Application of Submicron-sized Binder Particles in Dry Granulation Using a Roller Compactor and Its Evaluation

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  • Kamata Takayuki
    Graduate School of Pharmaceutical Sciences, Kobe Gakuin University Nippon Boehringer Ingelheim Co., Ltd.
  • Wada Koichi
    Nippon Boehringer Ingelheim Co., Ltd.
  • Ichikawa Hideki
    Graduate School of Pharmaceutical Sciences, Kobe Gakuin University

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  • ローラーコンパクターを用いた乾式造粒におけるサブミクロン結合剤粒子の応用とその評価
  • ローラーコンパクター オ モチイタ カンシキゾウリュウ ニ オケル サブミクロン ケツゴウザイ リュウシ ノ オウヨウ ト ソノ ヒョウカ

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<p>The method to improve the properties of dry granules was investigated by introducing pre-coating process with an active pharmaceutical ingredient (API) and a submicron-sized binder prior to conventional roller compaction. Hydroxypropylcellulose (HPC) and acetaminophen (APAP) were used as models of a binder and a low-compactible API, respectively. The submicron-sized HPC (HPC-subMP) was obtained by a lab-scale spray dryer. The APAP particles were pre-coated with 5–10% of the HPC-subMP by a high shear mixer, formed into granules using a lab-scale roller compactor, mixed with other excipients and then compressed to make them tablets containing 50% APAP. The tablets prepared with the HPC-subMP showed a high tensile strength without significant retardation of the disintegration time in comparison to those with a raw HPC particle, indicating that the use of API particles pre-coated with submicron-sized binder particles in roller compaction was effective to prepare granules suitable for tableting without any fundamental changes of materials and manufacturing processes.</p>

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