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Classification of loratadine and possible therapeutic significance reported.

Biotech Week December 29, 2004 2004 DEC 29 – (NewsRx.com & NewsRx.net) — Scientists from Croatia have reported on the classification of loratadine based on the biopharmaceutics drug classification concept and possible in vitro-in vivo correlation.

“Loratadine was studied both in vitro and in vivo (in healthy humans) to classify it according to the Biopharmaceutics Classification System (BCS) in order to gain more understanding of the reasons for its highly variable nature with respect to plasma time profiles,” wrote M.Z.I. Khan and colleagues, PLIVA Research Institute, “and to determine the most appropriate dissolution test conditions for in vitro assessment of the release profile of the drug from solid dose forms.

“Based on the solubility of loratadine determined under various pH conditions and its permeability through Caco-2 monolayers, loratadine was classified as a Class 11 drug. website loratadine side effects

“Plasma profiles were predicted by convolution analysis using dissolution profiles obtained under various pH and hydrodynamic conditions as the input function and plasma time data obtained from a syrup formulation as the weighting function,” continued the researchers. loratadinesideeffectsnow.net loratadine side effects

“The predicted profiles based on dissolution studies done at gastric pH values were in reasonable agreement with the mean bio-data suggesting dissolution testing should be done at gastric pH values.” “However,” the researchers concluded, “the bio-data were highly variable and it is suggested this may be due, at least in part, to high individual gastric pH variability and dissolution occurring in the intestine on some occasions, and therefore, dissolution testing should also be done in simulated intestinal fluid.” Khan and colleagues published their study in Biological & Pharmaceutical Bulletin (Classification of loratadine based on the biopharmaceutics drug classification concept and possible in vitro-in vivo correlation. Biol Pharm Bull, 2004;27(10):1630-1635).

Additional information can be obtained by contacting M.Z.I. Khan, PLIVA Research Institute Ltd, Prilaz Baruna Filipovica 29, Zagreb 10000, Croatia.

The publisher of the journal Biological & Pharmaceutical Bulletin can be contacted at: Pharmaceutical Society Japan, 2-12-15-201 Shibuya, Shibuya-Ku, Tokyo, 150, Japan.

The information in this article comes under the major subject areas of Biopharmaceutics, Lortadine, Permeability Testing and Therapy.