Abstract: The present disclosure provides extended release trihexyphenidyl compositions suitable for once- or twice-daily administration. The compositions comprise a core comprising organic acid that is coated with at least one drug layer comprising trihexyphenidyl hydrochloride, and a functional coat over the drug-layered core. The extended release compositions of the disclosure provide reduced Cmax, a Cmin:Cmax ratio of ?0.4, and extended release, while maintaining therapeutically effective concentration, of trihexyphenidyl for at least about 16 hours. The compositions of the disclosure improve solubility of trihexyphenidyl hydrochloride, at a pH of greater than or equal to 5, to maintain its minimum effective concentration at such pH.

Abstract: A sustained-release preparation containing pseudoephedrine is provided comprising pseudoephedrine or a pharmaceutically acceptable salt thereof, and a hardened oil or stearic acid. The sustained-release preparation containing pseudoephedrine may contain a hardened oil or stearic acid in an amount of 100% by mass to 500% by mass with respect to the content of the pseudoephedrine or a pharmaceutically acceptable salt thereof. In addition, the sustained-release preparation containing pseudoephedrine may have a first part and a second part, the first part may contain the pseudoephedrine or a pharmaceutically acceptable salt thereof, and the first part or the second part may contain an optional active ingredient.

Abstract: The invention relates to a pharmaceutical dosage form which is particularly useful for the prevention of an overdose of the pharmacologically active ingredient contained therein after accidental or intentional simultaneous administration of a plurality of the dosage forms containing an overall supratherapeutic dose of the pharmacologically active ingredient.

Abstract: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile, or a pharmaceutically acceptable salt, amorphous form, polymorph form, or pharmaceutical composition (including solid formulations or liquid formulations) thereof and the use thereof for treating diseases and disorders which can be treated with a RET kinase inhibitor, such as RET-associated diseases and disorders, e.g., proliferative disorders such as cancers, including hematological cancers and solid tumors, and gastrointestinal disorders such as IBS are disclosed.

Abstract: Disclosed is a method of preparing a product composition comprising steps of: Preparing a mixture composition comprising a surfactant and a high melting point fatty compound and benefit agent; Separately preparing an aqueous base composition comprising an aqueous carrier and water soluble polymer, wherein the base composition is substantially free of a detersive surfactant selected from anionic surfactants, zwitterionic surfactant, amphoteric surfactant, and combinations thereof; Mixing the mixture composition and the aqueous base composition to form a discrete particle of the mixture composition dispersed in the aqueous base composition. Alternatively, the method comprises steps of preparing a discrete particle of the mixture composition; and mixing it with the aqueous composition.

Abstract: The present disclosure discloses trehalose for use in treatment of neurological disorders, wherein the trehalose is for a single daily administration with the daily dose between about 0.25 to about 12.5 g/kg/day. The daily dose may be about 2.67 g/kg/day. A method for treating a neurological disorders is disclosed which involves administering trehalose to a subject as a single daily administration with a daily dose between about 0.25 to about 12.5 g/kg/day and in an embodiment of this method the daily dose is about 2.67 g/kg/day. Also disclosed herein is the use of trehalose in the manufacture of a medicament for treatment of neurological disorders, wherein the trehalose is formulated as a single daily dose with the trehalose present in the medicament in an amount of between about 0.25 to about 12.5 g/kg/day. In an embodiment the daily dose is about 2.67 g/kg/day.

Abstract: The present invention relates to an immediate release formulation of pharmaceutical compounds.

Abstract: The invention relates to a tamper-resistant tablet comprising (i) a matrix material in an amount of more than one third of the total weight of the tablet; and (ii) a plurality of particulates in an amount of less than two thirds of the total weight of the tablet; wherein said particulates comprise a pharmacologically active compound and a polyalkylene oxide; and form a discontinuous phase within the matrix material; and method of using said tablet to treat pain and other conditions.

Abstract: An abuse resistant oral pharmaceutical composition, comprising: a barrier layer, comprising a first polymer; a diffusion layer, comprising a second polymer, substantially covering the barrier layer, wherein the diffusion layer is bonded to the barrier layer and comprises a drug that is substantially homogeneously distributed within the second polymer and diffuses from the diffusion layer within the gastrointestinal (GI) tract; and optionally an expansion layer comprising an expandable polymer, wherein the expansion layer is substantially covered by the barrier layer. Methods of making the same and methods of using the same are also provided.

