The present disclosure provides a pharmaceutical composition of fused tricyclic gamma-amino acid derivatives and the use thereof. The pharmaceutical composition includes: (i) a compound having a structure represented by formula (I) or a pharmaceutically acceptable salt thereof, as an active material, in an amount of 1% to 45% by weight; (ii) optionally one or more fillers in an amount of 50% to 95% by weight; (iii) optionally one or more lubricating agents in an amount of 0.1% to 5.5% by weight; and the sum of weight percentages of the all components is 100%, wherein the pharmaceutically acceptable salt of the compound of formula (I) has a structure as follows.

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Described herein are cholix-IL-10 fusion proteins, and methods of use thereof, which can be characterized by a distinct response in an individual when administered. This distinct response can comprise changes in levels of one or more markers in the individual and/or co-localization of IL-10 in the Lamina propria of the individual. Further described herein, in some embodiments, are oral formulations of the cholix-IL-10 fusion proteins. Described herein are methods for the purification of an IL-10 delivery construct, including methods for refolding and enrichment, which can result in maintenance of a high percentage of the IL-10 delivery constructs in the biologically active dimer form. Described herein are oral formulations configured for site-specific release of a therapeutic protein in the small intestines or colon. In some cases, the therapeutic protein is in the form of a dimer, such as an IL-10 delivery construct capable of crossing the gut epithelium.

The present disclosure is directed to chemical compounds and to the use of such compounds in the treatment of diseases associated with a serotonin 5-HT.sub.2 receptor.

This application describes methods of treating alpha-1 antitrypsin deficiency (AATD) comprising administering Compound I, a deuterated derivative thereof, and/or a pharmaceutically acceptable salt thereof.

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The application also describes pharmaceutical compositions comprising Compound I, a deuterated derivative thereof, and/or a pharmaceutically acceptable salt thereof.

Provided herein are chewable oral formulations including pimobendan for use in mammals to treat cardiac disorders.

The present invention relates to controlled release pharmaceutical formulations comprising an atypical antipsychotic agent such as Paliperidone or pharmaceutical acceptable salt thereof in the form of a multi-layer tablet that provides zero order drug release. It also relates to a process for the preparation thereof.

The present invention relates in a first aspect to a fast disintegrating cannabinoid tablet, the tablet comprising a sugar alcohol composition comprising one or more sugar alcohol particles in an amount of at least 20% by weight of the tablet, a cannabinoid composition comprising one or more cannabinoids, and a disintegrant composition comprising one or more disintegrants operable to disintegrate the tablet within a period of 2 minutes or less in contact with oral saliva. In a second aspect, the invention relates to a modular tablet, wherein the tablet comprises a further tablet module that is different in composition.

The present invention relates to high drug load solid oral pharmaceutical compositions comprising dexamethasone or its pharmaceutically acceptable salts or solvates thereof. The present invention also relates to a process for preparing high drug load solid oral pharmaceutical compositions comprising dexamethasone or its pharmaceutically acceptable salts or solvates thereof. The preferred drug load in the compositions of the present invention is from about 26% to 50% by weight based on the total weight of the composition. The prepared compositions of dexamethasone as per the present invention exhibit desirable technical attributes.

Provided herein is an amorphous compound represented by Formula (I):

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and compositions thereof, which are useful in the treatment of disorders related to the activity of the c-KIT and PDGFRα kinases, and oncogenic forms thereof.

Provided herein are low impurity compositions comprising a compound represented by Formula (I):

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which are useful in the treatment of disorders related to the activity of the c-KIT and PDGFRα kinases, and oncogenic forms thereof.