2022 年 59 巻 9 号 p. 455-458
Content uniformity of Active Pharmaceutical Ingredients (APIs) is one of the most important quality issue in drug products and it can be a particularly serious in case of low content formulations. CTS-SGR (Continuous Spray Granulator) is a continuous granulator that produces granules directly from raw materials dissolved or dispersed in a liquid, so that the product granules will have a uniform composition if the ingredients in the spray solution is uniformly dissolved or dispersed. Here, we report the application of CTS-SGR to the production of granules containing low API content. Especially, mini-tablets could be successfully produced from the granules with less variation in content.
