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Subdivision of Tablets Containing Modified Delivery Technology: the Case of Orally Disintegrating Tablets

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Abstract

Purpose

Clinical practice suggests orally disintegrating tablets (ODTs) may be subdivided for dose adjustments, however there are no studies evaluating the effect of this practice in ODTs quality parameters. This work was therefore dedicated to elucidating the impact of the tablet subdivision on ten selected ODTs produced by different technologies.

Methods

Structural properties were assessed using weight; dimensions; image analysis; moisture content and porosimetry evaluations. Functional evaluations were also performed by disintegration and wetting assays. Tablets were evaluated just after subdivision and after an accelerated aging.

Results

Outcomes suggest the manufacturing method plays an important role in the suitability of ODTs for subdivision. While tablets containing granules immersed in a powdered matrix structure showed poor subdivision performance, with high weight variation and weight loss, tablets obtained by freeze-drying or direct compression of powder mixtures showed acceptable levels of these parameters and could be subdivided for immediate use. Aged tablets revealed structural and/or functional damages for all analyzed drug products, which includes softening of their matrices, water uptake and darkening, with loss of their disintegration and wetting capacities, which suggest inadequacy of ODTs subdivision for later use.

Conclusions

The results exposed in this study could be useful for the clinical decision on the subdivision of this tablets category.

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Acknowledgements

This research was financially supported by the Brazilian agency FAPDF (Grant n. 0193.001023/2015).

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Authors and Affiliations

  1. Laboratory of Food, Drugs and Cosmetics (LTMAC), University of Brasília (UnB), Brasília, DF, 70910-900, Brazil

    Ana Claudia Temer, Maíra Teles Teixeira, Tais Gratieri, Guilherme Martins Gelfuso & Marcilio Cunha-Filho

  2. Faculty of Ceilândia, University of Brasília (UnB), Brasília, DF, 72220-900, Brazil

    Livia Lira Sa-Barreto & Izabel Cristina Silva

  3. Laboratory of Nanosystems and Drug Delivery Devices (NanoSYS), School of Pharmacy, Federal University of Goiás, Goiânia, GO, Brazil

    Stephânia Fleury Taveira & Ricardo N. Marreto

Authors
  1. Ana Claudia Temer
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  2. Maíra Teles Teixeira
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  3. Livia Lira Sa-Barreto
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  4. Tais Gratieri
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  5. Guilherme Martins Gelfuso
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  6. Izabel Cristina Silva
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  7. Stephânia Fleury Taveira
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  8. Ricardo N. Marreto
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  9. Marcilio Cunha-Filho
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Corresponding author

Correspondence to Marcilio Cunha-Filho.

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Temer, A.C., Teixeira, M.T., Sa-Barreto, L.L. et al. Subdivision of Tablets Containing Modified Delivery Technology: the Case of Orally Disintegrating Tablets. J Pharm Innov 13, 261–269 (2018). https://doi.org/10.1007/s12247-018-9323-3

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  • DOI: https://doi.org/10.1007/s12247-018-9323-3

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