Abstract: Compositions comprised of a population of transformed bacteria formulated for topical application to a subject are described. The population of transformed bacteria are created from a non-pathogenic bacteria and transformed to express a compound of interest for a therapeutic or a cosmetic purpose. In one embodiment, the composition is for protection of the skin from ultraviolet rays.

Abstract: The current application relates to a liquid pharmaceutical composition for intiaoral transmucosal administration of a benzodiazepine drag to a mammal The composition comprises a physiologically acceptable hydrophobic phase, a eutectic mixture of benzodiazepine compound providing high solubility of the benzodiazepine in said hydrophobic phase, at least one physiologically acceptable organic solvent and at least one physiologically acceptable surfactant.

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: Provided are high concentration compositions of tissue kallikrein-1 (KLK1) and methods of parenterally administering such compositions to a subject in need thereof, where absorption into the circulation via, for example, intravenous or subcutaneous administration improves systemic pharmacokinetics, bioavailability, safety, and/or convenience relative to intravenous or other forms of administration. Also provided are recombinant human KLK1 (rhKLK1) polypeptides that can be readily concentrated to high protein concentrations, and substantially pure compositions thereof.

Abstract: Effective treatments of pain that accompanies post-operative surgeries are provided. Through the administration of an effective amount of a combination of bupivacaine and clonidine at or near a target site, one can alleviate or prevent pain. This administration of bupivacaine and clonidine or pharmaceutically acceptable salts thereof is particularly useful following surgery.

Abstract: It relates to a device comprising (a) a core comprising polyurethane; (b) a sheath comprising ethylene vinyl acetate copolymer, said sheath substantially or completely surrounding said core; and (c) one or more active pharmaceutical ingredients dissolved or dispersed in said core and/or said sheath; and to a process for its preparation.

Abstract: Described herein are methods of inhibiting or reversing the progression of cataract formation or presbyopia in an eye by administering a ?-crystallin charge masking agent. Both presbyopia and cataracts are caused by aggregation of the soluble crystalline lens proteins called the crystallins.

Abstract: A soft, chewable and orally dissolvable and/or disintegrable product includes a biopolymer-sugar based matrix and botanical powder dispersed throughout the biopolymer-sugar based matrix. The biopolymer-sugar based matrix includes at least one biopolymer, at least one sugar and optional additives. Soft, chewable and orally dissolvable and/or disintegrable product can also include flavor beads.

Abstract: The present invention is concerned with a refinement of the processing of particles that are to form a dry powder formulation which is to be administered to the lung using a dry powder inhaler (DPI) device. In particular, the present invention provides the processing of particles of active material and particles of carrier material in the presence of additive material to provide a powder composition which exhibits excellent powder properties and which is economical to produce.

Abstract: A composition is provided that comprises a therapeutic agent encapsulated by a milk-derived microvesicle. The compositions can include therapeutic agents such as phytochemical agents or chemotherapeutic agents, while the milk-derived microvesicle can be derived from raw milk or colostrum. Further provided are methods for isolating a microvesicle that includes the steps of obtaining an amount of milk, and subjecting the milk to a series of sequential centrifugations configured to yield greater than about 300 mg of microvesicle protein per 100 ml of milk. Methods of modifying an immune response and treating a cancer in which a milk-derived microvesicle composition is administered are also provided.

Abstract: Solid pharmaceutical preparation with the active substance glyceryl trinitrate for oromucosal or oral administration characterized in that it contains between 0.05 and 2 weight % glyceryl trinitrate, at least one carrier material, and at least one substance that reduces the volatility of the GTN, whereby this substance is a non-volatile ester stabilizer.

Abstract: Disclosed in certain embodiments is a controlled release oral dosage form comprising a therapeutically effective amount of a drug susceptible to abuse together with one or more pharmaceutically acceptable excipients; the dosage form further including a gelling agent in an effective amount to impart a viscosity unsuitable for administration selected from the group consisting of parenteral and nasal administration to a solubilized mixture formed when the dosage form is crushed and mixed with from about 0.5 to about 10 ml of an aqueous liquid; the dosage form providing a therapeutic effect for at least about 12 hours when orally administered to a human patient.

