Abstract: Oral liquid colchicine formulations are described herein. Methods of using the oral liquid colchicine formulations are also provided.

Abstract: Novel thyroid hormone oral dosage forms and methods of making and using the thyroid hormone oral dosage forms are disclosed.

Abstract: This invention relates to methods of preparing nanotherapeutic compounds and compositions comprising nanotherapeutic compounds. The nanotherapeutic compounds prepared according to the methods provided herein are useful for the treatment of disease, for example, cancer, in a subject in need thereof.

Abstract: A method of activating heteromeric KCNQ2/3, KCNQ3/5, or KCNQ4/5 voltage-gated potassium channels in a cell membrane is described, as are compositions for use with same, as well as methods of reducing neuronal excitability and of ameliorating symptoms of epilepsy, anxiety, neuropathic pain, hypertension, cardiovascular disease, a neurodegenerative disorder, alcohol withdrawal, cancer, inflammation, or ophthalmic disease in a subject. These KCNQ2/3 (or KCNQ3/5 or KCNQ4/5) channels are heteromers that comprise KCNQ2 (or KCNQ5) subunits and KCNQ3 (or KCNQ4) subunits. In one embodiment, the method comprises: (a) contacting the cell membrane with a first agent that binds a KCNQ2 (or KCNQ5) subunit; and (b) contacting the cell membrane with a second agent that binds a KCNQ3 (or KCNQ4) subunit.

Abstract: A single-dose cosmetic product and process of manufacturing thereof. The single-dose cosmetic product contains a solid portion of parenchyma of an aloe vera plant, a coating with waxy properties completely enclosing the solid portion and at least one tear tape located between the coating and the solid portion. The cosmetic product allows a better handling and application of the aloe vera and also preserves the properties and stability of a 100% aloe vera product without the use of additives. The manufacturing process of this cosmetic product allows the properties of the aloe vera parenchyma to remain intact.

Abstract: A device for leveling the feeder platform relative to the die table of a tablet compression machine where the device has a base having top surface, a die table engaging surface and a proximate feeder platform surface. The die table surface and the proximate feeder surface are essentially flat and level or parallel with each other. The surfaces are sized such that when mounted on a tablet compression machine, the die table engaging surface is level with and parallel to the die table and the proximate feeder platform surface is approximately parallel to the feeder platform. The proximate feeder platform surface has three or more adjustable sensors attached so that the sensors are in a non-linear arrangement and are level with and parallel to the die table.

Abstract: Pharmaceutical compositions comprising a therapeutically active agent and an absorption enhancer such as NAC, NAD, 5-CNAC, 4-MOAC, 4-CNAB or a salt thereof, for use in the treatment of a condition treatable by said therapeutically active agent, are provided. The compositions are for concomitant oral administration of two or more of the unit dosage form, which form together a therapeutically effective amount of the therapeutically active agent and an effective amount of the absorption enhancer. Multi-dose compositions comprising the two or more of the unit dosage form are also provided.

Abstract: The present invention is directed to a hemostatic material comprising a compacted, hemostatic aggregates of cellulosic fibers. In some aspects, the hemostatic material further includes additives, such as carboxymethyl cellulose (CMC) or other polysaccharides, calcium salts, anti-infective agents, hemostasis promoting agents, gelatin, collagen, or combinations thereof. In another aspect, the present invention is directed to a method of making the hemostatic materials described above by compacting a cellulosic-based material into hemostatic aggregates. In another aspect, the present invention is directed to a method of treating a wound by applying hemostatic materials described above onto and/or into the wound of a patient.

Abstract: The present disclosure provides a hydrogel tablet for relieving alcoholism and protecting the liver as well as the preparation process and application thereof. The present disclosure firstly provides a composition with the effects of relieving alcoholism and protecting the liver, which comprises the following components on the basis of weight parts: 20˜40 parts of chitosan, 25˜55 parts of sodium alginate, 3˜20 parts of gelatin, 1˜10 parts of calcium carbonate and 0.05˜0.5 parts of gallic acid. Based on this composition, the present disclosure further provides a hydrogel tablet for relieving alcoholism and protecting the liver. In the present disclosure, chitosan, sodium alginate and calcium carbonate are compounded at an appropriate proportion to form powder particles of chitosan/sodium alginate (shell)-calcium carbonate (core), into which are additionally added gelatin and gallic acid to get a product that is the hydrogel tablet.

