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Continuous twin-screw wet granulation without adding granulation liquid
Dániel Fekete1, Richárd Ferdinánd Tóth1, Zsombor Kristóf Nagy1
1Department of Organic Chemistry and Technology, Faculty of Chemical Technology and Biotechnology, Budapest University of Technology and Economics, Műegyetem rkp. 3., H-1111 Budapest, Hungary.
Summary
A novel wet granulation method uses potassium sodium tartrate tetrahydrate (PST) to create an in-situ liquid, enabling energy-efficient, continuous pharmaceutical manufacturing with scalable, high-quality tablet production.
Area of Science:
- Pharmaceutical Science
- Chemical Engineering
- Materials Science
Background:
- Granulation is crucial for solid pharmaceutical development.
- Continuous manufacturing is increasingly adopted in the pharmaceutical industry.
- Existing wet granulation methods often require significant cooling and liquid addition.
Purpose of the Study:
- To investigate a new, liquid-free wet granulation technique for continuous powder-to-tablet manufacturing.
- To assess the operational feasibility and scalability of this novel granulation method.
- To develop a more energy-efficient continuous pharmaceutical production system.
Main Methods:
- A new wet granulation method was developed using potassium sodium tartrate tetrahydrate (PST) as an excipient.
- PST releases its water of crystallization upon heating, acting as an in-situ granulation liquid.
- The process was integrated into a fully continuous powder-to-tablet line and scaled from 0.5 to 10 kg/h.
Main Results:
- The novel wet granulation technique produced granules with excellent flowability.
- Immediate-release tablets manufactured via this method exhibited high breaking force (>100 N) and tensile strength (>1.5 MPa).
- The continuous setup demonstrated successful scalability with consistent process parameters.
Conclusions:
- This liquid-free wet granulation method offers an energy-efficient alternative for continuous pharmaceutical manufacturing.
- The use of PST enables in-situ liquid formation, simplifying the process and reducing cooling requirements.
- The technology is scalable and produces high-quality granules and tablets suitable for pharmaceutical applications.