Abstract: Embodiments may include a method for reducing a solvent concentration in a plurality of microparticles. The method may involve contacting a mixture including the plurality of microparticles and the solvent with water to form an aqueous suspension. A first portion of the solvent may dissolve into the water of the aqueous suspension to reduce the solvent concentration in the plurality of microparticles from a first solvent concentration in the mixture to a second solvent concentration in the aqueous suspension. The method may also include transferring the aqueous suspension to a concentration unit that may further reduce the solvent concentration from the second solvent concentration to a third solvent concentration. The method may further include transferring a microparticle concentrate with the third solvent concentration to a washing unit to form an amalgam of washed microparticles with a fourth solvent concentration. The method may also include drying the amalgam of washed microparticles.

Abstract: Solid lipid particles comprising a lipid hydrophobic matrix and from about 5 wt. % to about 30 wt. % of curcumin, and methods of making and treatment thereof.

Abstract: An oral pharmaceutical dosage form is provided which contains at least two medicaments, in which form the medicaments on the one hand are brought together in a leakproof and in-vivo water soluble wrapping and on the other hand are separated so that the active principle of the combined medicaments cannot come into contact with one another. At least one of the medicaments can be chosen from the following therapeutic classes: non-steroidal anti-inflammatory drug (NSAID), proton pump inhibitor (PPI), beta-blocker, statin, conversion enzyme inhibitor (CEI), biguanide, myorelaxant, calcium inhibitor, corticoid, antidepressant, benzodiazepine, non-atropine-like intestinal transit retarder, intestinal antibacterial, and the following therapeutic molecules: spironolactone, propranolol, clarithromycin, amoxycillin, low-dose acetylsalicylic acid, potassium, and clopidogrel.

Abstract: The present invention relates generally to Vitamin B12 pharmaceutical composition and method of using the same for the treatment of Vitamin B12 deficiency and the various disorders that are related to such deficiency. In particular embodiments, the present invention is directed towards treatment methods comprising sublingual or buccal administration of a Vitamin B12 composition useful in the practice of such treatment. The present invention features compositions that include one or more Vitamin B 12 compounds, propylene glycol, a solid adsorbent and a solid water-soluble excipient, wherein the Vitamin B 12 compounds are in a propylene glycol solution.

Abstract: Disclosed in certain embodiments is a controlled release oral dosage form comprising a therapeutically effective amount of a drug susceptible to abuse together with one or more pharmaceutically acceptable excipients; the dosage form further including a gelling agent in an effective amount to impart a viscosity unsuitable for administration selected from the group consisting of parenteral and nasal administration to a solubilized mixture formed when the dosage form is crushed and mixed with from about 0.5 to about 10 ml of an aqueous liquid; the dosage form providing a therapeutic effect for at least about 12 hours when orally administered to a human patient.

Abstract: Disclosed in certain embodiments is a controlled release oral dosage form comprising a therapeutically effective amount of a drug susceptible to abuse together with one or more pharmaceutically acceptable excipients; the dosage form further including a gelling agent in an effective amount to impart a viscosity unsuitable for administration selected from the group consisting of parenteral and nasal administration to a solubilized mixture formed when the dosage form is crushed and mixed with from about 0.5 to about 10 ml of an aqueous liquid; the dosage form providing a therapeutic effect for at least about 12 hours when orally administered to a human patient.

Abstract: Disclosed in certain embodiments is a controlled release oral dosage form comprising a therapeutically effective amount of a drug susceptible to abuse together with one or more pharmaceutically acceptable excipients; the dosage form further including a gelling agent in an effective amount to impart a viscosity unsuitable for administration selected from the group consisting of parenteral and nasal administration to a solubilized mixture formed when the dosage form is crushed and mixed with from about 0.5 to about 10 ml of an aqueous liquid; the dosage form providing a therapeutic effect for at least about 12 hours when orally administered to a human patient.

Abstract: Pharmaceutical compositions comprising tadalafil or a pharmaceutically acceptable salt thereof are provided. The present invention also relates to a process for preparation of pharmaceutical compositions comprising tadalafil or a pharmaceutically acceptable salt thereof. The present invention also relates to method of administering the compositions comprising tadalafil in a subject in need thereof.

