This invention relates to coated digestive enzyme preparations and enzyme delivery systems and pharmaceutical compositions comprising the preparations. This invention further relates to methods of preparation and use of the systems, pharmaceutical compositions and preparations to treat persons having ADD, ADHD, autism, cystic fibrosis and other behavioral and neurological disorders.

The present invention relates to a granular pharmaceutical composition obtained by coating a nucleus with: (1) a layer containing a material having a damp-proofing function, and (2) a drug layer containing linaclotide, a pharmaceutically acceptable salt, or a hydrate thereof, and (3) a layer containing a material having a damp-proofing function. Also, the present invention relates to a method for manufacturing the granular pharmaceutical composition obtained by coating the nucleus with (1) the layer containing the material having a damp-proofing function, (2) the drug layer containing the linaclotide, the pharmaceutically acceptable salt, or the hydrate thereof, and (3) the layer containing the material having a damp-proofing function.

An improved solubility of a pharmaceutical composition or formulation containing a large amount of 9-ethyl-6,6-dimethyl-8-(4-morpholin-4-yl-piperidin-1-yl)-11-oxo-6,11-dihydro-5H-benzo[b]carbazole-3-carbonitrile or a salt thereof can be achieved by forming granules of the compound or salt thereof and allowing the granules to be present together with a disintegrating agent.

The disclosure provides new, stable, pharmaceutically acceptable amorphous solid dispersions of 1-(4-fluoro-phenyl)-4-((6bR,10aS)-3-methyl-2,3,6b,9,10,10a-hexahydro-1H,7H-pyrido[3′,4′:4,5]pyrrolo[1,2,3-de]quinoxalin-8-yl)-butan-1-one, together with methods of making and using them, and pharmaceutical compositions comprising them.

A method includes combining nicotine with a liquid carrier to form a liquid mixture and spray drying the liquid mixture to form a first plurality of particles. The first pluralities of particles are then milled to form a second plurality of particles.

The present invention relates to a solid composition comprising a PYY compound and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid and their use in medicine.

Extended release, abuse deterrent dosage forms comprising crush-resistant controlled-release particles that provide abuse deterrent properties to the dosage forms. The crush-resistant controlled-release particles, which comprise plastic/elastic polymers and at least one active pharmaceutical ingredient (API) or a pharmaceutically acceptable salt thereof, are prepared by a hot melt extrusion process.

The present invention relates to a solid oral dosage form comprising naproxen and vitamin B1. Preferably, it is a solid oral dosage form for use in the treatment of pain such as low back pain. It is a fixed-dose combination (FDC) which increases patient compliance. The method of preparing such solid oral dosage form comprises the preparation of naloxone granules, the intragranular addition of vitamin B1 and optionally the extragranular addition of other B-vitamins such vitamin B6 and vitamin B12.

A process for the preparation of oral delayed release solid formulations and the formulations obtainable from said process are now described. Said process comprises the following steps: a) melting at least one lipid; b) spraying said at least one melted lipid on at least one active ingredient in the form of a moving powder; c) cooling the resulting mixture; d) optional granulation of the mixture; e) optional compression of the mixture.

The object of the present invention is the use of arginine and/or a salt thereof as a stabilizer of an acid active ingredient having a pKa of between 1 and 5 such as S-Adenosyl-L-methionine, and an edible formulation comprising an acid active ingredient, arginine and/or a pharmaceutically acceptable salt thereof, and at least one physiologically acceptable excipient.