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Quality Deviation Handling on the Polymeric Coating of Pharmaceutical Tablets

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Abstract

Purpose

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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Acknowledgements

The authors thank Luiz Gonzaga Camargo Nascimento and Espaço da Escrita – Pró-Reitoria de Pesquisa - UNICAMP - for the language services provided. The authors also thank Close-Up International for the no published data kindly shared for this research and Kerry Inc. for the technical inputs and the granted images.

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Authors and Affiliations

  1. Laboratory of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, State University of Campinas, Rua Candido Portinari 200, Campinas, SP, 13083-871, Brazil

    Erica Costa Fernandes, Viviane Beraldo-de-Araújo & Laura Oliveira-Nascimento

  2. Kerry do Brasil Ltda, Mercedes Benz Avenue, 460 - Distrito Industrial, Campinas, SP, 13054-750, Brazil

    Erica Costa Fernandes & Nathalia Rondolfo

Authors
  1. Erica Costa Fernandes
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  2. Nathalia Rondolfo
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  3. Viviane Beraldo-de-Araújo
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  4. Laura Oliveira-Nascimento
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Corresponding author

Correspondence to Viviane Beraldo-de-Araújo.

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Conflict of Interest

In accordance with our ethical obligation as researchers, we are reporting that Erica Costa Fernandes and Nathalia Rondolfo have an employment relationship with a company that may be affected by the research reported in the enclosed paper. We have in place an approved plan for managing any potential conflicts arising from that involvement.

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Fernandes, E.C., Rondolfo, N., Beraldo-de-Araújo, V. et al. Quality Deviation Handling on the Polymeric Coating of Pharmaceutical Tablets. J Pharm Innov 14, 332–340 (2019). https://doi.org/10.1007/s12247-018-9359-4

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  • DOI: https://doi.org/10.1007/s12247-018-9359-4

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