Abstract: The present invention relates to pharmaceutical compositions of the poorly soluble drugs, and pharmaceutically acceptable salts thereof, in a controlled-release gastric retained oral dosage form. Such compositions are formulated so as to deliver the majority of the incorporated drug into the stomach and upper gastrointestinal tract, with restricted drug delivery in the lower gastrointestinal tract. The dosage forms have multiple layers including an active layer with a first swellable polymer with raltegravir incorporated therein and a non-active layer with a second swellable polymer having a similar molecular weight or a higher molecular weight as the swellable polymer in the active layer.

Abstract: The invention relates to a dosage form containing cineole for peroral application in capsule form, wherein the dosage form containing cineole is designed as a capsule-in-capsule system, wherein the capsule-in-capsule system has an outer capsule (outside capsule) having an outer capsule shell and a plurality of inner capsules (inside capsules) located in the outer capsule, wherein the inner capsules are completely enclosed by the capsule shell of the outer capsule and the inner capsules are designed as microcapsules, which each contain the active ingredient 1,8-cineole. The invention further relates to the production and use of said dosage form containing cineole.

Abstract: Disclosed in certain embodiments is a controlled release oral dosage form comprising a therapeutically effective amount of a drug susceptible to abuse together with one or more pharmaceutically acceptable excipients; the dosage form further including a gelling agent in an effective amount to impart a viscosity unsuitable for administration selected from the group consisting of parenteral and nasal administration to a solubilized mixture formed when the dosage form is crushed and mixed with from about 0.5 to about 10 ml of an aqueous liquid; the dosage form providing a therapeutic effect for at least about 12 hours when orally administered to a human patient.

Abstract: Provided herein are nanoparticles that include a lipid layer and a compartment surrounded by the lipid layer. The lipid layer may include a lipid and a lipoprotein. The lipid may include a POPE lipid covalently attached to a hydrophilic polymer by a disulfide bond. The lipoprotein may include a trigger protein. The concentration of the first lipid may be between 1 mol % and 30 mol %. The disulfide bond of the first lipid is stable under conditions that include 10% human serum and is broken under conditions that include 50 micromolar glutathione. The hydrophilic polymer may include a PEG molecule. The trigger protein may include an amino acid repeat region, such as (GPX)n. The trigger protein may include a peptide bond that is cleaved by a gelatinase (e.g., gelatinase-B protease), or a member of the ADAM family of proteases (e.g., ADAM10 protease). Also provided are methods of using the nanoparticles.

Abstract: Provided are polymersomes for co-delivery of hydrophobic metallic nanoparticles and pharmaceutical agents and suspensions of such polymersomes. Also provided are methods of making such polymersomes and suspensions of polymersome and methods of using the same to treat diseases or conditions.

Abstract: Purified therapeutic nanoparticles are provided herein. Such nanoparticles comprise an active pharmaceutical ingredient and human serum albumin, wherein the weight ratio of human serum albumin to the active ingredient in the therapeutic nanoparticles is from 0.01:1 to 1:1, and wherein the nanoparticles are substantially free of free human serum albumin that is not incorporated in the nanoparticles. The present disclosure also provides pharmaceutical compositions that comprise the purified therapeutic nanoparticles and are also substantially free of free human serum albumin. Methods for preparing and using the purified therapeutic nanoparticles and compositions thereof are also provided.

Abstract: An aqueous emulsion for use in veterinary medicine which contains beta carotene and can be administered parenterally from a sterile multi-dose container contains acetylcysteine in an amount of between 1 and 8 wt.-% as a substance which stabilizes the emulsion and protects preservatives and beta carotene from being decomposed. The beta carotene-containing emulsion can additionally contain at least one antioxidant and at least one preservative. As the antioxidant, ascorbyl palmitate or alpha-tocopherol can be added. The emulsion can further contain a solubilizer, for example isopropyl myristate or Solutol® HS 15.

Abstract: An L-menthol pharmaceutical dosage form includes an effective amount of L-menthol for treating a gastrointestinal disorder. The L-menthol is within a plurality of particulates having a core and an enteric coating over the core. The core includes an L-menthol source that is at least 80% pure L-menthol. The dosage form may be used to treat gastrointestinal disorders, such as irritable bowel syndrome.

