INTAC&#0174 - Grunenthal Group Presents Data Demonstrating the Strength of Its Tamper Resistant Technology at the American Association of Pharmaceutical Science Annual Meeting and Exposition

BEDMINSTER, N.J. and AACHEN, Germany, Oct. 16, 2012 /PRNewswire/ -- Grunenthal, a global family-owned pharmaceutical company specializing in pain management, today announced that data will be presented in two posters at this year's annual meeting of the American Association of Pharmaceutical Science taking place in Chicago, IL from October 14 18, 2012.

Grunenthal experts will discuss and present details of their innovative INTAC® technology in the following two posters:

• "INTAC®: A Novel Formulation Platform to Protect Intended Drug Action" (abstract #1106); Authors: L. Barnscheid^*, K. Wening^*, E. Galia^*, J. Bartholomaus⁺ (Grunenthal GmbH / ⁺Pharmakreativ)

The study showed that tablets using the INTAC® technology are characterized by outstanding resistance against pulverization by exhibiting a breaking strength of more than 500 N. Additionally, the company's extended release formulation does not require aversive additives, protecting the intended drug action and raising hurdles against misuse and abuse of opioid products.

• "Development of a Standardized Hammer Test for the Assessment of INTAC® Tablets" (abstract #1110); Authors: L. Barnscheid^*, K. Wening^*, B. Hoher⁺, R. Dahlmann⁺ (^*Grunenthal GmbH / ⁺Institute of Plastics Processing (IKV) at RWTH Aachen University)

In order to assess the INTAC® technology's ability to prevent pulverization of a tablet, Grunenthal developed a mechanical test that was representative, reproducible and reliable to evaluate this measure. The study found that a representative test to measure pulverization could be defined, and an apparatus was constructed to allow for reproducible and reliable testing.

The posters will be presented on Tuesday, October 16^th from 9:30 AM -12:30 PM CDT in Hall F in McCormick Place. At booth #2648, the Grunenthal team will also provide information on INTAC®. Booth visitors are invited to personally experience the outstanding crush resistant properties of INTAC® tablets in attempting to smash the tablets with a hammer.

Prescription opioids are at the center of a major public health crisis of misuse and abuse in the United States¹. Today, prescription drug abuse is the fastest growing drug problem in the U.S., and drug overdose death rates have risen steadily in the U.S. Technological approaches that intend to prohibit or reduce the ability to abuse specific time-release drugs by tampering with the formulation through crushing are therefore considered an effective means to address the issue². Opioid manufacturers are looking to address ways in which they can adapt formulations of drugs to offer tamper resistance.

About INTAC® Technology

Tablets produced using INTAC® technology are designed to resist crushing even by heavy hammer blows, foiling the key step in most forms of opioid abuse. In addition to their high breaking strength, tablets produced by the INTAC® process form a gel in aqueous solutions that cannot be readily injected, and they resist extraction of active drug by a wide range of solvents. The mechanical stability is created by the combination of specific excipients together with a unique manufacturing process. INTAC® is the leading tamper resistance technology now in use, with two FDA-approved products already available in the United States. INTAC® manufacturing is established on a commercial scale in the U.S. and Europe. The technology is available for licensing to interested companies for various opportunities. Companies licensing INTAC® technology for their products are following a proven approach with a track record of regulatory approval. For more information about INTAC® please visit http://www.intac.grunenthal.com.

About Grunenthal

The Grunenthal Group is an independent, family-owned, international research-based pharmaceutical company headquartered in Aachen, Germany. Building on its unique position in pain treatment, its objective is to become the most patient-centric company and thus to be a leader in therapy innovation.

Grunenthal is one of the last remaining five research-oriented pharmaceutical companies with headquarters in Germany which sustainably invests in research and development. These investments amounted to about 25 percent of revenues in 2011. Grunenthal's research and development strategy concentrates on selected fields of therapy and state-of-the-art technologies. We are intensely focused on discovering new ways to treat pain better and more effectively, with fewer side-effects than current therapies.

Altogether, the Grunenthal Group has affiliates in 26 countries worldwide. Grunenthal products are sold in more than 155 countries and today approximately 4,200 employees are working for the Grunenthal Group worldwide. In 2011, Grunenthal achieved revenues of 947 mn. More information please visit www.grunenthal.com.

¹ Epidemic: Response to America's Prescription Drug Abuse Crisis. Executive Office of the President of the United States, 2011.

² Black et al. 2012 J. Pain 13:S58

SOURCE Grunenthal Group