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: 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: 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: 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.

Abstract: A thermogenic cannabis composition for oral administration, including cannabis extract and at least one thermogenic agent, and method of producing same.

Abstract: The invention discloses taste masking formulations for bitter natural compounds, selected from the extracts, fraction and pure phytochemicals produced in combination with a synthetic polymer or a natural polymer. The invention also relates to the novel process of producing the taste masking formulations. The invention also relates to taste masking formulations of Bacopa extracts with no bitter taste or negligible bitter taste in combination with synthetic polymers such as Eudragit or natural polymers such as Shellac.

Abstract: A dosage form comprising a tablet core and one or more discontinuous coated regions in various configurations on the surface of the dosage form is disclosed. A method for making the dosage form is also disclosed.

Abstract: Provided herein is an amorphous compound represented by Formula (I): and compositions thereof, which are useful in the treatment of disorders related to the activity of the c-KIT and PDGFR? kinases, and oncogenic forms thereof.

Abstract: Embodiments herein include implantable medical devices including chemical sensors with bioerodible masking layers to allow for staged activation of the sensors. In an embodiment, an implantable medical device includes a substrate defining wells and a first chemical sensor and a second chemical sensor disposed within separate wells of the substrate. The first chemical sensor and the second chemical sensor can be configured to detect one or more analytes. The device can include a first bioerodible masking layer disposed over the second chemical sensor, sealing off the second chemical sensor. The device can further include a protective planarization layer disposed over at least one of the first chemical sensor and the second chemical sensor such that the outermost surface of the medical device over the first sensor is flush with the outermost surface of the medical device over the second sensor. Other embodiments are also included herein.

Abstract: Amorphous solid dispersions and pharmaceutical compositions of the protein kinase inhibitor nilotinib. The pharmaceutical compositions may be used in methods of treating a proliferative disorder such as cancer. In particular, the present disclosure provides a pharmaceutical composition in the form of an orally disintegrating tablet. In some embodiments, the pharmaceutical compositions can be administered without regard to food consumption. In other embodiments, the pharmaceutical compositions can be administered at a significantly lower dose as compared to a commercially available immediate-release nilotinib formulation, while providing a comparable therapeutic effect.

Abstract: A laundry care composition comprises a laundry care ingredient or adjunct and at least one compound that is capable of changing from a first color state (i.e., the initial color state in the composition) to a second color state that is perceptibly different from the first color state. A method for treating textile articles comprises the steps of: (a) providing a laundry care composition as described above; (b) adding the laundry care composition to a liquid medium; and (c) placing the textile articles in the liquid medium.

Abstract: Multiparticulate compositions including an active agent and a gelling agent are disclosed. The multiparticulate compositions are prepared by an aqueous-based spray and congeal process.

Abstract: The invention pertains to dispersible tablets comprising as active ingredient N-{3-[5-(2-Amino-4-pyrimidinyl)-2-(1,1-dimethylethyl)-1,3-thiazol-4-yl]-2-fluorophenyl}-2,6-difluorobenzenesulfonamide, methanesulfonate salt, processes for preparing the same, and processes for using the same.

Abstract: Compositions and kits for oral administration of a phosphodiesterase-4 (PDE4) inhibitor and one or more additional active agents that reduces or eliminates a side effect associated with the PDE4 inhibitor are provided. Also provided are methods for use of these compositions and kits for treating conditions treatable with a PDE4 inhibitor therapy and for increasing patient compliance with treatment with PDE4 inhibitors.

Abstract: The present invention relates to the technical field of medicine and relates to an instant release pharmaceutical preparation of an anticoagulant and a preparation method therefor. The instant release pharmaceutical preparation of an anticoagulant comprises a vicagrel compound or a pharmaceutically acceptable form thereof, the preparation is a tablet or a capsule, the vicagrel or the pharmaceutically acceptable form thereof is provided at a suitable particle size, and the D90 thereof <50 ?m. With regard to the drug-containing particles obtained by the present invention, a pharmaceutical preparation formed therefrom exhibits rapid release characteristics in an in vitro dissolution test and exhibits considerable advantages in pharmacokinetics in vivo, showing a greater degree (AUC) and rate (Cmax) of drug absorption.

