PROBLEM TO BE SOLVED: To provide a composition comprising physically modified, partially pregelatinized starch, which is useful as a multi-functional excipient for solid dosage forms, a method for making such composition, and solid dosage forms prepared using the composition.SOLUTION: Such composition is characterized by a predominance of particles having both birefringent and non-birefringent portions, a sedimentation volume of between 1.5 and 9 ml/g, and a cold water solubility of between 1 and 8 %. This free-flowing starch may have an average particle size greater than 30 &mum, and a moisture content of between 5 and 12 %wt. The placebo tablet prepared from such composition at 13 kN using a manual tablet press equipped with a 1.11 cm (7/16") standard concave punches has a crushing strength of at least 160 Newtons, and a disintegration time of no more than 10 minutes.COPYRIGHT: (C)2006,JPO&NCIPI【課題】優れた圧縮プロフィール、良好な崩壊及び溶解特性、並びに優れた流動性を呈する多機能性の澱粉賦形剤の提供。【解決手段】 大部分の粒子が複屈折性部分と非複屈折性部分の両方を有し、また1.5~9ml/gの沈降体積、並びに1~8%の冷水溶解度を有するさらさらした流動性を有し、30μmより大きい平均粒子サイズ、及び5~12重量%の含水率を有する多機能性の澱粉賦形剤、並びに1.11cmの標準凹型パンチを備えた手動式錠剤成形機を用いて、13kNの圧縮力で、前記組成物から、少なくとも160Nの破砕強度、及び10分以下の崩壊時間を有するプラシーボ錠剤を製造する方法に関する。【選択図】 図2
