Abstract: Provided herein are methods for treating chronic pain by administering low doses of buprenorphine twice daily (or once daily) via a transmucosal drug delivery device. The methods and devices efficiently treat chronic pain without significant side effects.

Abstract: The present disclosure relates to a formulations and methods for transdermal delivery of a medicament through the skin of a subject. In aspects, the formulation comprises a therapeutically effective amount of a medicament and a penetrant portion in which the penetrant portion comprises: a phospholipid, a fatty acid ester formed from a low molecular weight alcohol, and a long-chain fatty acids. In some embodiments, the penetrant portion further comprises one or more of a viscosity-improving agent, a penetration enhancer, and an emulsifier.

Abstract: An improved medical implant device directed to, inter alia, (i) avoiding unwanted initial drug “burst” problems, (ii) providing a more level amount of drug delivery, (iii) reducing blood clotting, (iv) reducing the amount of drug material that remains in the implant device, and/or (v) novel materials for an implant device.

Abstract: The present disclosure generally relates to a soft chewable formulation, especially suitable for delivering active ingredients to animals and processes for preparation thereof. In some embodiments of the disclosure, a soft chewable veterinary formulation includes a starch, one or more carbohydrates, a flavoring agent, a lipid, and at least one active ingredients. In accordance with some embodiments, the starch in the soft chewable formulations includes a certain ratios of regular starch and pre-gelatinized starch.

Abstract: Embodiments provide devices, preparations and methods for delivering therapeutic agents (TAs) such as clotting factors (CFs, e.g., Factor 8) within the GI tract. Many embodiments provide a swallowable device e.g., a capsule for delivering TAs into the intestinal wall (IW). Embodiments also provide TA preparations configured to be contained within the capsule, advanced from the capsule into the IW and/or surrounding tissue (ST) and degrade to release the TA into the bloodstream to produce a therapeutic effect (e.g., improved clotting). The preparation can be operably coupled to delivery means having a first configuration where the preparation is contained in the capsule and a second configuration where the preparation is advanced out of the capsule into the IW or ST (e.g., the peritoneal cavity). Embodiments are particularly useful for delivery of CFs for treatment of clotting disorders (e.g., hemophilia) where such CFs are poorly absorbed and/or degraded within the GI tract.

Abstract: The invention relates to inhalable imatinib formulations, manufacture, and uses thereof.

Abstract: The disclosure provides a nanoemulsion including an oil phase containing at least one cannabinoid and a water phase; wherein at least one of the oil phase and the water phase includes one or more emulsifying agents; and wherein the zeta potential of the nanoemulsion is less than about ?10 mV. Further provided are processes for preparing such nanoemulsions.

Abstract: Methods and products for treating a subject diagnosed with an autism spectrum disorder, an intellectual disability, an anxiety disorder, a mood disorder, a disorder of social interaction, irritability, aggression, self-injurious behavior, hyperactivity, inattention, or Fragile X syndrome or brain neuroinflammation by administering a water-insoluble ticagrelor or ticagrelor salt, pre-dissolved in oil/surfactant/cosurfactant mixture and emulsified in an aqueous solution, containing a second agent, which may include a magnesium ion containing-compound, a zinc ion containing-compound, a lysine or lysine salt, an arginine or arginine salt, lecithin, or a combination thereof.

Abstract: The present disclosure provides pharmaceutical compositions comprising lipid nanoparticles capable of delivering polynucleotide payloads to target non-liver organs.

Abstract: The present invention provides: a liquid-crystal polyester solution composition which changes little in solution viscosity with the flow initiation temperature of the liquid-crystal polyester powder, and a liquid-crystal polyester powder useful for the liquid-crystal polyester solution composition. This liquid-crystal polyester powder is soluble in aprotic solvents and is characterized in that the proportion of particles having a particle diameter, as determined by dry sieving test according to JIS K 0069 (1992), of less than 250 ?m is 23.5 mass % or less. The present invention further provides a method for producing the liquid-crystal polyester solution composition, the method comprising dissolving the liquid-crystal polyester powder in an aprotic solvent to obtain the liquid-crystal polyester solution composition.

