Assessment of Temperature-Dependent Drug Release of Solubilizing Nanoformulations Using the SITUA

doi:10.1007/978-1-0716-3786-9_27

. 2024:2789:301-311.

doi: 10.1007/978-1-0716-3786-9_27.

Assessment of Temperature-Dependent Drug Release of Solubilizing Nanoformulations Using the SITUA

Stephan T Stern¹, Sarah L Skoczen², Young Hwan Park³

Affiliations

¹ Nanotechnology Characterization Laboratory, Cancer Research Technology Program, Frederick National Laboratory for Cancer Research, Frederick, MD, USA. sternstephan@mail.nih.gov.
² Nanotechnology Characterization Laboratory, Cancer Research Technology Program, Frederick National Laboratory for Cancer Research, Frederick, MD, USA.
³ SN BioScience, Inc., #Na-420, Biz Growth Center, Seongnam-si, Gyeonggi-do, Republic of Korea.

PMID: 38507012
DOI: 10.1007/978-1-0716-3786-9_27

Assessment of Temperature-Dependent Drug Release of Solubilizing Nanoformulations Using the SITUA

Stephan T Stern et al. Methods Mol Biol. 2024.

. 2024:2789:301-311.

doi: 10.1007/978-1-0716-3786-9_27.

Authors

Stephan T Stern¹, Sarah L Skoczen², Young Hwan Park³

Affiliations

¹ Nanotechnology Characterization Laboratory, Cancer Research Technology Program, Frederick National Laboratory for Cancer Research, Frederick, MD, USA. sternstephan@mail.nih.gov.
² Nanotechnology Characterization Laboratory, Cancer Research Technology Program, Frederick National Laboratory for Cancer Research, Frederick, MD, USA.
³ SN BioScience, Inc., #Na-420, Biz Growth Center, Seongnam-si, Gyeonggi-do, Republic of Korea.

PMID: 38507012
DOI: 10.1007/978-1-0716-3786-9_27

Abstract

The evaluation of temperature-dependent drug release for solubilizing nanoformulations uses a modification of the stable isotope ultrafiltration assay (SITUA). This method is specific to parenterally administered solubilizing nanomedicines and can be used to assess drug release from the total dosage form for regulatory purposes of lot release. The principle upon which this method is based is the relationship between drug solubility and temperature in a plasma simulating media, 4.5% human serum albumin, that allows for discrimination of passing and failing lots based upon the release characteristics.

Keywords: Drug release; Nanomedicine; Stable Isotope Tracer Ultrafiltration Assay (SITUA).

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References

1. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) (2022) Drug products, including biological products, that contain nanomaterials guidance for industry. https://www.fda.gov/media/157812/download . Accessed 11 Sept 2023
1. Ambardekar VV, Stern ST (2015) NBCD pharmacokinetics and drug release methods. In: Crommelin DJA, de Vlieger JSB (eds) Non-biological complex drugs; the science and the regulatory landscape, AAPS advances in the pharmaceutical sciences series, vol 20, 1st edn. Springer International Publishing, pp 261–287. https://doi.org/10.1007/978-3-319-16241-6 - DOI
1. Skoczen SL, Stern ST (2018) Improved ultrafiltration method to measure drug release from nanomedicines utilizing a stable isotope tracer. Methods Mol Biol 1682:223–239 - DOI - PubMed

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[1] Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) (2022) Drug products, including biological products, that contain nanomaterials guidance for industry. https://www.fda.gov/media/157812/download . Accessed 11 Sept 2023

[2] Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) (2022) Drug products, including biological products, that contain nanomaterials guidance for industry. https://www.fda.gov/media/157812/download . Accessed 11 Sept 2023

[3] Ambardekar VV, Stern ST (2015) NBCD pharmacokinetics and drug release methods. In: Crommelin DJA, de Vlieger JSB (eds) Non-biological complex drugs; the science and the regulatory landscape, AAPS advances in the pharmaceutical sciences series, vol 20, 1st edn. Springer International Publishing, pp 261–287. https://doi.org/10.1007/978-3-319-16241-6 - DOI

[4] Ambardekar VV, Stern ST (2015) NBCD pharmacokinetics and drug release methods. In: Crommelin DJA, de Vlieger JSB (eds) Non-biological complex drugs; the science and the regulatory landscape, AAPS advances in the pharmaceutical sciences series, vol 20, 1st edn. Springer International Publishing, pp 261–287. https://doi.org/10.1007/978-3-319-16241-6 - DOI

[5] Skoczen SL, Stern ST (2018) Improved ultrafiltration method to measure drug release from nanomedicines utilizing a stable isotope tracer. Methods Mol Biol 1682:223–239 - DOI - PubMed

[6] Skoczen SL, Stern ST (2018) Improved ultrafiltration method to measure drug release from nanomedicines utilizing a stable isotope tracer. Methods Mol Biol 1682:223–239 - DOI - PubMed

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Assessment of Temperature-Dependent Drug Release of Solubilizing Nanoformulations Using the SITUA

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Assessment of Temperature-Dependent Drug Release of Solubilizing Nanoformulations Using the SITUA

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