Abstract: The disclosure provides a bi-layer, pressed particles, adhering troche, comprising, (a) a first layer of pressed particles comprising an ingredient to be released; (b) a second, adhesive layer of pressed particles comprising a mixture of at least 80% by weight gelatin particles and 1-15% by weight compression binder particles so that the gelatin particles have a greater tensile strength from one to another than if the gelatin particles had been pressed without the binder; wherein the troche has a first non-adhesive side and a second adhesive side; wherein the troche is at least 5 mm in two dimensions; and wherein the troche adhered in a mouth dissolves without smearing or breaking apart.

Abstract: The present disclosure provides pharmaceutical compositions that provide immediate release of active ingredients and have abuse deterrent properties. In particular, the pharmaceutical compositions comprise at least one pharmaceutically active ingredient, at least one non-cellulose polysaccharide, at least one hydrophilic gelling polymer, and an effervescent system.

Abstract: In a metered dose inhaler, comprising a canister and metering valve, containing a suspension aerosol formulation comprising particles of formoterol fumarate dihydrate and fluticasone propionate suspended in an HFA propellant, a method of reducing deposition of particles on the surfaces of the canister and the metering valve, the method comprising the step of adding a wetting agent to the formulation.

Abstract: A bioactive material delivery system can include a thermoresponsive polymer membrane and nanowires distributed within the thermoresponsive polymer membrane. Magnetic activation of a thermoresponsive polymer membrane can take place via altering the magnetization or dimensions of nanowires dispersed or ordered within the membrane matrix.

Abstract: Fixed dose HER2 antibody formulations for subcutaneous administration are provided along with their use in the treatment of cancer. The formulations include fixed dose subcutaneous formulations of pertuzumab and subcutaneous co-formulations of pertuzumab and trastuzumab, and their use in the treatment of cancer.

Abstract: Compositions and methods for treating sexual dysfunction and enhancing sexual satisfaction using topical application of a therapeutic agent such as an alpha-1 adrenergic receptor agonist to the nipple-areola complex are disclosed.

Abstract: Described herein are methods for reducing the risks of exposure to air pollutants, comprising nasally administering to a subject in need thereof a composition that counteracts the effects of one or more air pollutants, wherein the composition is adapted for nasal administration. In some embodiments the composition comprises an agent that binds to one or more air pollutants, wherein the agent comprises one or both of nonporous silicon dioxide and porous silicon dioxide and/or the composition provides a physical barrier between one or more air pollutants and internal nasal surfaces. Also described are nasal compositions comprising an agent comprising one or both of nonporous silicon dioxide and porous silicon dioxide, a lipophilic or partly lipophilic vehicle, and a surfactant, wherein the composition is adapted for nasal administration. The compositions also may comprise other agents, such as an immunosuppressant. Also described are methods of making and using the compositions.

Abstract: The present invention relates to pharmaceutical compositions for the treatment or prevention of ophthalmologic diseases or disorders, wherein the pharmaceutical composition comprises a solid carrier in form of a non-woven or woven made of water-soluble fibers and at least one therapeutically active agent, wherein said solid carrier is impregnated with said at least one therapeutically active agent, wherein the solid carrier readily disintegrates upon contact with the eye. Also encompassed are such composition for use in the treatment or prevention of ophthalmologic conditions and the use of the non-wovens/wovens described herein as carriers for at least one therapeutically active agent in an ophthalmologic pharmaceutical composition.

Abstract: The present invention relates to methods and pharmaceutical compositions for the treatment of retinal capillary non-perfusion. In particular, the present invention relates to a method of treating retinal capillary non-perfusion in a subject in need thereof comprising administering to the subject a therapeutically effective amount of a ROCK inhibitor.

Abstract: The present invention relates to animal feed compositions comprising polypeptides having lysozyme activity and polypeptides having phytase activity and uses thereof.

Abstract: A method of making an oral soluble film, containing at least one active agent, includes providing a well of a predetermined size; depositing a film forming composition in the well; depositing an active agent composition in the well, the active agent composition being different than the film forming composition, the film forming composition and the active agent composition forming an admixture in the well; and drying the admixture in the well. Alternatively, the method includes providing a well of a predetermined size; depositing a film forming composition including at least one active agent in the well, the film forming composition having a viscosity below 2000 centipoise; and drying the film forming composition in the well.

