Provided is an orally disintegrating tablet comprising brexpiprazole or a salt thereof that rapidly disintegrates in the oral cavity while having hardness suitable for practical use.

More specifically, provided is an orally disintegrating tablet comprising (A) brexpiprazole or a salt thereof, (B) D-mannitol, (C) partially pregelatinized starch, and (D) a lubricant.

Compositions of SGLT2 inhibitors and their use for treating primary biliary cholangitis (PBC) are described here. The SGLT2 inhibitor compositions, including oral dosage forms, contain a therapeutically effective dose of a SGLT2 inhibitor for preventing, partially ameliorating or fully ameliorating symptoms of PBC, including of the hepatic encephalopathy, development of varices, jaundice, variceal bleeding cholangiocarcinoma, hepatocellular carcinoma, evidence of cirrhosis, and colorectal cancer.

Described herein are compounds of Formula I:

##STR00001##

wherein R.sub.1-R.sub.6 are as described herein, for use in the treatment of a coronavirus infection; a method of inhibiting a coronavirus 3CL protease, by contacting the 3CL protease with a compound of Formula I; as well as methods pharmaceutical composition comprising a compound of Formula I and at least one phospholipid, wherein a weight ratio of the phospholipid(s) to the compound in the composition is in a range of from 10:1 to 1:10. Further described herein is a method of treating a coronavirus infection in a subject in need thereof, by administering to the subject at least one compound that exhibits at least two of: inhibition of an activity of a 3CL protease of the coronavirus; inhibition of inflammation in the subject; and inhibition of autophagy in the subject.

A novel dosage form for intra-oral delivery of nicotine for use in nicotine replacement therapy; a process for preparation of said dosage form and intermediate compositions therefor; and methods for treatment.

Described herein are formulations of a somatostatin modulator, methods of making such formulations, and methods of using such formulations in the treatment of conditions, diseases, or disorders that would benefit from modulation of somatostatin activity.

Provided herein are compositions and methods of reducing certain psychoactive and physiological effects of tetrahydrocannabinol (THC), some of which may be undesirable, while preserving beneficial effects of cannabis in a human in need thereof. The methods described involve administration of therapeutically effective amounts of guineensine. Also, provided are compositions wherein guineensine is part of an herbal composition and is formulated for sublingual delivery.

Pharmaceutical compositions are provided, which comprise cabozantinib or pharmaceutically acceptable salts thereof, and at least one pharmaceutically acceptable excipient, wherein the inventive compositions exhibit enhanced bioavailability compared to the currently marketed or commercially available formulations. The present invention also provides manufacturing processes thereof and use of the said inventive compositions for the prevention, treatment or prophylaxis of disorders in human patients in need thereof. The present invention relates to oral pharmaceutical compositions of cabozantinib, methods for their administration, processes for their production, and use of these compositions for treatment of diseases treatable by cabozantinib.

Orally adhering lozenges comprising soluble dietary fiber are provided herein. The orally adhering lozenges provided herein may be in the form of tablet-type lozenges comprising compressed powders and/or granules in at least two layers. The orally adhering lozenges include at least 30% soluble dietary fiber. The orally adhering lozenges also include an adhesive component to adhere the lozenge inside the mouth. The orally adhering lozenges are also low in cariogenic sugar, non-resistant starch, and polyols.

Disclosed herein are inclusion complexes comprising vilazodone or a pharmaceutically acceptable salt thereof and an inclusion material, compositions and pharmaceutical formulations comprising the inclusion complexes, and methods for preparing the inclusion complexes, compositions or pharmaceutical formulations.

The present invention relates to pharmaceutical compositions comprising fixed dose combinations of a DPP-4 inhibitor drug and a partner drug, processes for the preparation thereof, and their use to treat certain diseases.