Rajawat, Gopal SinghBelubbi, TejashreeNagarsenker, Mangal SAbrahamsson, BertilCristofoletti, RodrigoGroot, Dirk WLangguth, PeterParr, AlanPolli, James EMehta, MehulShah, Vinod PTajiri, TomokazuDressman, Jennifer2019-07-302019-07-302019-06-081520-60173118122510.1016/j.xphs.2019.05.033http://hdl.handle.net/10029/623205Literature data pertaining to the physicochemical, pharmaceutical, and pharmacokinetic properties of ondansetron hydrochloride dihydrate are reviewed to arrive at a decision on whether a marketing authorization of an immediate release (IR) solid oral dosage form can be approved based on a Biopharmaceutics Classification System (BCS)-based biowaiver. Ondansetron, a 5HT3 receptor antagonist, is used at doses ranging from 4 mg to 24 mg in the management of nausea and vomiting associated with chemotherapy, radiotherapy, and postoperative treatment. It is a weak base and thus exhibits pH-dependent solubility. However, it is able to meet the criteria of "high solubility" as well as "high permeability" and can therefore be classified as a BCS class I drug. Furthermore, ondansetron hydrochloride 8 mg IR tablets (Zofran® 8 mg) and multiples thereof (16 mg = Zofran® 8 mg × 2 tablets and 24 mg = Zofran® 8 mg × 3 tablets) meet the criteria of "rapidly dissolving" in dissolution testing. Ondansetron hydrochloride has a wide therapeutic window and is well-tolerated after oral administration. Based on its favorable physicochemical properties, pharmacokinetic data and the minimal risks associated with an incorrect bioequivalence decision, the BCS-based biowaiver procedure can be recommended for ondansetron hydrochloride dihydrate IR tablets.eninfo:eu-repo/semantics/closedAccessbiopharmaceutics classification system (BCS)biowaiverdissolutionondansetron hydrochloride dihydratepermeabilitysolubilityArticleJ Pharm Sci 2019; 108(10):3157-68