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Methodology to estimate the break force of pharmaceutical tablets with curved faces under diametrical compression

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journal contribution
posted on 2019-02-22, 13:17 authored by M Al-Sabbagh, P Polak, RJ Roberts, GK Reynolds, IC Sinka
This paper develops a methodology to estimate the break force of curved faced tablets under diametrical compression. Common excipients used in pharmaceutical tablet formulations, including microcrystalline cellulose, calcium phosphate and mannitol as well as their mixtures were characterised. Compacts of different densities were manufactured and their compressive and tensile strength was measured. The break force of curved face tablets having a comprehensive range of face curvatures and thickness was measured using the diametrical compression method ("hardness" test). Equation σd=FπD2atD+bWD-1 introduced by Shang et al. (2013) was used to relate the break force (F) to tablet geometry (D, t, W) and material tensile strength (σd). Here, we propose a method to estimate the parameters a and b using data for curved faced tablets made from three pure excipients. The method was validated for four mixtures. The errors were analysed and compared with the USP29 method σd=10FπD2(2.84(t/D)-0.126t/W+3.15(W/D)+0.01)-1. The proposed method has better accuracy, however, requires additional characterisation of the compressive strength of the material.

Funding

The mannitol, calcium phosphate, and microcrystalline cellulose were provided by AstraZeneca. iHolland UK provided the punch set. Muhanad Al-Sabbagh gratefully acknowledges the Iraqi Ministry of Higher Education and Scientific Research for his PhD studentship. Peter Polak gratefully acknowledges AstraZeneca for his PhD studentship.

History

Citation

Int J Pharm, 2018, 554, pp. 399-419

Author affiliation

/Organisation/COLLEGE OF SCIENCE AND ENGINEERING/Department of Engineering

Version

  • AM (Accepted Manuscript)

Published in

Int J Pharm

Publisher

Elsevier

eissn

1873-3476

Acceptance date

2018-10-06

Copyright date

2018

Available date

2019-10-08

Publisher version

https://www.sciencedirect.com/science/article/pii/S037851731830749X?via=ihub

Notes

The file associated with this record is under embargo until 12 months after publication, in accordance with the publisher's self-archiving policy. The full text may be available through the publisher links provided above.

Language

en

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