Abstract: The present invention relates to a process of producing a nano Omega-3 microemulsion system includes: (i) preparing a dispersal phase by heating Omega-3; (ii) preparing a carrier by heating a liquid PEG (polyethylene glycol); (iii) adding the carrier to the dispersal phase; (iv) emulsifying as follows: when the temperature arrives at 60° C., adding ACRYSOL K-140 to the mixture of the carrier and dispersal phase in step (iii), continuing to stir at a speed of 500 to 700 rpm, at a temperature of 60 to 80° C., in vacuum, for 3 to 5 hours, controlling the quality of resulting product by dissolving into water and measuring the transparency, the reaction is quenched, the temperature is decreased slowly until it is in the range of 40 to 60° C.; emulsifying for the entire mixture for 30 minutes; (v) filtrating the product by injecting through nanofilter system before filling-packaging.

Abstract: Provided herein are capsules containing pimavanserin, processes for manufacturing said capsule, and pharmaceutical compositions containing pimavanserin.

Abstract: A process for the preparation of oral delayed release solid formulations and the formulations obtainable from said process are now described. Said process comprises the following steps: a) melting at least one lipid; b) spraying said at least one melted lipid on at least one active ingredient in the form of a moving powder; c) cooling the resulting mixture; d) optional granulation of the mixture; e) optional compression of the mixture.

Abstract: The invention relates to a scored tablet (1) comprising a convex upper face (2), an at least partially concave lower face (3) and a side wall (4) extending between the upper and lower faces; two score grooves (5, 6) are formed in the concave lower face, said grooves being perpendicular to one another and continuous with score slits (8, 9, 10, 11) located in the side wall.

Abstract: The present invention relates to a solid pharmaceutical formulation comprising misoprostol or a pharmaceutically acceptable salt thereof. In particular, the invention relates to a dispersible tablet comprising misoprostol or a pharmaceutically acceptable salt thereof.

Abstract: A three-dimensional printing system and equipment assembly for the manufacture of three-dimensionally printed articles is provided. The equipment assembly includes a three-dimensional printing build system, an optional liquid removal system and an optional harvester system. The build system includes a conveyor, plural build modules and at least one build station having a powder-layering system and a printing system. The equipment assembly can be used to manufacture pharmaceutical, medical, and non-pharmaceutical/non-medical objects. It can be used to prepare single or multiple articles.

Abstract: The present invention relates to an injectable pre-formulation comprising: a) at least one of a mono-, di-, or tri-acyl lipid and/or a tocopherol; b) optionally at least one phospholipid; c) at least one biocompatible, organic solvent; and d) at least one prostacyclin analogue or a salt thereof; wherein the pre-formulation forms, or is capable of forming, at least one liquid crystalline phase structure upon contact with excess aqueous fluid. Such compositions may additionally comprise polar co-solvents. Methods of treatment, particularly for management of pulmonary artery hypertension (PAH), severe PAH, Raynard's disease, ischemia and related conditions are provided, as well as corresponding uses of the compositions. Administration devices comprising the formulations and kits comprising the devices are also provided.

Abstract: The present invention relates to a pharmaceutical composition comprising a) a therapeutically effective amount of a compound of formula (I), or a pharmaceutically acceptable salt thereof, b) one or more, e.g. 1, 2 or 3, surfactants with lubricant properties; c) one or more, e.g. 1, 2 or 3, dry binders with disintegrant properties; d) one or more, e.g. 1, 2 or 3, fillers, and e) one or more, e.g. 1, 2 or 3, disintegrants.

Abstract: The invention relates to pharmaceutical compositions comprising calcium lactate as an active agent and a polysaccharide, polymer, lipid, or a combination thereof. The pharmaceutical compositions are useful treating cancer. The invention also relates to foods and nutrient compositions comprising calcium lactate.

Abstract: A method of treating a subject suffering from mental disorder including the step of administering an effective amount of a cholecystokinin-2 receptor antagonist or a pharmaceutical acceptable salt thereof to the subject. A method of treating a subject suffering from pain associated with nerve injury including the step of administering an effective amount of a cholecystokinin-2 receptor antagonist or a pharmaceutical acceptable salt thereof to the subject. A pharmaceutical composition including the cholecystokinin-2 receptor antagonist or a pharmaceutical acceptable salt thereof as active ingredient, one or more antidepressant compounds, and a pharmaceutically acceptable excipient.