Abstract: A package, system and methods allow for custody and control of drugs, especially for an abuse-prone drug. A package for custody and control of a dose of an active agent, includes a unit dose of an active agent, and an individual package sealing the unit dose therein, the package having a custody and control product identifier unique to each unit dose provided on the package. A system for custody and control of a dose of an active agent, includes an individual package of one unit dose of an active agent, the package having a custody and control product identifier unique to each unit dose provided on the package, and a database containing data reflecting the custody and control identifier corresponding to each unit dose and an identifier configured to be able to identify the party to whom each unit dose is provided.

Abstract: Technologies are described for formulations and methods to produce sublingual antidepressant and antianxiety tablets. The tablets may comprise sublingual tablet base and ketamine. The tablets may comprise 2.00 weight percent to 23.00 weight percent ketamine. The methods may comprise placing sublingual tablet base into a chamber. The methods may comprise adding a first ingredient into the chamber. The first ingredient may include ketamine. The methods may comprise mixing the first ingredient into the sublingual tablet base in the chamber to form a mixture. The methods may comprise pressing the mixture into a mold. The methods may comprise drying the mixture in the mold to form the tablet.

Abstract: A high dose orodispersible dosage form of oxcarbazepine is provided. Drug-containing particles of oxcarbazepine are included within a porous bound matrix. The dosage form disperses in saliva or water in less than 15 sec and it has sufficient hardness to withstand handling and storage. It can be used to treat diseases or disorders that are therapeutically responsive to oxcarbazepine or a derivative thereof.

Abstract: Methods of treating atrial arrhythmia include administering an effective amount of at least one antiarrhythmic pharmaceutical agent to a patient in need thereof, such that the at least one antiarrhythmic pharmaceutical agent first enters the heart through the pulmonary vein to the left atrium. Other methods of treating atrial arrhythmia include administering by inhalation an effective amount of at least one antiarrhythmic pharmaceutical agent to a patient in need thereof. An amount of the at least one antiarrhythmic pharmaceutical agent may peak in the coronary sinus of the heart at a time ranging from 10 seconds to 30 minutes from initiation of the administering. Unit doses, aerosols, and kits are also contemplated.

Abstract: The present invention relates to formulae for infants comprising large lipid globules and/or lipid globules with a coating of phospholipids for rendering the growth trajectory or body development during the first year of life more similar to that observed for human milk fed infants.

Abstract: A process is described for preparing a composition in the form of an emulsion that includes a high concentration of one or more avermectins. This process can include partitioning the avermectin between an active phase, including at least one glycol, and an oily phase of the emulsion. A composition thus obtained, is also described that can be used in the treatment of dermatological disorders such as rosacea.

Abstract: The present invention relates to a microvesicle that is derived from nucleated mammalian cells, which are smaller than the nucleated cells. The microvesicles of the present invention can be used in the delivery of a therapeutic or diagnostic substance to specific tissues or cells, and more particularly, relates to microvesicles derived from monocytes, macrophages, dendritic cells, stem cells or the like, which can be used to deliver specific therapeutic or diagnostic substances for treating and/or diagnosing tissue associated with cancer, diseased blood vessels, inflammation, or the like.

Abstract: Irinotecan phospholipid liposomes with improved storage stability are provided, with related methods of treatment and manufacture. The irinotecan liposomes can have reduced formation of lyso-phosphatidylcholine (lyso-PC) during storage, and prior to administration to a patient.

Abstract: An object of the present invention is to provide a liposome and a liposome composition in which release of a drug in blood is suppressed during accumulation of the liposome and the liposome composition in a target site such as a tumor and the drug is rapidly removed after the liposome and the liposome composition are sufficiently accumulated. According to the present invention, there is provided a liposome containing at least a phospholipid to which a hydrophilic polymer is bonded, a phospholipid having a negative charge within a range of a pH of 6 to 8, and a phospholipid which is electrically neutral within a range of a pH of 6 to 8, in which an average carbon chain length of the phospholipid to which the above-described hydrophilic polymer is bonded is shorter than an average carbon chain length of the above-described phospholipid which is electrically neutral within a range of a pH of 6 to 8.

