Hydrodynamic methods for conformally coating non-uniform size cells and cell clusters for implantation, thus preventing immune rejection or inflammation or autoimmune destruction while preserving cell functionality. A method for conformally coating cells and c clusters with hydrogels that are biocompatible, mechanically and chemically stable and porous, with an appropriate pore cut-off size. The methods of the invention are advantageously reproducible and result in a relatively high yield of coated versus non-coated cell clusters, without compromising cell functionality. Conformal coating devices configured to perform the methods of the invention, methods of optimally utilizing said devices and purifying the coated islets, and coated biomaterials made by said methods.

Described are immediate release oral dosage forms that contain abuse-deterrent features. In particular, the disclosed dosage forms provide deterrence of abuse by ingestion of multiple individual doses. In addition, the disclosed dosage forms provide protection from overdose in the event of accidental or intentional ingestion of multiple individual doses.

The invention relates to pharmaceutical compositions comprising 6-thioguanidine (6-TG) wherein the composition is formulated for release of 6-TG in the distal intestine. Methods for treating a disease or condition of the distal ileum that responds to 6-TG wherein the 6-TG is released in the distal intestine are also disclosed.

The present disclosure provides programmable osmotic-controlled oral compositions providing delayed release of a therapeutically acceptable amount of a drug. The programmable osmotic-controlled compositions of the disclosure provide a lag time that is independent of the presence or absence of food, type of food, pH, gastric emptying, gastric motility, and volume and viscosity of gastric fluid. The compositions of the disclosure can be programmed to provide a desired and precise lag time, and release drug, after the lag time, at a rhythm, e.g., that matches the human circadian rhythm of a condition's symptoms and/or of the individual being treated in the application of the therapy to optimize therapeutic outcome and minimize side effects.

The present invention relates to a composition of a multivitamin, vitamins B and C, and a preparation method therefor, and in particular, to a composition of a multivitamin, vitamins B and C for stimulating gastrointestinal system motility and a preparation method therefor. The composition is suitable for preventing and/or treating the statuses or diseases related to a lack of gastrointestinal motility.

The invention relates to the use of pharmaceutical compositions of the SGLT2 inhibitor, remogliflozin etabonate, to treat primary sclerosing cholangitis (PSC). Methods and compositions associated with the invention can improve or maintain clinical outcomes of PSC symptoms, such as ascites accumulation, hepatic encephalopathy, development of varices, jaundice, variceal bleeding, cholangiocarcinoma, hepatocellular carcinoma, evidence of cirrhosis, and colorectal cancer.

A novel binder is provided. The binder comprises a polyvinyl alcohol-based polymer which has an average saponification value of 85.0 mol % to 89.0 mol % as measured according to JIS K6726 and meets requirement (A): based on data obtained by measurement of the polyvinyl alcohol-based polymer by liquid chromatography, a value represented by formula (3) shown below is 22 or more, wherein the measurement is performed with a liquid chromatography system equipped with a charged aerosol detector and a Thermo Scientific Acclaim™ 300 column (catalog number: 060266, carbon load: 8%, maximum pressure: 4500 psi, particle size: 3 μm, pore size: 300 A, stationary phase: C18, surface area: 100 m.sup.2/g, length: 150 mm, diameter: 4.6 mm, pH: 2.5 to 7.5, material: glass lined tubing) under the measurement conditions described below, wherein the data represent a baseline-normalized intensity over a retention time of 5.0 to 12.0 minutes at a sampling interval of 500 ms, and wherein the value represented by formula (3) is calculated from formulae (1) and (2) shown below, wherein the intensity at a retention time T.sub.i [min] is represented by P.sub.i [pA].
Measurement Conditions Concentration of an aqueous polyvinyl alcohol-based polymer solution: 0.1% by mass Injection volume of the aqueous polyvinyl alcohol-based polymer solution: 2 μL Column temperature: 50° C. Flow rate: 1.0 mL/min Eluent: a mixed solvent of water and methanol Eluent gradient conditions: the ratio of water and methanol in the eluent changes from 95:5 to 15:85 at a constant rate over a run time from minutes 0 to 10; and the ratio of water and methanol in the eluent is constant at 15:85 over a run time from minutes 10 to 15.

Formulae

T.sub.n=Σ(T.sub.i×P.sub.i)/Σ(P.sub.i)  Formula (1)

T.sub.w=Σ(T.sub.i.sup.2×P.sub.i)/Σ(T.sub.i×P.sub.i)  Formula (2)

{(T.sub.w/T.sub.n)−1}×1000  Formula (3)

The present invention relates to pharmaceutical compositions and unit dosage forms comprising a quinoline compound, or a pharmaceutically acceptable salt thereof, which are useful for treatment of a disease, disorder, or condition such as inflammatory diseases, respiratory diseases, organ diseases, viral infections, and sequelae and associated conditions such as acute respiratory distress syndrome.

A preparation containing saxagliptin having improved stability and a method for producing the same are provided. According to an embodiment of the present invention, a preparation containing saxagliptin including a plain tablet part containing one or more first additive agent selected from a group consisting of D-mannitol, lactose, anhydrous lactose, and anhydrous dibasic calcium phosphate, the plain tablet part containing less than 35% by weight of crystalline cellulose with respect to 100% by weight of the plain tablet part, and a film coating part in contact with the plain tablet part and containing saxagliptin, a salt thereof, or a hydrate thereof, and a method for producing the same are provided.

The invention is directed to pharmaceutical compositions such as tablets that exhibit delayed release properties when administered as either whole or half tablets. The invention is also directed to delayed release tablets comprising deferiprone for oral administration, for which twice daily administration is bioequivalent to the same daily dose of an immediate release tablet administered thrice daily. The invention is also directed to methods of making and using the same.