Validation and applications of an expedited tablet friability method

International Journal of Pharmaceutics
Frederick Osei-Yeboah, Changquan Calvin Sun

Abstract

The harmonized monograph on tablet friability test in United States Pharmacopeia (USP), European Pharmacopeia (Pharm. Eur.), and Japanese Pharmacopeia (JP) is designed to assess adequacy of mechanical strength of a batch of tablets. Currently, its potential applications in formulation development have been limited due to the batch requirement that is both labor and material intensive. To this end, we have developed an expedited tablet friability test method, using the existing USP test apparatus. The validity of the expedited friability method is established by showing that the friability data from the expedited method is not statistically different from those from the standard pharmacopeia method using materials of very different mechanical properties, i.e., microcrystalline cellulose and dibasic calcium phosphate dihydrate. Using the expedited friability method, we have shown that the relationship between tablet friability and tablet mechanical strength follows a power law expression. Furthermore, potential applications of this expedited friability test in facilitating systematic and efficient tablet formulation and tooling design are demonstrated with examples.

References

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Citations

Apr 25, 2015·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Xingchu Gong, Changquan Calvin Sun
May 1, 2016·International Journal of Pharmaceutics·Sarsvat Patel, Changquan Calvin Sun
May 31, 2016·Journal of Pharmaceutical Sciences·Sathyanarayana R PerumallaChangquan C Sun
Nov 24, 2016·Pharmaceutical Development and Technology·Ahmad Ainurofiq, Syaiful Choiri
Oct 7, 2017·Pharmaceutical Research·Shubhajit Paul, Changquan Calvin Sun
Aug 8, 2018·Drug Development and Industrial Pharmacy·Ghulam Abbas, Muhammad Hanif
Jul 6, 2016·Pharmaceutical Research·Changquan Calvin Sun
Jan 18, 2020·Drug Development and Industrial Pharmacy·Priscila Debastiani BarrosÉlcio José Bunhak
Sep 3, 2020·International Journal of Pharmaceutics·Chenguang Wang, Changquan Calvin Sun
Nov 19, 2020·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Nada KittikunakornFeng Zhang
Jan 24, 2021·International Journal of Pharmaceutics·Kunlin Wang, Changquan Calvin Sun
Oct 20, 2020·Pharmaceutical Development and Technology·D Nagasamy VenkateshE B Souto
Mar 11, 2020·International Journal of Pharmaceutics: X·Deanna M MudieDavid T Vodak
Dec 25, 2019·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Shao-Yu Chang, Changquan Calvin Sun
Nov 19, 2018·Journal of Pharmaceutical Sciences·Hongbo ChenChangquan Calvin Sun
Jun 16, 2021·AAPS PharmSciTech·William R KetterhagenJared A Baird
Oct 4, 2020·International Journal of Pharmaceutics·Jiangnan DunChangquan Calvin Sun
Oct 12, 2020·International Journal of Pharmaceutics·Hongbo ChenChangquan Calvin Sun

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