The present invention relates to a composition comprising levamlodipine besylate hydrate and its production, pharmaceutical preparations and use, especially the composition of (S)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydro-3,5-pyridinedicarboxylic acid-3-ethyl ester, 5-methyl ester benzenesulfonic acid hydrate and its production method and use. The composition of levamlodipine besylate crystallized in pure water and dried is easy for industrial production, has no organic solvent residue, good thermal stability and good dissolution amount in solid-form preparations.

The disclosed invention relates to a low-dose celecoxib oral formulation, and a preparation method therefor, which is characterized in that the strength of the formulation is 60-90% of the original strength of the commercial celecoxib product, and the celecoxib formulation with such reduced strength is bioequivalent to the commercial celecoxib product. The celecoxib formulation can be used for the treatment of mild to moderate pain and mild to moderate chronic pain.

A solid pharmaceutical composition comprising a quinazoline derivative or a medicinal salt thereof, and a preparation method therefor. Specifically, provided is a solid pharmaceutical composition comprising N.sup.6-(1-acryloylpiperidin-4-yl)-N.sup.4-(3-chloro-4-fluorophenyl)-7-methoxyquinazoline-4,6-diamine or a medicinal salt thereof, and a preparation method therefor and use thereof.

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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.

The invention provides ingestible particles comprising a water-swellable or water-soluble polymeric component, a lipid component, and optionally an amino acid, a vitamin and/or a micro-nutrient. The polymeric component may be embedded in the lipid component. The particle may further comprise an inert core and/or an outer layer which rapidly disintegrates after oral ingestion. The invention further provides methods for preparing the ingestible particles and uses thereof.

Modified release formulations of gamma-hydroxybutyrate having improved dissolution and pharmacokinetic properties are provided, and therapeutic uses thereof.

Provided herein are methods for treating progressive familial intrahepatic cholestasis (PFIC) with an ileal bile acid transport (IBAT) inhibitor such as odevixibat, or a pharmaceutically acceptable salt thereof. Such methods can include reducing mean pruritus score, mean serum bile acid concentration, increasing height, normalizing weight, improving sleep, and improving liver parameters.

Provided herein are methods of administering a once-nightly dosage of gamma-hydroxybutyrate after a high-fat meal.

Extended release pyridostigmine dosage forms, suitable for maintaining stable plasma concentrations with reduced or minimized initial burst release/dose dumping of pyridostigmine, are provided. The dosage forms include matrix tablets, gastroretentive tablets, and pellets, the latter being suitable for dosing in capsules, tablets, and sachets, as well as for sprinkling on foodstuffs. The disclosure also provides methods for improving patient compliance by administering once-a-day extended release pyridostigmine bromide dosage forms that provide a superior controlled drug release.

The present application discloses pharmaceutical compositions and methods of treating neurological disorders and seizure disorders with the high dose modified release compositions of huperzine. The pharmaceutical compositions and methods described herein, allow for higher dosing of huperzine, while avoiding rapid peak plasma levels, thereby avoiding the dose-limiting adverse events associated with the immediate release formulations.