In vitro-in vivo correlation of modified release dosage form of lamotrigine.
The plasma concentration profile of lamotrigine was predicted from the dissolution test data of the modified release 100 mg lamotrigine tablet by applying the in vitro-in vivo correlation (IVIVC). Three different release formulations (L-1, L-2 and L-3) and its profiles of in vitro data were generated in different dissolution media. Pharmacokinetics evaluation of these formulations was carried out in 12 healthy volunteers. In vitro-in vivo correlation was established from the generated dissolution and bioavailability data. A good correlation between the percentages dissolved vs absorbed (r2>0.989) was obtained using level A correlation. Evaluation of the internal predictability of level A correlation was calculated in terms of percent prediction error, which was found to be below 15%.
Shah
Hiten J
HJ
Bioanalytical Laboratory, Torrent Pharmaceutical Ltd, Bhat, Gandhinagar-382428, Gujarat, India. hitenshah@torrentpharma.com
Subbaiah
Gunta
G
Patel
Dasharath M
DM
Patel
Chhagan N
CN
D000328:Adult; D000927:Anticonvulsants / Q000008:administration & dosage / Q000493:pharmacokinetics*; D001682:Biological Availability; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations; D006801:Humans; D000077213:Lamotrigine; D008297:Male; D012995:Solubility; D013607:Tablets; D014227:Triazines / Q000008:administration & dosage / Q000493:pharmacokinetics*
D000927:Anticonvulsants; D003692:Delayed-Action Preparations; D013607:Tablets; D014227:Triazines; D000077213:Lamotrigine