Abstract: A method of inhibiting excitotoxicity by indirectly activating ?4?2 nicotinic acetylcholine receptors (nAChRs) which indirectly activate synaptic AMPA and NMDA receptors is disclosed Inhibitors of ?7 nACHRs, such as macrocyclic diterpenoids, more specifically cembranoids or methyllycaconitine (MLA), indirectly activate ?4?2 nAChRs and can be used to treat neurodegenerative diseases, including, but not limited to, Alzheimer's Disease, Parkinson Disease, AIDS related dementia and the delayed effects of stroke. They can also be used to treat diseases associated with neuronal impairment, including, but not limited to glaucoma caused by optical nerve damage, delayed effects of epilepsy; and multiple sclerosis.

Abstract: The present invention relates to the administration of compositions comprising polyethylene glycol, for improving the general gastrointestinal health of an animal increasing growth performance and treating osteopenia, osteoporosis and other bone disorders.

Abstract: Methods for alleviating sore throat conditions and related compositions. In some such compositions, at least one non-hexose sugar alcohol and/or at least one non-hexose sugar alcohol precursor may be present in a concentration effective for reducing a concentration of sore-throat causing microorganisms in a patient's throat. The composition may further comprise at least one coating agent in a concentration effective for prolonging the presence of the at least one non-hexose sugar alcohol and/or at least one non-hexose sugar alcohol precursor in a patient's throat to treat the sore throat condition.

Abstract: The present invention relates to pharmaceutical compositions comprising ospemifene or a pharmaceutically acceptable salt thereof having an average particle size of more than 20 microns and one or more pharmaceutically acceptable excipients comprising at least one solubility enhancing agent. The compositions of the invention may be advantageously used for the treatment or prevention of atrophy-related diseases or disorders in women, especially in women during or after the menopause.

Abstract: The present invention is directed to pharmaceutical compositions of effective amounts of NMDA receptor antagonists and preservative for the administration to a patient in need of effective analgesia and anesthesia. The compositions of the invention advantageously do not cause any significant neurotoxicity. The preferred NMDA receptor antagonist is ketamine. The preferred preservative is benzalkonium chloride.

Abstract: Compositions and a methods are described for treating disorders of the small and large bowel, such as Crohn's disease, ulcerative colitis and irritable bowel syndrome, without producing any treatment-related systemic side effects and with minimal or no abdominal discomfort. A method of administration of civamide that is incorporated into soft gelatin capsules and administered with meals is described. Surprisingly, the method provides for diminishment of pain and inflammation of the small and large bowel without producing any systemic side effects or significant abdominal discomfort.

Abstract: The invention provides methods for classifying a cancer as susceptible to transmembrane prostate androgen induced (TMEPAI)-directed therapies, and methods for treating such cancers. The field of the invention pertains generally to medicine, pathology and oncology. More particularly, it addresses the treatment of breast cancer, such as triple-negative breast cancer, using a transmembrane prostate androgen induced (TMEPAI)-directed therapy.

Abstract: The present invention relates to combinations and methods for the treatment of neurological disorders related to glutamate excitotoxicity and Amyloid ? toxicity. More specifically, the present invention relates to novel combinatorial therapies of Alzheimer's disease, Alzheimer's disease related disorders, amyotrophic lateral sclerosis, multiple sclerosis, Parkinson's disease, Huntington's disease, neuropathic pain, alcoholic neuropathy, alcoholism or alcohol withdrawal, or spinal cord injury, based on baclofen and acamprosate combination.

Abstract: The present invention provides for systems, compositions, methods and kits for regulating energy metabolism in pets. The systems, compositions, and kits can comprise, and methods can make use of, pet foods, pet treats, pet supplements, and pet drinks. In one aspect, the invention provides for pet food, treat, supplement, and drink compositions that comprise a combination of (a) leucine, and (b) a sirtuin activator, or any precursors or metabolites of (a) or (b). These combinations may be effective for reducing weight or adipose volume in the pet. In another aspect, the invention provides for methods of regulating energy metabolism by the administration of one or more compositions comprising leucine, a leucine metabolite, and/or a sirtuin activator. The invention also provides for kits comprising compositions of leucine, a leucine metabolite, and/or a sirtuin activator packaged in an oral dose form with usage instructions.

