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: 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 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: 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 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: 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 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: 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: 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: 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: 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 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: 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: 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.

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 pharmaceutical compositions useful for (and to a method of) treating autoimmune, respiratory and/or inflammatory diseases and conditions. The method involves administering to a subject in need thereof roflumilast N-oxide by inhalation. The present disclosure particularly relates to the treatment of asthma and chronic obstructive pulmonary disease (COPD) by administering roflumilast N-oxide by inhalation.

Abstract: The invention relates to a tablet dosage form for buccal absorption of active ingredients comprising a population of particles and an active ingredient to be released in the oral cavity for absorption through the oral mucosa, the population of particles comprising directly compressible (DC) and non-directly compressible (non-DC) sugar alcohol particles, the non-DC particles providing the tablet with a plurality of discrete non-DC areas.

Abstract: A system for predicting medications to prescribe to a patient includes a text encoding module and a medication prediction module. The text encoding module is configured to obtain a clinical-information vector from clinical information of the patient. The medication prediction module configured to apply a machine-learned medication-prediction algorithm to the clinical-information vector to select a subset of medications to prescribe to the patient. The machine-learned medication-prediction algorithm is designed with a diversity-promoting regularization model, and is configured to simultaneously consider correlations among different medications and dependencies between patient information and medications when selecting a subset of medications to prescribe to the patient.

Abstract: Pharmaceutical composition of memantine for administering orally which comprises a premixture comprising: i) between 74 and 85% w/w total of the premixture of a granulate of pellets comprising memantine between 10 and 15% w/w total of the premixture; coated by first coating of polyvinylpyrrolidone and a second coating comprising between 80 and 95% w/w total of the coating of cationic copolymer of dimethylaminoethyl methacrylate, butyl methacrylate and methyl methacrylate and between 5 and 20% w/w total of the coating of magnesium stearate; ii) between 4 and 7% w/w total of the premixture of sucralose; iii) between 11 and 19% w/w total of the premixture of essences. All the components have a particle size smaller than 710 microns. The composition can be a suspension, a powder for preparing a suspension or an oral disintegrating tablet. It can also be used to be administered through a nasogastric tube.

Abstract: Modified release formulations of gamma-hydroxybutyrate having improved dissolution and pharmacokinetic properties are provided, and therapeutic uses thereof.

Abstract: An ophthalmic composition or dosage form can include a therapeutically effective amount of a cross-linking agent and a pharmaceutically acceptable carrier. The composition or dosage form can be used to treat an ophthalmic condition by administering a therapeutically effective amount of the composition to an eye of a subject during a treatment period.

Abstract: A method of treating diarrhea in a patient includes administering an H1 receptor antagonist and an H2 receptor antagonist to the patient.

Abstract: The invention relates to a disintegrating oral tablet suitable for active pharmaceutical ingredients comprising a population of particles and at least one flavor ingredient, the population of particles comprising directly compressible (DC) and non-directly compressible (non-DC) sugar alcohol particles, the non-DC particles providing the tablet with a plurality of discrete non-DC areas, and the non-DC areas resulting in a burst of the at least one flavor ingredient upon mastication of the tablet.

Abstract: The invention relates to an oral tablet for taste masking of active ingredients, the tablet comprising a population of particles and an active ingredient with off-note taste, the population of particles comprising directly compressible (DC) and non-directly compressible (non-DC) sugar alcohol particles, the non-DC particles providing the tablet with a plurality of discrete non-DC areas, and the non-DC areas resulting at least partly in induced taste masking of the active ingredient upon mastication of the tablet.

Abstract: There is provide an extended release dosage form comprising a release modifying excipient comprising high amylose starch, cross-linked hydroxypropylated amylopectin, and a pre-gelatinized common starch; wherein the release modifying excipient is substantially free of crosslinks between amylose and amylopectin and substantially free of crosslinks between amylose and amylose. It has been found that the extended release properties of conventional cross-linked high amylose starches (e.g., Contramid®) can be reproduced by intimately mixing i) cross-linked chemically modified amylopectin; ii) a high amylose, non-chemically modified starch and; iii) a pre-gelatinized common starch. Producing a release modifying excipient in this way means that no chemical cross linking between (a) amylose and amylopectin or (b) amylose and amylose has occurred—properties heretofore considered vital for Contramid® function.

Abstract: The invention relates to an oral tablet suitable for fast release of active pharmaceutical ingredients comprising a population of particles, the population of particles comprising directly compressible (DC) and non-directly compressible (non-DC) sugar alcohol particles, the non-DC particles providing the tablet with a plurality of discrete non-DC areas, and the non-DC areas promoting fast release of active ingredients upon mastication of the tablet.

