ArticleAAPS PharmSciTech2026
Development and Evaluation of Tofacitinib Tablets with Comparative Dissolution and Pharmacokinetic Studies in Beagle Dogs.
Article in AAPS PharmSciTech, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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6 authors.
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Abstract
Tofacitinib (Tofa), a Biopharmaceutics Classification System Class III drug, exhibits pH-dependent solubility and a strong tendency to agglomerate, potentially affecting tablet uniformity, in vitro dissolution behavior, and in vivo performance. In this study, a Tofa free base tablet (WT2) prepared by wet granulation was evaluated in Beagle dogs and compared with a marketed reference tablet (RT). In vitro dissolution studies showed comparable drug release between WT2 and RT at pH 1.2 and 4.0, whereas WT2 exhibited slower, though still complete, dissolution at pH 6.8. Despite these differences, pharmacokinetic studies demonstrated comparable systemic exposure under both fasted and fed conditions. The geometric mean ratios and 90% confidence intervals for maximum plasma concentration (C
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