Preparation of Rapidly Disintegrating Tablets Containing Itraconazole Solid Dispersions

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概要

• 論文の詳細を見る

• The disintegratability of tablets prepared from two types of solid dispersions containing the water-soluble polymer TC-5 and the enteric polymer HP-55 as an excipient were compared. The disintegratability was better in the tablets of solid dispersions containing non-water-soluble HP-55 than those containing TC-5. In consideration of the dissolubility of solid dispersions containing HP-55, the mean diameter of the solid dispersion (coating powder) must be controlled to 120μm or less, but as this markedly increases the adhesion/aggregation tendency of the particles (angle of repose : 47°), control of the adhesion/aggregation tendency emerged as another problem. Therefore, surface-modification was performed in a high-speed agitating granulator using 0.1% light anhydrous silicic acid as a surface modifier, and marked improvement in the flowability was observed. This made continuous tableting using a rotary tablet machine possible even with the poorly flowable solid dispersions. Also, in tableting of the solid dispersions, no recrystallization of amorphous itraconazole by the tableting pressure was observed, and the tablets maintained satisfactory dissolubility. Moreover, it was possible to obtain the rapidly disintegrating tablets with very satisfactory properties, i.e., a tablet hardness of 30N or higher and a disintegration time of 30s or less, by the addition of croscarmellose as a disintegrant at 2% to the surface-modified solid dispersion and selection of the tableting pressure at 4.5kN.

• 社団法人日本薬学会の論文
• 2007-11-01

著者

• Sonoda Ryoichi

  Drug Formulation Dep. Central Res. Laboratories Kaken Pharmaceutical Co. Ltd.

• OSHIMA Takao

  Drug Formulation Department, Central Research Laboratories, Kaken Pharmaceutical Co., Ltd.

• OHKUMA Moriyuki

  Drug Formulation Department, Central Research Laboratories, Kaken Pharmaceutical Co., Ltd.

• SUNADA Hisakazu

  Faculty of Pharmacy, Meijo University

• Oshima Takao

  Drug Formulation Dep. Central Res. Laboratories Kaken Pharmaceutical Co. Ltd.

• Ohkuma Moriyuki

  Drug Formulation Department Central Research Laboratories Kaken Pharmaceutical Co. Ltd.

• Sunada Hisakazu

  Faculty Of Pharmacy Meijo University

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