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J Pharm Sci. 2019 Jun 8. pii: S0022-3549(19)30366-1. doi: 10.1016/j.xphs.2019.05.033. [Epub ahead of print]

Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Ondansetron.

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Department of Pharmaceutics, Bombay College of Pharmacy, Kalina, Santacruz (E), Mumbai, India.
Pharmaceutical Development, AstraZeneca R&D, Mölndal, Sweden.
Division of Bioequivalence, Brazilian Health Surveillance Agency (Anvisa), Brasilia, Brazil.
RIVM (National Institute for Public Health and the Environment), Bilthoven, The Netherlands.
Pharmaceutical Technology and Biopharmaceutics, Institute of Pharmacy and Biochemistry, Johannes Gutenberg-University, Mainz, Germany.
BioCeutics LLC, Cary, North Carolina 28594.
Department of Pharmaceutical Sciences, School of Pharmacy, University of Maryland, Baltimore, Maryland 21201.
Division of Clinical Pharmacology, Centre for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland 20993.
International Pharmaceutical Federation (FIP), The Hague, The Netherlands.
Astellas Pharma Inc., Analytical Research Laboratories, Yaizu, Japan.
Institute of Pharmaceutical Technology, Johann Wolfgang Goethe University, Frankfurt am Main, Germany. Electronic address:


Literature 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.


biopharmaceutics classification system (BCS); biowaiver; dissolution; ondansetron hydrochloride dihydrate; permeability; solubility


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