Abstract: This disclosure relates to macro- and micro-sized elastin-like polymers (ELP). The addition of a polyethyleneimine (PEI) block to the terminal end of ELP allows the particle radius as well as LCST to be controlled by changing any combination of polymer concentration, ion concentration, and pH. The addition of the PEI block also provides the ability to crosslink the copolymers and achieve a stable particle radius.

Abstract: The present Invention relates to a pellet comprising melatonin and methods of treating insomnia.

Abstract: Embodiments of the present invention provide for novel compositions and methods for making and using a thermally stable human papilloma virus (HPV) formulation or other stabilized multimeric virus formulation. Certain embodiments concern lyophilizing HPV formulations in the presence or absence of adjuvants. Other embodiments concern lyophilizing HPV capsomere vaccines in order to increase stability of an immunogenic composition against HPV infection for storage, delivery and use. In yet other embodiments, a single immunogenic composition can include a thermally stable formulation of multiple virus serotypes. Yet other embodiments disclosed herein concern multi-targeted antigen complexes lyophilized in formulations of use to prolong stability and/or enhance immunogenicity. Other embodiments concern exposing lyophilized multi-targeted antigen complexes to elevated temperatures to enhance immunogenicity of the antigens of the complex to multiple pathogens.

Abstract: A solid tablet includes an active material and a base material that gum, rice bran, rice hull, carbonate, carnauba wax, and maltodextrin and an edible oil.

Abstract: A drug delivery device includes a foam body having a negative Poisson's ratio, the foam body formed of a material configured to dissolve in a biological fluid; and a liquid drug contained in cells of the foam body, the drug exerting a pressure on walls of the cells that is above atmospheric pressure.

Abstract: The invention relates to a pharmaceutical formulation, e.g. a paediatric formulation, of odevixibat, which comprises a plurality of small particles. The formulation may be used in the treatment of liver diseases such as bile acid-dependent liver diseases, and particularly cholestatic liver diseases such as biliary atresia, progressive familial intrahepatic cholestasis (PFIC), Alagille syndrome (ALGS) and paediatric cholestatic pruritus. The invention also relates to a process for the preparation of the pharmaceutical formulation.

Abstract: Methods of making orally available softgels includes pre-wetting a probiotic with an edible oil to produce a wetted supplement, wherein the edible oil is present in a range of 25% to 75% by weight of a total weight of the probiotic and edible oil, heating the wetted supplement to a temperature in a range of 35° C. to 40° C., blending the wetted supplement and a molten chocolate component together to produce a liquid fill material, encapsulating the liquid fill material in a softgel coating to produce an orally available softgel, and cooling the orally available softgel to have a softgel capsule shell comprising 5% to 15% by weight water. The fill material is a solid at room temperature in the cooled orally available softgel.

Abstract: Disclosed is a transdermal therapeutic system comprising an active agent impermeable backing layer, at least one adhesive layer comprising at least 70% by weight of at least one polysiloxane polymer, at least one tetrahydrocannabinol (THC) and at least one solubilizer, and optionally a protective layer for removal before use, a method for its preparation and its use as a medicament.

Abstract: Provided are a composition and a method for preventing, treating, or ameliorating a skin disease or condition. In some cases, the method comprises administering to the subject in need thereof a therapeutically effective amount of a composition comprising at least about 10 v/v % of thujopsene. In some cases, the skin disease or condition comprises a skin inflammatory disease, an allergic disease, a skin wound, a skin aging-related condition, or particulate matter (PM2.5)-associated condition.

Abstract: The present disclosure generally relates to compositions comprising unique combinations of cannabinoids, antioxidants, and cofactors. The present disclosure also provides methods of making the compositions and methods for using the compositions for the treatment of mitochondrial ATP deficit disorders.

