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Dissolution Test of Tacrolimus Capsule: Effects of Filtration and Glass Adsorption

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Abstract

Tacrolimus is a potent, narrow therapeutic index, immunosuppressive drug used to avoid organ rejection in patients that have undergone organ transplantation. Dissolution tests are widely used to evaluate drug product quality and performance. Analysis of tacrolimus during dissolution testing is sensitive to several factors, such as sample solution storage time and container material. The filtration process, tacrolimus glass adsorption, and sample solution storage time are found to impact the tacrolimus dissolution results. Based on observations in this work, the use of G4 or equivalent filter flush before collection and polypropylene test tubes or vials instead of glass test tubes or vials are recommended for tacrolimus drug product dissolution test.

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Acknowledgements

Internal funding for this work was provided by the Office of Generic Drugs.

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Authors and Affiliations

  1. Division of Pharmaceutical Analysis, Office of Testing and Research, Center for Drug Evaluation and Research, United States Food and Drug Administration, 645 S. Newstead Avenue, St Louis, Missouri, USA

    Kui Zeng, Zongming Gao & Michael Trehy

  2. Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, Maryland, USA

    Wenlei Jiang

Authors
  1. Kui Zeng
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  2. Zongming Gao
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  3. Michael Trehy
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  4. Wenlei Jiang
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Correspondence to Kui Zeng.

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Zeng, K., Gao, Z., Trehy, M. et al. Dissolution Test of Tacrolimus Capsule: Effects of Filtration and Glass Adsorption. AAPS PharmSciTech 19, 961–964 (2018). https://doi.org/10.1208/s12249-017-0856-4

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  • DOI: https://doi.org/10.1208/s12249-017-0856-4

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