharmaceuticals, nutraceuticals and functional foods.

Abstract: The present disclosure provides methods, systems, compositions, and kits to address the need for microbiome-related treatment of health conditions and disease. The present disclosure provides for treatment of metabolic conditions using microbial compositions.

Abstract: The present invention belongs to the pharmaceutical field, and in particular, it relates to a pharmaceutical formulation of palbociclib and a preparation method thereof. The pharmaceutical formulation comprises palbociclib, an acidic auxiliary material, and optionally a hydrophilic high-molecular material, which has better solubility and in vitro dissolution property as compared with the conventional formulation and can be used for enhancing in vivo absorption and bioavailability of palbociclib.

Abstract: A solubilisation product consists of resveratrol, polysorbate 80 and polysorbate 20, and at least one medium-chain triglyceride.

Abstract: A supplement for preventing and/or treating gastrointestinal distress, including ulcer conditions, in animals is disclosed. The supplement is in a gel form and comprises mastic gum and an emulsifying agent such as lecithin. The supplement may also comprise a vegetable oil, B vitamins, one or more prebiotics or probiotics, and one or more minerals as well as, pH buffers and flavoring. The amount of mastic gum is from about 1 to about 6 grams per 10 cubic centimeters of gel.

Abstract: The invention provides methods and compositions for preventing or treating (e.g., slowing the progression of, arresting, and/or reversing) tissue calcification 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 (e.g., slowing the progression of, arresting, and/or reversing) tissue calcification in a subject with diabetes, chronic kidney disease, end stage renal failure, or a subject undergoing hemodialysis and/or receiving anticoagulant therapy. The invention further provides methods and compositions for reducing one or more symptoms of chronic obstructive pulmonary disorder (COPD), including using menaquinone-7 (MK-7) and/or menaquinol-7 (MKH2-7), for preventing or treating (e.g., slowing the progression of, arresting, and/or reversing) one or more symptoms of COPD.

Abstract: Disclosed are abuse resistant oral pharmaceutical compositions that reduce the likelihood of improper administration of drugs that are susceptible to abuse. The oral pharmaceutical formulations contain abuse deterrent agents that cause discomfort to the user when administered in an improper manner and make the extraction of an active ingredient more difficult. Methods of making and using the compositions are also disclosed.

Abstract: The invention provides methods and compositions for preventing or treating (e.g., slowing the progression of, arresting, and/or reversing) tissue calcification 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 (e.g., slowing the progression of, arresting, and/or reversing) tissue calcification in a subject with diabetes, chronic kidney disease, end stage renal failure, or a subject undergoing hemodialysis and/or receiving anticoagulant therapy. The invention further provides methods and compositions for reducing one or more symptoms of chronic obstructive pulmonary disorder (COPD), including using menaquinone-7 (MK-7) and/or menaquinol-7 (MKH2-7), for preventing or treating (e.g., slowing the progression of, arresting, and/or reversing) one or more symptoms of COPD.

Abstract: Methods of enhancing cognition and/or memory and methods of treating cognitive and cerebrovascular disorders by intranasally administering an in situ gelling composition comprising micelles formed with tocopherol or a derivative thereof are provided. The micelles encapsulate a biological active agent such as vinpocetine. The methods provide for enhanced brain targeting of the biological active agent.

Abstract: Abiraterone acetate lipid formulations.

Abstract: Dosage forms, drug delivery systems, and methods related to sustained release of dextromethorphan or improved therapeutic effects are disclosed. Typically, bupropion or a related compound is orally administered to a human being to be treated with, or being treated with, dextromethorphan.

Abstract: The invention relates to particular substituted deuterated heterocycle fused gamma-carbolines, their prodrugs, in free, solid, pharmaceutically acceptable salt and/or substantially pure form as described herein, pharmaceutical compositions thereof, and methods of use in the treatment of diseases involving 5-HT2A receptor, serotonin transporter (SERT) and/or pathways involving dopamine D1/D2 receptor signaling systems, and/or the treatment of residual symptoms.

Abstract: The present invention relates to two novel oral pharmaceutical compositions of dabigatran etexilate or its pharmaceutically acceptable salts thereof, and the processes of preparation thereof.

Abstract: The present disclosure relates to a novel aqueous coating composition comprising a polymer, at least one glidant, and at least one emulsifier, and at least one plasticizer, for soft capsule shells or softgel capsules, providing an enteric release profile, and to a method of enteric coating of soft capsule shells or containers; and to the resulting enteric coated soft capsule shells or softgel capsules with the aqueous coating composition.

Abstract: A process for providing fluoresence to a dental ceramic body by treating at least a portion of the outer surface of the dental ceramic body or a precursor thereof with a bismuth containing substance, characterized by the steps of placing the dental ceramic body or the precursor thereof into a closeable container, in particular a crucible; generating a bismuth containing atmosphere in the container and exposing at least a portion of the outer surface of the dental ceramic body or of the precursor to the bismuth containing atmosphere at a temperature above 1000° C.

Abstract: Testosterone ester triglyceride formulations, optionally further including adducts. Methods of in-situ control of the manufacture or formation of such adducts are also described.