Abstract: The presently disclosed subject matter provides a solid immediate release pharmaceutical particulate dosage form containing one population of particulates, and/or a solid immediate release pharmaceutical multi-particulate dosage form containing at least two different populations of particulates. In certain embodiments, the immediate release pharmaceutical dosage forms contain at least three different populations of multi-particulates. Each population of particulates is designed for a specific function to accomplish the desired combination of abuse deterrence and overdose protection.

Abstract: The disclosure provides a sustained release injectable neurosteroid formulation comprising neurosteroid particles having a D50 of less than 10 microns, the neurosteroid particles comprising a neurosteroid of Formula I: or a pharmaceutically acceptable salt thereof, wherein: is a double or single bond and the variables, e.g., R1, R2, R3, R4, R4a, R5, R6, R7, R8, R9, R10, and R10a are described herein. The formulation comprises neurosteroid particles comprising the neurosteroid and a polymeric surface stabilizer and provides an effective plasma concentration of the neurosteroid at steady state for at least 48 hours, and in some embodiments for at least 4 weeks. The sustained release injectable neurosteroid formulation can formulated for intramuscular or subcutaneous administration.

Abstract: The present invention generally relates to microfluidic droplets and, in particular, to multiple emulsion microfluidic droplets. In certain aspects, particles such as gel particles can be prepared in an aqueous carrier from aqueous droplets (or a non-aqueous carrier from non-aqueous droplets). For example, in some embodiments, double-emulsion droplets of a first fluid, surrounded by a second fluid, contained in a carrier fluid may be prepared, where the first fluid forms a gel and the second fluid is removed. For instance, the second fluid may be dissolved in the carrier fluid, or the second fluid may be hardened, then removed, for example, due to a change in pH. Other embodiments of the present invention are generally directed to kits containing such microfluidic droplets, microfluidic devices for making such microfluidic droplets, or the like.

Abstract: A two-compartment capsule includes a body, a diaphragm between, which seals off the body and provides a first compartment to hold a first dry ingredient, and a cap applied to the body whereby a space between the inner portion of the cap and the diaphragm defines a second compartment for holding a second dry ingredient. This disclosure also provides particular formulations for use in such a capsule. Examples include a probiotic, a digestive enzyme, an expectorant, a bronchodilator, a stool softener, a platelet aggregation inhibitor, a form or derivative of vitamin E, a statin, and aspirin.

Abstract: Provided are lipid membrane microcapsules encapsulating or containing bioactives, and methods of production and use.

Abstract: The present invention provides nanoparticles and methods for treating and preventing skin inflammatory conditions or disorders. The conditions or disorders include allergic contact dermatitis (ACD), irritant contact dermatitis, atopic dermatitis (AD), photoallergic dermatitis, and contact hypersensitivity (CHS), as well as other conditions or disorders associated with the skin.

Abstract: Embodiments disclosed herein relates to ganglioside GM3-containing mixed lipids nanoparticles having an overall size between 60-100 nm, the making thereof and the uses. The nanoparticles selectively targeted to CD169+ expressing cells such as dendritic cells and macrophage. The nanoparticles are endocytosed by the CD169+ expressing cells.

Abstract: This disclosure teaches phospholipid nanoparticle compositions of cannabinoids formed from phospholipids and simpler lipids in an unfired sequential process that encapsulate a high concentration of cannabinoids, and create standardized precision-metered dosage forms of cannabinoids; yielding an increase cannabinoid transport across hydrophobic mucosa; increase the bioavailability of the cannabinoid 2-fold to 8-fold, decrease the dose of cannabinoids 2-fold to 8-fold less than an amount of cannabinoids needed to illicit the same therapeutic effect compared to raw and non-encapsulated cannabinoids; where the nanoparticle dynamic structure reduces the adverse effects of cannabinoids; and enable safe more efficacious cannabinoid therapy.

