CA2496044A1 — A process for manufacture of stable oral multiple units pharamceutical composition containing benzimidazoles

USPTO Abstract

This invention relates to process for manufacture of a stable, oral, multiple unit pharmaceutical composition containing high concentration of benzimidazole upto about 40%w/w without the use of micronized benzimidazole, disintegrating agent and fillers. Surfactants in these compositions are in enteric polymer layer and not in contact with benzimidazole. Multiple unit pharmaceutical composition of the invention shows minimum acid degradation in 0.1 N HCI after two h ours a nd pH 6.8 buffer release of more than 85% w/w after 45 minutes. Multiple unit pharmaceutical composition is in the form unagglomerated, uniformly shaped and sized enteric-coated pellets, which are processed continuously or in batches in single equipment such as fluid bed bottom spray processor. The invention involves sequential deposition of a) alkaline material layer on non-pariel seeds to obtain treated non-pariel seeds b) drug layer to obtain drug pellets c) sealant polymer layer to obtain sealed pellets d) enteric polymer layer to obtain enteric coated pellets. The enteric-coated pellets obtained are capable of being filled in smallest size capsule (size 5) for ease of administration and patient acceptance.