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Index Copernicus Value (2010): 5.45
CNCSIS B+ (code 820) since 2007

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Journal Info

Title: Studia Universitatis Vasile Goldis, Seria Stiintele Vietii (Life Sciences Series)
Abbreviated title: Studia Univ. VG, SSV
Publisher: "Vasile Goldis" University Press
Owner: Western University "Vasile Goldis" Arad, Romania
ISSN: 1584-2363
e-ISSN: 1842-7863
ISSN-L: 1584-2363

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Correlated evaluations of in vitro release profiles and structural parameters for topical semisolid dosage forms containing metronidazole Print E-mail
Written by Ciolan D.F., Mînea A., Lupuleasa D., Stănescu A.A., Nicoară A.C., Rădulescu F.Ș., Miron D.S.   
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Article Title: Correlated evaluations of in vitro release profiles and structural parameters for topical semisolid dosage forms  containing metronidazole
Authors: Ciolan D.F., Mînea A., Lupuleasa D., Stănescu A.A., Nicoară  A.C., Rădulescu F.Ș., Miron D.S.
Affiliation:
University of Medicine and Pharmacy „Carol Davila” Bucharest, Faculty of Pharmacy, no.6 Traian Vuia St., 020956, Bucharest, Romania. 1Department of Pharmaceutical Chemistry, 2Department of Pharmaceutical Technology and Biopharmaceutics, 3Department of Drug Industry and Pharmaceutical Biotechnologies, 4Department of Pharmaceutical Physics and Informatics.
Abstract: The in-vivo performance of topical semisolid dosage forms is determined by a series of factors, related to the thermodynamic activity of the active pharmaceutical ingredient, the history of the formulation, as well as the complexity of interaction between various components of the vehicle and the complex biological barrier. The paper presents the role of correlated in vitro release (IVR) tests and structural analysis in the comparative quality assessment of topical formulations containing metronidazole in various concentrations. A simple in vitro evaluation protocol was implemented, based on previous reports relating the release rate with in vivo dermatopharmacokinetics. The similarity was assessed using a compendial nonparametric statistical method for log slopes (Wilcoxon Rank Sum/Mann Whitney rank test). The experimental data confirmed that IVR tests were discriminatory for the composition and manufacturing factors. In some cases, scaling the value of the diffusion rate with the label claimed dose strength led to similarity. The results of hysteresis loop test revealed a significant impact of structural parameters on the IVR, induced by composition variables.
Keywords: metronidazole, in vitro release, topical semisolids, vertical diffusion cells, hysteresis loop test.
*Correspondence: Alina Mînea, University of Medicine and Pharmacy „Carol Davila” Bucharest, Faculty of Pharmacy, Department of Pharmaceutical Technology and Biopharmaceutics, no.6 Traian Vuia St., 020956, Bucharest, Romania, Tel. +40-(21)-3180740, email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it .