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Journal of Pharmaceutical Innovation

, Volume 14, Issue 4, pp 332–340 | Cite as

Quality Deviation Handling on the Polymeric Coating of Pharmaceutical Tablets

  • Erica Costa Fernandes
  • Nathalia Rondolfo
  • Viviane Beraldo-de-AraújoEmail author
  • Laura Oliveira-Nascimento
Original Article
  • 102 Downloads

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.

Keywords

Film coating Tablets Quality control Pan coater Troubleshooting 

Notes

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.

Compliance with Ethical Standards

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.

References

  1. 1.
    Felton LA. Mechanisms of polymeric film formation. Int J Pharm. 2013;457(2):423–7.CrossRefGoogle Scholar
  2. 2.
    Bose S, Bogner RH. Solventless pharmaceutical coating processes: a review. Pharm Dev Technol. 2007;12(2):115–31.CrossRefGoogle Scholar
  3. 3.
    Porter S, Sackett G, Liu L. Development, optimization, and scale-up of process parameters: pan coating. In: Qiu Y, Chen Y, Zhang GGZ, Yu L, Mantri RV, editors. Developing solid oral dosage forms. 2nd ed. Boston: Academic Press; 2017. p. 953–96.CrossRefGoogle Scholar
  4. 4.
    Bruce HF, Sheskey PJ, Garcia-Todd P, Felton LA. Novel low-molecular-weight hypromellose polymeric films for aqueous film coating applications. Drug Dev Ind Pharm. 2011;37(12):1439–45.CrossRefGoogle Scholar
  5. 5.
    Felton LA, McGinity JW. Adhesion of polymeric films to pharmaceutical solids. Eur J Pharm Biopharm. 1999;47(1):3–14.CrossRefGoogle Scholar
  6. 6.
    Felton LA, Porter SC. An update on pharmaceutical film coating for drug delivery. Expert Opin Drug Deliv. 2013;10(4):421–35.CrossRefGoogle Scholar
  7. 7.
    Chen W, Chang SY, Kiang S, Marchut A, Lyngberg O, Wang J, et al. Modeling of pan coating processes: prediction of tablet content uniformity and determination of critical process parameters. J Pharm Sci. 2010;99(7):3213–25.CrossRefGoogle Scholar
  8. 8.
    Yu LX. Pharmaceutical quality by design: product and process development, understanding, and control. Pharm Res. 2008;25(4):781–91.CrossRefGoogle Scholar
  9. 9.
    Eserian JK, Lombardo M. Comprimidos revestidos por película: tipos de defeitos e suas causas. Rev Eletrôn Farm. 2014;11(3):16.CrossRefGoogle Scholar
  10. 10.
  11. 11.
    ANVISA, Consulta a produtos registrados – Anvisa. 2018. [Online]. Available: http://portal.anvisa.gov.br/consulta-produtos-registrados. Accessed: 28-May-2018.
  12. 12.
    Béchard SR, Quraishi O, Kwong E. Film coating: effect of titanium dioxide concentration and film thickness on the photostability of nifedipine. Int J Pharm. 1992;87(1–3):133–9.CrossRefGoogle Scholar
  13. 13.
    Obara S, McGinity JW. Properties of free films prepared from aqueous polymers by a spraying technique. Pharm Res. 1994;11(11):1562–7.CrossRefGoogle Scholar
  14. 14.
    Koo OMY, Fiske JD, Yang H, Nikfar F, Thakur A, Scheer B, et al. Investigation into stability of poly(vinyl alcohol)-based Opadry® II films. AAPS PharmSciTech. 2011;12(2):746–54.CrossRefGoogle Scholar
  15. 15.
    Kalbag A, Wassgren C, Sumana Penumetcha S, Pérez-Ramos JD. Inter-tablet coating variability: residence times in a horizontal pan coater. Chem Eng Sci. 2008;63(11):2881–94.CrossRefGoogle Scholar
  16. 16.
    McGinity JW, Felton LA. Aqueous polymeric coatings for pharmaceutical dosage forms drugs and the pharmaceutical sciences. 3rd ed. vol. 210. New York; 2008.Google Scholar
  17. 17.
    Felton LA. Characterization of coating systems. AAPS PharmSciTech. 2007;8(4):258–66.CrossRefGoogle Scholar
  18. 18.
    Muliadi AR, Sojka PE. A review of pharmaceutical tablet spray coating. Atomization Sprays. 2010;20(7).CrossRefGoogle Scholar
  19. 19.
    Nayak BK, Elchidana P, Sahu PK. A quality by design approach for coating process parameter optimization. Indian J Pharm Sci. 2017;79(3):345–52.CrossRefGoogle Scholar
  20. 20.
    Yu LX, Amidon G, Khan MA, Hoag SW, Polli J, Raju GK, et al. Understanding pharmaceutical quality by design. AAPS J. 2014;16(4):771–83.CrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2018

Authors and Affiliations

  1. 1.Laboratory of Pharmaceutical Technology, Faculty of Pharmaceutical SciencesState University of CampinasCampinasBrazil
  2. 2.Kerry do Brasil LtdaCampinasBrazil

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