Discussion about the topics related to pharmaceutical research and development (R&D).
This is Seddeeq Mohammed from sudan working in hikma pharmaceutical Sudan.
I am having an issue regarding sitagliptin 50mg and Metformin 1000 mg formulation (Janumet formula)… Tablets are very weak and Friability 0.6% hardness NMT 25 Kp… Which causes splitting, capping and broken edges during coating process.
Is there any chance to solve this issue??
Review the binder quantity.
Respected sir,
The problem is with the insufficient quantity of Binder added to the formulation or over dryness of the granules which lead to fail friability and cause capping and splitting of tablets.
Ensure that there is no capping or broken edges at the time of compression, because concave punches will lead to these kind of problems.
Also ensure whether avg weight of tab / granules filled in cavity doesn’t exceeds its limit. Because once it exceeds, tab may get elongate will lead to cracks over the surface of the tablet.
Dear Mr.,
I believe that the amount of moisture is not enough to promote a good compaction of your granules. If possible, increase the moisture content of the granules.