Faculty Articles

Title

Crush resistance and insufflation potential of poly(ethylene oxide)-based abuse deterrent formulations.

ISBN or ISSN

1744-7593

Publication Title

Expert Opinion on Drug Delivery

Volume

13

Issue

10

Publication Date / Copyright Date

10-1-2016

First Page

1375

Last Page

1382

Publisher

Taylor & France Group

DOI Number

10.1080/17425247.2016.1211638

Abstract

OBJECTIVES: This study was conducted to evaluate suitable methods of testing crush-resistant tablets composed largely of thermoplastic polymers. The objectives were, i) to evaluate the effect of thermal processes on crush resistance, ii) to develop test method(s) to indicate whether a crush-resistant tablet is susceptible to tampering by insufflation based on generated particle sizes, and iii) to find an appropriate analytical tool for discriminatory studies.

METHODS: We investigated the crush-resistance properties of poly(ethylene oxide) (PEO) tablets using three manual and four electrical devices. PEO tablets were directly compressed or further heat-treated to mimic thermal manufacturing processes (i.e. hot-melt extrusion, sintering). Differential scanning calorimetry was also utilized to evaluate effect of thermal processes on polymer properties.

RESULTS: Non-heat treated tablets were easily crushed by all methods. Heat-treated tablets were only susceptible to cryogenic grinding and high-powered domestic blender. Our results confirm that manual methods are not suitable for discriminatory study.

CONCLUSIONS: Testing methods for crush resistance may not be applicable to all products nor allow control over all process factors. Notwithstanding, the use of high-powered electrical devices may be an effective discriminatory tool for testing heat treated PEO-based ADFs.

Disciplines

Medicine and Health Sciences | Pharmacy and Pharmaceutical Sciences

Keywords

Calorimetry, Differential Scanning, Chemistry, Pharmaceutical, Delayed-Action Preparations, Insufflation, Polyethylene Glycols, Polymers, Tablets

Peer Reviewed

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