Research In The Field of Transferring The Technology of «ORTOF-S» Tablets Into Production

Abstract

This study aims to transfer the technology for producing "Ortof-S" tablets, an innovative analgesic formulation, into industrial-scale production. Utilizing wet granulation within a high-shear mixer, the research investigates critical factors affecting granulation, such as mass, mixing time, and drying temperature, to optimize production parameters. Materials include diclofenac sodium, omeprazole, and various excipients. Laboratory testing established foundational parameters, while industrial tests examined granulation under scaled conditions to enhance bulk density, flowability, and moisture content. Key results demonstrate that higher mass and prolonged mixing significantly improve granulate quality, enabling consistent tablet strength and bioavailability. The study recommends specific granulation protocols for varying masses, providing a framework for scaling production while ensuring tablet efficacy. This research advances the pharmaceutical industry by establishing efficient methodologies for scaling up innovative solid dosage forms, supporting industrial implementation and alignment with GMP standards for quality control.