Abstract: This disclosure relates to pectin-based polymer compositions and methods of use thereof to cover, protect, and seal injuries, e.g., surgical wounds, in a mesothelial tissue. The methods include obtaining a bioadhesive pectin-based polymer composition including a complex of high-methoxyl pectin (HMP) and carboxymethylcellulose (CMC) in a ratio from about 10 to 1 to 1 to 10 by weight; applying the composition to an injured mesothelial tissue; and applying pressure for at least one minute to enable the composition to bind to the mesothelial tissue.

Abstract: Nanocrystals, compositions, and methods that aid particle transport in mucus are provided. In some embodiments, the compositions and methods involve making mucus-penetrating particles (MPP) without any polymeric carriers, or with minimal use of polymeric carriers. The compositions and methods may include, in some embodiments, modifying the surface coatings of particles formed of pharmaceutical agents that have a low water solubility. Such methods and compositions can be used to achieve efficient transport of particles of pharmaceutical agents though mucus barriers in the body for a wide spectrum of applications, including drug delivery, imaging, and diagnostic applications. In certain embodiments, a pharmaceutical composition including such particles is well-suited for administration routes involving the particles passing through a mucosal barrier.

Abstract: This disclosure features methods and compositions for treating diseases of the gastrointestinal tract with a JAK or other kinase inhibitor.

Abstract: The present invention provides a blister package including a sheet in which pockets are formed, and a lid material sealing the sheet, wherein the sheet has a first pocket accommodating an RF tag and a second pocket accommodating an article at a position separated from the first pocket.

Abstract: The disclosure provides new transdermal pharmaceutical compositions comprising 1-(4-fluoro-phenyl)-4-((6bR,10aS)-3-methyl-2,3,6b,9,10,10a-hexahydro-1H,7H-pyrido[3?,4?:4,5]pyrrolo[1,2,3-de]quinoxalin-8-yl)-butan-1-one or 1-(4-fluoro-phenyl)-4-((6bR,10aS)-2,2-d2-3-methyl-2,3,6b,9,10,10a-hexahydro-1H,7H-pyrido[3?,4?:4,5]pyrrolo[1,2,3-de]quinoxalin-8-yl)-butan-1-one or comprising -(4-fluoro-phenyl)-4-((6bR,10aS)-1,1,2,2-d4-3-methyl-2,3,6b,9,10,10a-hexahydro-1H,7H-pyrido[3?,4?:4,5]pyrrolo[1,2,3-de]quinoxalin-8-yl)-butan-1-one, in free base, co-crystal or salt form, together with methods of making and using them.

Abstract: Provided herein are pharmaceutical compositions for oral administration comprising N-(5-(4-(4-((dimethylamino)methyl)-3-phenyl-1H-pyrazol-1-yl)pirimidine-2-ylamino)-4-methoxy-2-morpholinophenyl)acrylamide or a pharmaceutically acceptable salt, hydrate, or solvate thereof as an active ingredient; and a combination of (i) a cellulose derivative and (ii) a sugar or polyol as diluents. The disclosed compositions are characterized by improved manufacturability, while maintaining the pharmaceutical benefits of minimizing the effect according to changes in pH environment in the stomach, possessing excellent stability, and exhibiting good bioavailability.

Abstract: The disclosure provides an oral extended release formulation for the treatment of treatment-resistant depression and treatment-resistant anxiety.

Abstract: There is provided a complex comprising rifaximin and a complexing agent, wherein the complexing agent is a polyvinyl pyrrolidone (PVP) or a cyclodextrin. There is also provided a process for preparing the complex, a pharmaceutical composition including the complex and therapeutic uses of the complex.

Abstract: Provided is packaged medicine capable of inhibiting deterioration of electrodes over a long period of time and reliably transmitting a signal after ingestion even when a long period of time has elapsed since production to ingestion. The packaged medicine includes a solid medicine including drug powder and a micro-device, a container provided with a solid medicine accommodating space accommodating the solid medicine therein, and inert gas encapsulated in the solid medicine accommodating space. The micro-device includes two electrodes with mutually different ionization tendencies and a transmitter operable to transmit a signal using electromotive force generated when the electrodes come in contact with electrolyte.

Abstract: The invention relates to a method for treating insects, comprising the separation of the cuticles from the soft part of the insects, followed by the separation of the soft part of the insects into an oil fraction, a solid fraction and an aqueous fraction. The invention further relates to powders, in particular a powder obtainable by the method of treating insects according to the invention, and to the use of these powders in food.

