Technology Introduction

Overview

Collegium has developed a novel, patented formulation platform technology, DETERx™, that provides extended release drug delivery and tamper-resistance.  The DETERx™ formulation is specifically designed to retain its time-release mechanism following common methods of tampering (e.g. crushing, chewing, heating for IV injection, etc.).  This approach is different from other tamper-resistant or abuse deterrent formulations that include an antagonist (to counteract the physiological effect of the drug) or an aversive agent (such as an irritant to make abuse unpleasant).  The DETERx™ approach (no antagonists or aversive agents) has the advantage of minimizing risk to legitimate patients.

DETERx™ Description

DETERx™ formulations consist of small spherical beads that are filled into a capsule.  The beads are prepared using a standard spray congealing process. They contain a solid dispersion of the active drug in an extended release matrix.  All of the formulation excipients used are Generally Recognized As Safe (GRAS), NF-grade and are listed in FDA’s Inactive Ingredient Database for oral administration.  A number of API’s (e.g. opioids, amphetamines) have been incorporated into DETERx™ to demonstrate extended release and tamper-resistant properties of the technology. The drug release profile achieved using the DETERx™ technology can be customized by simply altering various formulation parameters including bead size and nature and ratio of excipients.

As each individual bead has extended release and tamper-resistant properties, the DETERx™ formulation can be administered as capsule or as a sprinkle (opening the capsule) without compromising the extended release profile. This provides an added advantage for patients with difficulty in swallowing.