Continuous twin screw granulation - An advanced alternative granulation technology for use in the pharmaceutical industry

Abstract

Hot melt extrusion has been an exciting technology in the pharmaceutical field owing to its novel applicability. Twin-screw granulation presents a great potential and offers many advantages relative to conventional granulation processes. Different twin-screw granulation techniques, such as twin-screw dry granulation, twin-screw wet granulation, and twin-screw melt granulation, are currently being developed as robust and reproducible granulation processes. The competence of twin-screw granulation as a continuous manufacturing process has contributed to its suitability as an alternative granulation option within the pharmaceutical industry. In this article, different types of twin-screw granulation techniques were discussed. In addition, the screw elements, scale-up process, continuous twin-screw granulation which involves process analytical tools, and excipients were explored. This economical, industrially scalable process can be automated for continuous manufacturing to produce granules for the development of oral solid dosage forms. However, extensive research using process analytical tools is warranted to develop processes for the continuous manufacture of granules.

Keywords: Continuous manufacturing; Hot melt extruder; Screw elements; Twin-screw dry granulation; Twin-screw melt granulation; Twin-screw wet granulation.