Rheological and in vitro release measurements of manufactured acyclovir 5% creams: confirming sensitivity of the in vitro release
| Autor: | Vinod P. Shah, Alina Mînea, Dalia Simona Miron, Victor A. Voicu, Jean-Michel Cardot, Flavian Ștefan Rădulescu |
|---|---|
| Přispěvatelé: | University of Medicine and Pharmacy 'Carol Davila' Bucharest (UMPCD), Romanian Academy [IASI], Romanian Academy of Sciences, Université Clermont Auvergne (UCA), Microbiologie Environnement Digestif Santé (MEDIS), Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Université Clermont Auvergne (UCA), Pharmaceutical consultant, US Product Quality Research Institute |
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
vitro release (IVR)
Chromatography Chemistry [SDV]Life Sciences [q-bio] microstructure Pharmaceutical Science 02 engineering and technology General Medicine 021001 nanoscience & nanotechnology 030226 pharmacology & pharmacy Qualitative composition In vitro 03 medical and health sciences 0302 clinical medicine Topical Drug Classification System (TCS) Rheology qualitative and quantitative composition Acyclovir creamin Sensitivity (control systems) 0210 nano-technology |
| Zdroj: | Pharmaceutical Development and Technology Pharmaceutical Development and Technology, Taylor & Francis, 2021, pp.1-9. ⟨10.1080/10837450.2021.1945625⟩ |
| ISSN: | 1083-7450 1097-9867 |
| Popis: | International audience; Previous evaluation of marketed acyclovir 5% creams using in vitro release testing (IVRT) and its correlation with the qualitative composition confirmed the discriminative characteristics of this methodology. This was in line with the principles of Topical drug Classification System (TCS). For the current research, experimental formulations were designed and prepared by applying controlled changes in manufacturing process, sources of raw materials, and amount of the excipients. The topical semisolids were representative for the four classes of TCS. The outcome of the IVRT and rheological assessments was evaluated in relation with the nature of the change and the functional role of the excipients. The variations in propylene glycol content from 5% to 40% impacted both the in vitro release rates (gradual decrease from 16.23 to 8.97 mu g/cm(2)/min(0.5)) and the microstructural characteristics (proportional increase of yield stress from 17.98 to 46.40 Pa). The inert excipients e.g. cetostearyl alcohol or white soft paraffin altered majorly the rheological behavior, as their functionality is mainly related to vehicle properties. IVRT was discriminative for the microstructural differences induced by both categories of excipients according to TCS dichotomy. This simple, reliable, and reproducible test reflected the impact of difference in quantitative composition and characteristics of excipients. |
| Databáze: | OpenAIRE |
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