We have been working with a client to investigate the effects of API particle size on dissolution. We suggested an outline protocol to supply the client with the required tablets.
Our client’s key requirements were to produce compacts at a set tensile strength using production tooling to replicate the production process. The compaction simulator can be used to prepare small batches of compacts for laboratory testing.
It was important for us to replicate the production process, so all the settings were sent by the client to enable us to replicate their production press.
Our Case Study Highlights:
The test formulation is compressed using a compaction profile this can be theoretical or based upon production press movement (sine wave or replicated profile). The speed is controlled by setting the duration of the compaction profile. This is usually specified by the client.
Compacts were made at the required target settings. A small number of tablets will be checked for tensile strength and once the optimum settings are confirmed, the compacts will be made.
10 tablets were placed into labelled bags to allow traceability of the point of manufacture. The customer was also sent the raw data for each of the compacts made, so tensile strength can be checked as well as weight. The tablets were sent back to the customer to allow them to conduct the relevant dissolution testing. The project was completed within the customers timescale.
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