title: In vitro-in vivo correlation of modified release dosage form of lamotrigine.
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%.
authors.affiliation: Bioanalytical Laboratory, Torrent Pharmaceutical Ltd, Bhat, Gandhinagar-382428, Gujarat, India. hitenshah@torrentpharma.com
authors.forename: Hiten J
authors.initials: HJ
authors.lastname: Shah
authors.forename: Gunta
authors.initials: G
authors.lastname: Subbaiah
authors.forename: Dasharath M
authors.initials: DM
authors.lastname: Patel
authors.forename: Chhagan N
authors.initials: CN
authors.lastname: Patel
mesh_terms: 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*
chemical_list: D000927:Anticonvulsants; D003692:Delayed-Action Preparations; D013607:Tablets; D014227:Triazines; D000077213:Lamotrigine