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Evaluation of tablet punch configuration on mitigating capping by a quality by design approach

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Abstract

Capping is a common problem in the manufacture of some types of tablets and unless resolved, the tableting process cannot proceed. Hence, all factors that can help to lessen the likelihood of capping without unnecessarily reduce turret speed and/or compaction force would be tenable. This study investigated the influence of tablet punch configuration on mitigation of tablet capping. Tablets were prepared from high-dose paracetamol-potato starch granules in a rotary tablet press with flat face plain (FFP), flat face bevel edge (FFBE) and flat face radius edge (FFRE) punch configurations. The directly compressible (DC) fillers tested were microcrystalline cellulose (MCC), pre-gelatinised starch (PGS) and lactose. Design of experiments (DoE), a tool of quality by design (QbD) paradigm, was used and the interaction of input variables (compression force, tablet punch configuration and DC filler) affecting the response factors (tablet hardness and capping rating) were evaluated. FFP punches were able to mitigate capping best. FFRE punches showed more potential than FFBE punches at alleviating capping in a particular compression force range, without the limitations of the FFP punches that produce cylindrical tablets that were more friable. Incorporation of PGS in the tablet formulation was observed to be more efficient at mitigating capping than the other DC fillers when FFBE and FFRE punches were used. Overall, this study serves as a model for prospective product development based on the QbD framework and the optimal use of compaction tools.

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References

  1. Desai PM, Liew CV, Heng PWS. Review of disintegrants and disintegration phenomena. J Pharm Sci. 2016;105:2545–55.

    Article  CAS  Google Scholar 

  2. Aulton ME, Taylor K. Aulton’s pharmaceutics: the design and manufacture of medicines. 4th ed. Churchill Livingstone: Elsevier; 2013.

    Google Scholar 

  3. Carlin BAC. Direct compression and the role of fillers-binders. In: Augsburger LL, Hoag SW, editors. Pharmaceutical dosage forms: tablets. New York, London: Informa healthcare; 2008. p. 173–216.

    Chapter  Google Scholar 

  4. Freeman T. Correlating die-filling performance with powder properties. Pharm Technol. 2011;35:s24–8.

    Google Scholar 

  5. Akseli I, Ladyzhynsky N, Katz J, He X. Development of predictive tools to assess capping tendency of tablet formulations. Powder Technol. 2013;236:139–48.

    Article  CAS  Google Scholar 

  6. Anuar MS, Briscoe BJ. The elastic relaxation of starch tablets during ejection. Powder Technol. 2009;195:96–104.

    Article  CAS  Google Scholar 

  7. Fassihi AR, Parker MS. Formulation effects on capping tendencies. Int J Pharm. 1986;31:271–3.

    Article  CAS  Google Scholar 

  8. van der Voort MK, Zuurman K, Vromans H, Bolhuis GK, Lerk CF. Stress relaxation of compacts produced from viscoelastic materials. Int J Pharm. 1997;151:27–34.

    Article  Google Scholar 

  9. Akseli I, Stecuła A, He X, Ladyzhynsky N. Quantitative correlation of the effect of process conditions on the capping tendencies of tablet formulations. J Pharm Sci. 2014;103:1652–63.

    Article  CAS  Google Scholar 

  10. Garr JSM, Rubinstein MH. An investigation into the capping of paracetamol at increasing speeds of compression. Int J Pharm. 1991;72:117–22.

    Article  CAS  Google Scholar 

  11. Desai PM, Van Vaerenbergh G, Holman J, Liew CV, Heng PWS. Continuous manufacturing: the future in pharmaceutical solid dosage form manufacturing. Pharmaceutical Bioprocessing. 2015;3:357–60.

    Article  Google Scholar 

  12. Akande OF, Rubinstein MH, Rowe PH, Ford JL. Effect of compression speeds on the compaction properties of a 1:1 paracetamol-microcrystalline cellulose mixture prepared by single compression and by combinations of pre-compression and main-compression. Int J Pharm. 1997;157:127–36.

    Article  Google Scholar 

  13. Wu CY, Hancock BC, Mills A, Bentham AC, Best SM, Elliott JA. Numerical and experimental investigation of capping mechanisms during pharmaceutical tablet compaction. Powder Technol. 2008;181:121–9.

    Article  CAS  Google Scholar 

  14. Eiliazadeh B, Pitt K, Briscoe B. Effects of punch geometry on powder movement during pharmaceutical tabletting processes. Int J Solids Struct. 2004;41:5967–77.

    Article  Google Scholar 

  15. Natoli D. Small changes to tablet shape bring big results. Int Pharm Ind. 2014;6:114–7.

    Google Scholar 

  16. Newton JM, Haririan I, Podczeck F. The influence of punch curvature on the mechanical properties of compacted powders. Powder Technol. 2000;107:79–83.

    Article  CAS  Google Scholar 

  17. Alderborn G, Nystrom C. Radial and axial tensile strength and strength variability of paracetamol tablets. Acta Pharm Suecica. 1984;21:1–8.

    CAS  Google Scholar 

  18. Charoo NA, Shamsher AAA, Zidan AS, Rahman Z. Quality by design approach for formulation development: a case study of dispersible tablets. Int J Pharm. 2012;423:167–78.

    Article  CAS  Google Scholar 

  19. Desai PM, Er PXH, Liew CV, Heng PWS. Functionality of disintegrants and their mixtures in enabling fast disintegration of tablets by a quality by design approach. AAPS PharmSciTech. 2014;15:1093–104.

    Article  CAS  Google Scholar 

  20. Verma S, Lan Y, Gokhale R, Burgess DJ. Quality by design approach to understand the process of nanosuspension preparation. Int J Pharm. 2009;2009:377,185–98.

    Google Scholar 

  21. Sarkar S, Ooi SM, Liew CV, Heng PWS. Influence of rate of force application during compression on tablet capping. J Pharm Sci. 2015;104:1319–27.

    Article  CAS  Google Scholar 

  22. Kadiri MS, Michrafy A. The effect of punch’s shape on die compaction of pharmaceutical powders. Powder Technol. 2013;239:467–77.

    Article  CAS  Google Scholar 

  23. Krok A, Peciar M, Fekete R. Numerical investigation into the influence of the punch shape on the mechanical behavior of pharmaceutical powders during compaction. Particuology. 2014;16:116–31.

    Article  Google Scholar 

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Acknowledgements

The authors would like to acknowledge the financial support from GEA-NUS PPRL fund (N-148-000-008-001) and A*STAR SERC grant no. 102 161 0049 (R-148-000-157-305).

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Authors and Affiliations

  1. GEA-NUS Pharmaceutical Processing Research Laboratory, Department of Pharmacy, National University of Singapore, 18 Science Drive 4, Singapore, 117543, Singapore

    Parind M. Desai, Parthiban Anbalagan, Cheryl J. N. Koh, Paul W. S. Heng & Celine V. Liew

  2. Product and Process Engineering Department, GlaxoSmithKline, King of Prussia, PA, 19406, USA

    Parind M. Desai

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  1. Parind M. Desai
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  2. Parthiban Anbalagan
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  3. Cheryl J. N. Koh
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  4. Paul W. S. Heng
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  5. Celine V. Liew
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Correspondence to Celine V. Liew.

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Desai, P.M., Anbalagan, P., Koh, C.J.N. et al. Evaluation of tablet punch configuration on mitigating capping by a quality by design approach. Drug Deliv. and Transl. Res. 8, 1635–1643 (2018). https://doi.org/10.1007/s13346-017-0425-0

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