Abstract: Provided are a metformin hydrochloride osmotic pump tablet and a preparation method therefor. According to the preparation method, a hetero-type stamping-prepared metformin hydrochloride tablet core is used, and a controlled-release coating is wrapped outside the stamped metformin hydrochloride tablet core, such that the metformin hydrochloride osmotic pump tablet is prepared.

Abstract: Described are solid dispersions of hydrophobic active ingredients and cationic copolymers of N,N-diethylaminoethyl methacrylate and methyl methacrylate in a weight ratio of the monomers of from 35:65 to 55:45. Also described are the preparation and use of such solid dispersions for pharmaceutical dosage forms.

Abstract: The present disclosure relates to pharmaceutically acceptable complex formulae comprising complexes of Abiraterone acetate and pharmaceutically acceptable excipients, process for the preparation thereof and pharmaceutical compositions containing them. The complex formulae of the present disclosure have improved physicochemical properties which results in reduced food effect which allows significant dose reduction and the abandoning of the requirement of taking the drug on an empty stomach.

Abstract: Provided is a pharmaceutical composition for oral administration, including (a) a taxane, (b) a medium chain triglyceride, (c) an oleoyl glycerol complex having 30 to 65% by weight of monooleoyl glycerol contents; 15 to 50% by weight of dioleoyl glycerol contents; and 2 to 20% by weight of trioleoyl glycerol contents, (d) a surfactant, and optionally (e) polyoxyl glyceryl fatty acid ester and a process for preparing the same.

Abstract: The present invention relates to an oral sustained-release triple layer tablet, more particularly, a triple layer tablet consisting of an inner immediate-release layer containing a pharmaceutically active ingredient and two outer layers containing swellable polymers. Upon exposure to aqueous media, the two outer layers swell to form gelled layers surrounding the lateral side of the inner layer rapidly, thereby control effectively the release of the pharmaceutically active ingredient from the inner immediate-release layer.

Abstract: A method for drying to increase the useful life of botanicals and shorten the time to market after harvest of the botanicals. The method may include flash freezing the botanicals, at a desired optimal temperature range, soon after harvest. The method may include storing the frozen botanicals indefinitely prior to drying. The method may include drying the frozen botanicals using a lyophilizer at a desired optimal temperature and pressure.

Abstract: A method for producing powderized cannabis oil, and the resulting powderized cannabis oil, in which concentrated cannabis oil is mixed with and absorbed by a modified starch powder, preferably maltodextrin, in a ratio of at least three grams of starch powder for every one-eighth of a gram of cannabis oil is disclosed. Further disclosed are beverages, baked goods and single-serve beverage brewing cartridges utilizing or incorporating the powderized cannabis oil to create human-consumable products that contain an emulsified, tasteless, and odorless dose of cannabis oil.

Abstract: Extended release, abuse deterrent dosage forms comprising crush-resistant controlled-release particles that provide abuse deterrent properties to the dosage forms. The crush-resistant controlled-release particles, which comprise plastic/elastic polymers and at least one active pharmaceutical ingredient (API) or a pharmaceutically acceptable salt thereof, are prepared by a hot melt extrusion process.

Abstract: The present invention relates to a solid composition and an aqueous dispersion comprising nanoparticles of the anti-retroviral drug lopinavir. The solid composition and aqueous dispersion additionally comprise a mixture of a hydrophilic polymer and a surfactant. The surfactant is selected from vitamin-E-polyethylene glycol-succinate (Vit-E-PEG-succinate), a polyoxyethylene sorbitan fatty acid ester, N-alkyldimethylbenzylammonium chloride, sodium deoxycholate, dioctyl sodium sulfosuccinate, polyethyleneglycol-12-hydroxystearate, polyvinyl alcohol (PVA), and a block copolymer of polyoxyethylene and polyoxypropylene, or a combination thereof. The hydrophilic polymer is suitably selected from polyvinyl alcohol (PVA), a polyvinyl alcohol-polyethylene glycol graft copolymer, a block copolymer of polyoxyethylene and polyoxypropylene, polyethylene glycol, hydroxypropyl methyl cellulose (HPMC), and polyvinylpyrrolidone, or a combination thereof.

