Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Ondansetron
| Autor: | Alan F. Parr, Tomokazu Tajiri, Bertil Abrahamsson, Jennifer B. Dressman, Mangal S. Nagarsenker, Vinod P. Shah, Rodrigo Cristofoletti, James E. Polli, Peter Langguth, Mehul Mehta, Gopal Singh Rajawat, D.W. Groot, Tejashree Belubbi |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Nausea
Pharmaceutical Science Administration Oral Biological Availability dissolution 02 engineering and technology Bioequivalence Pharmacology 030226 pharmacology & pharmacy Dosage form Biopharmaceutics Ondansetron Excipients 03 medical and health sciences ondansetron hydrochloride dihydrate 0302 clinical medicine Pharmacokinetics Medicine Humans Dissolution testing Dosage Forms Ondansetron hydrochloride business.industry biopharmaceutics classification system (BCS) solubility 021001 nanoscience & nanotechnology Biopharmaceutics Classification System biowaiver Therapeutic Equivalency medicine.symptom permeability 0210 nano-technology business medicine.drug Tablets |
| Popis: | 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|