Directly Compressible Acetaminophen Compositions Prepared by Fluidized-Bed Granulation |
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Authors: | Cheng-Hsiung Lid Shou-Chiung Chen Yung-Chi Lee Theodore D Sokoloski Ming-Thau Sheu |
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Affiliation: |
a Graduate Institute of Pharmaceutical Sciences, Taipei Medical College, Taipei, Taiwan, ROC
b Pharmaceutical Sciences, King of Prussia, PA, USA |
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Abstract: | Polyvinylpyrrolidone (PVP) in aqueous solution was used as a binding agent in a fluidized-bed system to agglomerate acetaminophen powder into directly compressible granules. It was found that a minimal amount of 5% w/w PVP in a concentration of 7.5% w/v or less was needed to produce granules with an acceptable flow and the corresponding tablets having enough hardness without capping. There was a strong correlation between the time for 80% dissolved (T80) and the logarithm of granule volume-surface mean diameter. A directly compressible acetaminophen composition to manufacture tablets having a T80 value less than 30 min can be prepared simply by adding an appropriate amount of disintegrant (crospovidone, sodium starch glycolate, or pregelatinized starch) to the agglomerated granules. |
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