Abstract: The invention pertains to methods that include administering to a subject a transoral dosage form comprising a pharmaceutical carrier and sufentanil, and maintaining a mean pH ranging from about 3.5 to about 5.5 during a dosing period after administration of the transoral dosage form as determined using an in vitro donor media test. Related dosage forms are also disclosed. Also disclosed are transoral dosage forms and related methods, wherein a transoral dosage form may comprise: (1) about 5 to about 1000 micrograms of sufentanil; (2) about 50 micrograms to about 100 milligrams of naloxone; and (3) acidifying material in an amount sufficient to provide a mean pH ranging from about 3.5 to about 5.

Abstract: Disclosed herein are treatments for diseases such as sleep apnea, hyperuricemia, autistic spectrum disorder (ASD) and other brain disorders using controlled-release (CR, e.g., extended-release (ER) or prolonged-release (PR)) oral dosage formulations comprising an effective amount of Torsemide.

Abstract: There is described, inter alia, a coated bead comprising: (a) a granule; (b) a first layer coated over the granule, the first layer comprising a first amount of an active pharmaceutical ingredient comprising a central nervous system stimulant; and (c) a second layer coated over the first layer, the second layer being present in an amount sufficient to substantially delay release of the active pharmaceutical ingredient in the first layer until after the coated bead reaches a distal intestine portion of a subject to whom the coated bead is administered; and (d) the third layer coated over the second layer, the third layer comprising a second amount of the active pharmaceutical ingredient, the third layer being configured to permit substantially immediate release of the active pharmaceutical ingredient comprised therein. Embodiments related to a solid oral pharmaceutical composition are also described.

Abstract: The present invention provides a pharmaceutical formulation for oral administration comprising an agonist of two or more of the 5-HT1B, 5-HT1D and 5-HT1F receptors, such as a triptan, e.g. zolmitriptan, in a matrix constituent with extended release characteristics, and further comprising a 5-HT1A-R agonist, such as buspirone, in a constituent with immediate-release characteristics. The special formulation is particularly well-suited for use in the treatment of movement disorders by combining the two active ingredients in a manner that achieves synergy from both the combination per se and the special release parameters of the pharmaceutical formulation, allowing for ease of administration and reducing the risk of adverse effects of each of the two active ingredients.

Abstract: Provided are solid oral/per os formulations that include a single cannabinoid, combination of cannabinoids, cannabis extract and combination of cannabis plant constituents. Also provided are methods of making the formulations, as well as therapeutic applications in the treatment and alleviation of various human disorders and/or conditions.

Abstract: An oral formulation, and preparation method and use thereof; the oral formulation comprises 1-50 parts by weight of an A-nor-5a-androstane compound, 20-95 parts by weight of a filling agent, 0-20 parts by weight of a disintegrant, 0.1-30 parts by weight of a binder, 0.1-5 parts by weight of a lubricant and 0.1-5 parts by weight of a glidant. The oral formulation has a high stability and a good dissolution performance.

Abstract: The present invention relates to a tablet comprising Afatinib or a pharmaceutically acceptable salt thereof, wherein the tablet is obtained by direct compression. The present invention further relates to a process for manufacturing a tablet of the invention as well as the use of the tablet of the invention.

Abstract: The present invention provides extended release pharmaceutical compositions structured for once a day administration comprising skeletal muscle relaxant such as cyclobenzaprine or its pharmaceutically acceptable salt thereof that extends the release of the drug under in-vitro conditions for at least 8 to 12 hours. The invention also provides process for the preparation of such structured compositions.

Abstract: Compositions, systems and methods for administration of small volume sufentanil drug dosage forms to the sublingual mucosa of a subject for treatment of pain using a device are disclosed.

Abstract: Provided herein are high strength/high drug load tablets comprising 2-hydroxy-6-((2-(1-isopropyl-1H-pyrazol-5-yl)pyridin-3-yl)methoxy)benzaldehyde (“Compound 1”), dispersible tablets comprising Compound 1, processes of manufacturing such tablets, and methods for treating patients with the tablets. Compound 1 is useful for treating hematological disorders such as sickle cell disease, pulmonary disease such as idiopathic pulmonary fibrosis, and hypoxia and hypoxemia conditions.

Abstract: The present invention relates to a high adhesion dermal therapeutic system comprising an adhesive polymeric matrix with a salt of Diclofenac.

