Wet granulation is still an important process for tablet manufacturing, and we are always looking to add new predictive methods to sit alongside compaction simulation.
Merlin can characterise formulations at an early stage of development to help save time and money.
Wet granulation is still an important process for tablet manufacturing, and we are always looking to add new predictive methods to sit alongside compaction simulation.
Granulation end point determination
This test assesses the change in formulation behaviour with increasing amounts of granulating fluid. As a powder blend is mixed a torque is generated and the torque generated is directly related to the consistency of the wet powder mass in the bowl of the machine. The test will use standard methods set up based on mass of powder in the bowl of the machine at 50 rpm speed.
Mass of sample will depend on the bulk density of the sample as the measuring bowl needs a volume of around 50 ml.
Testing: What are the benefits?
The MTR chamber holds around 50 ml volume of powder. Using a small batch size, we are able to run investigations to successfully assess the changes in the powder as it wets and determine the optimum granulation fluid proportions for the formulation.
We can assess the change in formulation behaviour with differing amount of granulating fluid. The binder can be present in dry form in the blend and water used as the granulating fluid or incorporate the binder in the granulating fluid.
We can also assess the sensitivity to mixing time to determine if this has an effect on product quality. Granulating fluid is added at the start and the effects of mixing time of the formulation is determined.
Resistance to overmixing
This test explores the sensitivity to mix time. An amount of granulating fluid is added to the powder mass at the start of the test and the torque increase on mixing is measured. Binder ratio can be determined from the multiple addition test or supplied prior to testing. One test will be performed at 50 rpm using water as a granulating fluid unless otherwise requested.
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