Twin-Screw Extruder in Pharmaceutical Industry: History, Working Principle, Applications, and Marketed Products: an In-depth Review

Abstract

Twin-screw extruder (TSE), originally built and developed for plastic and rubber industries approximately 100 years ago, is now slowly but steadily gaining popularity in the pharmaceutical industry for manufacturing various dosage forms. TSE has proven to be a robust, multi-purpose, and environment-friendly instrument that has displayed the potential to revolutionize the manufacturing processes in the pharmaceutical industry. Having the facility to arrange process analytical tools at various segments, TSE has given an opportunity to the manufacturers for monitoring the quality of the product at critical stages of the manufacturing process and thus helped in shifting the focus of the pharmaceutical industry from “end product testing” to “building the quality at each stage.” The broad applicability of TSE in formulating ranges of dosage forms is been evident from the large numbers of research papers (more than 100) that have been published and marketed formulations that have entered the market in the last 10 years. The published research papers have demonstrated the applicability of TSE in preparing a variety of dosage forms and intermediates such as pharmaceutical salts, co-crystals, solid dispersions, transdermal gels, solid lipid nanoparticles, and ready to compressed granules.