Abstract: The invention relates to a dosage form that is suitable for releasing an active ingredient over a long period of time. For this purpose, the active ingredient is released in two-stages in order to do away with an excessively frequent ingestion of the dosage form. The dosage forms according to the invention are for treating dizziness in humans. They are administered with or after a meal. The concept according to the invention provides that the pharmaceutical form has a dimensionally stable portion which, after ingestion of the dosage form by the patients, does not dissolve in the chyme-filled stomach for a number of hours. In this way, this dimensionally stable portion remains in the stomach until same is evacuated by the so-called “housekeeper waves”. Another portion of the dosage form is formed in such a way that it dissolves within a short time of the patients ingesting same. In this way, a quick invasion of the active ingredient with corresponding plasma levels is ensured.

Abstract: The present invention provides a composition exhibiting delayed transit through the gastrointestinal tract comprising one or more active agents, fenugreek fiber and at least one pharmaceutically acceptable excipient. The present invention further relates to gastroretentive dosage forms comprising fenugreek fibers.

Abstract: Provided are a solid composite formulation for oral administration, the solid composite formulation including: an ezetimibe granules-part including ezetimibe, said ezetimibe having a particle size distribution wherein the average particle size d(0.9) for the bottom 90% is about 10 ?m or less; and a rosuvastatin mixture-part including rosuvastatin or a pharmaceutically acceptable salt thereof, and a method of preparing the composite formulation.

Abstract: Pharmaceutical formulation in the form of agglomerates comprising A) an excipient content composed of a) 60-97% by weight of sugar or sugar alcohols, b) 1-25% by weight of a disintegrant, c) 1-15% by weight of water-insoluble, film-forming polymers d) 0-15% by weight of water-soluble polymers and e) 0-15% by weight of further pharmaceutically customary excipients the total of the components a) to e) being 100% by weight, and B) at least one active ingredient.

Abstract: Disclosed are a ferroporphyrin solid dispersion, preparation method therefor and a pharmaceutical composition comprising the solid dispersion, wherein the weight ratio of ferroporphyrin to the carrier material in the dispersion is 1:1-1:10. The solid dispersion of the present invention masks the undesirable taste of ferroporphyrin, ameliorates irritation thereof to the digestive tract, and at the same time increases the solubility thereof and improves the bioavailability thereof.

Abstract: The presently disclosed subject matter is directed to a granule, wherein the granule has an active agent and a wax dispersed therein, and the granule exhibits excellent friability when compressed to form a pharmaceutical composition. The subject matter disclosed herein is also directed to methods of preparing the granules and the pharmaceutical compositions comprising the granules. The compositions and methods disclosed provide granules and pharmaceutical compositions for immediate release of the active agent and do not substantially prolong the release of the active agent from the granule.

Abstract: The present invention relates to oral pharmaceutical compositions comprising nitisinone, or a pharmaceutically acceptable salt thereof, their use in the treatment of tyrosinemia, such as Hereditary Tyrosinemia type-1 (HT-1), or alkaptonuria. The compositions have improved stability characteristics. The invention also relates to processes for producing nitisinone.

Abstract: The present invention relates to non-stoichiometric crystalline hydrates of 1-(?-D-glucopyranosyl)-4-methyl-3-[5-(4-fluorophenyl)-2-thienylmethyl]benzene, processes for their preparation, and their use as medicaments. In addition the present invention relates to pharmaceutical compositions comprising an effective amount of the novel crystalline hydrates.

Abstract: A bacteria starter material for use in biomass generators without causing jamming of the feeder mechanism, particularly under high temperature and/or high humidity conditions, the starter material comprising one or more species of waste-decomposing bacteria, sucrose, and a soy based protein. Preferably, DI-PAC® sugar (sucrose and maltodextrin) and powdered KIKKOMAN® Soy Sauce are used as the sugar and protein ingredients. The starter material may also comprise a dried bran culture comprising Pseudomonas. The starter material ingredients are blended together and formed into a tablet or pellet having a particular shape, size, and hardness characteristics suitable for use in the feeder mechanism of a biomass generator.

Abstract: An oral pharmaceutical composition comprising a drug and one or more pharmaceutically acceptable excipients in a monolithic dosage form, wherein the dosage form is configured such that when the dosage form is divided into more than one piece and at least one of the pieces is administered to a subject the Cmax, AUC, and/or rate of drug released after administration is substantially the same or lower and the Tmax is higher than the Cmax, AUC, rate of drug released, and/or Tmax after administration of: (1) a comparable composition in intact dosage form of equal drug dosage of the administered at least one piece; (2) a bioequivalent drug composition in an intact dosage form of equal drug dosage to the administered at least one piece; and (3) a divided piece of a bioequivalent drug composition, wherein the divided piece comprises a drug dosage equal to the dosage of the administered piece of the oral composition. Methods of making the same and methods of using the same are also provided.

