Process for manufacture of stable oral multiple unit pharmaceutical composition containing benzimidazoles

摘要

This invention relates to a process for the manufacture of a stable, oral, multiple unit pharmaceutical composition containing high concentrations of benzimidazole up to about 35 to 45% w/w, preferably up to about 40% w/w, a disintegrating agent, and one or more fillers. Surfactants in these compositions are in an enteric polymer layer and preferably not in contact with the benzimidazole. The process preferably involves sequential deposition of: (a) an alkaline material layer on non-pariel seeds to obtain treated non-pariel seeds; (b) a drug layer of the benzimidazole to obtain drug pellets; (c) a sealant polymer layer to obtain sealed pellets; and (d) an enteric polymer layer to obtain enteric-coated pellets.