乾式造粒法を用いた口腔内速崩壊錠の調製と評価―粉末セルロースの賦形剤としての利用―

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タイトル別名
  • Preparation and Evaluation of Rapidly Disintegrating Tablets in the Oral Cavity by the Dry Compression Method―Availability of Powdered Cellulose as an Excipient―

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<p>A rapidly disintegrating tablet is known to be a form that can be swallowed easily because it is deformed by sputum in the human oral cavity. In this study, the tablet was prepared by the dry granulation and compression method using powdered cellulose (PC) as the main excipient. Powdered cellulose is expected to be good for not only compressibility but also disintegration due to its swelling property. It also has the advantage of lower cost compared with other excipients such as microcrystalline cellulose. Batches containing some model drugs, PC, lactose (Lac) and L-HPC as excipients were compacted to flakes by a Roller Compactor, then the flakes were crushed and sieved to granules. The granules were mixed with sucrose fatty acid esters (SE) as a lubricant and AEROSIL (AERO) as a fluidized ingredient then compressed to tablets by a rotary tableting machine. The tablets were evaluated mainly by tensile strength and disintegration time. Consequently, the rapidly disintegrating tablets containing PC were successfully prepared by the dry granulation and compression method. Fluidity of the granules and tensile strength of the tablets were improved by using 0.1% AERO. As the amounts of SE were increased, the tensile strength became lower and the disintegration time became longer, but from the pressure transmission ratio, the optimal amounts were 1-2%. PC had very good compressibility and disintegrated more rapidly after blending with L-HPC than using L-HPC alone. Although the evaluations on sensory test worsened as the amounts of PC increased, it was improved by using saccharides such as Lac. Optimal proportions of PC, Lac and L-HPC could be determined by Artificial Neural Network.</p>

収録刊行物

  • 薬剤学

    薬剤学 66 (6), 473-481, 2006

    公益社団法人 日本薬剤学会

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