Abstract: The present invention is based on the discovery of new and advantageous properties of a class of known polymeric emulsifiers. The emulsifier class was found to be resistant to degradation by crude bacterial antigen preparations, which degradation caused emulsion instability when using prior art emulsifiers. This allows the formulation of safe, stable, and effective vaccines based on these emulsions of oil and water comprising such bacterial antigens. The polymeric emulsifier is a block copolymer having a general formula A-B-A in which component B is the divalent residue of a water-soluble polyalkylene glycol and component A is the residue of an oil-soluble complex monocarboxylic acid. Preferred emulsifier is a PEG-30-di-(polyhydroxystearate).

Abstract: The present invention generally relates to emulsions and extended release formulations including cannabis-derived compounds and related methods. It more specifically relates to emulsion-based and extended release formulations. In one aspect, the present invention is directed to an emulsion. The emulsion includes a compound derived from cannabis and an active ingredient. In another aspect, the present invention is directed to an extended release formulation. The formulation includes a compound derived from cannabis and an active ingredient.

Abstract: Methods for the treatment of stroke, such as stroke of undetermined origin, by administration of xenon (Xe)-loaded liposome compositions are provided. In some aspects, Xe is encapsulated in echogenic liposomes and release of Xe can be enhanced by application of ultrasound stimulation. Compositions for use in treating stroke, such as liposomes loaded with Xe or Xe in combination with H2 or H2S, are also provided.

Abstract: Formulations (e.g., solutions) comprising one or more water-soluble polymer(s), liposomes, and an aqueous carrier, are provided. The provided solutions are useful for rinsing, and/or immersing therein, a contact lens and/or in the treatment of ocular discomfort, for example, an ocular discomfort associated with a contact lens. Also provided are kits comprising the solution and a contact lens; articles-of-manufacturing comprising the solution and configured for dispending the solution; and methods utilizing the solution.

Abstract: The present invention relates to pharmaceutical compositions comprising at least one liposome and a therapeutic agent for treating dementia with a high drug to lipid ratio and a high encapsulation efficiency. The pharmaceutical composition improves the pharmacokinetic profile and sustains the release of the therapeutic agent. Also provided is the method for treating dementia using the pharmaceutical composition disclosed herein.

Abstract: The present invention provides, among other things, a process of encapsulating messenger RNA (mRNA) in liposomes comprising a. providing a first stream comprising an mRNA solution at a first controlled flow rate, b. providing a second stream comprising a lipid solution at a second controlled flow rate, and c. mixing the first stream and the second stream to form mRNA-encapsulated liposomes, wherein the first controlled flow rate and the second controlled flow rate are achieved without use of a pump.

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: Formulations are provided for the oral administration of avanafil, a Type V phosphodiesterase inhibitor (“PDE V inhibitor”), and analogs thereof. The formulations are orally disintegrating tablets (ODTs) that rapidly dissolve or disintegrate in the oral cavity. The tablets contain an absorption enhancing composition that increases the duodenal absorption of the active agent, following transfer from the low pH environment of the stomach to the more basic pH of the duodenum. Methods for administering the active agent using the dosage forms are provided. The invention also encompasses a method of selecting components and compositions to incorporate in the formulations which will facilitate increased absorption of the active agent in the duodenum and thus serve as “absorption enhancing compositions” herein. Also provided are methods for manufacturing orally disintegrating tablets to optimize the physical properties of the dosage forms, particularly hardness and disintegration time.

Abstract: Provided herein in some embodiments are pharmaceutical compositions comprising a prostacyclin (PGI2) receptor agonist selected from 2-(((1r,4r)-4-(((4-chlorophenyl)(phenyl)carbamoyloxy)methyl)cyclohexyl)methoxy)acetic acid (Compound 1) and pharmaceutically acceptable salts, solvates, and hydrates thereof, as disclosed herein. In some embodiments the pharmaceutical compositions comprise a compound selected from 2-(((1r,4r)-4-(((4-chlorophenyl)(phenyl)carbamoyloxy)methyl)cyclohexyl)methoxy)acetic acid (Compound 1), and pharmaceutically acceptable salts, solvates, and hydrates thereof, in an amount equivalent to a therapeutically effective amount of Compound 1, the composition having a release rate by weight of the compound in an aqueous medium that is one or more of release rates (a), (b) and (c) as disclosed herein. The compositions of the present invention are useful in the treatment of PGI2 related disorders, such as those disclosed herein.

