Eurand’s allergy pill performs well in study

Cetirizine is a leading prescription antihistamine sold in the US and other markets as Zyrtec by Pfizer. The AdvaTab version of the pill is a taste-masked, stabilized formulation that utilizes Eurand’s Microcaps tastemasking and AdvaTab technologies. This technology produces tablets that are dissolvable, disintegrating rapidly in the mouth to be taken with or without water.

In a pharmacokinetic study, AdvaTab cetirizine was determined to be bioequivalent to immediate release cetirizine tablets, and to have superior organoleptic properties in terms of taste and texture.

The study was designed to evaluate the pharmacokinetic profile and organoleptic (sensory) properties of AdvaTab Cetirizine (10mg) compared with those of Zyrtec (10mg) immediate release tablets and Zyrtec (10mg) chewable tablets under fed conditions. The study was conducted using 16 healthy volunteers.

Plasma profiles of cetirizine were determined for each volunteer following administration of each tablet type either with or without water over a 24 hour period. In addition, the organoleptic properties of the AdvaTab product were assessed in the trial. AdvaTab Cetirizine was determined to be bioequivalent to both immediate release and chewable immediate release tablets in all conditions tested.

Eurand expects to complete the development program by end of 2006 and enter into agreements with strategic partners for the marketing and distribution of the product in the US, Europe and other countries throughout the world. Subject to regulatory approvals, Eurand anticipates that it will manufacture and supply its partners’ commercial requirements for the product.