Abstract: The present disclosure discloses an expectorant compound, and specifically discloses compounds represented by formula I and formula II, pharmaceutically acceptable salts or tautomers thereof.

Abstract: Disclosed are an oral solid dosage form composition comprising an active ingredient and a solubilizing carrier wherein a foaming ingredient is used to improve disintegration, dispersion or dissolution, and a preparation method therefor.

Abstract: The present invention relates to extended release pharmaceutical dosage forms of oxcarbazepine.

Abstract: A cell-penetrating peptide (CPP) comprising a plurality of mono(amino acid)s, oligo(amino acid)s, or poly(amino acid)s where a plurality of the amino acids comprise a positively charged guanylurea unit with a small molecule fragment and each of the mono(amino acid)s, oligo(amino acid)s, or poly(amino acid)s comprising a drug attached through a linker. The CPP can be used for treating cancers.

Abstract: Described herein, in part, are tablets, such as immediate release multi-layer or bilayer tablets for orally delivering olanzapine and samidorphan, methods of using said tablets in the treatment of disorders described herein, and kits comprising said tablets.

Abstract: This invention discloses uses for nicardipine in preparing anti-lung cancer products. This invention provides uses for nicardipine in the preparation of products to treat non-small cell lung cancer. From carrying out cancer drug repositioning for the FDA- and CFDA-approved drug nicardipine, experiments for this invention show, based on screening of non-anti-cancer drugs for various cancer cell lines (tissue types) and mutation sites, that nicardipine has a new use as an anti-small cell lung cancer and/or anti-non small cell lung cancer medication, thus achieving a new purpose for an old drug.

Abstract: Oral dosage forms of metaxalone having improved bioavailability in the fed and fasted states, including dosage forms that employ a reduced dose based on such improved bioavailability.

Abstract: The present invention is directed to a hemostatic material comprising a compacted, hemostatic aggregates of cellulosic fibers. In some aspects, the hemostatic material further includes additives, such as carboxymethyl cellulose (CMC) or other polysaccharides, calcium salts, anti-infective agents, hemostasis promoting agents, gelatin, collagen, or combinations thereof. In another aspect, the present invention is directed to a method of making the hemostatic materials described above by compacting a cellulosic-based material into hemostatic aggregates. In another aspect, the present invention is directed to a method of treating a wound by applying hemostatic materials described above onto and/or into the wound of a patient.

Abstract: A modified release benzonatate solid tablet or capsule is described which comprises a benzonatate adsorbate in a matrix with a sufficient amount of one or more pharmaceutically acceptable modified release pH-independent, substances to provide a modified release profile to the benzonatate, wherein there is substantially no benzonatate release from the tablet or capsule in the buccal cavity and no more than about 25% release of the benzonatate within 1 hour as determined in an in vitro dissolution assay.

Abstract: The disclosure provides for pharmaceutical compositions comprising an alginate salt, such as sodium alginate. The disclosure further provides for processes and methods for making pharmaceutical compositions. In yet a further aspect, the disclosure provides for methods of utilizing a pharmaceutical composition for treatment of acid reflux diseases. In another aspect, the disclosure provides for formulations suitable for oral use in dosage forms of capsules and dry powders.

Abstract: Epileptic seizures are difficult to diagnose and are often difficult to distinguish from several conditions with similar presentations, and therefore, diagnosis of seizures is often a long, expensive, and unreliable process. This invention provides biomarkers for identifying seizures and epilepsy, assays for measuring and assessing biomarker concentration, predictive models based on biomarkers and computational systems for detecting, assessing and diagnosing phasic and tonic changes associated with seizures and epilepsy in all clinical and healthcare settings. Diagnostic and treatment methods, systems, kits, and predictive models provided herein, provide quantitative and/or qualitative assessment in order to allow patients to proceed immediately to diagnostic and/or treatment protocols, and assess therapeutic treatment effectiveness.

Abstract: Nanocrystals, compositions, and methods that aid particle transport in mucus are provided. In some embodiments, the compositions and methods involve making mucus-penetrating particles (MPP) without any polymeric carriers, or with minimal use of polymeric carriers. The compositions and methods may include, in some embodiments, modifying the surface coatings of particles formed of pharmaceutical agents that have a low water solubility. Such methods and compositions can be used to achieve efficient transport of particles of pharmaceutical agents though mucus barriers in the body for a wide spectrum of applications, including drug delivery, imaging, and diagnostic applications. In certain embodiments, a pharmaceutical composition including such particles is well-suited for administration routes involving the particles passing through a mucosal barrier.

