Abstract: It is disclosed a therapeutic composition for use in the treatment of COVID-19 and other cytokine storm associated disorders, wherein the therapeutic composition comprises at least one active agent being selected from the following active agent groups a) to e): a) complement factor 3-targeting inhibitor of complement activation cascade b) carboxypeptidase B enzyme c) complement factor 5a receptor-targeting inhibitor of complement activation cascade d) endothelin A receptor-targeting inhibitor of extravasation e) bone morphogenic protein. It is further disclosed a method of treating COVID-19 and other cytokine storm associated disorders, wherein said method comprises administering an effective amount of at least one active agent being selected from the above mentioned active agent groups a) to e).

Abstract: The invention relates to a method for producing a low-viscosity cellulose ether product, and to the use thereof.

Abstract: The present invention is concerned with a modified release pharmaceutical composition comprising an effective amount of at least one antipsychotic agent so that the antipsychotic agent(s) are released in such a manner to better accord with physiological and chronotherapeutic requirements of patients.

Abstract: The present invention relates to extended release liquid compositions of metformin. The extended release liquid compositions are in the form of suspensions or reconstituted powder for suspensions. Said extended release liquid compositions comprise cores of metformin coated with a release-controlling agent, wherein the coated cores are dispersed in a suspension base. Said extended release liquid compositions provide the desired uniform extended release profile throughout the shelf-life of the composition. Furthermore, said extended release liquid compositions are bioequivalent to a reference composition. It also relates to processes for the preparation of said extended release liquid compositions.

Abstract: The present invention relates to extended release liquid compositions of metformin. The extended release liquid compositions are in the form of suspensions or reconstituted powder for suspensions. Said extended release liquid compositions comprise cores of metformin coated with a release-controlling agent, wherein the coated cores are dispersed in a suspension base. Said extended release liquid compositions provide the desired uniform extended release profile throughout the shelf-life of the composition. Furthermore, said extended release liquid compositions are bioequivalent to a reference composition. It also relates to processes for the preparation of said extended release liquid compositions.

Abstract: Formulations containing pH-sensitive nanoparticles for the enteric delivery of therapeutic agents are provided. The nanoparticles include a pH-sensitive polymer that protects the therapeutic agent against degradation in the stomach and allows it to be released in the small intestine or colon. The nanoparticle formulation is particularly effective at protecting sensitive biotherapeutic agents from degradation when administered orally, and makes it possible to avoid administration of such agents by injection. Also provided are methods for producing the formulations, as well as methods of treating diseases employing the formulations.

Abstract: There is provided a method for producing hypromellose acetate succinate (HPMCAS), the method not requiring any special device and facilitating removal of impurities. More specifically, there is provided a method for producing HPMCAS, including an esterification step of esterifying hypromellose with an acetylating agent and a succinoylating agent in the presence of an aliphatic carboxylic acid to obtain a reaction product solution containing HPMCAS; a precipitation step of precipitating the HPMCAS by mixing the reaction product solution with water to obtain a suspension of the precipitated HPMCAS; a neutralization step of neutralizing the suspension with a basic substance to obtain a neutralized suspension; and a washing step of washing the HPMCAS contained in the neutralized suspension to obtain the washed HPMCAS.

Abstract: The present invention relates to a disintegrant free pharmaceutical composition comprising apremilast or pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients. Particularly the present invention relates to disintegrant free immediate release dosage form comprising apremilast or pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients. It further relates to process of preparing such composition and its use in psoriatic arthritis and psoriasis.

Abstract: The present specification discloses porogen compositions comprising a core material and shell material, methods of making such porogen compositions, methods of forming such porous materials using such porogen compositions, biocompatible implantable devices comprising such porous materials, and methods of making such biocompatible implantable devices.

Abstract: Provided is a novel additive for an orally disintegrating tablet which imparts a rapid disintegration property and a tablet hardness to the orally disintegrating tablet and a method for producing the same. An additive for an orally disintegrating tablet according to one embodiment of the present invention includes a D-mannitol, a low-substituted hydroxypropyl cellulose (excluding those having a mean particle size of 20 ?m or less and a substitution degree of the hydroxypropoxy groups of 11%, having a mean particle size of 45 ?m or less and a substitution degree of the hydroxypropoxy groups of 14% and having a mean particle size of 45 ?m or less and a substitution degree of the hydroxypropoxy groups of 11% together with a 90% cumulated particle size of 100 ?m or less), a crospovidone and a crystalline cellulose.