Abstract: The present invention relates to a novel cannabinoid oral pharmaceutical dosage form, based on a Type IV or Type IV-like formulation, as classified using the Lipid Formulation Classification System. The formulation is contained in a container. By Type IV-like, it is meant that the formulation comprises no oil, for example no triglycerides or mixed glycerides.

Abstract: The invention relates to vascular disrupting agent (VDA) such as combretastatins for treating avascular or hypo vascular micro-tumors with a diameter below 20 mm.

Abstract: Described herein are compounds of Formula I: wherein R1-R6 are as described herein, for use in the treatment of a coronavirus infection; a method of inhibiting a coronavirus 3CL protease, by contacting the 3CL protease with a compound of Formula I; as well as methods pharmaceutical composition comprising a compound of Formula I and at least one phospholipid, wherein a weight ratio of the phospholipid(s) to the compound in the composition is in a range of from 10:1 to 1:10. Further described herein is a method of treating a coronavirus infection in a subject in need thereof, by administering to the subject at least one compound that exhibits at least two of: inhibition of an activity of a 3CL protease of the coronavirus; inhibition of inflammation in the subject; and inhibition of autophagy in the subject.

Abstract: The invention relates to the use of a compound of Formula (I) as described herein and its effective dose in the prevention and/or treatment of fibrosis diseases. The compound can effectively prevent and/or treat a fibrosis disease without cytotoxicity or genotoxicity.

Abstract: A tablet includes an active material and a base material that carnauba wax and an oil.

Abstract: The present invention relates a method for the use of a product with propyl propane thiosulfonate (PTSO), whose purpose is the treatment and/or prophylaxis of malignant neoplasms such as solid cancers and myeloproliferative syndromes in humans. In a preferred embodiment, the method includes the selection of the PTSO compound which general formula is R-SOa-S-R, where “R” represents the n-propyl group (—CH2—CH2—CH3) and “a” is 2.

Abstract: Various methods and compositions of treating 4-hydroxyphenylpyruvate dioxygenase-like (HPDL)-related diseases or disorders are presented herein. Also presented herein are methods of increasing CoQ10 biosynthesis, and methods of determining whether a subject will benefit from a CoQ10 or CoQ10 alternative treatment. Also presented herein are pharmaceutical compositions and dosage forms comprising 4-hydroxymandelic acid (4-HMA), and/or its metabolites. Further presented herein are compounds that inhibit 4-hydroxyphenylpyruvate dioxygenase-like (HPDL). Further presented herein are methods of identifying and/or assessing modulators of HPDL. Yet further presented herein are example methods and systems for isotopic labelling in cells by metabolizing cells in the presence of gaseous isotopic tracer.

Abstract: Stilene compounds of formula I have a dual effect of enriching T lymphocytes CD8+ solid tumors and targeting the destruction of the inner wall of tumor blood vessels. While killing tumor cells by cytotoxic T lymphocyte antigen CD8+, the stilbenes cut off the blood supply to tumor tissues, cause rapid necrosis in solid tumors, greatly improve the killing effects on tumors, and inhibit tumor metastasis. Thereby, they can be used to prepare anti-tumor medicaments, and also used in combination with tumor immunotherapeutics to achieve synergistic anti-tumor effects. In addition, the stilbene compounds can inhibit the growth of ocular surface blood vessels and be used in the preparation of medicaments for treating various eye diseases.

Abstract: Provided are novel prodrugs of treprostinil, as well as methods of making and methods of using these prodrugs.

Abstract: The invention provides a process for preparing an aqueous pharmaceutical solution of calcium gluconate. The process comprises the steps of: (i) mixing calcium gluconate, calcium saccharate and water at a mixing temperature of 60-100° C. to form a bulk solution; (ii) filling portions of the bulk solution into containers at a filling temperature of 60-100° C.; and (iii) sealing the containers with a closure. The invention also provides a batch of containers obtainable by this process.

Abstract: Provided herein are rumen-protected compositions. The compositions include coated rumen-protected compositions which comprise a coating and a bioactive core comprising a physiologically active ingredient. The coating includes a chitosan organic salt, an emulsifier, and a fatty acid source. Further provided are rumen-protected pellet compositions, which may optionally comprise a coating. The pellet compositions include a bioactive core comprising a physiologically active ingredient and a chitosan organic salt. Further provided are methods of making the compositions and methods of delivering methionine to an animal.

