Bibliographic citations
Paredes, A., (2024). Equivalencia de perfiles de disolución de tabletas de metronidazol 500 mg. multifuentes e innovador dispensadas en establecimientos farmacéuticos del Perú [Universidad Nacional de Trujillo]. https://hdl.handle.net/20.500.14414/21167
Paredes, A., Equivalencia de perfiles de disolución de tabletas de metronidazol 500 mg. multifuentes e innovador dispensadas en establecimientos farmacéuticos del Perú []. PE: Universidad Nacional de Trujillo; 2024. https://hdl.handle.net/20.500.14414/21167
@mastersthesis{renati/1048147,
title = "Equivalencia de perfiles de disolución de tabletas de metronidazol 500 mg. multifuentes e innovador dispensadas en establecimientos farmacéuticos del Perú",
author = "Paredes Ayala, Amarilis Silvia Iris",
publisher = "Universidad Nacional de Trujillo",
year = "2024"
}
The objective of the present study was to determine the equivalence of dissolution profiles of multisource metronidazole 500 mg and innovative Flagyl® tablets sold in pharmaceutical establishments in Peru. To this end, the UV/vis spectrophotometric method was first validated for the bioexemption study of metronidazole 500 mg tablets, analyzing the parameters: linearity, accuracy, precision, selectivity and filter effect, in the dissolution media at pH 1.2; 4.5 and 6.8; finding that the method complies with what is established. In the dissolution test, 12 tablets from each laboratory were used for the media: acid pH 1.2; acetate pH 4.5 and phosphate 6.8; using apparatus II (paddles), 75 rpm, average temperature of 37 °C +/- 0.5 °C, medium volume 900 mL and dissolution time, for pH 1.2 it was up to 60 minutes and for the media pH 4.5 and pH 6.8 were reached after 90 minutes. Subsequently, 10 mL aliquots of the media were taken, without replacement, and the reading was carried out in the UV spectrophotometer at 278 nm for the pH 1.2 medium and at 320 nm for the pH 4.5 and 6.8 media. For the analysis of the dissolution profiles, the Akaike statistic was used, finding that the best fitting model is the Weibull mathematical model for the three media, which when applying the T-student test statistic, a difference was found. statistically significant (p < 0.05), between the multi-source products compared to the innovative one. The mean dissolution times (MDT) and dissolution efficiencies (ED%) of the multisource tablets differed statistically from Flagyl ® (p < 0.05). In the evaluation of the similarity factor (f2) in three dissolution media, it was found that all values were less than 50. Therefore, it was concluded that the 500 mg multisource metronidazole tablets and the innovative one does not present similarity.
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