100% visual inspection of tablets produced with continuous direct compression and coating.

Visual appearance of tablets is an important property for patients. Since the visual appearance is most strongly influenced by the applied coating, this necessitates a high level of process control and homogeneity in the coating process. In recent years, a number of tablet coaters have been developed that can be used in combination with continuous tablet production lines. In this study, 180 kg of tablets were produced using a continuous direct compaction line with a throughput of 25 kg/h. Tablets were consequently subdivided into 12 lots and coated in a semi-batch drum coater directly after compression. For a detailed understanding of intra-lot and lot-to-lot variability, a 100% visual inspection of the tablets was performed using an automatic tablet inspection and sorting machine. All tablets were analyzed from all 6 sides and the unsuitable tablets were sorted out. In the worst lot, only 1 out of around 300 tablets was sorted out due to color mismatch. For some tablets, edge chipping was also observed, which would presumably not be detected during routine sampling. Root causes for the defects could be found in the intentionally chosen set of old punches and in the operation parameters of the coater. Nonetheless, the lot-to-lot variability according to all criteria was very low. Copyright © 2022 Elsevier B.V. All rights reserved.

Citation

Shirin Barimani, Rok Šibanc, Dejan Tomaževič, Robin Meier, Peter Kleinebudde. 100% visual inspection of tablets produced with continuous direct compression and coating. International journal of pharmaceutics. 2022 Feb 25;614:121465

Mesh Tags

Substances

PMID: 35026312

search → result