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tablet hardness
Hi, Thanks for the query! Several factors influence the hardness of tablets including but not limited to the composition of formulation (ingredients), type of binder used, binder fluid temperature, moisture content (%w/w), and morphology of the granules. Most of the Domperidone formulations availablRead more
Hi,
Thanks for the query!
Several factors influence the hardness of tablets including but not limited to the composition of formulation (ingredients), type of binder used, binder fluid temperature, moisture content (%w/w), and morphology of the granules. Most of the Domperidone formulations available in the market are formulated using wet granulation approach with Povidone/maize starch as the binder.
It will be helpful to support you if you can give more details of your Domperidone formulation:
You mentioned that the tablet hardness when tested at the CMO (in Asia) was 50-60N but the same batch of tablets showed lower hardness i.e., about 35N when tested in the EU. The probable root cause for reduced hardness over time is due to elevated humidity levels which may be attributed to the absorption of moisture into the tablets causing bond disruption and loss in tablet strength. In some cases loss of moisture could also account for reduction in tablet hardness over time or on storage. I recommend you to check the moisture content of the tablets at the CMO (in Asia) and compare it against the moisture content of the batches on arrival in the EU? This may help.
We can increase tablet hardness by controlling the critical process parameters (for example, increasing the compression force and reducing rotation speed) and critical quality attributes (for example, reducing the tablet thickness.
As I mentioned earlier, I can be of help if you can give more details of your issue(s).
Thanks,
Dr. Shashi Rudrangi