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

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

Gopal Singh Rajawat, Tejashree Belubbi, Mangal S Nagarsenker, Bertil Abrahamsson, Rodrigo Cristofoletti, Dirk W Groot, Peter Langguth, Alan Parr, James E Polli, Mehul Mehta, Vinod P Shah, Tomokazu Tajiri, etc.

J Pharm Sci. 2019 Oct;108(10):3157-3168.

PMID: 31181225

Abstract:

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.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
AP103639049-A	Ondansetron hydrochloride		103639-04-9	Price

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