We helped a client understand the strength of the tablets they were manufacturing to see if it would change during scale-up.
Scale-up Issues
A client had a natural product and was concerned to know if the strength of the tablets and overall manufacturability would change on scale up as their in-house production press heated up.
It is well known that when production presses are used, friction causes the temperature to increase significantly. This increase in temperature can cause issues with a powder's characteristics.
Temperatures in excess of 50°C are common during scale-up using a production press. Issues that occur when temperatures rise are usually only seen during scale-up of tablet manufacturing due to friction. Some of the issues that might occur are the effects of compression speed and the build-up of heat during compaction as these issues are not usually spotted on a smaller scale as the production press is not running for the same amount of time.
Our Case Study Highlights:
- Strength of tablets assessed to see if a change was seen during scale-up.
- Friction from the production press causes the temperature to increase affecting powder characteristics.
- Manufacturing process mimicked so any changes to the powder can be observed.
- A heated die was used to mimic the press temperatures.
- Properties of the powder changes when temperature was increased.
Testing with a Heated Die
We carried out compression tests at dwell times encountered in production to mimic the manufacturing process so that any changes observed with the powder could be documented for the client. This allowed them to make any decisions on how they wanted to move forward and identified whether any changes needed to be made.
The temperature of the die was changed using a heated die, which is controlled to precise temperatures at intervals between 20°C and 60°C. The testing required only ~ 50g of product. We only use small amounts of material to predict the effects of scale-up.
The results from the testing showed how the properties of the tablets changed with changes in press temperature and allowed the company to consider this during scale-up and commercialisation.
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