DEVELOPMENT OF IN VITRO-IN VIVO CORRELATION FOR ENCAPSULATED METOPROLOL TARTRATE

作者：Khaled Abdulhakim A A; Pervaiz Khalid; Karim Sabiha; Farzana Kalsoom; Murtaza Ghulam^*

来源：Acta Poloniae Pharmaceutica, 2013, 70(4): 743-747.

• metoprolol tartrate
• Eudragit (R) FS
• convolution
• IVIVC

This study was aimed to develop level A, B and C in vitro-in vivo correlation (IVIVC) for encapsulated metoprolol tartrate (T1, T2 and T3 having metoprolol tartrate/polymer ratio of 1: 1, 1: 1.5 and 1 : 2, w/w). The in vitro data were correlated with in vivo data. For level A IVIVC, drug absorption data were calculated using Wagner-Nelson method. In addition, convolution approach was used to approximate plasma drug levels from in vitro dissolution data. The coefficient of determination (R-2) for level A IVIVC was 0.720, 0.905, 0.928 and 0.878 for Mepressor (R), T1, T2 and T3 formulations, respectively, with acceptable percent error (< 15%). The value of R-2 for level B and C IVIVC was 0.231 and 0.714, respectively. It is also concluded that level A IVIVC is a proficient mathematical model for biowaiver studies involving study parameters as those implemented for T1S (T1 formulation tested for dissolution in the presence of sodium lauryl sulfate) revealing that IVIVC level A is dosage form specific, rather than to be drug specific.

• 出版日期2013-8