Grünenthal Press Releases 2012

Stronger! INTAC™ formulation technology protects intended action of extended release drugs

Bedminster, NJ - April 30, 2012. During this year's Drug and Delivery Formulations Summit (San Diego, CA) Grünenthal presents its new INTAC™ formulation technology designed to be crush-resistant and to protect intended action of extended release prescription opioid drugs.

Prescription opioids are at the center of a major public health crisis of misuse and abuse in the United States. Prescription drug abuse is the fastest-growing drug problem in the US and drug overdose death rates have risen steadily in the US.1 Prescription drugs are the second most-abused category of drugs after marijuana2 and there are various routes of abuse of prescription drugs including crushing or dissolving tablets. In the case of controlled release tablets, such tampering typically destroys the intended drug action. 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 an effective means to address the issue.

At one of today's sessions, Dr. Eric Galia, Project Director International Technical Alliance Management of Grünenthal presents the company's INTAC™ technology. INTAC™ is a formulation platform that provides extraordinary hardness as a means of tamper deterrence while keeping the intended time-release characteristics of the product. The technology uses polyethylenoxide (PEO) of high molecular weight and a hot melt extrusion process that combines the two factors of heat and pressure. Tablets produced utilizing this process have an extraordinary mechanical strength. The resulting physicochemical properties not only impede pulverization of the tablets but also result in low extractability of active drug from the tablets in a wide range of solvents. These features combined create a significant hurdle to the non-oral misuse/abuse of controlled release formulations.

Grünenthal also participates in the show with a booth dedicated to the INTAC™ technology. Attendees are able to test the difference in crush resistance of INTAC™ tablets versus conventional prolonged release tablets themselves by actually trying to crush the tablets with a hammer.

About INTAC™
INTAC™, Grünenthal's tamper resistant formulation technology, is designed to deter various relevant routes of abuse / inadvertent misuse from tablet tampering by imposing a specific mechanical stability to the tablet. This mechanical stability is created by the combination of specific excipients together with a unique manufacturing process. Grünenthal’s proprietary INTAC™ approach is established at commercial manufacturing scale and is featured in FDA-approved products which are marketed by US partners. Grünenthal considers its patent protected INTAC™ to be the leading technology for abuse-deterrent and tamper-resistant opioid products. The INTAC™ technology is available for licensing to interested companies for various product opportunities.

About Grünenthal
The Grünenthal Group is an independent, family-owned international research based pharmaceutical company headquartered in Aachen, Germany. Building on its unique position in pain, its objective is to become the most patient-centric company and to be a leader in therapy innovation. Grünenthal is one of the last five research-oriented pharmaceutical corporations with headquarters based in Germany which sustainably invests in research and development. These investments amounted to about 25 % of revenues in 2011. Grünenthal’s research and development strategy concentrates on select fields of therapy and state-of-the-art technologies. We focus on the intensive search for new ways to treat pain better, more effectively and with fewer side-effects than before. Altogether, the Grünenthal Group has affiliates in 26 countries worldwide. Grünenthal products are sold in more than 155 countries and approx. 4,500 employees are working for the Grünenthal Group worldwide. In 2011, Grünenthal reached estimated revenues of 947 Mio €.

More information:

Grünenthal USA, Inc.    
Alexander Kraus, PhD
Vice President
Program Management Global TRF Business
One Pluckemin Way
Bedminster, NJ 07921
Phone: +1 908-745-2271   

Grünenthal GmbH, Germany
Kai Strothmann, PhD
Phone: +49 241 569 1796

1 Epidemic: Responding to America’s Prescription Drug Abuse Crisis. Executive Office of the President of the United States, 2011.
2 University of Michigan, 2009, Monitoring the Future: A Synopsis of the 2009 Results of Trends in Teen Use of Illicit Drugs and Alcohol.

Sarah Holmes-Klotz
Associate Director Human Resources/Finance
Phone: 908 306 0024