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Evaluating the effect of coating equipment on tablet film quality using terahertz pulsed imaging.
Eur J Pharm Biopharm. 2013 Nov; 85(3 Pt B):1095-102.EJ

Abstract

In this study, terahertz pulsed imaging (TPI) was employed to investigate the effect of the coating equipment (fluid bed and drum coater) on the structure of the applied film coating and subsequent dissolution behaviour. Six tablets from every batch coated with the same delayed release coating formulation under recommended process conditions (provided by the coating polymer supplier) were mapped individually to evaluate the effect of coating device on critical coating characteristics (coating thickness, surface morphology and density). Although the traditional coating quality parameter (weight gain) indicated no differences between both batches, TPI analysis revealed a lower mean coating thickness (CT) for tablets coated in the drum coater compared to fluid bed coated tablets (p<0.05). Moreover, drum coated tablets showed a more pronounced CT variation between the two sides and the centre band of the biconvex tablets, with the CT around the centre band being 22.5% thinner than the top and bottom sides for the drum coated tablets and 12.5% thinner for fluid bed coated tablets. The TPI analysis suggested a denser coating for the drum coated tablets. Dissolution testing confirmed that the film coating density was the drug release governing factor, with faster drug release for tablets coated in the fluid bed coater (98 ± 4% after 6h) compared to drum coated tablets (72 ± 6% after 6h). Overall, TPI investigation revealed substantial differences in the applied film coating quality between tablets coated in the two coaters, which in turn correlated with the subsequent dissolution performance.

Authors+Show Affiliations

School of Pharmacy, University of Otago, Dunedin, New Zealand; TeraView Ltd., St. John's Innovation Park, Cambridge, UK; Cavendish Laboratory, University of Cambridge, Cambridge, UK.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23563103

Citation

Haaser, Miriam, et al. "Evaluating the Effect of Coating Equipment On Tablet Film Quality Using Terahertz Pulsed Imaging." European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V, vol. 85, no. 3 Pt B, 2013, pp. 1095-102.
Haaser M, Naelapää K, Gordon KC, et al. Evaluating the effect of coating equipment on tablet film quality using terahertz pulsed imaging. Eur J Pharm Biopharm. 2013;85(3 Pt B):1095-102.
Haaser, M., Naelapää, K., Gordon, K. C., Pepper, M., Rantanen, J., Strachan, C. J., Taday, P. F., Zeitler, J. A., & Rades, T. (2013). Evaluating the effect of coating equipment on tablet film quality using terahertz pulsed imaging. European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V, 85(3 Pt B), 1095-102. https://doi.org/10.1016/j.ejpb.2013.03.019
Haaser M, et al. Evaluating the Effect of Coating Equipment On Tablet Film Quality Using Terahertz Pulsed Imaging. Eur J Pharm Biopharm. 2013;85(3 Pt B):1095-102. PubMed PMID: 23563103.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluating the effect of coating equipment on tablet film quality using terahertz pulsed imaging. AU - Haaser,Miriam, AU - Naelapää,Kaisa, AU - Gordon,Keith C, AU - Pepper,Michael, AU - Rantanen,Jukka, AU - Strachan,Clare J, AU - Taday,Philip F, AU - Zeitler,J Axel, AU - Rades,Thomas, Y1 - 2013/04/04/ PY - 2012/09/07/received PY - 2013/03/05/revised PY - 2013/03/17/accepted PY - 2013/4/9/entrez PY - 2013/4/9/pubmed PY - 2014/8/13/medline KW - Delayed release KW - Dissolution KW - Film coating KW - Image analysis KW - Terahertz pulsed imaging (TPI) KW - Unit operation SP - 1095 EP - 102 JF - European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V JO - Eur J Pharm Biopharm VL - 85 IS - 3 Pt B N2 - In this study, terahertz pulsed imaging (TPI) was employed to investigate the effect of the coating equipment (fluid bed and drum coater) on the structure of the applied film coating and subsequent dissolution behaviour. Six tablets from every batch coated with the same delayed release coating formulation under recommended process conditions (provided by the coating polymer supplier) were mapped individually to evaluate the effect of coating device on critical coating characteristics (coating thickness, surface morphology and density). Although the traditional coating quality parameter (weight gain) indicated no differences between both batches, TPI analysis revealed a lower mean coating thickness (CT) for tablets coated in the drum coater compared to fluid bed coated tablets (p<0.05). Moreover, drum coated tablets showed a more pronounced CT variation between the two sides and the centre band of the biconvex tablets, with the CT around the centre band being 22.5% thinner than the top and bottom sides for the drum coated tablets and 12.5% thinner for fluid bed coated tablets. The TPI analysis suggested a denser coating for the drum coated tablets. Dissolution testing confirmed that the film coating density was the drug release governing factor, with faster drug release for tablets coated in the fluid bed coater (98 ± 4% after 6h) compared to drum coated tablets (72 ± 6% after 6h). Overall, TPI investigation revealed substantial differences in the applied film coating quality between tablets coated in the two coaters, which in turn correlated with the subsequent dissolution performance. SN - 1873-3441 UR - https://www.unboundmedicine.com/medline/citation/23563103/Evaluating_the_effect_of_coating_equipment_on_tablet_film_quality_using_terahertz_pulsed_imaging_ DB - PRIME DP - Unbound Medicine ER -