Paracetamol Bioavailability Study by Means of Salivary Samples
R`afat M. Nejem, Mahmoud Mohamed Is, Nahed Talab Shaa
Abstract
R`afat M. Nejem, Mahmoud Mohamed Is, Nahed Talab Shaa
Abstract
Bioequivalence of two different marketed paracetamol tablets, Decamol (500 mg, B.N., 4151, Megapharm) and Otamol (500 mg, B.N, 41093, Al-Quds-pharm), were compared to the innovator product, Dexamol (500 mg, B.N.12603, Dexxon). The bioavailability study was carried out in healthy volunteers in a crossover sequence using saliva drug levels as a parameter. In vitro studies, it was shown that all three products, Decamol, Otamol and Dexamol, were pharmaceutically equivalent. The bioavailability data obtained could be correlated to the in vitro data of the three tablet brands. In vivo investigations indicated no statistically significant differences in the bioavailability of Decamol and Otamol from Dexamol tablets. Therefore, all the three products are considered bioequivalent.
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Bioequivalence of two different marketed paracetamol tablets, Decamol (500 mg, B.N., 4151, Megapharm) and Otamol (500 mg, B.N, 41093, Al-Quds-pharm), were compared to the innovator product, Dexamol (500 mg, B.N.12603, Dexxon). The bioavailability study was carried out in healthy volunteers in a crossover sequence using saliva drug levels as a parameter. In vitro studies, it was shown that all three products, Decamol, Otamol and Dexamol, were pharmaceutically equivalent. The bioavailability data obtained could be correlated to the in vitro data of the three tablet brands. In vivo investigations indicated no statistically significant differences in the bioavailability of Decamol and Otamol from Dexamol tablets. Therefore, all the three products are considered bioequivalent.
Key concepts: Bioavailability, Bioequivalence, Innovator, Pharmacology, Chemistry, Crossover study, Saliva, Chromatography