Biowaiver Monograph for Immediate-Release Dosage Forms: Levamisole Hydrochloride

This work describes the potential applicability of the BCS-based Biowaiver to oral solid dosage forms contain-ing Levamisole hydrochloride, an anthelmintic drug on the WHO List of Essential Medicines. Solubility and permeability data of levamisole hydrochloride were searched in the literature and/or measured experimen-tally. Levamisole hydrochloride is a highly soluble drug, but there is no clear evidence of high permeability in humans, indicating that it should provisionally be assigned to BCS class III. The biowaiver procedure would thus be applicable for solid oral dosage forms containing levamisole hydrochloride as the only active ingredi-ent. Due to the lack of data in the literature regarding excipient effects on the bioequivalence of products containing levamisole, it is currently recommended that the products comply with the ICH and WHO guide-lines: the test formulation should have the same qualitative composition as the comparator, contain very similar quantities of those excipients, and be very rapidly dissolving at pH 1.2, 4.5, and 6.8. However, for cer-tain well-studied excipients, there appears to be opportunity for additional regulatory relief in future ver-sions of the ICH BCS Guidance M9, such as not requiring that the quantities of these common excipients in the test and comparator be the same. (c) 2022 Published by Elsevier Inc. on behalf of American Pharmacists Association.