Development of in vitro-in vivo correlation for encapsulated metoprolol tartrate.
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 (R2) for level A IVIVC was 0.720, 0.905, 0.928 and 0.878 for Mepressor, T1, T2 andT3 formulations, respectively, with acceptable percent error (< 15%). The value of R2 for level B and C IVIVC was 0.231and 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 (T1formulation 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.
Department of Mathematics, The Islamia University of Bahawalpur, Bahawalpur 63100, Pakistan.
Abdulhakim A A
AA
Khaled
Khalid
K
Pervaiz
Sabiha
S
Karim
Kalsoom
K
Farzana
Ghulam
G
Murtaza
D058671:Adrenergic beta-1 Receptor Antagonists / Q000097:blood / Q000737:chemistry* / Q000493:pharmacokinetics*; D019540:Area Under Curve; D001682:Biological Availability; D002626:Chemistry, Pharmaceutical; D003198:Computer Simulation; D006863:Hydrogen-Ion Concentration; D008657:Metabolic Clearance Rate; D008790:Metoprolol / Q000097:blood / Q000737:chemistry* / Q000493:pharmacokinetics*; D008954:Models, Biological; D008956:Models, Chemical; D011109:Polymethacrylic Acids / Q000737:chemistry*; D012995:Solubility; D013678:Technology, Pharmaceutical / Q000379:methods
D058671:Adrenergic beta-1 Receptor Antagonists; D011109:Polymethacrylic Acids; C038300:methylmethacrylate-methacrylic acid copolymer; D008790:Metoprolol