Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
SHR Neuro Krebs Kardio Lipid Stoffw Microb
Tiffner, KI; Kanfer, I; Augustin, T; Raml, R; Raney, SG; Sinner, F.
Comparative in vitro release testing (IVRT) of acyclovir products
INT J PHARMACEUT. 2021; 609: 121186
Doi: 10.1016/j.ijpharm.2021.121186
Web of Science
PubMed
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FullText_MUG
- Co-Autor*innen der Med Uni Graz
- Sinner Frank Michael
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- Abstract:
- The aim was to evaluate whether an in vitro release test (IVRT) could differentiate the release rates from five pharmaceutically equivalent acyclovir cream products and one ointment compared to that from a reference product, Zovirax cream (USA), to identify a test product with an inequivalent drug release rate that could serve as negative control for bioequivalence (BE) in a separate in vivo study. The reference product showed equivalent drug release rates compared to itself. The six test products failed to show equivalent drug release rates compared to the reference product. Aciclovir 1A pharma cream was selected to serve as a negative control for subsequent BE studies, since it exhibited the greatest difference in release rate among all creams, compared to the reference product. The results of this study indicate that IVRT results can be highly sensitive and may discriminate clinically relevant differences between products. Results from an appropriately validated IVRT method can support a demonstration of BE by showing that the drug release rates from test and reference products are statistically equivalent, mitigating the risk that differences may exist between the products which may influence in vivo performance of the drug product.
- Find related publications in this database (Keywords)
- In vitro release testing
- Acyclovir