Abstract: The present invention relates to an additive composition, and more particularly, to an additive composition capable of stabilizing pores of particles in a solid formulation. The present invention provides an additive composition including a naturally derived raw material, which enables formulation without using any synthetic additives. Further, the present invention provides an additive composition in which particles are uniformly distributed by reducing pores of particles in a formulation, as well as tablets, powders or the like including the same.

Abstract: The invention relates to cannabinoid tablet compositions and methods associated therewith. Specifically, the invention relates to a hard-pressed, scored cannabinoid tablet that can be easily divided to provide multiple doses.

Abstract: An improved customizable dosage form comprising a substrate, such as a tablet core, that has two or more distinct, discrete cavities on opposing sides of its exterior surface; and/or two or more distinct, discrete cavities on a first side of its exterior surface and an identification feature on a second opposing side of its exterior surface. A process for making such a customizable dosage form wherein one or more active ingredients and inactive ingredients such as colors, flavors and/or sensates are deposited into at least one of the cavities.

Abstract: The present invention relates to a solid dosage form comprising two or more compounds selected from N,N-dimethyltryptamine and its deuterated analogues and pharmaceutically acceptable salts thereof, and methods of treatment (e.g., of a psychiatric disorder or a neurological disorder) comprising administering the solid dosage form to a patient in need thereof.

Abstract: A pharmaceutical dosage form comprises a capsule shell and a fill composition, wherein the fill composition comprises an emulsion of (a) simethicone, (b) loperamide or a pharmaceutically acceptable salt thereof, and (c) at least two surfactants, wherein the emulsion has a hydrophilic lipophilic balance ranging from about 8 to about 12. Also described are methods of making the pharmaceutical dosage forms and methods for treating humans suffering from gastrointestinal distress.

Abstract: A pharmaceutical composition containing a metal oxide coated particle comprising 1) an amorphous solid dispersion (ASD) core containing an active pharmaceutical ingredient (API) and a polymer; and 2) a metal oxide coating, and the method of making said metal oxide coated particle by atomic layer deposition (ALD). The metal oxide coated particle is useful because it prevents the ASD from crystallization and helps maintain the ASD in an amorphous form.

Abstract: A method for effecting weight loss by administering a combination of topiramate and phentermine is provided. The phentermine is generally administered in immediate release form, in a daily dose in the range of 2 mg to 8 mg, in combination with a daily dose of topiramate selected to prevent the loss of effectiveness of phentermine alone. Methods for treating obesity, conditions associated with obesity, and other indications are also provided, as are compositions and dosage forms containing low doses of phentermine and topiramate, e.g., 3.75 mg phentermine and 23 mg topiramate.

Abstract: A microcapsule includes an active component encapsulated within a polymerized hydrolyzed protein shell. The microcapsule has an average diameter that is less than one hundred micrometers as determined by a laser diffractometer.

Abstract: Disclosed is a lipid composition including, per 100% of its weight:—from 40% to 99.9% by weight of a component including, per 100% of its weight, from 90% to 100% by weight of beeswax and up to 10% by weight of at least one other lipid excipient,—from 0.1% to 60% by weight of at least one lipophilic surfactant.

Abstract: The present application relates to a metal-nucleic acid nanoparticle which is a nanoparticle having a spherical structure formed by assembly of metal ions with nucleic acids via coordination. The preparation thereof is mixing a metal ion solution with a nucleic acid solution to obtain a mixture followed by vortex, heating, centrifugation, washing with water and resuspension to obtain the metal-nucleic acid nanoparticles.

Abstract: Disclosed are particles comprising lithium salts and methods for their use in treating inflammatory conditions.

Abstract: The present invention provides stable, dry powder messenger RNA formulations for therapeutic use, and methods of making and using the same.

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

Abstract: The invention provides methods of making microparticle and nanoparticle ocular implants from a compositions comprising: 99 to 60% (w/w) of a photopolymerizable composition selected from the group of fragments or monomers consisting of polyalkylene glycol diacrylate and polyalkylene glycol dimethacrylate, wherein the photopolymerizable composition has a molecular weight in the range of 100 to 20,000 Dalton; a biodegradable polymer selected from the group consisting of aliphatic polyester-based polyurethanes, polylactides, polycaprolactones, polyorthoesters and mixtures, copolymers, and block copolymers thereof; a photoinitiator; and a therapeutic agent.

