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

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

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...

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Bibliographic Details
Published in:Methods in molecular biology (Clifton, N.J.) Vol. 2789; p. 301
Main Authors: Stern, Stephan T, Skoczen, Sarah L, Park, Young Hwan
Format: Journal Article
Language:English
Published: United States 2024
Subjects:
Drug Liberation
Humans
Isotopes
Solubility
Temperature
Ultrafiltration
Drug release
Nanomedicine
Stable Isotope Tracer Ultrafiltration Assay (SITUA)
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Summary: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.
ISSN:1940-6029
DOI:10.1007/978-1-0716-3786-9_27