Abstract: This disclosure features methods and compositions for treating diseases of the gastrointestinal tract with a JAK inhibitor.

Abstract: The present disclosure relates to pharmaceutical compositions, including dosage forms, such as tablets or capsules, comprising venglustat, in free base, or pharmaceutically acceptable salt form, a diluent/filler and a lubricant, optionally in combination with one or more additional therapeutic agents, to processes for manufacture thereof, and to methods of use in the treatment or prevention of disease.

Abstract: The present disclosure relates generally to bilayer tablets comprising a combination of two active pharmaceutical ingredients, and more specifically to bilayer tablets comprising acetylsalicylic acid, pseudoephedrine, and a dissolution aid. The bilayer tablets utilize a combination of granulated and non-granulated acetylsalicylic acid along with a unique distribution of sodium carbonate as a dissolution aid that provide acetylsalicylic acid and pseudoephedrine in a single dosage form having rapid dissolution and long-term storage stability (low degradation). The present disclosure also provides methods of preparing and of using the bilayer tablets.

Abstract: A novel orally administrable dosage form including a drug/active layer for loading a therapeutic agent and an extension layer for retaining the API or drug dosage form in the stomach of a subject in need thereof. Also disclosed is a method of treating diseases with the dosage form.

Abstract: The present invention relates to stabilization of a certain benzothia(dia)zepine derivative in a solid formulation containing the same. In the present invention, in a solid formulation containing the benzothia(dia)zepine derivative mentioned above, a combination of polyethylene glycol and polyvinyl alcohol is not blended, or alternatively, in the case of blending polyethylene glycol and polyvinyl alcohol in the solid formulation, the aforementioned derivative is isolated from the combination of polyethylene glycol and polyvinyl alcohol.

Abstract: Disclosed herein are methods for obtaining N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N-(4-(2-methylpropyloxy)phenylmethyl) carbamide (pimavanserin) comprising the step of contacting an intermediate according to Formula (A) or a salt thereof, with an intermediate Formula B, or a salt thereof, to produce pimavanserin or a salt thereof wherein Y is —ORi or —NR2aR2b; R3 is hydrogen or substituted or unsubstituted heteroalicyclyl, R4 is substituted or unsubstituted aralkyl; X is —OR22 or —NR23R24; (wherein R22 is hydrogen or substituted or unsubstituted C1-6alkyl and one of R23 and R24 is hydrogen and the other is hydrogen or N-methylpiperidin-4-yl); and R21 is —OCH2CH(CH3)2 or F; Also disclosed herein is the tartrate salt of N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N?-(4-(2-methylpropyloxy)phenylmethyl) carbamide and methods for obtaining the salt.

Abstract: The porous-cellulose particles according to the present invention are constituted by gathered crystalline celluloses having a type I crystal form including a glucose molecule as a constitutional unit. That is, porous-cellulose particles having high sphericity have been achieved from a natural raw material. The porous-cellulose particles have an average particle diameter of 0.5 to less than 50 ?m, a specific surface area of 50 to 1000 m2/g, and a sphericity of 0.85 or more. Cosmetic products containing such porous-cellulose particles have excellent texture properties.

Abstract: This present invention relates to a method for making a two-layered product (3) comprising a hydrophilic first material (1) made from electrospun fibers connected to a hydrophobic second material (2) made from electrospun fibers, and wherein said first material (1) contains a drug substance, characterized in that —said method comprises using a press (5) comprising a first surface (100) and a second surface (200), and wherein said second surface (200) has a temperature being higher than the temperature of said first surface (100), —said first (1) and second material (2) being arranged in a layered combination between the first (100) and second surface (200) of the press (5), wherein a pressure is provided towards said layered combination from said first (100) and second surface (200) of said press (5), and whereby said first material (1) comes into contact with said first surface (100) of said press (5), —wherein the combination of pressure between the first (100) and second surface (200) and the temperature o

Abstract: Preparations and formulations capable of crossing and incorporating into a membrane of a cell or an organelle or an exosome are described. Methods of treatments utilizing the preparations and formulations are also described.

