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In vitro-in vivo correlation of modified release dosage form of lamotrigine
Hiten J Shah1, Gunta Subbaiah, Dasharath M Patel
1Bioanalytical Laboratory, Torrent Pharmaceutical Ltd, Bhat, Gandhinagar-382428, Gujarat, India. hitenshah@torrentpharma.com
Abstract:
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%.
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