Study of Production of Fine Globular Granules for Oral Solid Dosage Form in the Unique Multi-functional Rotor Processor

Abstract

In pharmaceutical field, technology for manufacturing fine globular granules with a narrow size of particle distribution (100–200 μm) are crucially important in enhancing patient adherence and controlling drug release from functional granules, e.g., sustained release or taste-masking granules. A unique multi-functional rotor processor, “Granurex®” (GX, Freund, Japan), facilitate manufacturing the fine globular granules. In this study, we examined the relationships between operational conditions of the multi-functional rotor processor and the physical characteristics of the obtained granules, and optimized the manufacturing conditions for producing fine globular granules. In addition, we developed highly drug-loaded fine globular granules which composed of almost drug substance (>97%). We believe fundamental information obtained in this study will be important for the development of processes for the facile manufacture of fine globular granules of various drugs.