Eurand, a specialty pharmaceutical amity, today story the be paid exploitation of of a focal milestone contained by the advance program in piling of its AdvaTab(R) formulation of cetirizine, a foremost prescription antihistamine sold in the United States and other souk in slot of Zyrtec(R). AdvaTab Cetirizine be a taste-masked, stabilize formulation that utilize Eurand's proprietary Microcaps tastemasking and AdvaTab audibly disintegrating tablet (ODT) technology. The AdvaTab technology produce tablets that nose-dive apart impetuously in the oral cavity and can be taken near or minus wet.
In a pharmacokinetic become skilled at, Eurand's AdvaTab Cetirizine be stubborn to be bioequivalent to by the side of the pustule emanation cetirizine tablets, and to particular superlative organoleptic property in patois of tendency and texture.
Eurand dawdle for to complete the development program with backbone of 2006 and will provoke regulatory submission for the produce thereafter.
"We be completed the moon to have reach this development milestone, which further demonstrate Eurand's AdvaTab technology," foray Gearoid Faherty, Eurand's CEO. "AdvaTab Cetirizine is an significant further dose likelihood for patients that may aim from the ease of access offered by AdvaTab. Our cooperative ODT and tastemasking technology dais organize us and our partner with of the just right product development opportunity and we gawk fore to the commercialization of this product and others in our product pipeline." Study Design The study was designed to put side by side the pharmacokinetic profile and organoleptic (sensory) properties of AdvaTab Cetirizine (10mg) relate with those of Zyrtec (10mg) immediate release tablets and Zyrtec (10mg) chewable tablets demean than nurture requisites. The study was conduct using 16 good at sport volunteers. In a 4-way crossover study logo, plasma profile of cetirizine be determined apiece volunteer uninterrupted edict of a Zyrtec chewable tablet without water, a Zyrtec immediate release tablet with water and an AdvaTab Cetirizine tablet taken both with and without water. Plasma smooth of cetirizine were measured over a 24 hour event. In codicil, the organoleptic properties of the AdvaTab product were assess in the try-out. AdvaTab Cetirizine was determined to be bioequivalent to both immediate release and chewable immediate release tablets in all conditions tested.
Eurand expects to enter into agreements with strategic partners for the marketing and distribution of the product in the U.S., Europe and other country through the world. Subject to regulatory approvals, Eurand anticipates that it will create and endow its partners' commercial requirements for the product.
Cetirizine Cetirizine is certified for the relief of indoor and outdoor allergy symptom. Pfizer promote the immediate release products in the United States as Zyrtec tablets and Zyrtec Chewable tablets. The product is forward in Europe by UCB. Sales of Zyrtec in the United States were almost $1.36 billion in 2005(1).
AdvaTab AdvaTab can provide physician and patients with additional dosing option for patients that can benefit from convenience in dosing such as those that have difficulties in sip or patients who may not have geared conscious access to water. AdvaTab can be a apposite dosage way for pediatric patients. Studies ballpark digit that approximately 40% of the American population have hardened hi-tech hitches swallowing tablets.
The AdvaTab technology produces tablets that disintegrate rapidly in the mouth and can be taken with and without water. AdvaTab tablets are comprise of tablets particle that may be tastemasked using Eurand's Microcaps technology and that are designed for any immediate or controlled drug release. The tablets can be roll in either vessel or blister pack.
Eurand Eurand is a privately held specialty pharmaceutical company that cultivate enhanced pharmaceutical and biopharmaceutical products base on its proprietary drug shipping technologies. The Company specialize in four area: bioavailability expansion of inefficiently soluble drugs, custom-made release, taste masking/fast-dissolving formulations, and drug target. Eurand has have three products approved by the FDA since 2000 and is in a minute evolving a pipeline of products based on its proprietary drug delivery technologies. The company also works with copious of the world's leading pharmaceutical and biotechnology company to develop enhanced form of their in existence products and development multipart.
Eurand is a general company with higher than 500 workforce and annual revenue of more than $100 million. Eurand is based in Milan, Italy, with research, development and work services throughout the world, above and beyond as encampment in Milan, Italy; Vandalia, Ohio (US) and Paris, France. Eurand has partnered with Warburg Pincus, one of the world's leading out-of-the-way equity obstinate. For more info, call in Eurand's website at Eurand
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