Abstract: The present invention provides controlled release dosage formulations of compounds having the Formula: or pharmaceutically acceptable salts thereof, and in particular, aplindore. The dosage forms are useful, inter alia, for reducing side effects from administration of such compounds.

Abstract: A wiping composition and a wiping product containing the composition are disclosed. The wiping composition contains a combination of an antimicrobial agent with a preservative enhancing agent that not only provides antiseptic properties when applied to an adjacent surface, but also is well suited to preserving the substrate that is used to apply the composition. In particular, the composition has been unexpectedly found to inhibit or destroy bacteria, particularly Burkholderia cepacia, even when the active ingredients are used at extremely low levels.

Abstract: The disclosure provides for improved pharmaceutical compositions containing deferasirox (DFX) and methods of manufacturing the same. In particular, the compositions are prepared using thermokinetic compounding and provide improved properties as well as more efficient methods of manufacture.

Abstract: Disclosed is a multilayer solid pharmaceutical dosage form, wherein a core containing an active ingredient is coated with a first sustained-release coating layer, a drug layer containing the active ingredient is applied onto the first layer, and a second sustained-release coating layer is applied onto the drug layer.

Abstract: The present invention is directed to film coating compositions for use on oral dosage forms such as compressed tablets and other orally-ingestible substrates which contain a water-soluble polymer and guar gum. The film coating compositions can be applied either directly to a substrate or after the substrate has been coated with a subcoat. In preferred aspects, the water-soluble polymer is a cellulosic or vinyl polymer. Aqueous suspensions containing the inventive film coating compositions and the coated substrates themselves are also disclosed. The resulting coated substrates have relatively low coefficients of static and dynamic friction on wet surfaces rendering them easier to swallow than prior art compositions.

Abstract: Delivery of a drug is controlled to impart a delay before release after administration by formulating the drug with a disruption agent to provide a core, and coating the core with a regulatory membrane comprising a water-soluble gel-forming polymer and a water-insoluble film-forming polymer.

Abstract: Pharmaceutical preparations include at least one component that enhances sexual response and at least one other compound that enhances sexual sensitivity and pleasure. The component that enhances sexual response enhances blood flow to the genital region. Examples include compounds that dilate blood vessels, such as compounds that increase the amount of nitric oxide (NO) in the blood. The component that enhances sexual sensitivity and pleasure includes one or more cannabinoid compounds from the plant genus Cannabis, including extracted compounds, synthetic forms, and derivatives thereof. Examples include tetrahydrocannabinol (THC), the main psychoactive constituent of Cannabis, and cannabidiol (CBD), which is less or non-psychoactive and modulates THC activity. The ratio of THC/CBD can be selected depending on age, gender, physical health, and/or psychological condition of the user.

Abstract: The present invention discloses multiple approaches to preventing the capsule walls and other material from interfering with the performance of an electronic device once the device is activated by surrounding fluid. In accordance with the teachings of the present invention, a miniature ingestible device (MID) may be created using excipients and films. The MID, in accordance with various aspects of the present invention, will have a coating or laminating surrounding an electronic device and separating and isolating the device from the pharmaceutical product or drug within the capsule once the capsule is ingested as well as from the capsule itself as the capsule walls begin to collapse during the disintegration process.

Abstract: Described herein are controlled release oral pharmaceutical compositions for delivering active pharmaceutical ingredients to the colon and methods for making the same. In particular, an oral pharmaceutical composition comprising a soft capsule and a controlled release matrix for delivering active pharmaceutical ingredients to the colon are described.

Abstract: An excipient composition having good bulk density and improved flow characteristics is provided. The present invention particularly provides a coprocessed excipient composition and a method of producing the same. The coprocessed excipient comprises cellulose derived polymer and a deagglomerated coprocessing agent. The coprocessing agent is fumed silica, colloidal silica or silicon dioxide. The coprocessed excipient is prepared in a continuous process and has excellent compactability and improved flow property as measured by Johanson flow rate number increase from 1.1 to 5.0 fold, is characterized by a Brookfield cohesion factor of less than 0.2 kPa and a bulk density of at least 0.249 g/ml.

Abstract: The present invention is directed to an excipient which can be used to manufacture tablets containing oily active ingredients such as oily drugs, and pharmaceutical compositions containing the same.