Latent Moisture Content Leading to Hydrolysis in Stability Batches

Issue: film-coated tablets packed in blisters: out of specification for hydrolysis products after 9 and 12 months stability storage for the early registration batches.

Cause: Relequa®Moisture Profiling™ showed that there was residual moisture in the early batches.

Cost: several Quality Control laboratory investigations; unnecessary further development in R&D lab; delayed regulatory approval and launch of product.

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Visualizing Moisture Release Activity

Issue: Follow-up investigation on release of moisture from the problem stability batch in case study Latent Moisture Content Leading to Hydrolysis in Stability Batches.

Outcome: Exposure of the tablet matrix under the film coat shows faster release of moisture.

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Elucidation of Analytical Error Due to Moisture Trapped in a Tablet Matrix

Issue: active ingredient failing content assay because of absorption of moisture by a sample awaiting assay.

Cause: Relequa®Moisture Profiling™ showed that the moisture status of the stability batches had changed due to moisture ingress. This resulted in a weight gain that introduced an error into the content assay calculation.

Cost: internal investigations into stability results; possible implications for the approved shelf-life of the product; external specialist resource for testing and reporting; delay in manufacture until cause of problem resolved.

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Re-Packing Investigation

Issue: Repacking of tablets and capsules into dosette boxes. Is there an increased risk in patient safety?

A prospective study was performed with Relequa®Moisture Profiling™ showing the change in the moisture status over a very short period of epilepsy tablets following re-packing in polythene sachets

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