Faculty Articles
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
NSUWorks Citation
Muppalaneni, Srinath; Mastropietro, David J.; and Omidian, Hamid, "Crush resistance and insufflation potential of poly(ethylene oxide)-based abuse deterrent formulations." (2016). Faculty Articles. 96.
https://nsuworks.nova.edu/hpd_corx_facarticles/96