Abstract: Solid films and articles having a surface with discrete regions patterned with a deposited low molecular weight organic compound, such as pharmaceutical actives and new chemical entities, are provided. The organic compound may be present at ?about 99 mass % in the one or more discrete regions and may be crystalline or amorphous. The deposited organic compound may be deposited as a film having high surface area. The deposited organic compound exhibits enhanced solubility and bioavailability, by way of non-limiting example. Methods of organic vapor jet printing deposition method of such a low molecular weight organic compound in an inert gas stream are also provided.

Abstract: A fast acting orally disintegrating film (ODF) for administration of local anesthetic for alleviating physical and psychological discomfort in the oral cavity during procedures such as dental procedures or for relieving pain generally such as toothaches. The ODF comprises an active pharmaceutical ingredient such as lidocaine free base or a pharmaceutically acceptable salt thereof in a therapeutically acceptable amount such as about 24 mg, at least one primary hydrophilic film forming polymer, at least one secondary hydrophilic film forming polymer, wherein the ratio of the primary hydrophilic film forming polymer to the secondary hydrophilic film forming polymer is about 1:1 to about 20:1 by weight. The ODF further comprises a plasticizer wherein the ratio of the total weight of primary and secondary hydrophilic film forming polymer to the weight of the plasticizer is about 4:1 to about 4:3.

Abstract: The present invention relates to water-soluble films incorporating anti-tacking agents and methods of their preparation. Anti-tacking agents may improve the flow characteristics of the compositions and thereby reduce the problem of film adhering to a user's mouth or to other units of film. In particular, the present invention relates to edible water-soluble delivery systems in the form of a film composition including a water-soluble polymer, an active component selected from cosmetic agents, pharmaceutical agents, vitamins, bioactive agents and combinations thereof and at least one anti-tacking agent.

Abstract: A method and article for alleviating a subject's urge to urinate is described. The article includes a support and a composition with a stimulation agent such as menthol, menthol derivatives, capsaicin, or a combination thereof. The support may be in the form of a wipe, patch or pant. In human subjects, the composition is applied to select dermatomes for a desired period of time.

Abstract: A modular transdermal drug delivery system is provided, the system including: an upper module in which an outer backing layer is laminated to a pressure-sensitive adhesive layer that is covered by a removable release liner prior to assembly; and a lower module with a porous drug reservoir layer laminated to a skin-contact adhesive that affixes the system to the skin during drug delivery, where the skin-contact adhesive is, in one embodiment, an adhesive layer that is substantially co-extensive with the porous drug reservoir layer and, prior to use, protected with a second removable release liner. Methods of manufacture and use are also provided, as is an assembled transdermal drug delivery system fabricated by affixing the pressure-sensitive adhesive layer of the upper module to the porous drug reservoir layer of the lower module.

Abstract: A method of inducing anesthesia in a subject is provided. In some embodiments, the method provides administering to the subject via the respiratory system or via injection, an effective amount of a compound or a mixture of compounds selected from the group consisting of methyl-ethyl ethers, methyl-isopropyl ethers, and methyl-propyl ethers.

Abstract: Disclosed herein are naphthoquinone analogs, such as plumbagin, pharmaceutical compositions that include naphthoquinone analogs, such as plumbagin, and methods of treating diseases and/or conditions such as cancer with naphthoquinone analogs, such as plumbagin. Also included are combination therapies wherein a naphthoquinone analog, such as plumbagin, and a hormone therapy agent are provided to a subject suffering from a condition such as cancer.

Abstract: Methods of treating developmental encephalopathies by administering compositions including ketamine, norketamine, or other derivatives of ketamine, or a pharmaceutically acceptable salt of any of the foregoing, are provided. The methods and compositions may be used to treat conditions such as Dravet syndrome.

Abstract: Therapeutic compositions and methods for treatment of late-onset Gaucher disease are described herein. The compositions comprise compounds having activity as pharmacological chaperones for mutant forms of the beta-glucocerebrosidase. Methods of treatment involve providing therapeutically effective amounts of such compositions to subjects in need thereof.

Abstract: The present invention includes a method for the treatment of retinitis pigmentosa in a human that comprises administering to the human a therapeutically effective amount of N-acetylcysteine amide (NACA).