Abstract: The solid preparation which improved the dissolution profile and the stability of the 6,7-unsaturation-7-carbamoyl morphinan derivative is provided. When 6,7-unsaturation-7-carbamoyl morphinan derivative, croscarmellose sodium and ferric oxide were contained, not titanium oxide in the solid preparations and the coating solid preparations, a dissolution rate after 15 minutes of the dissolution test is more than 85%, and stability, particularly, light stability can be improve.

Abstract: Disclosed are pharmaceutical compositions comprising Compound I, having the formula: and an effective amount of sofosbuvir wherein the sofosbuvir is substantially crystalline. Also disclosed are methods of use for the pharmaceutical composition.

Abstract: The present patent application relates a process for the production of compressed tablets using specific coated particles, wherein the coating (system) comprises at least one wax and/or at least one fat. Furthermore it relates to compressed (compacted) tablets and as well as to specific coated particles.

Abstract: In a process for preparing an esterified cellulose ether a cellulose ether is esterified with (i) an aliphatic monocarboxylic acid anhydride or (ii) a dicarboxylic acid anhydride or (iii) a combination of an aliphatic monocarboxylic acid anhydride and a dicarboxylic acid anhydride in the presence of an alkali metal carboxylate and an aliphatic carboxylic acid, wherein the molar ratio [alkali metal carboxylate/anhydroglucose units of cellulose ether] is not more than [1.20/1] and the molar ratio [aliphatic carboxylic acid/anhydroglucose units of cellulose ether] is from [3.55/1] to [9.0/1].

Abstract: The present specification discloses porogen compositions comprising a core material and shell material, methods of making such porogen compositions, methods of forming such porous materials using such porogen compositions, biocompatible implantable devices comprising such porous materials, and methods of making such biocompatible implantable devices.

Abstract: Provided is an orally disintegrating tablet coated with film that allows the time elapsed before a film thereof dissolves to be shorter, has a good feel when the tablet is taken, and is capable of being easily mass-produced. The orally disintegrating tablet coated with film is coated with a film coating composition, the film coating composition comprises a water-soluble and ethanol-insoluble film coating base; and at least one plasticizer selected from the group consisting of propylene glycol and polyethylene glycol in a liquid or semisolid state at room temperature.

Abstract: Esterified cellulose ethers which have i) as ester groups aliphatic monovalent acyl groups or groups of the formula —C(O)—R—COOA or a combination of aliphatic monovalent acyl groups and groups of the formula —C(O)—R—COOA, wherein R is a divalent aliphatic or aromatic hydrocarbon group and A is hydrogen or a cation, and ii) a content of not more than 0.85 weight percent acetone-insoluble esterified cellulose ether particles, when the esterified cellulose ether is present in a mixture of 12.5 weight parts of esterified cellulose ether and 87.5 weight parts of acetone at 21° C., the weight percent acetone-insoluble esterified cellulose ether particles being based on the total weight of the esterified cellulose ether, wherein iii) not more than 14 percent of the acetone-insoluble esterified cellulose ether particles have a particle size of more than 90 micrometers.

Abstract: The present invention provides a novel drug delivery system for the controlled release of therapeutically active substances at a predetermined, essentially constant release rate over a prolonged period of time. The delivery system comprises at least one core comprising said therapeutically active substance(s), at least one membrane encasing the core and an intermediary layer of a substantially inert material, wherein the intermediary layer is applied between the core and the membrane or between two membrane layers.

Abstract: A process for producing an aqueous composition comprising a dispersed esterified cellulose ether comprises the steps of grinding, in the presence of an aqueous diluent an esterified cellulose ether comprising (i) groups of the formula —C(O)—R—COOA or (ii) a combination of aliphatic monovalent acyl groups and groups of the formula —C(O)—R—COOA, wherein R is a N divalent aliphatic or aromatic hydrocarbon group and A is hydrogen or a cation, blending a salt of a fatty acid with the esterified cellulose ether and choosing the amounts of aqueous diluent, esterified cellulose ether and salt of a fatty acid that the produced aqueous composition comprises at least 20 percent of the dispersed esterified cellulose ether and heating the aqueous composition to a temperature of from 37 to 80 C during or after the grinding step.

