02. May 2017
A Wurster coating fluid bed process to directly produce enteric coated API particles was developed at lab and pilot scale - Generating API with a 3-dimensional structure was critical and was achieved through a wet milling process.
The starting particle size had D50 ~ 90 μm, and the D50 of the resulting coated particles could be as small as 180 μm. -Coated API particles achieved up to 8 h enteric protection in the gastric environment and rapid release in the intestinal environment.
10. April 2017
Abstract The aim of this study was to develop esomeprazole magnesium (EMZ-Mg) enteric-coated pellets and pellet-based tablets, as well as to investigate the effects of pellet size and compression method on acid tolerance, content uniformity, compressibility, and stability of preparations. This study used two types of pellet cores, namely, microcrystalline cellulose (MCC) core with a particle size of 150–300 μm and sucrose core with a particle size of 600–700 μm. Enteric-coated pellets,...
07. February 2017
Abstract Enteric-coated fixed-dose combinations of ezetimibe and lovastatin were prepared by fluid bed coating aiming to avoid the acidic conversion of lovastatin to its hydroxyacid derivative. In a two-step process, sucrose beads were layered with a glass solution of ezetimibe, lovastatin and Soluplus®, top-coated with an enteric layer. The impact of different bead size, enteric polymers (Eudragit L100® and Eudragit L100-55®) and coating time was investigated. Samples were evaluated by...