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

  1. Author:
    Stern,Steve
    Skoczen,Sarah
    Park, Young Hwan

  2. Author Address

    Nanotechnology Characterization Laboratory, Cancer Research Technology Program, Frederick National Laboratory for Cancer Research, Frederick, MD, USA. sternstephan@mail.nih.gov., SN BioScience, Inc., #Na-420, Biz Growth Center, Seongnam-si, Gyeonggi-do, Republic of Korea.,
    1. Year: 2024
  2. Journal: Methods in Molecular Biology (Clifton, N.J.)
    1. 2789
    2. Pages: 301-311
  4. Type of Article: Article
  1. 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. © 2024. The Author(s), under exclusive license to Springer Science+Business Media, LLC, part of Springer Nature.

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External Sources

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

Library Notes

  1. Fiscal Year: FY2023-2024
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