New ALERRT(SM) Instrument Aids Pharmaceutical Companies in Development of Abuse-Deterrent Formulations: Study Reports on Comparison of Work Requirements to Manipulate Opioid Formulations

BETHESDA, Md., June 15, 2015 /PRNewswire/ -- Pharmaceutical companies developing abuse-deterrent products can now obtain quantitative information on "tamper resistance" using the new ALERRT(SM) [Assessing Labor, Effort and Resources Required for Tampering] scales.  Researchers presented data at the Annual Meeting of the College on Problems of Drug Dependence showing how ALERRT(SM) can be applied to compare opioid formulations.

"The development of the ALERRT(SM) scales for measurement of work involved in tampering with pharmaceutical drug products is a significant advance in this evolving science. These scales provide quantitative information on tamper resistance," said Edward J. Cone, Ph.D., Principal Scientist, Drug Delivery and Abuse Deterrent Drug Products, PinneyAssociates. "For pharmaceutical developers, these objective comparisons support decision-making in early development efforts."

To make products safer and to impede drug abusers' attempts to alter or "tamper" with opioid products for faster drug delivery, pharmaceutical companies are developing abuse-deterrent formulations.  Each formulation is being developed with specific properties designed to resist tampering by patients and abusers and to deter abuse by various routes of administration.  Guidelines from the Food and Drug Administration (FDA) recommend that "the degree of effort required to bypass or defeat" abuse-deterrent properties be assessed.

The ALERRT(SM) visual analog scales measure the amount of "work" involved in physical manipulation of a given formulation using common household tools such as a pill crusher, food grater, or coffee grinder. 

"The data collected using the ALERRT scale need to be interpreted within the real-world context of drug abuse," said Dr. Cone.

The ALERRT(SM) scales and name are proprietary to Pinney Associates, Inc.

All of the co-authors work for PinneyAssociates and provide consulting services to developers and marketers of opioid products. All decisions related to the study were made by the authors. The study was paid for by PinneyAssociates and no funding was received from the pharmaceutical industry.

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