Abstract: Provided herein are methods and compositions for modulating a microorganism's response to an antimicrobial agent. In one embodiment, the method comprises contacting the microorganism with an antimicrobial agent and bicarbonate. In one embodiment, provided herein are methods for treating a microbial infection comprising administering to a subject in need an effective amount of (i) bicarbonate and (ii) an antimicrobial agent. Also provided herein are methods of screening for antimicrobial compounds.

Abstract: The disclosure is directed to medroxyprogesterone compositions suitable for subcutaneous injection comprising about 260 mg/ml to 440 mg/ml medroxyprogesterone acetate, about 0.6 mg/ml to 1.5 mg/ml docusate sodium and, polyethylene glycol. Methods of using these compositions are also described.

Abstract: Methods and compositions for treating a lysosomal movement associated disease in an animal, in which the position of lysosomes can influence disease progression, comprising administering an effective amount of a first lysosome migration inhibitor or a pharmaceutically acceptable salt, solvate, clathrate, stereoisomer, enantiomer or prodrug thereof.

Abstract: A composition and method of treatment in a subject, whereby the subject is administered via the oral mucosa a rapidly infusing composition that includes (a) a pharmaceutically acceptable binder and/or excipient system containing gelatin and mannitol, and (b) a therapeutically effective amount of an active therapeutic ingredient (ATI). Preferably, a composition and method of treating pain in a subject, whereby the subject is administered via the oral mucosa a rapidly infusing composition that includes (a) a pharmaceutically acceptable binder and/or excipient system containing gelatin and mannitol, and (b) a therapeutically effective amount cannabidiol (CBD).

Abstract: Microbiota restoration therapy (MRT) compositions (e.g., oral MRT compositions) and methods for manufacturing MRT compositions are disclosed. An example method for manufacturing an MRT composition may include collecting a stool sample, purifying the stool sample to form a purified sample, stabilizing the purified sample to form a stabilized sample, converting the stabilized sample to a solid, adding one or more additives and/or excipients to the solid to form a treatment composition, and encapsulating the treatment composition.

Abstract: Embodiments of the invention provide swallowable devices, preparations and methods for delivering drugs and other therapeutic agents within the GI tract. Many embodiments provide a swallowable device for delivering the agents. Particular embodiments provide a swallowable device such as a capsule for delivering drugs into the intestinal wall or other GI lumen. Embodiments also provide various drug preparations that are configured to be contained within the capsule, advanced from the capsule into the intestinal wall and degrade to release the drug into the bloodstream to produce a therapeutic effect. 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 intestinal wall. Embodiments of the invention are particularly useful for the delivery of drugs which are poorly absorbed, tolerated and/or degraded within the GI tract.

Abstract: A product and process of manufacturing an edible soft-chewable dosage form for the delivery of pharmaceutically active ingredients or nutritional agents orally to an animal or human subject, by forming a granulated soft-chew mass by appropriate mixing and sifting steps, and forming tablets with a compression press. Such soft-chew dosage forms have hardness of less than about two kilopond (2 kp) and friability of less than about one percent (1%) at three-hundred (300) rotations when measured according to the United States Pharmacopeia (USP) test. The process for manufacturing such compressed soft-chew tablets employs compression (tablet) pressing equipment to produce soft-chew tablets of consistent weight and texture.

Abstract: An oral methylphenidate extended release tablet is described, which can be scored and still retain its extended release profile. The tablet contains a combination of an uncoated methylphenidate-ion exchange resin complex, a barrier coated methylphenidate-ion exchange resin complex-matrix, and an uncomplexed methylphenidate active component. Following administration of a single dose of the extended release methylphenidate chewable tablet, a therapeutically effective amount of methylphenidate is reached in less than about 20 minutes and the composition provides a twelve-hour extended release profile.

Abstract: The present disclosure relates to a dry process for preparing a solid pharmaceutical dosage form of vitamin K1 comprising: a) blending vitamin K1 with a first diluent under a first set of pre-determined conditions to obtain a first mixture; b) contacting the first mixture with a second diluent under a second set of pre-determined conditions to obtain a second mixture; c) mixing the second mixture with the excipients selected from a group consisting of disintegrant, lubricant and glidant under a third set of pre-determined conditions to obtain a third mixture; and d) compressing or encapsulating the third mixture to obtain the solid pharmaceutical dosage form of vitamin K1.

Abstract: This disclosure features methods and compositions for treating diseases of the gastrointestinal tract with IL-10 or an IL-10 agonist.