Influence of Composition and Geometry on Chewability of Egalet ADPREM Tablets Olsen

1. Influence of Composition and Geometry on Chewability of Egalet� ADPREM Tablets Olsen M.R., Lindhardt K., �verg�rd J.M., Haahr A.-M., Hemmingsen P.H., Lyhne-Iversen L.I.� Egalet a/s, DK-3500 V�rl�se, Denmark �lli@egalet.com INTRODUCTION Egalet a/s is a specialty pharma focused on pain management and engaged in developing tamper resistant extended release opioid products (Figure 1) by applying the Egalet ADPREM (Abuse Deterrent Prolonged Release Erosion Matrix) technology to the field of extended release opioids. Figure 1: Egalet� ADPREM tablets Egalet� formulations are based on an injection moulded polymer system consisting of an erodible matrix partly covered with a water-impermeable, non-erodible shell (Figure 2). The well-defined fixed surface erosion area at both ends of the cylindrical tablet allows a tightly controlled, extended release for up to 12 hours and a potential for once-daily dosing. Figure 2: Cross-section of an Egalet� ADPREM tablet. The opioid is dispersed in a matrix (light grey) partly covered by an essentially non-erodible shell (dark grey). The opioid is released by erosion of the matrix. Egalet� ADPREM tablets do inherently possess abuse deterrent features due the tamper resistance making it extremely difficult to attain more than the intended amount of drug within the specified release time. Consequently it will be immensely difficult to abuse the tablets by common types of intentional drug abuse such as: Injection Buccal absorption Extraction in various organic and aqueous media Chew and/or crushing Snorting Smoking In order to be tamper resistant, a tablet must be resistant to simple chewing.