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

Abstract: The tablet of the present invention is a tablet 1 having a cup portion 12 formed at least above or below a side portion 11, wherein the outer surface of the cup portion 12 includes first, second and third curved surfaces 12a, 12b and 12c having different curvatures R1, R2 and R3, the first curved surface 12a is at least continuous with the second curved surface 12b, the second curved surface 12b is continuous with the first curved surface 12a and the third curved surface 12c, and the third curved surface 12c is at least continuous with the second curved surface 12b.

Abstract: Disclosed herein are the sublingual pharmaceutical compositions comprising remdesivir or its pharmaceutically acceptable salts or solvates thereof. The present invention also relates to a process for preparing sublingual pharmaceutical compositions comprising remdesivir or its pharmaceutically acceptable salts or solvates thereof. Compositions of remdesivir prepared as per present invention are able to increase bioavailability by avoiding first-pass metabolism. The compositions of remdesivir prepared as per present invention are useful in the treatment of viral infections including coronavirus infection (COVID-19). The compositions of remdesivir prepared as per present invention exhibit desired pharmaceutical technical attributes such as pH, assay, related substance, disintegration and dissolution.

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

Abstract: The present invention relates to a cosmetic composition for wrinkle reduction comprising, as an active ingredient, a Gynostemma pentaphyllum gypenoside fraction and, more specifically, to a cosmetic composition for wrinkle reduction, wherein the Gynostemma pentaphyllum gypenoside fraction includes at least one gypenoside selected from the group consisting of gypenoside UL1, gypenoside UL2, gypenoside UL3, gypenoside UL4, gypenoside UL5, gypenoside UL6, and gypenoside UL7.

Abstract: A pharmaceutical formulation for prolonged release of the active ingredient 3-(3-dimethylamino-1-ethyl-2-methylpropyl)phenol or a pharmaceutically acceptable salt thereof in a matrix containing between 1 and 80 wt. % of at least one pharmaceutically acceptable hydrophilic or hydrophobic polymer as a matrix forming agent and exhibiting in vivo the following release rate: 3 to 35% by weight (based on 100% by weight active ingredient) 3-(3-dimethylamino-1-ethyl-2-methyl-propyl)phenol released after 0.

Abstract: The present invention describes novel pharmaceutical compositions and methods for treatment of diseases, disorders, or conditions characterized by recurrent seizures, particularly, epilepsy. According to the invention, compounds which inhibit the activity or expression of non-receptor Fyn tyrosine kinase can prevent activation epileptic pathophysiology and provide protection from and treatment of epilepsy. Particularly preferred is the class of small molecule Fyn kinase inhibitors such as sacaratinib and its prodrugs, derivatives, analogs and the like.

Abstract: The addition of a salt to an ALA formulation that is dissolved in the mouth unexpectedly significantly reduces the degree of burning or irritation from ALA exposure during administration. This invention is particularly useful for an oral dissolved form of administration due to the extended time of ALA exposure that is possible with such formulations. The salt-inclusive formulations of the invention can increase efficacy of the ALA administration, reduce negative side effects, or both.

Abstract: The invention refers to a pharmaceutical or nutraceutical composition comprising a core a) comprising an active ingredient and a water-insoluble polymer, a coating layer b) above the core a) comprising a salt of an alginic acid, and a coating layer c) above the coating layer b) comprising an anionic (meth)acrylate copolymer polymerized from a (meth)acrylate monomer mixture comprising 5-75% by weight in relation to the total weight of the (meth)acrylate monomer mixture of (meth)acrylate monomers with an anionic group, wherein the amount of the water-insoluble polymer in the core a) is 2 to 20% by weight in relation to the weight of the core a) and the amount of the salt of an alginic acid in the coating layer b) is 5 to 85% by weight in relation to the weight of the core a) and the amount of the anionic (meth)acrylate copolymer in the coating layer c) is 10 to 75% by weight in relation to the weight of the core a) and to the coating layer b).

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

Abstract: An injectable pharmaceutical composition of a sulfonylurea drug and a preparation method thereof were described. The pharmaceutical composition contains a sulfonylurea drug, a cyclodextrin and an additive.

Abstract: The present invention provides compositions, systems, kits, and methods for preparation prior to a colonoscopy or other gastrointestinal procedure. In particular, the present invention provides a colon lavage system comprising an aqueous portion and a solid portion.

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: The present invention relates to a new pharmaceutical composition containing nicotinic acid and/or nicotinamide and/or related compounds for beneficially influencing the intestinal microbiota and blood lipid levels. In certain embodiments, the pharmaceutical composition is partially or entirely released into the lower small intestine and/or large intestine.