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AAPS PharmSciTech. 2016 Aug;17(4):978-87. doi: 10.1208/s12249-015-0433-7. Epub 2015 Oct 16.

Reutilization of Tacrolimus Extracted from Expired Prograf® Capsules: Physical, Chemical, and Pharmacological Assessment.

Author information

1
Nanomedicine Research Unit, Department of Pharmaceutics, King Saud University, P.O. Box 2457, Riyadh, 11451, Saudi Arabia.
2
King Abdullah Institute for Nanotechnology, King Saud University, Riyadh, Saudi Arabia.
3
King Salman Bin Abdulaziz Chair for Kidney Disease, King Saud University, Riyadh, Saudi Arabia.
4
Prince Naif Center for Immunology Research, King Saud University, Riyadh, Saudi Arabia.
5
Nanomedicine Research Unit, Department of Pharmaceutics, King Saud University, P.O. Box 2457, Riyadh, 11451, Saudi Arabia. aalshamsan@ksu.edu.sa.
6
King Abdullah Institute for Nanotechnology, King Saud University, Riyadh, Saudi Arabia. aalshamsan@ksu.edu.sa.
7
King Salman Bin Abdulaziz Chair for Kidney Disease, King Saud University, Riyadh, Saudi Arabia. aalshamsan@ksu.edu.sa.

Abstract

In this study, we investigated whether tacrolimus extracted and purified from the commercial capsules (Prograf® 5 mg) have retained its original quality and activity beyond the capsules expiration date in order to be reused for research purposes after extraction. High-performance liquid chromatography (HPLC) assay method was developed and validated for the quantification of tacrolimus, using cyclosporine A as an internal standard (IS). Moreover, a combination of analytical methods, including nuclear magnetic resonance (NMR), gas chromatography-mass spectrometry (GC-MS), Fourier transform-infrared (FT-IR) spectroscopy, X-ray diffraction (XRD), and differential scanning calorimetry (DSC) were used to assess the quality of extracted/purified tacrolimus. Suppression of murine peripheral-blood mononuclear cells (PBMC) proliferation and the levels of interleukin-2 (IL-2) and interferon gamma (IFN-γ) were also assessed. The data obtained showed no detectable differences in the quality profile between the authentic sample and extracted drug. Also, the results showed that the extracted/purified tacrolimus was able to suppress T cell proliferation, induced by concanavalin A, indicating the retained pharmacological activity. We proved that tacrolimus extracted/purified from expired Prograf® capsuled retains its purity and immunosuppressive activity and can be reused for research and possibly in pharmaceutical manufacturing.

KEYWORDS:

extraction; immunosuppression; purity; tacrolimus; validation

PMID:
26729529
DOI:
10.1208/s12249-015-0433-7
[Indexed for MEDLINE]

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