Abstract: Aspects of the disclosure include methods for treating hyperhidrosis in a subject with a composition including a muscarinic antagonist and a muscarinic agonist. In practicing methods according to certain embodiments, a therapeutically effective amount of a composition including a muscarinic antagonist or a pharmaceutically acceptable salt thereof and a muscarinic agonist or a pharmaceutically acceptable salt thereof is administered to a subject and is sufficient to reduce hyperhidrosis in the subject and to reduce a dry mouth side effect of the muscarinic antagonist. Compositions for practicing the subject methods are also described as well as dose units containing one or more of the subject compositions.

Abstract: A three-dimensionally printed article comprises a build material and a support material, the support material comprising a hydroxypropyl methylcellulose having a DS of at least 1.0 and an MS of at least 0.6, wherein DS is the degree of substitution of methoxyl groups and MS is the molar substitution of hydroxypropoxyl groups. The support material can be removed from the build material by contacting the support material with water.

Abstract: A three-dimensionally printed article is comprised of a hydroxyethyl methylcellulose (HEMC) having a DS of 1.7 to 2.5 and an MS of at least 0.5, wherein DS is the degree of substitution of methoxyl groups and MS is the molar substitution of hydroxyethoxyl groups. The HEMC may advantageously be used as a support material when making a three-dimensionally printed article using a build material such as a different thermoplastic polymer such as a poly(acrylonitrile-butadiene-styrene), polylactic acid, polyethylene and polyprophylene. When the HEMC is a support material it may be easily removed from the build material by contacting the three dimensionally printed article with water, which may be at ambient temperatures and a pH that is neutral or close to neutral.

Abstract: Disclosed are pharmaceutical compositions comprising Compound I, having the formula: and an effective amount of sofosbuvir wherein the sofosbuvir is substantially crystalline. Also disclosed are methods of use for the pharmaceutical composition.

Abstract: This invention provides compositions for flat icings. The compositions comprises a gum system comprising Gum Arabic, carboxymethylcellulose and optionally, Gellan gum. The composition can be used as a flat icing for baked products such as doughnuts. Also provided is a method for using the composition as a flat icing and as a glaze.

Abstract: An object is to provide a hydromorphone hydrochloride- or oxycodone hydrochloride hydrate-containing sustained-release pharmaceutical composition for oral administration that reliably exhibits its main pharmacological effect and has excellent formulation stability that avoids dose dumping of the principal drug, such as alcohol resistance. The present invention provides a sustained-release pharmaceutical composition comprising (A) hydromorphone hydrochloride or oxycodone hydrochloride hydrate, (B) hydroxypropyl methylcellulose acetate succinate having a median size (D50) of 40 ?m or smaller, (C) hydroxypropyl cellulose, and (D) a saccharide, wherein the content ratio of the component (C) to the component (B) by weight in the composition, (C)/(B), is 11/3 to 3/11.

Abstract: There is disclosed a method for treating disorders modulated by at least opiate receptor activity or monoamine activity, including acute and chronic pain, comprising administering a pharmaceutical formulation comprising O-desmethyltramadol. Methods are also provided that are effective for overcoming resistance to tramadol in patients.

Abstract: Disclosed are pharmaceutical compositions comprising Compound I, having the formula: and an effective amount of sofosbuvir wherein the sofosbuvir is substantially crystalline. Also disclosed are methods of use for the pharmaceutical composition.

Abstract: The present invention relates to esters of diacids and cellulosic materials and methods for making thereof. The ester has the chemical composition of Formula (I) Formula I where R1, R2, and R3 can be the same or different, and each of which is selected from —H, —COR?, —R??, or —COR? COOH, with the proviso that at least one of the R1, R2, or R3 is —COR? COOH; R? is an alkyl, alkenyl, alkynyl, or aromatic group; R? is an alkyl, alkenyl, or alkynyl group having 4 or more carbon atoms (?C4); and R?? is an alkyl, alkenyl, alkynyl, polyol, or aromatic group.

