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Effect of Molecular Weight of Polyethylene Glycol Binders on Acetaminophen Tablets

Low-shear wet granulation

Hamid Rezaei*) and Adel Sakr

Industrial Pharmacy Graduate Program, University of Cincinnati Medical Center, Cincinnati, Ohio (USA)

*)Present address: AstraZeneca Pharmaceuticals LP, Wilmington, Delaware (USA)

The purpose of this study was to investigate the binding properties of polyethylene glycols (PEGs) using PEG-3350, MPEG-5000, PEG-8000, and PEG-20M in comparison to polyvinylpyrrolidone (povidone). Using a full factorial design, three binder levels and three compression forces, tablets were compressed on a rotary tablet press. ANOVA was used to analyze the results (p 0.05). Granule size distribution, bulk/tapped density, and angle of repose were determined to characterize flow and compressibility of granules. As binder levels increased, so did granule sizes, PEG-20M batches had the most uniform granules, with the highest flow rates. Tablet crushing strength increased for povidone, and PEG-20M batches with increasing binder levels from 5 % to 10 %, but not from 10 % t o 15 %. Using 5 % binders, only povidone and PEG-20M passed friability testing, while under the high compression forces, 10 % and 15 % PEG-3350, and PEG-8000 failed. Among batches using PEG binders, PEG-20M had the lowest friability. 10 % PEG-20M resulted in the highest, and povidone the second highest dissolution rate. Under conditions studied, PEG-20M was not only an effective binder compared to the reference binder, but also enhanced the drug dissolution rate by its channeling action.