title: Crush resistance and insufflation potential of poly(ethylene oxide)-based abuse deterrent formulations.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: a Department of Pharmaceutical Sciences, College of Pharmacy , Nova Southeastern University , Fort Lauderdale , FL , USA.
authors.forename: Srinath
authors.initials: S
authors.lastname: Muppalaneni
authors.affiliation: a Department of Pharmaceutical Sciences, College of Pharmacy , Nova Southeastern University , Fort Lauderdale , FL , USA.
authors.forename: David J
authors.initials: DJ
authors.lastname: Mastropietro
authors.affiliation: a Department of Pharmaceutical Sciences, College of Pharmacy , Nova Southeastern University , Fort Lauderdale , FL , USA.
authors.forename: Hossein
authors.initials: H
authors.lastname: Omidian
mesh_terms: D002152:Calorimetry, Differential Scanning; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D003692:Delayed-Action Preparations; D007327:Insufflation; D011092:Polyethylene Glycols / Q000737:chemistry*; D011108:Polymers / Q000737:chemistry*; D013607:Tablets
chemical_list: D003692:Delayed-Action Preparations; D011108:Polymers; D013607:Tablets; D011092:Polyethylene Glycols
keywords: Drug abuse; abuse deterrent; nasal insufflation; physical manipulation; poly(ethylene oxide); tamper resistant