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- Title
TESTING THE IN VITRO EQUIVALENCE OF TWO ACETYLCYSTEINE BASED PRODUCTS.
- Authors
Ognean, Laurentiu; Cernea, Cristina; Trinca, Sebastian; Cernea, Mihai; Moldovan, Meda
- 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.
- Subjects
INTERPRETATION (Philosophy); HYDROGEN-ion concentration; THERAPEUTIC equivalency in drugs; NEUTRALIZATION (Chemistry); ACIDITY function; ACIDS
- Publication
Studia Universitatis Vasile Goldis Seria Stiintele Vietii (Life Sciences Series), 2010, Vol 20, Issue 1, p75
- ISSN
1584-2363
- Publication type
Article