Testing the in vitro equivalence of two acetylcysteine based products

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Article Title:	Testing the in vitro equivalence of two acetylcysteine based products
Authors:	Laurentiu OGNEAN*, Cristina CERNEA, Sebastian TRINCA, Mihai CERNEA, Meda MOLDOVAN
Affiliation:	University of Agricultural Sciences and Veterinary Medicine, Cluj-Napoca, Romania
Abstract:	The main objective of this study was to compare two acetylcysteine based products with identical quantitative and qualitative composition (acetylcysteine 2g, sucrose and vanillin) and identical pharmaceutical form (oral powder). For the equivalence of the two items we chose the dilution profiles method of determined through HPLC. The data obtained was statistically analyzed and for interpretation, the f2 similarity factor was calculated. We resorted to using this test procedure in vitro because through HPLC, we could not determine the plasmatic concentrations of the 10 horses tested in vivo, in the initial implementation of a standardized protocol. Average percentages of the samples of tested and reference products, dissolved for test showed more than 85% after 5 minutes in each of the 3 different pH dissolution media, indicating similar dilution profiles, indicating there was no need for calculating the f2 similarity factor. Based on the obtained in vitro dissolution profiles, identical quantitative and qualitative composition (2 g acetylcysteine in 6 g powder) and the identical pharmaceutical formulation (oral powder) in vivo testing of the two investigated products is not necessary.
Keywords:	bioequivalence, in vitro, acetylcystein, horse, f2 similarity factor
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*Correspondence:	Laurenţiu Ognean, University of Agricultural Science and Veterinary Medicine, Faculty of Veterinary Medicine, Department of Physiology, Mănăştur street, no 3-5, 400037, Cluj-Napoca, Romania, Email: lognean@yahoo.com