Drug formulation is becoming increasingly complex. Poorly soluble APIs, personalized medicines, and advanced oral dosage forms require production methods that are scalable, reproducible, and precise. Continuous twin-screw granulation (TSG) offers a solution, enabling efficient, controllable, and modular manufacturing of solid dosage forms.
In the past few years, pharmaceutical manufacturing has seen rapid evolution. The post-COVID landscape has accelerated demand for flexible, high-throughput, and resilient processes, driving innovations in continuous TSG and hot-melt extrusion (HME). This retrospective highlights how recent advancements are improving efficiency, reproducibility, and patient-focused outcomes across oral dosage forms.
Key benefits of continuous TSG include:
Process Efficiency and Flexibility: Continuous operation reduces downtime, accelerates scale-up, and supports rapid response to changing demands.
Reproducibility and Process Control: Integration with process analytical technology (PAT) enables real-time monitoring of granule properties, ensuring consistent quality.
Modular Scalability: Lab-scale experiments translate directly to commercial production, thanks to consistent extruder geometry and modular design.
Granule Optimization: Fine-tuning parameters like screw configuration, feed rate, and barrel temperature allows control over particle size, density, and dissolution profiles.
Recent innovations have expanded TSG applications. Combining TSG with HME enables advanced drug delivery forms such as bilayer tablets and mucoadhesive films. These approaches enhance bioavailability, allow controlled or sequential release of APIs, and support non-invasive administration strategies. The integration of additive manufacturing and 3D printing with HME offers precision fabrication for personalized therapies, tailoring drug release profiles and dosage geometries.
Advanced process control, including model predictive control (MPC), now allows real-time adjustment of key variables such as moisture, API concentration, and throughput. When paired with PAT systems, MPC ensures consistent granule properties and supports robust, transferable production processes.
The versatility of TSG and HME supports a wide range of excipients, APIs, and dosage forms—from immediate-release tablets to solubility-enhanced dispersions and abuse-deterrent formulations. Continuous, modular manufacturing also enables efficient processing of sensitive or high-value materials, reducing waste and accelerating development timelines.
Thermo Fisher Scientific’s Pharma series extruders, combined with analytical and support tools, provide a comprehensive platform to address these challenges. Researchers and manufacturers can leverage these technologies to streamline formulation, de-risk scale-up, and develop robust, patient-centric dosage forms.
Continuous twin-screw granulation and HME are now integral to modern pharmaceutical development. By combining scientific insight with precise, scalable technology, formulators can achieve faster development, improved reproducibility, and better patient outcomes—all while staying agile in an evolving pharmaceutical landscape.
Download the full article to explore how continuous TSG is shaping the next generation of drug development.
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