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.
A comprehensive approach to qualify and validate the essential parameters of an in vitro release test (IVRT) method for acyclovir cream, 5.
Int J Pharm. 2018; 535(1-2): 217-227.
Doi: 10.1016/j.ijpharm.2017.09.049
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- Co-Autor*innen der Med Uni Graz
- Sinner Frank Michael
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- Abstract:
- The rate of release of an active pharmaceutical ingredient (API) from a topical semisolid dosage form can be influenced by its physical and structural properties. An In Vitro Release Test (IVRT) is an established method to characterize this rate of API release and compare the underlying sameness in product quality characteristics. The purpose of this work was to validate an IVRT method to compare acyclovir cream, 5% products. However, despite widespread use of the IVRT since 1997, there has been no established approach to validate an IVRT method. Our approach included: 1) qualification of the diffusion cell apparatus, 2) qualification of the laboratory, 3) validation of the HPLC analytical method, and 4) validation of numerous critical parameters of the IVRT method, itself, and resulted in a comprehensive and successful IVRT method validation. Subsequent to the IVRT validation work described here, the U.S. Food and Drug Administration (FDA) drafted a guidance on the development and validation of an IVRT method for acyclovir cream, 5%. Although there are notable differences between our approach and the approach in that guidance, this report illustrates how many of the same essential qualification parameters and validation concepts were considered and systematically addressed in our approach to IVRT validation. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.
- Find related publications in this database (using NLM MeSH Indexing)
- Acyclovir - chemistry
- Antiviral Agents - chemistry
- Chemistry, Pharmaceutical - methods
- Chromatography, High Pressure Liquid -
- Drug Liberation -
- Ointments - chemistry
- Reproducibility of Results -
- Find related publications in this database (Keywords)
- In vitro release testing
- Vertical diffusion cell
- Acyclovir cream
- Method validation
- Apparatus qualification