Resumo

CASANOVA-GODOY, Luis Antonio Martín; CASTILLO-SAAVEDRA, Ericson Félix; REYNOSO-LEYVA, Elva Milagros  e  AYALA-JARA, Carmen Isolina. Comparative study of dissolution profiles of prednisone 20 mg tablets marketed in Peru. Mem. Inst. Investig. Cienc. Salud [online]. 2018, vol.16, n.3, pp.13-21. ISSN 1812-9528.  https://doi.org/10.18004/mem.iics/1812-9528/2018.016(03)13-021.

The purpose of the study was to compare the dissolution profiles of prednisone 20 mg tablets marketed in Peru. A comparative quantitative study with a non-experimental design was carried out, which included twelve tablets for each formulation to be evaluated (referent and multi-source), under similar work conditions in three dissolution media: hydrochloric acid buffer pH 1.2, acetate buffer pH 4.5 and phosphate buffer pH 6.8. The dissolved temporal percentages of prednisone were evaluated by zero kinetic order and first kinetic order, Higuchi, cubic root and Weibull models for the dependent model; while the similarity factor (f2), mean dissolution time and dissolution efficiency were used for the independent model. In the dependent model, the release of prednisone was adjusted to the Weibull function kinetics, evaluated using the Akaike information criterion. In the independent model, the values of f2 in all the dissolution media fulfilled the range 50 - 100 established by the Food and Drug Administration, to indicate in vitro similarity between the dissolution profiles. Likewise, it was evidenced that there is no statistically significant difference between the formulations with respect to the mean dissolution time and the dissolution efficiency. The reference and multi-source prednisone 20 mg tablets marketed in Peru are similar based on in vitro dissolution profiles tests.

Palavras-chave : dissolution; prednisone; drug release; in vitro techniques (Source: MeSH NLM).

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