The present invention relates to the use of sodium meta-arsenite or potassium meta-arsenite in methods of a) reducing an inflammatory response due to a viral infection, b) treating or preventing an inflammatory condition due to a viral infection, or c) treating or preventing hypercytokinemia due to a viral infection. The invention also relates to a method of treating or preventing a viral infection in a subject.

The present invention relates to a pirfenidone formulation having improved safety and a method for producing same, wherein the pirfenidone formulation comprises pirfenidone as an active component, has two or more mutually different coatings selected from the group consisting of a coating containing a water-soluble polymer and a coating containing an enteric polymer, thereby specifically releasing pirfenidone in the small intestine, and has unique pharmacokinetic properties to reduce variability when pirfenidone is absorbed through the gastrointestinal tract, and reduce gastrointestinal side effects without affecting bioavailability of the active component, and therefore can remarkably improve low medication compliance.

A method of diagnosis and treatment of primary biliary cholangitis is provided. Additionally, a pharmaceutical composition and a solid dosage form for the treatment of primary biliary cholangitis, containing ursodeoxycholic and obeticholic acids, are provided. The technical contribution resides in obtaining a new all-purpose pharmaceutical composition and solid dosage form for the treatment of PBC, which includes both ursodeoxycholic and obeticholic acids, which is effective in use at all stages of PBC and has a complex mechanism of action. In particular, simultaneous blockage of the transport and synthesis of bile acids is achieved.

The present disclosure provides pharmaceutical compositions of niclosamide that may be administered orally. These compositions may allow the achievement of a therapeutically effective dose of niclosamide while preventing crystallization in the stomach which reduces bioavailability. These compositions may be used to treat one or more diseases or disorders such as a viral infection or cancer.

This disclosure relates to gastro-resistant, controlled release dosage forms comprising Compound (I): ##STR00001##
or a pharmaceutically acceptable salt and/or solvate thereof, the pharmacokinetic properties of these dosage forms, and the preparation of the same. The novel dosage forms disclosed herein are useful in reducing the risk of QT prolongation in a subject and in treating a disorder in a subject in need thereof, e.g., a subject diagnosed with schizophrenia, for example, in treating the negative symptoms in a subject diagnosed with schizophrenia having the CYP2D6 EM genotype.

The disclosure relates to oral formulations for gastric delivery of a pharmaceutically acceptable salt of a phenyl pyrrole aminoguanidine compound.

The present invention provides, in part, compositions comprising a peptide that is larazotide or larazotide derivative, or salt thereof, contained within a matrix that provides for controlled release and sustained release formulations. The present invention contemplates that these compositions, formulations and methods can be useful for treating diseases and disorders of the small bowel.

The present invention relates to a process to prepare solid pharmaceutical forms comprising a quantity of mesalazine comprised between 75 and 95%, i.e. between 1000 and 1600 mg of drug per dosage unit. Furthermore, the present invention relates to a granulate and/or tablets obtained/obtainable with the process according to the invention, preferably coated to allow the con -trolled release of the drug. Finally, the present invention relates to the use of the granulate and/or the tablets as a medicament, prefer -ably for the treatment of chronic inflammatory pathologies that preferably affect the intestinal tract.

Described herein are methods for the administration of reboxetine, or a pharmaceutically acceptable salt thereof, to a human being in need thereof, resulting in a first maximum plasma concentration and a second maximum plasma concentration, wherein the two maxima are separated by a time period of about 2 hours to about 6 hours.

The invention relates to an extract of Ashwagandha that exhibit enhanced bioactivity and bioavailability comprising of enriched withanolide glycosides and saponins; with negligible amount of alkaloids, withanolide aglycones and oligosaccharides. The extract as disclosed prepared from root, stems, leaves and whole plant of Ashwagandha further shows improved immunomodulatory activity, anti-inflammatory activity, anti stress activity, antidiabetic activity and sleep quality. The disclosure also provides a method of improving bioactivity of withanolide glycosides even at lower doses, by the administration of an enteric coated formulation of extract of Ashwagandha to humans. The enteric coating protects the composition from hydrolysis in the acidic environment of the stomach to release the withanolide glycoside in neutral/alkaline pH in gastrointestinal tract (GIT) thus enhancing the absorption. Further the process of preparation of the extract of Ashwagandha enriched with withanolide glycosides and saponins are disclosed along with various formulations.