A dosage form contains a biologically active ingredient for treating or preventing a disease in the animal or human body, where treatment or prevention requires release of 50% or more of the biologically active ingredient in the small intestine within the pH range from 3 to 5.5. The dosage form contains: a) a core, containing the biologically active ingredient; b) an intermediate coating layer (ICL) onto or above the core, containing an alkaline agent; and c) an enteric coating layer (ECL) onto or above the ICL, containing an enteric polymer. The relation of alkaline agent to enteric polymer is 5 to 95% when calculated by the formula:

[00001]$\frac{\mathrm{quantity}\mathrm{of}\mathrm{alkaline}\mathrm{agent}\mathrm{in}\mathrm{grams}\mathrm{in}\mathrm{the}\mathrm{ICL}\times 100}{\begin{array}{c}(\mathrm{quantity}\mathrm{of}\mathrm{alkaline}\mathrm{agent}\mathrm{in}\mathrm{grams}\mathrm{in}\mathrm{the}\mathrm{ICL}+\\ \mathrm{quantity}\mathrm{of}\mathrm{enteric}\mathrm{polymer}\mathrm{in}\mathrm{grams}\mathrm{in}\mathrm{the}\mathrm{ECL}).\\ \mathrm{The}\mathrm{ICL}\mathrm{has}a\mathrm{thickness}\mathrm{of}\mathrm{about}22\mu m\mathrm{or}\mathrm{more}.\end{array}}$

The present invention relates to a pharmaceutical dosage form comprising an active ingredient such as methotrexate or a pharmaceutically acceptable salt thereof, in particular in the form of pellets, such as multiparticulates, mini-tablets or granulate. It further relates to oral dosage forms for which saturation kinetics limits the oral use of higher dosages of active ingredients.

The invention relates to a pharmaceutical composition comprising elafibranor, GFT1007 or a pharmaceutically acceptable salt of elafibranor or of GFT1007, for use to treat primary biliary cholangitis (PBC) without provoking and/or worsening at least one adverse event associated to PBC.

The invention relates to a pharmaceutical composition comprising elafibranor, GFT1007 or a pharmaceutically acceptable salt of elafibranor or of GFT1007, for use to treat primary biliary cholangitis (PBC) without provoking and/or worsening at least one adverse event associated to PBC.

The present invention relates to pharmaceutical compositions comprising Ibrutinib. More particularly, the present invention relates to a tablet composition comprising Ibrutinib and one or more pharmaceutically acceptable excipients and process for preparing such compositions.

A dosage form comprising a tablet core and one or more discontinuous coated regions in various configurations on the surface of the dosage form is disclosed. A method for making the dosage form is also disclosed.

Provided is a device for granulating, agglomerating, pelletising, drying and/or coating, the device including a swirl chamber, a distribution chamber, wherein the swirl chamber is separated from the distribution chamber by a base and wherein a powder to be granulated or a powder mixture to be granulated is presented in the swirl chamber, the device further including at least one agitator for thoroughly mixing the powder to be granulated or the powder mixture to be granulated and at least one addition device for a liquid, wherein the base is designed in several parts and at least one base part is horizontally and/or vertically displaceable, with the result that that the base becomes a distributor plate. Also provided is a method for granulating, agglomerating, pelletising, drying and/or coating using such a device and a base suitable for use as a distributor plate in a convective drying apparatus.

The disclosure provides cysteamine salt and cystamine formulations comprising enteric coatings. The disclosure also provides composition for use in treating diseases and disorders that can be treated with cysteamine.

The presently disclosed subject matter relates to a composition and method of using the composition for oral delivery of a bioactive agent to a subject. More particularly, the presently disclosed subject matter relates to a composition comprising an effective amount of at least one bioactive agent layered over a substrate and a method of reducing zoonotic infectious disease by administering the composition to a subject. The presently disclosed subject matter further relates to a method of preparing the composition.

The present invention relates to a colonic purgative composition and a preparation method therefor, and more specifically, to a colonic purgative composition comprising sodium picosulfate, potassium sulfate and magnesium sulfate, and a preparation method therefor.