Quality Deviation Handling on the Polymeric Coating of Pharmaceutical Tablets

This work aimed to map and discuss tablet-coating choice, quality deviations of this process, and corrective actions taken by Research and Development (R&D) teams from pharmaceutical industries.

Methods

A cross-sectional study of polymeric film coating was conducted in Brazil: a questionnaire based on literature information was sent to R&D divisions from several different companies that produce coated tablets in the country, which focused on the main type of coating systems used, most common quality issues, corrective action to each nonconformity, and the main influences in the choice of the coating system.

Results

The most used film coating systems are hydroxypropylmethylcellulose + Polyethylene glycol (HPMC/PEG) and polyvinyl alcohol + PEG (PVA/PEG), and the most common non-conformities are orange peel, picking sticking, chipping, and peeling. The main suggestive corrective actions include temperature control, pan speed, spray, and pressure rate. All results were analyzed by us according to literature and authors’ expertise. Finally, stability was the main factor that influences the selection of a coating system.

Conclusion

These data brought knowledge on routine industrial practices, when real deviations happen and matter, with no reports found in the literature.

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