PRODUCTION OF SUSTAINED RELEASE ENTERIC COATING PREPARATION

摘要

PROBLEM TO BE SOLVED: To obtain a sustained release enteric coating preparation having excellent appearance, strength and safety. SOLUTION: An enteric substance having an average particle diameter of <=10μm and pH or 5-8 (e.g. hydroxypropyl methyl cellulose acetate succinate) is applied to the surface of a formed solid material containing a drug-active substance while spraying a wax in melted state. The spraying of wax melt is carried out by a conventional rotary granulator while fluidizihng the formed solid material and the addition of the fine powder of the enteric substance is performed by manual operation or with a powder-supplying and scattering apparatus. There is no particular restriction on the mixing weight ratio of the meltable substance and the enteric substance. It has high rate of dissolution of the drug component in the 2nd liquid of the Japanese Pharmacopoeia. The sustained release effect can be imparted in addition to the enteric property without applying an additional coating layer simply by decreasing the weight of the enteric substance relative to the meltable substance.