AdvaTab Cetirizine HCl
Develop the first ODT formulation of a popular allergy product
| Drug | Cetirizine hydrochloride is the key ingredient in the popular allergy product, ZYRTEC®. The drug suffers from a very bitter taste and chemical instability. To date, no other ODT form of cetirizine has been developed; only conventional or chewable tablets are available commercially. |
| Goal | Develop an orally disintegrating tablet (ODT) of Cetirizine |
| Challenges | Develop an ODT formulation with superior mouthfeel and organoleptic properties |
| Solution | The Microcaps® technology provided a durable protective polymer barrier around the drug, providing barriers between the drug and the taste buds, and between the drug and the other formulation components. Eurand utilized a modified polymer layer, such that rapid drug release was achieved once the tablet was ingested. The AdvaTab® technology ensured that the dosage form disintegrated rapidly and pleasantly in the mouth without water, while still being a hard and durable tablet. |
Chart: Comparison of pharmacokinetic profiles of Eurand’s AdvaTab Cetirizine to both the ZYRTEC® chewable and immediate-release tablets (healthy human subjects, N=12).
| Result | Using their AdvaTab and Microcaps technologies, Eurand successfully developed a stable ODT formulation that demonstrated clinical bioequivalence to the ZYRTEC® reference tablet. |
| Product Achieved | Out-licensing opportunities available |
ZYRTEC® is a registered trademark of McNeil-PPC, Inc.