Abstract: The present disclosure relates to pharmaceutical compositions of pyrimidinedione derivative compounds and methods of preparing and uses thereof. The disclosure also relates to methods of enhancing bioavailability of pyrimidinedione derivative compounds in pharmaceutical compositions administered to a subject and methods of reducing the amount of a pyrimidinedione derivative compound in a pharmaceutical composition while achieving the same bioavailability in a subject.

Abstract: An esterified cellulose ether which comprises (i) aliphatic monovalent acyl groups or (ii) groups of the formula —C(O)—R—COOA, wherein R is a divalent aliphatic or aromatic hydrocarbon group and A is hydrogen or a cation, or (iii) a combination of aliphatic monovalent acyl groups and groups of the formula —C(O)—R—COOA, and which has a) a viscosity of from 1.2 to 1.8 mPaos, measured as a 2.0 wt % solution of the esterified cellulose ether in 0.43 wt % aqueous NaOH at 20° C., or b) a viscosity of up to 5 mPa·s, measured as a 10 wt % solution of the esterified cellulose ether in acetone at 20° C., or c) a combination of the viscosities of a) and b), is useful for preparing solid dispersions comprising drugs.

Abstract: The use of a granular material which is for orally fast disintegrating tablets and comprises at least one kind of water soluble polymer and tannic acid allows production of tablets that can be produced by a simple process with simple production equipment, disintegrate fast in the mouth, and have a proper level of moldability for practical use. The at least one kind of water soluble polymer is preferably selected from the group consisting of povidone, hydroxypropyl cellulose, pullulan, a polyvinyl alcohol-polyethylene glycol graft copolymer and copolyvidone.

Abstract: Modified release formulations of viloxazine and methods of administering the same are disclosed. High-drug load formulations of viloxazine are further disclosed.

Abstract: The present invention includes pH dependent, dry film coating compositions containing calcium silicate for use on orally-ingestible substrates such as tablets and the like. The film coating compositions can be applied as an aqueous suspension either directly to a substrate or after the substrate has been coated with a subcoat. In preferred aspects, the polymer is either an enteric or reverse-enteric polymer. Methods of preparing the dry film coatings, methods of preparing corresponding aqueous suspensions, methods of applying the coatings to substrates and the coated substrates themselves are also disclosed.

Abstract: The present patent application relates to a novel coating system, coated compositions with such a coating system, as well as to the use of such compositions in the production food, feed, dietary supplements and/or pharmaceutical products, as well as to food, feed, dietary supplements and/or pharmaceutical products comprising such compositions.

Abstract: A solid dispersion product comprising itraconazole and hydroxypropyl methylcellulose, which satisfies the Formula 0.35>?Htr (1) (wherein ?Htr represents the endotherm (J/g) accompanying a transition at about 240° C.). The solid dispersion product shows an improved bioavailability.

Abstract: Miniature pumps for dispensing a volume a flowable substance are described. One pump embodiment includes an environmentally-responsive plug layer that can contract in size, e.g., when exposed to an environmental change such as temperature, to allow an activation solution to flow to a layer of expandable material, such as a superporous hydrogel. Expansion of the expandable material urges a diaphragm into a chamber that holds the dispensable fluid, gas, or gel, forcing the fluid, gas or gel out of the pump.

Abstract: The present invention relates to a multilayered coated tablet comprising at least three layers, i.e., first, second and third layer wherein the first and third layers contain at least one active pharmaceutical ingredient and the second layer is either a placebo or an immediate-release drug layer. Further, the tablet has a delayed-release coating, wherein the coating may contain one or more pore-forming agents and/or orifices on one or both sides. Furthermore, it may contain an immediate-release layer of the drug over the delayed-release coating layer. The present invention further relates to processes for preparing such a multilayered coated tablet.

Abstract: The present invention relates to solid orally administrable pharmaceutical administration forms comprising 5-chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}-methyl)-2-thiophenecarboxamide (rivaroxaban, active compound (I)), characterized in that a partial amount of the active compound (I) is released rapidly and a partial amount is released in a controlled manner (modified, retarded, delayed), and to processes for their preparation, their use as medicaments and their use for the prophylaxis, secondary prophylaxis or treatment of disorders.

