Discriminative Dissolution Method Using the Open-Loop Configuration of the USP IV Apparatus to Compare Dissolution Profiles of Metoprolol Tartrate Immediate-Release Tablets: Use of Kinetic Parameters
Por:
Solis-Cruz, Bruno, Hernandez-Patlan, Daniel, Morales Hipolito, Elvia A., Tellez-Isaias, Guillermo, Alcantara Pineda, Alejandro, Lopez-Arellano, Raquel
Publicada:
1 ene 2023
Categoría:
Pharmaceutical science
Resumen:
The use of the USP IV apparatus (flow-through cell) has gained acceptance in recent years due to its versatility and ability to discriminate due to its hydrodynamic conditions. Therefore, the objective of the present study was to develop a discriminative dissolution method in the USP IV apparatus using the open-loop configuration, as well as to propose a method to compare non-cumulative dissolution profiles obtained in the open-loop configuration considering kinetic parameters and validate its predictive power through its comparison with independent and dependent methods using five commercial immediate-release tablet drugs (one reference drug and four generic drugs) of metoprolol tartrate as a model drug. The comparison of the non-accumulated dissolution profiles consisted of determining the geometric ratio of Cmax, AUC08, AUC0Cmax, and Tmax (kinetic parameters) of the generic/reference drugs, whereby generic drugs “C” and “D” presented the highest probability of similarity since their 90% confidence intervals were included, or they were very close to the acceptance interval (80.00–125.00%). These results were consistent with the f2, bootstrap f2, and dissolution efficiency approaches (independent models). In conclusion, the proposed comparison method can be an important tool to establish similarity in dissolution profiles and to facilitate the development/selection of new formulations and positively ensure bioequivalence in clinical studies. © 2023 by the authors.
Filiaciones:
Solis-Cruz, Bruno:
Laboratory 5: LEDEFAR, Multidisciplinary Research Unit, Superior Studies Faculty at Cuautitlan (FESC), National Autonomous University of Mexico (UNAM), Cuautitlan Izcalli, 54714, Mexico
Nanotechnology Engineering Division, Polytechnic University of the Valley of Mexico, Tultitlan, 54910, Mexico
Natl Autonomous Univ Mexico UNAM, Super Studies Fac Cuautitlan FESC, Multidisciplinary Res Unit, Lab 5,LEDEFAR, Cuautitlan 54714, Mexico
Polytech Univ Valley Mexico, Nanotechnol Engn Div, Tultitlan 54910, Mexico
Hernandez-Patlan, Daniel:
Laboratory 5: LEDEFAR, Multidisciplinary Research Unit, Superior Studies Faculty at Cuautitlan (FESC), National Autonomous University of Mexico (UNAM), Cuautitlan Izcalli, 54714, Mexico
Nanotechnology Engineering Division, Polytechnic University of the Valley of Mexico, Tultitlan, 54910, Mexico
Natl Autonomous Univ Mexico UNAM, Super Studies Fac Cuautitlan FESC, Multidisciplinary Res Unit, Lab 5,LEDEFAR, Cuautitlan 54714, Mexico
Polytech Univ Valley Mexico, Nanotechnol Engn Div, Tultitlan 54910, Mexico
Morales Hipolito, Elvia A.:
Laboratory 5: LEDEFAR, Multidisciplinary Research Unit, Superior Studies Faculty at Cuautitlan (FESC), National Autonomous University of Mexico (UNAM), Cuautitlan Izcalli, 54714, Mexico
Natl Autonomous Univ Mexico UNAM, Super Studies Fac Cuautitlan FESC, Multidisciplinary Res Unit, Lab 5,LEDEFAR, Cuautitlan 54714, Mexico
Tellez-Isaias, Guillermo:
Division of Agriculture, Department of Poultry Science, University of Arkansas, Fayetteville, AR 72701, United States
Univ Arkansas, Dept Poultry Sci, Div Agr, Fayetteville, AR 72701 USA
Alcantara Pineda, Alejandro:
LUAL Asesores, Iztapalapa, Mexico City, 09438, Mexico
LUAL Asesores, Mexico City 09438, Mexico
Lopez-Arellano, Raquel:
Laboratory 5: LEDEFAR, Multidisciplinary Research Unit, Superior Studies Faculty at Cuautitlan (FESC), National Autonomous University of Mexico (UNAM), Cuautitlan Izcalli, 54714, Mexico
Natl Autonomous Univ Mexico UNAM, Super Studies Fac Cuautitlan FESC, Multidisciplinary Res Unit, Lab 5,LEDEFAR, Cuautitlan 54714, Mexico
gold, Gold
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