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Opioid analgesics have high potential for abuse, and oral formulations are frequently tampered to produce greater effects.
General methods of opioid tampering include crushing and solution extraction for abuse viasnorting and injection,
respectively. To deter crushing, poly (ethylene oxide) (PEO) is commonly incorporated into abuse-deterrent medications
with further processing to improve mechanical strength. Evaluating the ease by which such tablets can resist crushing is
challenging since no compendial or universally-accepted methods exist. Furthermore, the choice of tool used is likely to result
in different particle sizes. Therefore, the purpose of this study wasto evaluatethe ability of different crushing methods (manual
and mechanical) and devices to reduce the particle size of a standard PEO-based tablet. Using a Carver press, tablets consisting
of 80 mg acetaminophen and 320 mg high molecular weight PEO (Polyox� WSR coagulant) were made under 2000 pounds of
compression. Tablets were then manipulatedby manual (pill crusher and pestle-mortar) and mechanical (ball mill and high
shear grinder) methods for one minute (n=3). The resultant mass was separated by particle size above and below 500 microns
using sieve analysis. It was found that ball mill and pestle-mortar respectively generated 18.1� 0.7and 16.3�2.0 %of particles
larger than 500 microns, whereas pill crusher and high shear grinder generated about three times as much such particles,
57.5�1.3 and 54.5�0.6%, respectively. Further analysis of particle size showed tablets crushed using a pill crusher or high shear
grinder displayed wide size distributions compared to narrower distributions obtained using a pestle-mortar or ball mill. It was
concluded that the type of tool (manual or mechanical) used to perform crush resistance studies is important to show the level
of resistance to particle size reduction.
Biography
Srinath Muppalaneni earned a BS in Pharmacy from Andhra University and a MS in Pharmaceutical Sciences from Campbell University. He is currently a Doctoral
candidate in Pharmaceutics at Nova Southeastern University (NSU) with dissertation research focusing on abuse-deterrent formulations. He has so far participated
in 6 inventions, 3 publications, 26 presentations, 1 grant, and 2 book chapters. He also won the best poster award at the 2013 OMICS 3rd International Conference
and Exhibition on Pharmaceutics & Novel Drug Delivery Systems.
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