Abstract: The present disclosure provides methods of producing lipid nanoparticle (LNP) formulations and the produced LNP formulations thereof. The present disclosure also provides therapeutic and diagnostic uses related to the produced LNP formulations.

Abstract: The present disclosure relates to spheroidal organosiloxane sub-micron/nanoparticle comprising a network consisting of organosiloxane, and a process to make them.

Abstract: Provided herein are compositions, systems, kits, and methods for treating a subject with a disease or condition by administering a composition comprising fullerenes to the subject such that H2S is generated in said subject. In certain embodiments, the disease or condition is associated with inflammation and/or below normal H2S levels. In certain embodiments, the fullerenes are polyhydroxy fullerenes (PHFs).

Abstract: The present disclosure is a substance for providing health benefits that is comprised of at least one cannabinoid and pearl powder.

Abstract: Described herein, inter alia, are compositions, formulations, methods, and systems for reducing regional fat deposits and treating fat-related conditions.

Abstract: A method for the treatment of a hepatitis disease, including administering to a subject in need thereof of an anti-pathogenic compound, such that the anti-pathogenic compound is derived from an herbal extract.

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: 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: Stable Phytonadione compositions for parenteral administration are provided which comprise (E) isomer of phytonadione at or greater than 97% w/w as the active ingredient, and is substantially free of (Z) isomer. Said compositions are stable, sterile, and particulate-free. Further, said compositions reduce or avoid allergic reactions to benzyl alcohol and polysorbate. In some aspects, the compositions are free or substantially free of benzyl alcohol and/or reduced amounts of polysorbate. Methods of manufacture and methods of administration also provided.

Abstract: The present invention provides a dosage regimen for safe and efficacious administration of esketamine and rapid-acting antidepressants in the treatment of major depressive disorder (MDD).

Abstract: In various embodiments, the present disclosure pertains to a composition composed of chlophedianol and menthol, or method of use thereof, having a form of a chewable composition, a chewable gummy, a chewable tablet, a chewable candy, a soft chewable, a hard chewable, a tablet, a capsule, a quick dissolving tablet or capsule, a lozenge, an orally disintegrating tablet, and a liquid composition.

Abstract: In various embodiments, methods are provided for applying transcutaneous and/or epidural spinal cord stimulation with and without selective pharmaceuticals to restore voluntary control of hand function in tetraplegic subjects.

Abstract: This disclosure provides methods for treating a subject having small cell lung cancer by determining expression levels of biomarkers highly correlated with a subtype of small cell lung cancer that are sensitive to treatment with pentamidine or a pharmaceutically acceptable salt thereof. The methods are drawn to determining a predictive gene expression profile of a subtype of small cell lung cancer and treating the subject with an effective amount of pentamidine or a pharmaceutically acceptable salt of pentamidine as a chemotherapy agent. The methods generally involve treatment of a subtype of small cell lung cancer predicted to be a responder to pentamidine or a pharmaceutically acceptable salt of pentamidine.

Abstract: The present invention relates in general to the field of compositions and methods for using N-acetylcysteine amide (NACA) or (2R,2R?)-3,3?-disulfanediyl bis(2-acetamidopropanamide) (diNACA) for treating cystinosis. This present invention also relates to the general field of using NAC, NACA or diNACA to treat ophthalmic, ocular or corneal effects of cystinosis. This present invention also relates to the general field of using NAC, NACA, diNACA, cysteamine (or cysteamine salts, e.g., the hydrochloride salt or other salts) or any other cystine-depleting agent for treating ophthalmic, ocular or corneal effects of cystinosis by administration in an ophthalmic or ocular insert.

Abstract: Disclosed herein is a multidrug pain management package to dispense two or more medicaments to treat pain comprising a primary n-polygon, and one or more concentric m-polygons, wherein each side of the n-polygon and m-polygons have at least n or m-medicament chambers capable of holding the two or more medicaments. Also disclosed herein is a multidrug pain management package comprising a disk, wherein the disk is divided into equally spaced regions, and wherein each region has chambers capable of holding medicaments. Also disclosed herein are single formulations to treat pain.

Abstract: Microvascular dysfunction remains a major contributor to the development of skin complications. The inventors assessed the impact of the local inhibition of soluble epoxide hydrolase (sEH), which metabolizes vasodilator and anti-inflammatory epoxyeicosanoids, on the diabetic skin microvascular dysfunction. The inventors have therefore developed some formulations of sEH inhibitors (GSK2256294 and t-AUCB) for topical administration. In particular, they show that an aqueous gel containing 400 mg/L t-AUCB dissolved in 50% dimethy lsulfo xide (DMSO) allowed a stable and continuous diffusion of t-AUCB from 2 hours after application on skin pig ears to over a period of 24 h. Compared to a control gel, the gel with t-AUCB did not significantly modify the basal skin blood flow but improved the altered hyperemic response of db/db mice 2 hours after application.

