Abstract: The invention enables direct oral granules enabling controlled release of magnesium, having both extended-release and non-extended-release fractions. The granules include extended-release particles having a magnesium-containing core and a lipophilic coating, with at least the cores of these extended-release particles having a mandated abrasion resistance which is determined by means of vibration screening over a period of 60 minutes and which allows these cores to be melt-coated, more particularly melt-coated with lipids in a fluidized bed. The invention further provides a method for characterizing the magnesium-containing cores, and also a process for producing the extended-release particles by means of hotmelt coating.

Abstract: The invention relates to coated particles with a taste-masked drug substance. The particles comprise a core with a melt-agglomerated active pharmaceutical ingredient (API), optionally a thermolabile API, and a coating comprising a triglyceride and a surfactant. The particles exhibit immediate drug release and a storage-stable release profile. Moreover, the invention provides a hot-melt granulation and hot-melt coating method for manufacturing such coated particles, and pharmaceutical compositions comprising the coated particles. The method allows the granulation of APIs with small particle sizes (e.g., mean particle size below 150 ?m, or even below 100 ?m or 50 ?m) into core particles, as well as coating said core particles, at moderate temperatures, thereby preventing the degradation of thermolabile active pharmaceutical ingredients.

Abstract: The present invention relates to novel pharmaceutical compositions in powder or granule form which comprise a low-dose drug attached to a water-soluble carrier, such as by adhesion or adsorption. The compositions further comprise an oily liquid which facilitates the attachment of the active ingredient to the carrier particles. Moreover, the invention provides methods for preparing such powders or granules, and compressed tablets incorporating them.