Abstract: The present invention addresses the problem of providing an intraocular irrigating solution that allows the intraocular tissue to be sufficiently protected during ophthalmic surgery and further has high safety. The problem is solved by an intraocular irrigating solution containing at least one of active sulfur molecules of which examples include cysteine persulfide and glutathione persulfide.

Abstract: In one embodiment, the invention provides a method of treating a subject who suffers from, or who is suspected of suffering from, a Mycobacterium infection, the method comprising administering to the subject a therapeutically effective amount of a urease inhibitor, optionally in combination with one or more anti-mycobacterial agents.

Abstract: A transdermal topical anesthetic formulation, which can be used to ameliorate or inhibit pain, has been developed. In the preferred embodiment, the topical anesthetic is a local anesthetic such as lidocaine, most preferably lidocaine free-base in a gel, and the dosage of the local anesthetic is effective in the painful area or immediately adjacent areas, to ameliorate or eliminate the pain. High concentration of local anesthetic in solution in the carrier is used to drive rapid release and uptake of the drug. Relief is typically obtained for a period of several hours.

Abstract: Compositions of iron prochelator compounds conjugated to a carbohydrate moiety are described herein. The glycoconjugates are prochelators that are activated in reducing conditions, such as in the intracellular space, so as to sequester iron. The glycoconjugate molecules are taken up by cells via the glucose transporter and may be used to target malignant cells.

Abstract: An oleogel comprising a non-polar liquid and a powder containing triterpene is provided as an oleogel that may be used for healing wounds.

Abstract: A bactericidal and virucidal pharmaceutical composition for use on epithelial tissues such as pulmonary, nasal and oral tissues, which comprises a non-steroidal anti-inflammatory drug (NSAID) in a concentration between 5 and 500 mM and a salt, being the NSAID preferably solubilized in a hypertonic saline solution applicable in therapies for viral infections of the Herpes simplex type. The composition can be used in therapies for herpes simplex viral infections, be used as a bactericidal mouthwash, or be vehiculated to the lung by using a nebuliser, for cystic fibrosis.

Abstract: Technologies are described for a formulation and production of a formulation. The methods may comprise depositing a non-steroidal anti-inflammatory drug (NSAID) compound into a chamber. The methods may comprise depositing a N-methyl-D-aspartate (NMDA) receptor antagonist into the chamber. The methods may comprise respectively depositing a muscle relaxant, a local anesthetic into the chamber, depositing an anticonvulsant into the chamber, depositing an antidepressant into the chamber, and depositing a calcium channel blocking agent into the chamber. The methods may comprise milling the NSAID compound, the NMDA receptor antagonist, the muscle relaxant, the local anesthetic, the anticonvulsant, the antidepressant, and the calcium channel blocking agent into a powder. The methods may comprise adding a solvent with the powder and mixing the solvent with the powder to form a solution. The methods may comprise adding a base cream to the solution and mixing the base cream and the solution to form the formulation.

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: Described herein are oral pharmaceutical compositions comprising liquid dosage forms of sodium naproxen in soft gel capsules. In one embodiment, the pharmaceutical composition comprises sodium naproxen, 0.2-1.0 mole equivalents of a de-ionizing agent per mole of naproxen, polyethylene glycol, and one or more solubilizers such as propylene glycol, polyvinyl pyrrolidone or a combination thereof.

Abstract: Pharmaceutical compositions of (E)-2,4,6-trimethoxystyryl-3-[(carboxymethyl)amino]-4-methoxybenzylsulphone and pharmaceutically acceptable salts thereof are described as well as methods of their use.

Abstract: The present invention relates to methods for producing particles of diclofenac using dry milling processes as well as compositions comprising diclofenac, medicaments produced using diclofenac in particulate form and/or compositions, and to methods of treatment of an animal, including man, using a therapeutically effective amount of diclofenac administered by way of said medicaments

Abstract: A compounded topical solution may include approximately 85% to approximately 95% (v/v) diclofenac sodium topical solution, 1.5% (w/w), and approximately 5% to approximately 15% (v/v) lidocaine hydrochloride topical solution, 4% USP.