Abstract: Provided are novel treprostinil based compounds, methods of treatment using the same, and their methods of making.

Abstract: The present invention provides a composition including citric acid, a pharmaceutically acceptable salt of citric acid, a hydrate of citric acid, a hydrate of the pharmaceutically acceptable salt of citric acid, or a mixture thereof. Administration or ingestion of the previous period composition inhibits renal fibrosis in diabetic nephropathy.

Abstract: The present disclosure relates to parenteral nutrition formulations, including ready-to-use parenteral nutrition formulations which are reconstituted from multi-chamber containers and amino acid formulations. More particularly, the present disclosure is directed to formulations comprising butyrate derivatives, specifically arginine butyrate, for use with adult or pediatric patients. The disclosure further provides for methods of reducing or preventing systemic and local inflammation of patients receiving parenteral nutrition, and methods of maintaining or ameliorating their systemic immunity and local immunity, as well as the patients' gut barrier functions.

Abstract: The present invention provides methods and kits a) for preventing and/or treating neuroblastoma (e.g., high-risk neuroblastoma) that is linked, in part, to high levels of ODC activity and increased cellular polyamine content, b) for predicting cancer patient survival, especially cancer patients whose cancer is linked, in part, to high levels of ODC activity and increased cellular polyamine contents, and c) for selecting treatment options for such patients based on the allelic nucleotide sequence or SNP at positions +263 and/or +316 of the ODC1 gene. The invention also provides, cancer treatment methods comprising the determination of the ODC1 genotype at the +263 and/or +316 positions, as a means to guide treatment selection, which includes, in some aspects the administration of pharmaceutically effective amounts of ?-difluoromethylornithine (DFMO), either as a monotherapy or in combination with one or more other drugs.

Abstract: The present invention is directed to pharmaceutical compositions comprising melphalan and a cyclodextrin derivative, and methods of making and using the same.

Abstract: A nutritional supplement for ingestion by humans for restoring growth hormone levels consisting of branched chain amino acids chosen from the group leucine, isoleucine, and valine; free form amino acids chosen from the group lysine, glutamine, ornithine, arginine, and glycine; and free form amino acid gamma-aminobutyric acid.

Abstract: The present disclosure relates to, inter alia, methods of treating mixed dyslipidemia with ethyl eicosapentaenoate.

Abstract: The present invention relates to the field of neonatal cholestasis, in particular the treatment of neonatal biliary atresia or diseases associated with biliary system destruction. Also, the invention relates to methods and/or compounds for treating or preventing biliary atresia or disease associated with biliary system destruction. It further relates to methods and/or compounds for slowing the progression of biliary atresia or disease associated with biliary system destruction.

Abstract: Disclosed is method using a composition is useful for preventing the occurrence of a cardiovascular event, particularly a composition which is expected to show a prophylactic effect on a cardiovascular event occurring in a hypercholesterolemia patient despite providing the patient with a treatment with HMG-CoA RI or a cardiovascular event occurring in a multiple risk patient.

Abstract: The present invention relates to ophthalmic compositions and methods for the treatment of dry eye and other inflammatory ocular conditions. In particular, the present invention relates to a composition comprising an esterified anti-inflammatory lipid mediator, which is an ester of an anti-inflammatory lipid mediator that is a reaction product of the anti-inflammatory lipid mediator and a monohydric alcohol or an amide wherein the majority of the anti-inflammatory lipid mediator is present in an ester form. In this way, the compositions are substantially free of an acid form of the anti-inflammatory lipid mediators. Anti-inflammatory lipid mediators can be selected from the group consisting of polyunsaturated fatty acids (e.g.

Abstract: The object of the present invention is a product obtainable by spray-drying an aqueous solution comprising iron bis-glycinate chelate and alginic acid and/or water-soluble salts thereof, preferably sodium alginate, potassium alginate and/or magnesium alginate, the use of said product for the prevention and/or treatment of anaemia, preferably sideropenic anaemia, in humans, the pharmaceutical formulations containing it, and the use of said formulations for the prevention and/or treatment of anaemia, preferably sideropenic anaemia, in humans.