Abstract: Liquid food product suitable to manage the ketogenic diet, which comprises at least lipids, carbohydrates, fibers, proteins and water.

Abstract: There is provided a vegetable-based lipid composition comprising very high levels of DHA, together with at least one other long-chain polyunsaturated fatty acid (typically as fatty acid esters). The composition typically contains low levels of EPA and palmitic acid. The composition is obtainable from a single source by conventional processing methods, and has improved stability properties.

Abstract: Disclosed herein are ionic liquids and deep eutectic liquids for the treatment of diabetes and related diseases including obesity and metabolic disorders.

Abstract: The present invention provides aceclofenac, amlodipine or doxazosin, or a pharmaceutically acceptable salt or solvate thereof, for use in the treatment or prophylaxis of Attention Deficit/Hyperactivity Disorder (ADHD). The invention also provides kits and methods for the treatment or prophylaxis of ADHD.

Abstract: Pharmaceutical compositions of 4-((L-valyl)oxy)butanoic acid and the pharmacokinetics of 4-((L-valyl)oxy)butanoic acid and ?-hydroxybutyric acid following oral administration of the pharmaceutical compositions to healthy subjects are disclosed.

Abstract: A controlled release pharmaceutical composition for eye injection for ophthalmic care. The composition comprises at least one active pharmaceutical ingredient and at least one biocompatible polymer and at least one biocompatible solvent. The composition, which is capable of forming an in-situ implant composition, comprises an injectable solution, suspension, emulsion or dispersion. The formulation can be injected through a needle that is suitable in size for an eye injection. The present compositions can be used for treatment of ophthalmic conditions, including glaucoma, dry and wet age-related macular degeneration, diabetic retinopathy, dry eye syndrome, and uveitis.

Abstract: This invention is a safe and effective method to treat chronic pain with the oral administration of procaine as a non-selective voltage sodium channel (VGSC) blocker. The dose of oral procaine has been estimated based upon the pharmacokinetics required to produce action potential inhibition in neurons of dorsal root ganglia. Intraneural ion trapping effects and low CSF pseudocholinesterase will increase the concentration of charged procaine within Nav 1.8 channels. The co-administration of benzodiazepines will increase the therapeutic ratio of procaine mitigating central nervous system toxicity. A dibucaine number is required prior to initiation of therapy. Side effects have hindered development of selective VGSC blockers. Modification of oral procaine administration with over 100 clinical practice years of known side effects may meet this unmet need.

Abstract: The invention relates to the application of inhibition of SLC4A4 (Solute Carrier Family 4 member 4) in the treatment of cancer. This either as monotherapy (such as for treating cancer refractive or poorly responding to immunotherapy) or as combination therapy in conjunction with an immunotherapeutic compound (such as for treating cancers poorly responding or refractive to immunotherapy). In particular, inhibition of SLC4A4 is capable of restoring response to immunotherapy such as immune checkpoint inhibitor therapy.

Abstract: Methods are described for preventing or treating skeletal diseases such as period paralysis by administering to a subject a Kv7 channel opener.

Abstract: The present application relates to a kind of fused ring phenolic compound, or a pharmaceutically acceptable salt or ester thereof, in the manufacture of medicaments for treating, inhibiting or preventing bacterial infections. The disclosed fused ring phenolic compounds can inhibit PPK1 and PPK2 and can be used to treat infections or conditions caused by bacteria such as Pseudomonas aeruginosa.

Abstract: Meltable compositions configured for oral use, the compositions including at least one cannabinoid or cannabimimetic, are provided. The compositions include one or more fillers, typically a sugar alcohol, and a lipid. A method of forming such compositions is also provided.