Abstract: The present invention relates to a stable orally disintegrating pharmaceutical formulation comprising imatinib or a pharmaceutically acceptable salt thereof and a one or more pharmaceutically acceptable excipients. The present invention further relates to a stable dispersible pharmaceutical formulation comprising imatinib or a pharmaceutically acceptable salt thereof, and a one or more pharmaceutically acceptable excipients. Moreover, the present invention also relates to a novel pharmaceutical sachet formulation comprising an effective amount of imatinib or a pharmaceutically acceptable salt thereof, a flavouring agent, a sweetener and a one or more pharmaceutically acceptable excipients.

Abstract: The present invention is directed to orally administered compositions of topically acting corticosteroids for the treatment of inflammation of the gastrointestinal tracts such as eosinophilic esophagitis. The present invention also provides a method for treating conditions associated with inflammation of the gastrointestinal tract in an individual. The method comprises administering to an individual in need thereof a pharmaceutical composition of the present invention as orally disintegrating tablets comprising a topically active corticosteroid adsorbed onto a pharmaceutically acceptable carrier such as silicified microcrystalline cellulose.

Abstract: Disclosed herein are pharmaceutical compositions and dosage forms including N-[5-(3,5-difluorobenzyl)-1H-indazol-3-yl]-4-(4-methyl-piperazin-1-yl)-2-(tetrahydro-2H-pyran-4-ylamino) benzamide that are useful in the treatment of subjects having cancer. The present disclosure also provides methods for preparing these pharmaceutical compositions and dosage forms, and methods of treating subjects having cancer utilizing the pharmaceutical compositions and dosage forms provided herein.

Abstract: The present disclosure provides sublingual epinephrine tablets and methods of treating anaphylaxis, methods for concomitant therapy during a cardiac event, treating hypoglycemia, and prophylaxis for immunotherapy, using sublingual epinephrine tablets.

Abstract: The present invention relates to formulations of certain amino acids, peptides and similar molecules in combination with trisodium citrate exhibiting improved bioavailability and enhanced uptake across digestive mucosa. The present invention relates particularly to formulation of trisodium citrate in combinations with leucine, iso-leucine, valine, arginine, sarcosine, glutathione, carnosine, glucosamine, creatine, protein hydrolysates and/or gamma-aminobutyric acid exhibiting improved uptake across digestive mucosa. More particularly, the improved uptake across digestive mucosa takes place across intestinal, esophageal and/or stomach mucosa.

Abstract: The invention provides compositions including epinephrine nanoparticles and methods for therapeutic use of the compositions for the treatment of conditions responsive to epinephrine such as a cardiac event or an allergic reaction, particularly anaphylaxis. The epinephrine nanoparticles can be incorporated into orally-disintegrating and fast-disintegrating tablet pharmaceutical formulations and can significantly increase the sublingual bioavailability of epinephrine, and thereby reduce the epinephrine dose required. Additionally, the invention provides methods for fabrication of stabilized epinephrine nanoparticles for use in the described compositions.

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 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 invention provides compositions including epinephrine fine particles, including epinephrine nanoparticles or nanocrystals and epinephrine microparticles or microcrystals, and methods for therapeutic use of the compositions for the treatment of conditions responsive to epinephrine such as a cardiac event or an allergic reaction, particularly anaphylaxis. The epinephrine fine particles can be incorporated into orally-disintegrating and fast-disintegrating tablet pharmaceutical formulations and can significantly increase the sublingual bioavailability of epinephrine, and thereby reduce the epinephrine dose required.

Abstract: Lowering total cholesterol and improving of blood lipid spectrum composition as seen in a decrease of low and very low density lipoprotein levels, triglycerides and Lipoprotein a, and an increase in high density lipoproteins through taking fumarate and/or fumarates and B vitamins. The fumarate is any of fumaric acid, neutral or acidic sodium fumarate, potassium fumarate, ammonium fumarate, fumarate of a general formula Fum-Me-Fum.nH2O, where Fum—fumaric acid anion, Me—zinc, calcium or magnesium, n=0-8 or mixture of these. The B group can be B12, B6, B2, preferably, at least two of these. Preferably also including at least one amino acid from the following: glycine, L-glutamic acid and/or its salts, L-arginine and/or its salts, L-carnitine and/or its salts, asparagine and/or its salts. Preferably also succinic, citric or isocitric acid and/or their salts. Preferably also including other vitamins, fillers, ballast substances, flavors, colors, sugars, oils.