Abstract: The present invention provides methods of detecting a cancer cell in an individual, methods of grading a cancer, and methods of treating a cancer. The methods involve use of functionalized magnetic nanoparticles that comprise a moiety that provides for selective association with, and/or metabolic uptake into, a cancer cell.

Abstract: The present invention is directed to a dosage form comprising an immediate release portion of a first active pharmaceutical ingredient and a delayed release portion of a second active pharmaceutical ingredient wherein (a) the immediate release portion comprises from about 1 mg to about 1000 mg of the first active pharmaceutical ingredient; and (b) the delayed release portion comprises from about 1 mg to about 1000 mg of the second active pharmaceutical ingredient; wherein the delayed release portion is coated with a delayed release coating comprising at least one swellable erodible polymer and a filler, and wherein the immediate release portion is in contact with the delayed release coating.

Abstract: It is an object to provide a coating composition, which is used for an orally-administered preparation, the administering property of which has been improved, and/or an easily administrable preparation that does not affect dissolution property. The aforementioned object can be achieved using a coating composition comprising a first thickener selected from the group consisting of a carboxyvinyl polymer and sodium alginate, a polyvalent metal compound, and at least one type of a second thickener selected from the group consisting of xanthan gum, guar gum and sodium alginate, with the proviso that when the first thickener is sodium alginate the second thickener is not sodium alginate, or using a coating composition comprising, as thickeners, hydroxypropylmethylcellulose and sugar or sugar alcohol having a solubility at 20° C. of 30 or more.

Abstract: Unit comprising neramexane, a pharmaceutically acceptable salt, solvate, conjugate, prodrug, polymorphic form, isomer, or derivative thereof; and a release-controlling excipient; wherein said unit has a diameter of from 0.1 to less than 6 mm.

Abstract: A drug in a solubility-improved form is combined with a concentration-enhancing polymer in a sufficient amount so that the combination provides substantially enhanced drug concentration in a use environment relative to a control comprising the same amount of the same solubility-improved form of drug without the concentration-enhancing polymer.

Abstract: A film coating agent for a solid formulation includes a water-soluble cellulose derivative, swelling clay, a cationic surfactant, and a fatty acid, wherein mass ratio of the swelling clay to the water-soluble cellulose derivative is 2:8 to 8:2, and content of the cationic surfactant is not less than 0.5 equivalents and not more than 3.0 equivalents relative to a cation exchange equivalent of the swelling clay.

Abstract: The present disclosure is directed to cellulose ether compositions for film-forming coating applications. A coating composition is provided which contains an aqueous solution of either a very low viscosity cellulose ether or a low-hydroxypropyl cellulose ether, the coating composition having low color. The low viscosity of the cellulose ether component enables the coating composition to contain a high concentration of cellulose ether. Provision of these high concentration cellulose ether coating solutions improves production efficiency by reducing the time required to coat a substrate.

Abstract: The present invention discloses stable, solid oral pharmaceutical composition comprising Lanthanum carbonate having more than 6 molecules of water per molecule of lanthanum carbonate and pharmaceutically acceptable carriers or diluents, wherein said carrier or diluent excludes monosaccharide/s or disaccharide/s, such that the composition has comparable in-vitro dissolution profile similar to that of FOSRENOL®. Also disclosed is a wet granulation process for making the same.

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: 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: The present invention provides oral formulations of poorly bioavailable and/or poorly absorbable, and/or poorly water soluble therapeutic agents. The invention features pharmaceutical composition including a biopolymer, a therapeutic agent, for example an antimicrobial agent such as ceftriaxone, and an absorption enhancer, for example a polyoxyethylene alkyl ether absorption enhancer. Methods of making and using the pharmaceutical compositions is also described.

Abstract: Described are controlled-release solid dosage forms of mesalamine. In one aspect of the invention the controlled-release solid dosage forms of mesalamine are capsules comprising a plurality of coated mini-tablets. Another aspect of the invention relates to a method of treating a patient suffering from inflammatory bowel disease, comprising the step of administering to the patient a therapeutically effective amount of the solid dosage form. The invention also relates to methods of inducing remission of inflammatory bowel disease and maintaining remission of inflammatory bowel disease. In certain aspects, the inflammatory bowel disease is ulcerative colitis or Crohn's disease.