Abstract: Disclosed are pharmaceutical compositions comprising, bucillamine, including bucillamine and allopurinol or colchicine, or pharmaceutically acceptable salts or solvates thereof, together with one or more pharmaceutically acceptable carriers, diluents and excipients. Methods for use of the said compositions in the treatment of gout and metabolic syndrome are also disclosed.

Abstract: The present invention provides an intestinal tract-protecting agent, an agent for the prophylaxis or improvement of a disease caused by damage in intestinal tract barrier function, which contains hydroxylated fatty acid, particularly hydroxylated unsaturated fatty acid, having a hydroxyl group at the 10-position and/or the 12-position, which is an intermediate of the metabolism of unsaturated fatty acid by lactobacillus.

Abstract: Described herein are pharmaceutical compositions providing enhanced bioavailability of polyunsaturated fatty acids and methods of manufacturing the same. In particular, described herein are pharmaceutical compositions comprising soft enteric capsules that provide enhanced bioavailability of omega-3 polyunsaturated fatty acids. The oral pharmaceutical compositions described herein are useful as nutritional supplements or for the treatment of cardiovascular-related diseases, such as hyper dyslipidemia and moderate to high triglyceride levels.

Abstract: The invention provides methods for increasing oral osteogenesis using LXA4 and its analogs. Methods are also provided for treating or preventing oral disorders that would benefit from increased oral osteogenesis using LXA4 and its analogs.

Abstract: The present invention relates to use of DHA analogs and their pharmaceutical compositions for treating ototoxicity, by administering these compounds or pharmaceutical compositions to subjects in need thereof. Ototoxicity is defined as damage to the structures of the ear, such as the cochlea and vestibular system, by drugs or toxins. Ototoxicity can result in irreversible hearing loss, tinnitus, dysequilibrium, Meniere's disease, or vertigo.

Abstract: This invention provides compounds, methods and compositions for the treatment of ophthalmic diseases and disorders, including retinal and choroidal disorders and related conditions. More particularly, the invention provides a method of using the provided pharmaceutical compositions for the treatment of ophthalmic diseases and disorders, including retinal and choroidal diseases, and related conditions, upon topical administration to the eye.

Abstract: Accelerated senescence has been shown to occur as a primary response to cellular stresses including DNA damaging agents (e.g., ionizing radiation) and is widely believed to be caused by continuous proliferative signaling in the presence of cell cycle arrest. The present disclosure provides a method of reducing cellular senescence in non-cancerous cells following exposure to ionizing radiation. The method comprises administering to a subject before, after, or concurrently with exposure to ionizing radiation an effective amount of a compound that inhibits activation of an insulin-like growth factor receptor (IGF-1R) or a compound that inhibits a protein involved in an IGF-1R induced signaling cascade.

Abstract: The present invention relates to compositions and kits including a chemical uncoupler, such as tyrphostin 9 or precursor or a salt thereof, and compositions including a chemical uncoupler, such as tyrphostin 9 in combination with one or more therapeutic agents, for example, L-carnitine, which are useful, for example, in treating obesity, preventing weight gain, promoting weight loss/slimming, and/or treating or preventing the development of diabetes.

Abstract: Pharmaceutical compositions and methods for treating and/or preventing age-related macular degeneration with melatonin analogues are provided.

Abstract: The invention relates to a composition comprising isoflavones from red clover. The red clover extract has been fermented to obtain a composition comprising aglycone isoflavones. The fermentation is preferably performed by a lactic acid bacteria or fermented dandelion extract.

Abstract: The invention is a method and composition for treating a topical microbial infection in a subject. The method includes the step of administering a therapeutically effective amount of a polyether ionophore, or a therapeutically acceptable salt thereof, to the subject.

Abstract: The present invention relates to a composition having antiviral activity for prophylaxis or treatment of flavivirus infection or a disease resulting therefrom in humans or animals, characterised in that the composition comprises quercetin, or analogues, or derivatives thereof. The composition may further comprise a pharmaceutically acceptable carrier. The antiviral activity may include inhibition of virus attachment to host cells and inhibition of intracellular virus replication. The flavivirus may comprise dengue virus type-1, dengue virus type-2, dengue virus type-3, and dengue virus type-4.

Abstract: Disclosed is a medicament characterized by the combination of: epigallocatechin gallate, methylated epigallocatechin gallate, or a pharmacologically permitted salt thereof; and a phosphodiesterase inhibitor.