Characterization, optimisation and process robustness of a co-processed mannitol for the development of orally disintegrating tablets

Pharmaceutical Development and Technology
Josephine Lay Peng SohTimothy Lukas

Abstract

This is a study to fully assess a commercially available co-processed mannitol for its usefulness as an off-the-shelf excipient for developing orally disintegrating tablets (ODTs) by direct compression on a pilot scale (up to 4 kg). This work encompassed material characterization, formulation optimisation and process robustness. Overall, this co-processed mannitol possessed favourable physical attributes including low hygroscopicity and compactibility. Two design-of-experiments (DoEs) were used to screen and optimise the placebo formulation. Xylitol and crospovidone concentrations were found to have the most significant impact on disintegration time (p < 0.05). Higher xylitol concentrations retarded disintegration. Avicel PH102 promoted faster disintegration than PH101, at higher levels of xylitol. Without xylitol, higher crospovidone concentrations yielded faster disintegration and reduced tablet friability. Lubrication sensitivity studies were later conducted at two fill loads, three levels for lubricant concentration and number of blend rotations. Even at 75% fill load, the design space plot showed that 1.5% lubricant and 300 blend revolutions were sufficient to manufacture ODTs with ≤ 0.1% friability and disintegrated withi...Continue Reading

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Citations

Feb 8, 2013·Expert Opinion on Drug Delivery·Ali Al-khattawi, Afzal R Mohammed
Apr 2, 2015·International Journal of Pharmaceutics·B DémuthM E Brewster
Mar 1, 2015·International Journal of Pharmaceutics·Frederick Osei-Yeboah, Changquan Calvin Sun
Aug 26, 2014·International Journal of Pharmaceutics·Joseph Kushner, Holger Schlack
Sep 3, 2021·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Marcel KokottRaphael Wiedey

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