Continuous granulation offers many opportunities to overcome the challenges of traditional batch production of tablets and capsules. It’s efficient, inherently scalable and has advanced to a point of true reliability and flexibility. It can also be implemented all at once, or a little at a time.
Consider the many ways below that twin-screw granulation can help you boost your oral drug formulation processes.
Continuous granulation – the future of oral drug manufacturing
Most oral drugs are available as tablets and capsules because it’s easy to store and consume medicine in this form. Traditionally pharmaceutical manufacturers have created such oral dosage forms in batches. Now, many are considering a continuous manufacturing process. Why? How?
Why continuous granulation?
Small, medium and large batches of pharmaceuticals are prone to variations and expensive delays:
- Manual steps invite human error
- Transportation from one step to the next may cause material segregation
- Time-consuming disassemby and cleaning delay production
- Production scale-up requires bigger, more expensive equipment
Continuous manufacturing reduces/eliminates the issues above and makes subsequent tableting easier. With online monitoring, continuous manufacturing also enables drugs to be released as soon as they’re manufactured – there’s no waiting on analytical results before products can ship.
Today, continuous manufacturing is no longer an “untested” process. Companies have gained experience and proven that it can be successfully implemented with a significant positive impact.
Set up continuous manufacturing so it really works!
Establishing a successful continuous twin-screw granulation (TSG) process can be tricky. Download this free whitepaper with expert advice for process design, development and scale-up for pharmaceuticals. The paper even includes information about how the parameters of twin-screw extruders can impact scale-up of a continuous process.
Consider twin-screw extruders for continuous mixing and granulation
Read the Equipment and Processing Report on PharmTech.com about the emerging use of twin-screw extruders for continuous wet granulation. Twin-screw granulators are already being used commercially for continuous granulation of oral solid-dosage (OSD) pharmaceuticals and mixing of wet gelatin mass for soft-gel capsules. The report, from August 15, 2018, covers a description of the instrument type, key advantages, process analytical technology and continuous gel-mass mixing.
Batch Processing – it’s OK to let go
It can seem daunting move away from batch processing which has served pharmaceutical manufacturers well for so many years. Many questions arise when looking at a new process:
- Will I lose flexibility for producing multiple products?
- How will I characterize the homogeneity of my mix?
Flexibility. There is great flexibility in continuous manufacturing. Switching production from one drug product to another is possible with quick, easy replacement of product contact parts to eliminate the risk of cross-contamination. And modularity allows the granulator to be easily set up for a different product’s required process steps.
Characterizing homogeneity: Online analytical technologies (e.g., near-infrared or NIR spectroscopy) allow manufacturers to characterize homogeneity and other material properties at any time in the process. So the ability to characterize properties is maintained in continuous manufacturing via online analyzers.
How to implement continuous granulation?
Quantum leap vs Slow migration…
The pharmaceutical manufacturing process can be continuously operated – from mixing of initial powders to packaging of final tablets. This can be done with a twin-screw extruder and subsequent drying in a fluidized bed system.
So the starting point can be small – a stand-alone twin-screw granulator. If more granules are needed, simply run the instrument continuously for a longer period of time.
Modules can be added along the way, expanding the parts of the process that operate continuously:
- Dosing systems
- Tablet presses
A full continuous system can be grown module by module, or be put into place all at once with an entire processing line installation. Such installations often take place by scale-out or scale-up.
Scale-out: creating other small copycat systems in different locations or simply run the process on one instrument scale for a longer time period
Scale-up: transferring the process to high volume, high speed production systems
|Stand-alone granulator||Modules (dosing systems, dryer, tablet press)||Full continuous system|
Thermo Scientific pharmaceutical twin-screw extruders are designed to bring you the benefits of continuous manufacturing – whatever your pace may be.
We offer 11 mm, 16 mm and 24 mm pharmaceutical extruders that can stand alone or be partially or fully integrated into your manufacturing process. Systems are available for dual twin-screw granulation (TSG) or hot melt extrusion (HME) processes, or for dedicated TSG. Modules expand their use throughout the process from raw materials to tableting.