Abstract: This invention relates to a dilute, ready-to-use solution of phenylephrine hydrochloride having improved stability and utility. In a particular embodiment, the formulation consists of an injectable form of phenylephrine hydrochloride with edetate disodium chelating agent in place of any sodium metabisulfite antioxidants to improve the solution's ability to remain stable and active in a dilute state after prolonged storage. This invention also relates to a form for injection of the solution that includes packaging the solution in a single-use container, as well as a form for containing the ready-to-use solution in a sterile, sealed container. Lastly this invention relates to methods of making the injectable solution for use in a single-use container, as well as for containment in a sterile, sealed container.

Abstract: This invention concerns a method of doing business which is combined with several scientific advancements of technological ingenuity that results in a novel way of doing business. It in fact teaches a “business method” which creates an innovative approach to obtain annual multi-billion dollar financial revenue as monthly rental income; which results from a rather large scale residential development community of 2000 dwelling units per 50 acre parcels; each parcel being developed upon heretofore 10,000 separately abandoned “Municipal Solid Waste” MSW landfill sites throughout the United States. These apartments are exclusively geared as rentals of a 1,020 square foot-two-bedroom apartment dwellings for only Covid-19 “First Responders” and military service personnel, for the unprecedented sum of just $800/month rent.

Abstract: This document provides dietary supplement compositions. For example, multi-supplement compositions having combinations of dietary supplement formulations useful for human or animal consumption are provided.

Abstract: Solid oral dosage forms containing 325 mg of acetaminophen and 97.5 mg of ibuprofen or 500 mg of acetaminophen and 150 mg of ibuprofen, wherein the ibuprofen has a [D50] between 1 and 9 ?m, are described.

Abstract: Provided herein is an amorphous compound represented by Formula (I): and compositions thereof, which are useful in the treatment of disorders related to the activity of the c-KIT and PDGFR? kinases, and oncogenic forms thereof.

Abstract: The present invention relates to compacted glycine granules, where at least 75% of the granules have a particle size of above 0.7 mm, and to a process for the preparation and use of granules of this type.

Abstract: The present invention is directed to orally administered compositions of topically acting corticosteroids for the treatment of inflammation of the gastrointestinal tracts such as eosinophilic esophagitis. The present invention also provides a method for treating conditions associated with inflammation of the gastrointestinal tract in an individual. The method comprises administering to an individual in need thereof a pharmaceutical composition of the present invention as orally disintegrating tablets comprising a topically active corticosteroid adsorbed onto a pharmaceutically acceptable carrier such as silicified microcrystalline cellulose.

Abstract: The present invention relates to stabilized liquid formulations of Levothyroxine or a pharmaceutically acceptable salt thereof, intended for parenteral administration. Further this invention also describes process of preparing such compositions.

Abstract: The invention provides an orodispersible solid pharmaceutical dosage unit having a weight between 30 and 1,000 mg, said dosage unit consisting of: 0.1-25 wt. % of estetrol particles containing at least 80 wt. % of an estetrol component selected from estetrol, estetrol esters and combinations thereof; and 75-99.9 wt. % of one or more pharmaceutically acceptable ingredients; the solid dosage unit comprising at least 100 ?g of the estetrol component; and wherein the solid dosage unit can be obtained by a process comprising wet granulation of estetrol particles having a volume weighted average particle size of 2 ?m to 50 ?m. The solid dosage unit is easy to manufacture and perfectly suited for sublingual, buccal or sublabial administration.

Abstract: This disclosure features methods and compositions for treating diseases of the gastrointestinal tract with a SMAD7 inhibitor.

Abstract: In an embodiment, a nutritional supplement including, about 0.5 mg to about 4 mg of folate, about 6.25 mg to about 50 mg of vitamin B-6, about 250 mcg to about 2000 mcg of vitamin B-12, about 75 mg to about 600 mg of coenzyme Q10 (CoQ10), about 1250 IU to about 10,000 IU of vitamin D3, about 25 mg to about 200 mg of magnesium, about 25 mg to 200 mg of N-acetyl-L-cysteine, about 5 mg to about 40 mg pyrroloquinoline quinone disodium (PQQ), about 25 mg to about 200 mg of curcumin extract, about 25 mg to about 200 mg of resveratrol, about 25 mg to about 200 mg berberine, about 12.5 mcg to about 100 mcg of chromium, and about 12.5 mcg to about 100 mcg of selenium. In an additional embodiment, the aforementioned nutritional supplement in a nutritional kit that further includes an omega-3 supplement.

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.