The disclosure relates to a dosage form comprising a hard gelatin or a HPMC capsule having a granule composition comprising tafamidis or its pharmaceutically acceptable salt particularly tafamidis meglumine or solid-state forms or polymorphic forms of tafamidis particularly a solid-state form comprising tafamidis and fumaric acid. The disclosure also relates to a tablet comprising tafamidis or its pharmaceutically acceptable salt particularly tafamidis meglumine or solid-state forms or polymorphic forms of tafamidis particularly a solid-state form comprising tafamidis and fumaric acid. The solid dosage forms disclosed herein do not form a rigid gel upon contacting with water or buffer solution in dissolution specifically pH 6.8 phosphate buffer and the compositions disclosed herein are indicated for the treatment of the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization.

The present document describes extended release gastro retentive dosage form comprising a carboxylated polysaccharide and cinnamaldehyde conjugate formed via an acetal, hemiacetal or cyclic hemiacetal formed between an aldehyde group of the cinnamaldehyde and a hydroxyl group of the carboxylated polysaccharide. The document also describes extended release gastro retentive dosage form comprising an artesunate emulsion having a pH value of from about 7.5 to 7.9 and comprising an artesunate or pharmaceutically acceptable salts thereof, and stereoisomers thereof stabilized with an emulsifying agent. The document also describes the use of the dosage forms for treatment of H. Pylori infection.

Provided is a fast-eluting three-dimensionally molded object, which is formed by fused deposition modeling type three-dimensional molding and quickly elutes an active component. The fast-eluting three-dimensionally molded object is formed by the fused deposition modeling type three-dimensional molding and includes an active component, a water-soluble thermoplastic polymer, a water-soluble sugar and/or a water-soluble sugar alcohol, and a plasticizer component. The fast-eluting three-dimensionally molded object has an elution rate of the active component of 80% or higher within 85 minutes by a dissolution test method in the Japanese Pharmacopoeia, Sixteenth Edition.

Provided herein are methods of treating or ameliorating a pediatric cholestatic liver disease by non-systemically administering to an individual in need thereof a therapeutically effective amount of a pediatric formulation comprising an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTI) or a pharmaceutically acceptable salt thereof. Also provided are methods for treating or ameliorating a pediatric liver disease, decreasing the levels of serum bile acids or hepatic bile acids, treating or ameliorating pruritis, reducing liver enzymes, or reducing bilirubin comprising non-systemically administering to an individual in need thereof a therapeutically effective amount of a pediatric formulation comprising an ASBTI or a pharmaceutically acceptable salt thereof.

The present disclosure relates to processes for preparing (3S,4R)-3-ethyl-4-(3Himidazo[1,2-a]pyrrolo[2,3-e]pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide, solid state forms thereof, and corresponding pharmaceutical compositions, methods of treatment(including treatment of rheumatoid arthritis and atopic dermatitis), kits, methods of synthesis, and products-by-process.

The present invention provides a method of treating insulin-dependent diabetes mellitus in a subject, comprising administering to the subject a therapeutically effective amount of a Janus kinase inhibitor, or a pharmaceutically acceptable salt or ester thereof, or a therapeutically effective amount of intravenous immunoglobulin, or a therapeutically effective amount of a therapeutic agent that destroys B lymphocytes, or a combination thereof. The present invention also provides kits containing the same.

The present invention relates to a pharmaceutical composition comprising topiramate, and more particularly, to a solid pharmaceutical composition comprising topiramate, a cellulose derivative, a lipid and optional pharmaceutical excipients, wherein the weight ratio of topiramate to the cellulose derivative is 100:10 to 100. The pharmaceutical compositions of the present invention have excellent formulation properties as well. The pharmaceutical compositions of the present invention can be used for monotherapy for patients who are newly diagnosed with epilepsy, or patients who have been previously treated with combination therapy and now for monotherapy. They can also be used for the add-on treatment of partial seizures in adults and children aged 2 to 16 years.

PCT Published Abstract

A solid pharmaceutical composition comprising topiramate and a process for the preparation thereof comprising:a topiramate, a cellulose derivative, a lipid and optionally a pharmaceutical adjuvant, wherein the weight ratio of topiramate to the cellulose derivative is 100:10˜100.

Uses and formulations of cannabinoids, in particular of cannabidiol, are provided.

The cannabinoids, in particular cannabidiol, are used for the treatment of patients suffering from inflammatory conditions associated with autoimmune diseases, chronic inflammatory diseases and inflammatory conditions in connection with infections, including cytokine release syndrome (CRS).

Formulations are especially for oral administration of cannabinoids, in particular of cannabidiol. These formulations are useful for treating patients suffering from conditions as referred to above.

A novel methacrylic copolymer contains units derived from at least one alkyl methacrylate and methacrylamide. The units derived from methacrylamide are present in at least 34 wt.-%, based on the total weight of the methacrylic copolymer. A method can be used for preparing these novel methacylic copolymers. Pharmaceutical compositions, nutraceutical compositions, coated pharmaceutical or nutraceutical dosage forms, as well as nano- or microparticles can contain the methacrylic copolymer. The methacrylic copolymer can be used as a coating, as a carrier, and as a matrix for an amorphous solid dispersion.

A pharmaceutical composition, suitably in the form of a tablet, is described comprising intragranular and extragranular components. The intragranular components comprise a pharmaceutically effective amount of paracetamol, calcium carbonate provided in the form of particles having a d50 greater than 11 .Math.m, and at least one binding agent and the extragranular components comprise a pharmaceutically effective amount of aspirin, and at least one hydrophilic colloid. Optionally the compositions comprise caffeine.