INFLUENCE OF DOSE AND USP DISSOLUTION APPARATUS IN THE RELEASE PERFORMANCE OF REFERENCE TABLETS: PROPRANOLOL-HCl AND RANITIDINE-HCl CASES

Objective: Due to quality of generic formulations depends on available information of reference drug products the aim of this work was to perform an in vitro dissolution study of two doses of propranolol-HCl and ranitidine-HCl reference tablets using USP basket or paddle apparatus and flow-through cell method. Methods: Two doses of propranolol-HCl (10-mg and 80-mg) and ranitidine-HCl (150-mg and 300-mg) of Mexican reference products were used. Dissolution profiles of propranolol-HCl were obtained with USP basket apparatus at 100 rpm and 1000 ml of 1% hydrochloric acid. Profiles of ranitidine-HCl were determined with USP paddle apparatus at 50 rpm and 900 ml of distilled water. All formulations were also studied with the flow-through cell method using laminar flow at 16 ml/min. Dissolution profiles were compared by model-independent (f2 similarity factor, mean dissolution time and dissolution efficiency) and model-dependent methods (dissolution data adjusted to some mathematical equations). Time data, derived from these adjustments, as t50%, t63.25%, and t85% were used to compare dissolution profiles. Results: With all approaches used and being high solubility drugs significant differences were found between low and high doses and between USP dissolution apparatuses (*P<0.05). Conclusion: In vitro dissolution performance of two doses of propranolol-HCl and ranitidine-HCl was not expected. Considering the same USP dissolution apparatus, the reference tablets did not allow the simultaneous release of the used doses. The results could be of interest for pharmaceutical laboratories or health authorities that classify some drug products as a reference to be used in dissolution and bioequivalence studies

Administración pública y gobernanza en la segunda década del siglo XXI

La administración pública constituye una de las ciencias sociales que están en constante transformación y una de las que se encuentran íntimamente vinculadas al contexto regional, nacional y mundial, así lo constatan los cambios que ha manifestado en las tres últimas décadas, tanto en el plano nacional como en el continental. En ese lapso hemos sido testigos de la irrupción y el desarrollo de conceptos, enfoques y campos e conocimiento, tales cómo las políticas públicas o ciencias de políticas, la nueva gestión pública, el neoinstitucionalismo y recientemente el de la gobernanza, para citar a los más visibles; todos, sin embargo, indisolublemente asociados a la Administración Pública, ya sea desde una perspectiva disciplinaria o desde su acción como brazo ejecutor del Estado