Abstract: Provided herein are methods of treatment, including methods of treating subjects having or at risk of having or having a viral infection, and specifically a SARS-CoV-2 viral infection. The methods provided include the administration of 4-methylumbelliferone (4-MU), palmitoylethanolamide (PEA), reservatrol, fisetin, H2, nebulized hyaluronidase or combinations thereof. Also provided herein are a respiratory assistance device, methods of generating a customized respiratory assistance device, methods of treating a coronavirus infection, and methods of inhibiting a coronavirus infectivity, virulence and/or spread.

Abstract: A method of treating or preventing inflammation and pain includes administering to a subject a functionalized 1,3-benzene diol represented by a formula selected from formulas (I)-(X) as defined herein, and hydrates, solvates, pharmaceutically acceptable salts, and complexes thereof. Further disclosed is a chemotherapeutic method, including administering to a patient: (1) at least one chemotherapeutic agent and (2) at least one functionalized 1,3-benzene diol represented by a formula selected from formulas (I)-(X) as defined herein, and hydrates, solvates, pharmaceutically acceptable salts, and complexes thereof, which is effective to treat or prevent inflammation and pain associated with administering the at least one chemotherapeutic agent.

Abstract: Provided herein are methods of treating non-hemorrhagic closed head injury (NHCHI) with 3,3?-diindolylmethane or an analog thereof. In one embodiment, NHCHI covers Traumatic Brain Injuries (TBIs) including mild to severe concussion, blast injury due to proximity to explosions, cerebral contusion, coup-contrecoup injury, DAI, Second Impact Syndrome, or CHI associated with deceleration injury.

Abstract: The present disclosure provides methods, uses, and pharmaceutical compositions comprising and azole derivative (e.g., sulconazole) in the treatment or prevention of fibrotic disease or disorder or fibrosis, including Crohn's disease.

Abstract: Disclosed are methods and compositions for treating or preventing a disease, a disorder, or symptom associated with picornaviruses in a subject including a therapeutically effective amount of a compound of Formula I, Formula II, or a pharmaceutically acceptable salt thereof, wherein X, Y, L, A, B, A1, A2, A3, R1, R2, R3, R4, R7, R8, R9, and R10 are as described herein.

Abstract: The present invention relates to a composition of disease-modifying antirheumatic drugs (DMARDs) for treatment of auto-immune diseases. More particularly, the invention relates to the microemulsion based emulgel composition of DMARD-leflunomide or its derivatives for treatment of auto-immune diseases such as rheumatoid arthritis, atopic dermatitis, psoriasis and skin cancer such as melanoma, squamous cell carcinoma. The invention also discloses a method for preparation of microemulsion based emulgel composition with improved physicochemical, pharmacokinetic properties of leflunomide to be used in pharmaceutical compositions. This invention discloses the delivery of leflunomide across human skin for the treatment of autoimmune and oncological conditions. The unique delivery of leflunomide in the form of microemulsion based emulgel composition is disclosed.

Abstract: The present invention relates to a pharmaceutical combination comprising a first active ingredient which is (R)-5-[3-chloro-4-(2,3-dihydroxy-propoxy)-benz[Z]ylidene]-2-([Z] propylimino)-3-o-tolyl-thiazolidin-4-one or a pharmaceutically acceptable salt thereof and a second active ingredient which is selected from the group consisting of methyl fumarate, dimethyl fumarate, (N,N-diethylcarbamoyl)methyl methyl (2E)but-2-ene-1,4-dioate, and 2-(2,5-dioxopyrrolidin-1-yl)ethyl methyl (2E)but-2-ene-1,4-dioate, or a pharmaceutically acceptable salt thereof.

Abstract: In some embodiments of the present disclosure, a sustained release osmotic-controlled pharmaceutical composition is provided, including: a core and a semi-permeable membrane coated on the core. The core includes a drug compartment, in which the drug compartment includes a first active ingredient, a first polymer and a first osmogen, and the first active ingredient includes lurasidone, a pharmaceutical acceptable salt of the lurasidone or a combination thereof. The semi-permeable membrane includes a membrane body and at least one pore distributed in the membrane body.